Lustral 50 mg инструкция на русском

Lustral®50mg Tablets

Ref:0973/090517/1/F

(sertraline hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Lustral 50mg Tablets but will be referred to as Lustral
throughout this Patient Information Leaflet. Please note that the leaflet also
contains information about other strengths of the medicine, Lustral 100mg.
what is in this leaflet:
1 What Lustral is and what it is used for
2 What you need to know before you take Lustral
3 How to take Lustral
4 Possible side effects
5 How to store Lustral
6 Contents of the pack and other information

1

What Lustral is and what it is used for

Lustral contains the active substance sertraline. Sertraline is one of a group
of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs); these
medicines are used to treat depression and/or anxiety disorders.
Lustral can be used to treat:
* Depression and prevention of recurrence of depression (in adults).
* Social anxiety disorder (in adults).
* Post traumatic stress disorder (PTSD) (in adults).
* Panic disorder (in adults).
* Obsessive compulsive disorder (OCD) (in adults and children and
adolescents aged 6-17 years old).
Depression is a clinical illness with symptoms like feeling sad, unable to
sleep properly or to enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety with symptoms like
being constantly troubled by persistent ideas (obsessions) that make you
carry out repetitive rituals (compulsions).
PTSD is a condition that can occur after a very emotionally traumatic
experience, and has some symptoms that are similar to depression and
anxiety. Social anxiety disorder (social phobia) is an illness linked to anxiety.
It is characterised by feelings of intense anxiety or distress in social
situations (for example: talking to strangers, speaking in front of groups of
people, eating or drinking in front of others or worrying that you might
behave in an embarrassing manner).
Your doctor has decided that this medicine is suitable for treating your
illness.
You should ask your doctor if you are unsure why you have been given
Lustral.

2

What you need to know before you take Lustral

Do not take Lustral:
* If you are allergic to sertraline or any of the other ingredients of this
medicine (listed in section 6).
* If you are taking or have taken medicines called monoamine oxidase
inhibitors (MAOIs such as selegiline, moclobemide) or MAOI like drugs
(such as linezolid). If you stop treatment with sertraline, you must wait
until at least one week before you start treatment with a MAOI. After
stopping treatment with a MAOI, you must wait at least 2 weeks before
you can start treatment with sertraline.
* If you are taking another medicine called pimozide (a medicine for mental
disorders such as psychosis).
Warnings and precautions
Talk to your doctor or pharmacist before taking Lustral.
Medicines are not always suitable for everyone. Tell your doctor before you
take Lustral, if you suffer from or have suffered in the past from any of the
following conditions:
* If you have epilepsy (fit) or a history of seizures. If you have a fit
(seizure), contact your doctor immediately.
* If you have suffered from manic depressive illness (bipolar disorder) or
schizophrenia. If you have a manic episode, contact your doctor
immediately.
* If you have or have previously had thoughts of harming or killing yourself
(see below-Thoughts of suicide and worsening of your depression or
anxiety disorder).
* If you have Serotonin Syndrome. In rare cases this syndrome may occur
when you are taking certain medicines at the same time as sertraline.
(For symptoms, see section 4. Possible Side Effects). Your doctor will
have told you whether you have suffered from this in the past.
* If you have low sodium level in your blood, since this can occur as a
result of treatment with Lustral. You should also tell your doctor if you are
taking certain medicines for hypertension, since these medicines may
also alter the sodium level in your blood.
* If you are elderly as you may be more at risk of having low sodium level
in your blood (see above).
* If you have liver disease; your doctor may decide that you should have a
lower dose of Lustral.
* If you have diabetes; your blood glucose levels may be altered due to
Lustral and your diabetes medicines may need to be adjusted.
* If you have suffered from bleeding disorders or have been taking
medicines which thin the blood (e.g. acetylsalicyclic acid (aspirin), or
warfarin) or may increase the risk of bleeding.
* If you are a child or adolescent under 18 years old. Lustral should only
be used to treat children and adolescents aged 6-17 years old, suffering
from obsessive compulsive disorder (OCD). If you are being treated for
this disorder, your doctor will want to monitor you closely (see belowChildren and adolescents).
* If you are having electro-convulsive therapy (ECT).
* If you have eye problems, such as certain kinds of glaucoma (increased
pressure in the eye).
* If you have been told that you have an abnormality of your heart tracing
after an electrocardiogram (ECG) known as prolonged QT interval.
Restlessness/Akathisia:
The use of sertraline has been linked to a distressing restlessness and need
to move, often being unable to sit or stand still (akathisia). This is most likely
to occur during the first few weeks of treatment. Increasing the dose may be
harmful so if you develop such symptoms you should talk to your doctor.
Withdrawal reactions:
Side effects relating to stopping treatment (withdrawal reactions) are
common, particularly if the treatment is stopped suddenly (see section
3 If you stop taking Lustral and section 4 Possible side effects). The risk of
withdrawal symptoms depends on the length of treatment, dosage, and the
rate at which the dose is reduced. Generally, such symptoms are mild to
moderate. However, they can be serious in some patients. They normally
occur within the first few days after stopping treatment. In general, such
symptoms disappear on their own and wear off within 2 weeks. In some
patients they may last longer (2-3 months or more). When stopping
treatment with sertraline it is recommended to reduce the dose gradually
over a period of several weeks or months, and you should always discuss
the best way of stopping treatment with your doctor.

Thoughts of suicide and worsening of your depression or anxiety
disorder:
If you are depressed and/or have anxiety disorders you can sometimes have
thoughts of harming or killing yourself. These may be increased when first
starting antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years
with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed
or have an anxiety disorder, and ask them to read this leaflet. You might ask
them to tell you if they think your depression or anxiety is getting worse, or if
they are worried about changes in your behaviour.
Children and adolescents:
Sertraline should not usually be used in children and adolescents less than
18 years old, except for patients with Obsessive Compulsive Disorder
(OCD). Patients under 18 have an increased risk of undesirable effects,
such as suicide attempt, thoughts of harming or killing themselves (suicidal
thoughts) and hostility (mainly aggressiveness, oppositional behaviour and
anger) when they are treated with this class of medicines. Nevertheless, it is
possible that your doctor decides to prescribe Lustral to a patient under 18 if
it is in the patient’s interest. If your doctor has prescribed Lustral to you and
you are less than 18 years old and you want to discuss this, please contact
him/her. Furthermore, if any of the symptoms listed above appear or worsen
while you are taking Lustral, you should inform your doctor. Also, the longterm safety of Lustral in regard to growth, maturation and learning (cognitive)
and behavioural development in this age group has not yet been
demonstrated.
Other medicines and Lustral:
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines can affect the way Lustral works, or Lustral itself can
reduce the effectiveness of other medicines taken at the same time.
Taking Lustral together with the following medicines may cause serious side
effects:
* Medicines called monoamine oxidase inhibitors (MAOIs), like moclobemide
(to treat depression) and selegiline (to treat Parkinson’s disease), the
antibiotic linezolid and methylene blue (to treat high levels of
methaemoglobin in the blood). Do not use Lustral together with these
medicines.
* Medicines to treat mental disorders such as psychosis (pimozide). Do not
use Lustral together with pimozide.
Talk to your doctor if you are taking the following medicines:
* Herbal medicine containing St. John’s Wort (Hypericum perforatum). The
effects of St. John’s Wort may last for 1-2 weeks.
* Products containing the amino acid tryptophan.
* Medicines to treat severe pain (e.g. tramadol).
* Medicines used in anaesthesia or to treat chronic pain (e.g. fentanyl,
mivacurium and suxamethonium).
* Medicines to treat migraines (e.g. sumatriptan).
* Blood thinning medicine (warfarin).
* Medicines to treat pain/arthritis (Non steroidal anti-inflammatory drug
(NSAID) such as ibuprofen, acetylsalicylic acid (aspirin)).
* Sedatives (diazepam).
* Diuretics (also called ‘water’ tablets).
* Medicines to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
* Medicines to treat diabetes (tolbutamide).
* Medicines to treat excessive stomach acid, ulcers and heartburn
(cimetidine, omeprazole, lanzoprazole, pantoprazole, rabeprazole).
* Medicines to treat mania and depression (lithium).
* Other medicines to treat depression (such as amitriptyline, nortriptyline,
nefazodone, fluoxetine, fluvoxamine).
* Medicines to treat schizophrenia and other mental disorders (such as
perphenazine, levomepromazine and olanzapine).
* Medicines used to treat high blood pressure, chest pain or regulate the
rate and rhythm of the heart (such as verapamil, diltiazem, flecainide,
propafenone).
* Medicines used to treat bacterial infections (such as rifampicin,
clarithromycin, telithromycin, erythromycin).
* Medicines used to treat fungal infections (such as ketoconazole,
itraconazole, posaconazole, voriconazole, fluconazole).
* Medicines used to treat HIV/AIDS and Hepatitis C (protease inhibitors
such as ritonavir, telaprevir).
* Medicines used to prevent nausea and vomiting after an operation or
chemotherapy (aprepitant).
* Medicines known to increase the risk of changes in the electrical activity
of the heart (e.g. some antipsychotics and antibiotics).
Lustral with food, drink and alcohol:
Lustral tablets can be taken with or without food.
Alcohol should be avoided whilst taking Lustral.
Sertraline should not be taken in combination with grapefruit juice, as this
may increase the level of sertraline in your body.
Pregnancy, breast-feeding and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
The safety of sertraline has not fully been established in pregnant women.
Sertraline will only be given to you when pregnant if your doctor considers
that the benefit for you is greater than any possible risk to the developing
baby.
Make sure your midwife and/or doctor know you are on Lustral. When taken
during pregnancy, particularly in the last 3 months of pregnancy, medicines
like Lustral may increase the risk of a serious condition in babies, called
persistent pulmonary hypertension of the newborn (PPHN), making the baby
breathe faster and appear bluish. These symptoms usually begin during the
first 24 hours after the baby is born. If this happens to your baby you should
contact your midwife and/or doctor immediately.
Your newborn baby might also have other conditions, which usually begin
during the first 24 hours after birth. Symptoms include:
* trouble with breathing,
* a blueish skin or being too hot or cold,
* blue lips,
* vomiting or not feeding properly,
* being very tired, not able to sleep or crying a lot,
* stiff or floppy muscles,
* tremors, jitters or fits,
* increased reflex reactions,
* irritability,
* low blood sugar.
If your baby has any of these symptoms when it is born, or you are
concerned about your baby’s health, contact your doctor or midwife who will
be able to advise you.
There is evidence that sertraline passes into human breast milk. Sertraline
should only be used in women during breast-feeding, if your doctor
considers that the benefit exceeds any possible risk to the baby.
Some medicines like sertraline may reduce the quality of sperm in animal
studies. Theoretically, this could affect fertility, but impact on human fertility
has not been observed as yet.
Driving and using machines:
Psychotropic drugs such as sertraline may influence your ability to drive or
use machines. You should therefore not drive or operate machinery, until you
know how this medication affects your ability to perform these activities.

®

Ref:0973/090517/1/B

Lustral 50mg Tablets
(sertraline hydrochloride)
3

How to take Lustral

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults:
Depression and Obssessive Compulsive Disorder
For depression and OCD, the usual effective dose is 50 mg/day. The daily
dose may be increased in 50 mg increments and at intervals of at least
one week over a period of weeks. The maximum recommended dose is
200 mg/day.
Panic disorder, Social anxiety disorder and Post Traumatic Stress
Disorder:
For panic disorder, social anxiety disorder and post traumatic stress
disorder, treatment should be started at 25 mg/day, and increased to
50 mg/day after one week.
The daily dose then may be increased in 50 mg increments over a period
of weeks. The maximum recommended dose is 200 mg/day.
Use in children and adolescents:
Lustral must only be used to treat children and adolescents suffering from
OCD aged 6-17 years old.
Obsessive Compulsive Disorder:
Children aged 6 to 12: the recommended starting dose is 25 mg daily.
After one week, your doctor may increase this to 50 mg daily. The
maximum dose is 200 mg daily.
Adolescents aged 13 to 17: the recommended starting dose is
50 mg daily.
The maximum dose is 200 mg daily.
If you have liver or kidney problems, please tell your doctor and follow the
doctor’s instructions.
Method of administration:
Lustral tablets may be taken with or without food.
Take your medication once daily either in the morning or evening.
Your doctor will advise you on how long to take this medication for. This
will depend on the nature of your illness and how well you are responding
to the treatment. It may take several weeks before your symptoms begin to
improve. Treatment of depression should usually continue for 6 months after
improvement.
If you take more Lustral than you should:
If you accidentally take too much Lustral contact your doctor at once or go to
the nearest hospital casualty department. Always take the labelled medicine
package with you, whether there is any medication left or not.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid
heart rate, shaking, agitation, dizziness and in rare cases unconsciousness.
If you forget to take Lustral:
Do not take a double dose to make up for a forgotten dose. If you forget to
take a dose, do not take the missed dose. Just take the next dose at the
right time.
If you stop taking Lustral:
Do not stop taking Lustral unless your doctor tells you to. Your doctor will
want to gradually reduce your dose of Lustral over several weeks, before
you finally stop taking this medicine. If you suddenly stop taking this
medicine you may experience side effects such as dizziness, numbness,
sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick
and shaking. If you experience any of these side effects, or any other side
effects whilst stopping taking Lustral, please speak to your doctor.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Nausea is the most common side effect. The side effects depend on the
dose and often disappear or lessen with continued treatment.
Tell your doctor immediately:
If you experience any of the following symptoms after taking this medicine,
these symptoms can be serious.
you develop a severe skin rash that causes blistering (erythema
* Ifmultiforme),
(this can affect the mouth and tongue). These may be signs of
a condition known as Stevens Johnson Syndrome, or Toxic Epidermal
Necrolysis (TEN). Your doctor will stop your treatment in these cases.
Allergic reaction or allergy, which may include symptoms such as an itchy
* skin
rash, breathing problems, wheezing, swollen eyelids, face or lips.
you experience agitation, confusion, diarrhoea, high temperature and
* Ifblood
pressure, excessive sweating and rapid heartbeat. These are
symptoms of Serotonin Syndrome. In rare cases this syndrome may occur
when you are taking certain medicines at the same time as sertraline. Your
doctor may wish to stop your treatment.
develop yellow skin and eyes which may mean liver damage.
* IfIf you
you experience depressive symptoms with ideas of harming or killing
* yourself
(suicidal thoughts).
start to get feelings of restlessness and are not able to sit or stand
* Ifstillyouafter
you start to take Lustral. You should tell your doctor if you start
to feel restless.
have a fit (seizure).
* IfIf you
* you have a manic episode (see section 2 “Warnings and precautions”).
The following side effects were seen in clinical trials in adults.
Very common (may affect more than 1 in 10 people):
Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry
mouth, ejaculation failure, fatigue.
Common (may affect up to 1 in 10 people):
throat, anorexia, increased appetite,
* Sore
feeling strange, nightmare, anxiety, agitation, nervousness,
* depression,
decreased sexual interest, teeth grinding,
and tingling, shaking, muscle tense, abnormal taste, lack of
* numbness
attention,
disturbance, ringing in ears,
* visual
hot flush, yawning,
* palpitations,
pain, vomiting, constipation, upset stomach, gas,
* abdominal
increased sweating, muscle pain, erectile dysfunction, chest pain
* rash,
pain,
* joint
* malaise.
Uncommon (may affect up to 1 in 100 people):
cold, runny nose,
* Chest
* hypersensitivity,
thyroid hormones,
* low
feeling too happy, lack of caring, thinking abnormal,
* hallucination,
aggression,
involuntary muscle contractions, abnormal coordination,
* convulsion,
moving a lot, amnesia, decreased feeling, speech disorder, dizziness
while standing up, passing out, migraine,
pupils,
* enlarged
pain, fast heartbeat, high blood pressure, flushing,
* ear
difficulty, possible wheezing, shortness of breath, nose bleed,
* breathing
of the oesophagus, difficulty swallowing, haemorrhoids,
* inflammation
increased saliva, tongue disorder, burping,
swelling, purple spots on skin, face oedema, hair loss, cold sweat, dry
* eye
skin, hives, itching,
muscular weakness, back pain, muscle twitching,
* osteoarthritis,
urination, unable to urinate, increase in urination, increase in
* nighttime
frequency of urination, problem urinating, urinary incontinence,

haemorrhage, sexual dysfunction, female sexual dysfunction,
* vaginal
menstrual irregularities, swelling in legs, chills, fever, weakness, thirst,
increase in liver enzyme levels, weight decreased, weight increased.
Rare (may affect up to 1 in 1,000 people):
problem, ear infection, cancer, swollen glands, high cholesterol,
* Intestine
low blood sugar,
symptoms due to stress or emotions, drug dependence, psychotic
* physical
disorder, paranoia, suicidal thoughts, sleep walking, premature ejaculation,
allergic reaction,
* severe
abnormal movements, difficulty moving, increased sensation,
* coma,
sensory disturbance,
tear problem, spots in front of eyes, double vision, light
* glaucoma,
hurts eye, blood in the eye,
problems controlling blood sugar levels (diabetes),
* heart
attack, slow heart beat, heart problem, poor circulation of arms and
* legs, closing
up of throat, breathing fast, breathing slow, difficulty talking,
hiccups,
in stool, sore mouth, tongue ulceration, tooth disorder, tongue
* blood
problem, mouth ulceration, problems with liver function,
problem with blisters, hair rash, hair texture abnormal, skin odour
* skin
abnormal, bone disorder,
urination, urinary hesitation, blood in urine,
* decreased
vaginal bleeding, dry vaginal area, red painful penis and
* excessive
foreskin, genital discharge, prolonged erection, breast discharge,
hernia,
tolerance decreased, difficulty walking, semen abnormal,
* increasedrug
in blood cholesterol levels, injury, relaxation of blood vessels
procedure,
of suicidal ideation and suicidal behaviours have been
* Cases
reported during sertraline therapy or early after treatment
discontinuation (see section 2).
After marketing sertraline, the following side effects have been
reported:
in white blood cells, decrease in clotting cells, endocrine
* Decrease
problem, low blood salt, increase in blood sugar levels,
abnormal dreams, suicidal behaviour,
* terrifying
muscular
movement problems (such as moving a lot, tense muscles,
* difficulty walking
and stiffness, spasms and involuntary movements of
muscles), sudden severe headache (which may be a sign of a serious
condition known as Reversible Cerebral Vasoconstriction Syndrome
(RCVS)),
abnormal, unequal sized pupils, bleeding problems (such as
* vision
stomach bleeding), progressive scarring of lung tissue (Interstitial Lung
Disease), pancreatitis, serious liver function problems, yellow skin and
eyes (jaundice),
oedema, skin reaction to sun, muscle cramps, breast enlargement,
* skin
problems with clotting, abnormal laboratory tests, bedwetting.
fainting, or chest discomfort which could be signs
* Light-headedness,
of changes in the electrical activity (seen on electrocardiogram) or
abnormal rhythm of the heart.
Additional side effects in children and adolescents
In clinical trials with children and adolescents, the side effects were generally
similar to adults (see above). The most common side effects in children and
adolescents were headache, insomnia, diarrhoea and feeling sick.
Symptoms that can occur when treatment is discontinued
If you suddenly stop taking this medicine you may experience side effects
such as dizziness, numbness, sleep disturbances, agitation or anxiety,
headaches, feeling sick, being sick and shaking (see section 3. “If you stop
taking Lustral”).
An increased risk of bone fractures has been observed in patients taking this
type of medicines.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard
5

How to store Lustral

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip. If your doctor tells you to stop taking this medicine, return any
unused tablets to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to. If your tablets become discoloured or show
any other signs of deterioration, consult your pharmacist who will tell you
what to do.
Storing your medicine
OUT OF THE SIGHT AND REACH OF CHILDERN
* KEEP
not take your tablets out of the blister strip until it is time to take your
* Do
dose.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Contents of the pack and other information

What Lustral contains
Each tablet contains sertraline hydrochloride equivalent to 50mg sertraline
as the active ingredient.
Other ingredients: calcium hydrogen phosphate, microcrystalline cellulose,
hydroxypropylcellulose, sodium starch glycollate, magnesium stearate,
titanium dioxide (E171), macrogol 400, macrogol 6000, polysorbate-80,
hypromellose E3, hypromellose E5.
What Lustral looks like and contents of the pack
Lustral are white, capsular shaped film-coated scored tablets coded with
‘ZLT-50’ on one side and ‘PFIZER’ on the other side.
Each blister pack contains 15 tablets and comes in boxes of 30 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Haupt Pharma Latina S.r.l : S.S. 156, Km
47, 600, Borgo San Michele, 04100 Latina, Italy and are procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0973

Lustral is a registered trademark of Pfizer Products Inc.
Revision date: 09/05/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

Tatig®50mg Tablets

Ref:0973/090517/2/F

(sertraline hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Tatig 50mg Tablets but will be referred to as Tatig
throughout this Patient Information Leaflet. Please note that the leaflet also
contains information about other strengths of the medicine, Tatig 100mg.
what is in this leaflet:
1 What Tatig is and what it is used for
2 What you need to know before you take Tatig
3 How to take Tatig
4 Possible side effects
5 How to store Tatig
6 Contents of the pack and other information

1

What Tatig is and what it is used for

Tatig contains the active substance sertraline. Sertraline is one of a group
of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs); these
medicines are used to treat depression and/or anxiety disorders.
Tatig can be used to treat:
* Depression and prevention of recurrence of depression (in adults).
* Social anxiety disorder (in adults).
* Post traumatic stress disorder (PTSD) (in adults).
* Panic disorder (in adults).
* Obsessive compulsive disorder (OCD) (in adults and children and
adolescents aged 6-17 years old).
Depression is a clinical illness with symptoms like feeling sad, unable to
sleep properly or to enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety with symptoms like
being constantly troubled by persistent ideas (obsessions) that make you
carry out repetitive rituals (compulsions).
PTSD is a condition that can occur after a very emotionally traumatic
experience, and has some symptoms that are similar to depression and
anxiety. Social anxiety disorder (social phobia) is an illness linked to anxiety.
It is characterised by feelings of intense anxiety or distress in social
situations (for example: talking to strangers, speaking in front of groups of
people, eating or drinking in front of others or worrying that you might
behave in an embarrassing manner).
Your doctor has decided that this medicine is suitable for treating your
illness.
You should ask your doctor if you are unsure why you have been given
Tatig.

2

What you need to know before you take Tatig

Do not take Tatig:
* If you are allergic to sertraline or any of the other ingredients of this
medicine (listed in section 6).
* If you are taking or have taken medicines called monoamine oxidase
inhibitors (MAOIs such as selegiline, moclobemide) or MAOI like drugs
(such as linezolid). If you stop treatment with sertraline, you must wait
until at least one week before you start treatment with a MAOI. After
stopping treatment with a MAOI, you must wait at least 2 weeks before
you can start treatment with sertraline.
* If you are taking another medicine called pimozide (a medicine for mental
disorders such as psychosis).
Warnings and precautions
Talk to your doctor or pharmacist before taking Tatig.
Medicines are not always suitable for everyone. Tell your doctor before you
take Tatig, if you suffer from or have suffered in the past from any of the
following conditions:
* If you have epilepsy (fit) or a history of seizures. If you have a fit
(seizure), contact your doctor immediately.
* If you have suffered from manic depressive illness (bipolar disorder) or
schizophrenia. If you have a manic episode, contact your doctor
immediately.
* If you have or have previously had thoughts of harming or killing yourself
(see below-Thoughts of suicide and worsening of your depression or
anxiety disorder).
* If you have Serotonin Syndrome. In rare cases this syndrome may occur
when you are taking certain medicines at the same time as sertraline.
(For symptoms, see section 4. Possible Side Effects). Your doctor will
have told you whether you have suffered from this in the past.
* If you have low sodium level in your blood, since this can occur as a
result of treatment with Tatig. You should also tell your doctor if you are
taking certain medicines for hypertension, since these medicines may
also alter the sodium level in your blood.
* If you are elderly as you may be more at risk of having low sodium level
in your blood (see above).
* If you have liver disease; your doctor may decide that you should have a
lower dose of Tatig.
* If you have diabetes; your blood glucose levels may be altered due to
Tatig and your diabetes medicines may need to be adjusted.
* If you have suffered from bleeding disorders or have been taking
medicines which thin the blood (e.g. acetylsalicyclic acid (aspirin), or
warfarin) or may increase the risk of bleeding.
* If you are a child or adolescent under 18 years old. Tatig should only
be used to treat children and adolescents aged 6-17 years old, suffering
from obsessive compulsive disorder (OCD). If you are being treated for
this disorder, your doctor will want to monitor you closely (see belowChildren and adolescents).
* If you are having electro-convulsive therapy (ECT).
* If you have eye problems, such as certain kinds of glaucoma (increased
pressure in the eye).
* If you have been told that you have an abnormality of your heart tracing
after an electrocardiogram (ECG) known as prolonged QT interval.
Restlessness/Akathisia:
The use of sertraline has been linked to a distressing restlessness and need
to move, often being unable to sit or stand still (akathisia). This is most likely
to occur during the first few weeks of treatment. Increasing the dose may be
harmful so if you develop such symptoms you should talk to your doctor.
Withdrawal reactions:
Side effects relating to stopping treatment (withdrawal reactions) are
common, particularly if the treatment is stopped suddenly (see section
3 If you stop taking Tatig and section 4 Possible side effects). The risk of
withdrawal symptoms depends on the length of treatment, dosage, and the
rate at which the dose is reduced. Generally, such symptoms are mild to
moderate. However, they can be serious in some patients. They normally
occur within the first few days after stopping treatment. In general, such
symptoms disappear on their own and wear off within 2 weeks. In some
patients they may last longer (2-3 months or more). When stopping
treatment with sertraline it is recommended to reduce the dose gradually
over a period of several weeks or months, and you should always discuss
the best way of stopping treatment with your doctor.

Thoughts of suicide and worsening of your depression or anxiety
disorder:
If you are depressed and/or have anxiety disorders you can sometimes have
thoughts of harming or killing yourself. These may be increased when first
starting antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years
with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed
or have an anxiety disorder, and ask them to read this leaflet. You might ask
them to tell you if they think your depression or anxiety is getting worse, or if
they are worried about changes in your behaviour.
Children and adolescents:
Sertraline should not usually be used in children and adolescents less than
18 years old, except for patients with Obsessive Compulsive Disorder
(OCD). Patients under 18 have an increased risk of undesirable effects,
such as suicide attempt, thoughts of harming or killing themselves (suicidal
thoughts) and hostility (mainly aggressiveness, oppositional behaviour and
anger) when they are treated with this class of medicines. Nevertheless, it is
possible that your doctor decides to prescribe Tatig to a patient under 18 if it
is in the patient’s interest. If your doctor has prescribed Tatig to you and you
are less than 18 years old and you want to discuss this, please contact
him/her. Furthermore, if any of the symptoms listed above appear or worsen
while you are taking Tatig, you should inform your doctor. Also, the long-term
safety of Tatig in regard to growth, maturation and learning (cognitive) and
behavioural development in this age group has not yet been
demonstrated.
Other medicines and Tatig:
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines can affect the way Tatig works, or Tatig itself can
reduce the effectiveness of other medicines taken at the same time.
Taking Tatig together with the following medicines may cause serious side
effects:
* Medicines called monoamine oxidase inhibitors (MAOIs), like moclobemide
(to treat depression) and selegiline (to treat Parkinson’s disease), the
antibiotic linezolid and methylene blue (to treat high levels of
methaemoglobin in the blood). Do not use Tatig together with these
medicines.
* Medicines to treat mental disorders such as psychosis (pimozide). Do not
use Tatig together with pimozide.
Talk to your doctor if you are taking the following medicines:
* Herbal medicine containing St. John’s Wort (Hypericum perforatum). The
effects of St. John’s Wort may last for 1-2 weeks.
* Products containing the amino acid tryptophan.
* Medicines to treat severe pain (e.g. tramadol).
* Medicines used in anaesthesia or to treat chronic pain (e.g. fentanyl,
mivacurium and suxamethonium).
* Medicines to treat migraines (e.g. sumatriptan).
* Blood thinning medicine (warfarin).
* Medicines to treat pain/arthritis (Non steroidal anti-inflammatory drug
(NSAID) such as ibuprofen, acetylsalicylic acid (aspirin)).
* Sedatives (diazepam).
* Diuretics (also called ‘water’ tablets).
* Medicines to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
* Medicines to treat diabetes (tolbutamide).
* Medicines to treat excessive stomach acid, ulcers and heartburn
(cimetidine, omeprazole, lanzoprazole, pantoprazole, rabeprazole).
* Medicines to treat mania and depression (lithium).
* Other medicines to treat depression (such as amitriptyline, nortriptyline,
nefazodone, fluoxetine, fluvoxamine).
Medicines
to treat schizophrenia and other mental disorders (such as
*
perphenazine, levomepromazine and olanzapine).
* Medicines used to treat high blood pressure, chest pain or regulate the
rate and rhythm of the heart (such as verapamil, diltiazem, flecainide,
propafenone).
* Medicines used to treat bacterial infections (such as rifampicin,
clarithromycin, telithromycin, erythromycin).
* Medicines used to treat fungal infections (such as ketoconazole,
itraconazole, posaconazole, voriconazole, fluconazole).
* Medicines used to treat HIV/AIDS and Hepatitis C (protease inhibitors
such as ritonavir, telaprevir).
* Medicines used to prevent nausea and vomiting after an operation or
chemotherapy (aprepitant).
* Medicines known to increase the risk of changes in the electrical activity
of the heart (e.g. some antipsychotics and antibiotics).
Tatig with food, drink and alcohol:
Tatig tablets can be taken with or without food.
Alcohol should be avoided whilst taking Tatig.
Sertraline should not be taken in combination with grapefruit juice, as this
may increase the level of sertraline in your body.
Pregnancy, breast-feeding and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
The safety of sertraline has not fully been established in pregnant women.
Sertraline will only be given to you when pregnant if your doctor considers
that the benefit for you is greater than any possible risk to the developing
baby.
Make sure your midwife and/or doctor know you are on Tatig. When taken
during pregnancy, particularly in the last 3 months of pregnancy, medicines
like Tatig may increase the risk of a serious condition in babies, called
persistent pulmonary hypertension of the newborn (PPHN), making the baby
breathe faster and appear bluish. These symptoms usually begin during the
first 24 hours after the baby is born. If this happens to your baby you should
contact your midwife and/or doctor immediately.
Your newborn baby might also have other conditions, which usually begin
during the first 24 hours after birth. Symptoms include:
* trouble with breathing,
* a blueish skin or being too hot or cold,
* blue lips,
* vomiting or not feeding properly,
* being very tired, not able to sleep or crying a lot,
* stiff or floppy muscles,
* tremors, jitters or fits,
* increased reflex reactions,
* irritability,
* low blood sugar.
If your baby has any of these symptoms when it is born, or you are
concerned about your baby’s health, contact your doctor or midwife who will
be able to advise you.
There is evidence that sertraline passes into human breast milk. Sertraline
should only be used in women during breast-feeding, if your doctor
considers that the benefit exceeds any possible risk to the baby.
Some medicines like sertraline may reduce the quality of sperm in animal
studies. Theoretically, this could affect fertility, but impact on human fertility
has not been observed as yet.
Driving and using machines:
Psychotropic drugs such as sertraline may influence your ability to drive or
use machines. You should therefore not drive or operate machinery, until you
know how this medication affects your ability to perform these activities.

Ref:0973/090517/2/B

Tatig®50mg Tablets
(sertraline hydrochloride)
3

How to take Tatig

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults:
Depression and Obssessive Compulsive Disorder
For depression and OCD, the usual effective dose is 50 mg/day. The daily
dose may be increased in 50 mg increments and at intervals of at least
one week over a period of weeks. The maximum recommended dose is
200 mg/day.
Panic disorder, Social anxiety disorder and Post Traumatic Stress
Disorder:
For panic disorder, social anxiety disorder and post traumatic stress
disorder, treatment should be started at 25 mg/day, and increased to
50 mg/day after one week.
The daily dose then may be increased in 50 mg increments over a period
of weeks. The maximum recommended dose is 200 mg/day.
Use in children and adolescents:
Tatig must only be used to treat children and adolescents suffering from
OCD aged 6-17 years old.
Obsessive Compulsive Disorder:
Children aged 6 to 12: the recommended starting dose is 25 mg daily.
After one week, your doctor may increase this to 50 mg daily. The
maximum dose is 200 mg daily.
Adolescents aged 13 to 17: the recommended starting dose is
50 mg daily.
The maximum dose is 200 mg daily.
If you have liver or kidney problems, please tell your doctor and follow the
doctor’s instructions.
Method of administration:
Tatig tablets may be taken with or without food.
Take your medication once daily either in the morning or evening.
Your doctor will advise you on how long to take this medication for. This
will depend on the nature of your illness and how well you are responding
to the treatment. It may take several weeks before your symptoms begin to
improve. Treatment of depression should usually continue for 6 months after
improvement.
If you take more Tatig than you should:
If you accidentally take too much Tatig contact your doctor at once or go to
the nearest hospital casualty department. Always take the labelled medicine
package with you, whether there is any medication left or not.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid
heart rate, shaking, agitation, dizziness and in rare cases unconsciousness.
If you forget to take Tatig:
Do not take a double dose to make up for a forgotten dose. If you forget to
take a dose, do not take the missed dose. Just take the next dose at the
right time.
If you stop taking Tatig:
Do not stop taking Tatig unless your doctor tells you to. Your doctor will
want to gradually reduce your dose of Tatig over several weeks, before you
finally stop taking this medicine. If you suddenly stop taking this
medicine you may experience side effects such as dizziness, numbness,
sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick
and shaking. If you experience any of these side effects, or any other side
effects whilst stopping taking Tatig, please speak to your doctor.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Nausea is the most common side effect. The side effects depend on the
dose and often disappear or lessen with continued treatment.
Tell your doctor immediately:
If you experience any of the following symptoms after taking this medicine,
these symptoms can be serious.
you develop a severe skin rash that causes blistering (erythema
* Ifmultiforme),
(this can affect the mouth and tongue). These may be signs of
a condition known as Stevens Johnson Syndrome, or Toxic Epidermal
Necrolysis (TEN). Your doctor will stop your treatment in these cases.
Allergic reaction or allergy, which may include symptoms such as an itchy
* skin
rash, breathing problems, wheezing, swollen eyelids, face or lips.
you experience agitation, confusion, diarrhoea, high temperature and
* Ifblood
pressure, excessive sweating and rapid heartbeat. These are
symptoms of Serotonin Syndrome. In rare cases this syndrome may occur
when you are taking certain medicines at the same time as sertraline. Your
doctor may wish to stop your treatment.
develop yellow skin and eyes which may mean liver damage.
* IfIf you
you experience depressive symptoms with ideas of harming or killing
* yourself
(suicidal thoughts).
start to get feelings of restlessness and are not able to sit or stand
* Ifstillyouafter
you start to take Tatig. You should tell your doctor if you start
to feel restless.
have a fit (seizure).
* IfIf you
* you have a manic episode (see section 2 “Warnings and precautions”).
The following side effects were seen in clinical trials in adults.
Very common (may affect more than 1 in 10 people):
Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry
mouth, ejaculation failure, fatigue.
Common (may affect up to 1 in 10 people):
throat, anorexia, increased appetite,
* Sore
feeling strange, nightmare, anxiety, agitation, nervousness,
* depression,
decreased sexual interest, teeth grinding,
and tingling, shaking, muscle tense, abnormal taste, lack of
* numbness
attention,
disturbance, ringing in ears,
* visual
hot flush, yawning,
* palpitations,
pain, vomiting, constipation, upset stomach, gas,
* abdominal
increased sweating, muscle pain, erectile dysfunction, chest pain
* rash,
pain,
* joint
* malaise.
Uncommon (may affect up to 1 in 100 people):
cold, runny nose,
* Chest
* hypersensitivity,
thyroid hormones,
* low
feeling too happy, lack of caring, thinking abnormal,
* hallucination,
aggression,
involuntary muscle contractions, abnormal coordination,
* convulsion,
moving a lot, amnesia, decreased feeling, speech disorder, dizziness
while standing up, passing out, migraine,
pupils,
* enlarged
pain, fast heartbeat, high blood pressure, flushing,
* ear
difficulty, possible wheezing, shortness of breath, nose bleed,
* breathing
of the oesophagus, difficulty swallowing, haemorrhoids,
* inflammation
increased saliva, tongue disorder, burping,
swelling, purple spots on skin, face oedema, hair loss, cold sweat, dry
* eye
skin, hives, itching,
muscular weakness, back pain, muscle twitching,
* osteoarthritis,
urination, unable to urinate, increase in urination, increase in
* nighttime
frequency of urination, problem urinating, urinary incontinence,

haemorrhage, sexual dysfunction, female sexual dysfunction,
* vaginal
menstrual irregularities, swelling in legs, chills, fever, weakness, thirst,
increase in liver enzyme levels, weight decreased, weight increased.
Rare (may affect up to 1 in 1,000 people):
problem, ear infection, cancer, swollen glands, high cholesterol,
* Intestine
low blood sugar,
symptoms due to stress or emotions, drug dependence, psychotic
* physical
disorder, paranoia, suicidal thoughts, sleep walking, premature ejaculation,
allergic reaction,
* severe
abnormal movements, difficulty moving, increased sensation,
* coma,
sensory disturbance,
tear problem, spots in front of eyes, double vision, light
* glaucoma,
hurts eye, blood in the eye,
problems controlling blood sugar levels (diabetes),
* heart
attack, slow heart beat, heart problem, poor circulation of arms and
* legs, closing
up of throat, breathing fast, breathing slow, difficulty talking,
hiccups,
in stool, sore mouth, tongue ulceration, tooth disorder, tongue
* blood
problem, mouth ulceration, problems with liver function,
problem with blisters, hair rash, hair texture abnormal, skin odour
* skin
abnormal, bone disorder,
urination, urinary hesitation, blood in urine,
* decreased
vaginal bleeding, dry vaginal area, red painful penis and
* excessive
foreskin, genital discharge, prolonged erection, breast discharge,
hernia,
tolerance decreased, difficulty walking, semen abnormal,
* increasedrug
in blood cholesterol levels, injury, relaxation of blood vessels
procedure,
of suicidal ideation and suicidal behaviours have been
* Cases
reported during sertraline therapy or early after treatment
discontinuation (see section 2).
After marketing sertraline, the following side effects have been
reported:
in white blood cells, decrease in clotting cells, endocrine
* Decrease
problem, low blood salt, increase in blood sugar levels,
abnormal dreams, suicidal behaviour,
* terrifying
muscular
movement problems (such as moving a lot, tense muscles,
* difficulty walking
and stiffness, spasms and involuntary movements of
muscles), sudden severe headache (which may be a sign of a serious
condition known as Reversible Cerebral Vasoconstriction Syndrome
(RCVS)),
abnormal, unequal sized pupils, bleeding problems (such as
* vision
stomach bleeding), progressive scarring of lung tissue (Interstitial Lung
Disease), pancreatitis, serious liver function problems, yellow skin and
eyes (jaundice),
oedema, skin reaction to sun, muscle cramps, breast enlargement,
* skin
problems with clotting, abnormal laboratory tests, bedwetting.
fainting, or chest discomfort which could be signs
* Light-headedness,
of changes in the electrical activity (seen on electrocardiogram) or
abnormal rhythm of the heart.
Additional side effects in children and adolescents
In clinical trials with children and adolescents, the side effects were generally
similar to adults (see above). The most common side effects in children and
adolescents were headache, insomnia, diarrhoea and feeling sick.
Symptoms that can occur when treatment is discontinued
If you suddenly stop taking this medicine you may experience side effects
such as dizziness, numbness, sleep disturbances, agitation or anxiety,
headaches, feeling sick, being sick and shaking (see section 3. “If you stop
taking Tatig”).
An increased risk of bone fractures has been observed in patients taking this
type of medicines.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard
5

How to store Tatig

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip. If your doctor tells you to stop taking this medicine, return any
unused tablets to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to. If your tablets become discoloured or show
any other signs of deterioration, consult your pharmacist who will tell you
what to do.
Storing your medicine
OUT OF THE SIGHT AND REACH OF CHILDERN
* KEEP
not take your tablets out of the blister strip until it is time to take your
* Do
dose.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Contents of the pack and other information

What Tatig contains
Each tablet contains sertraline hydrochloride equivalent to 50mg sertraline
as the active ingredient.
Other ingredients: calcium hydrogen phosphate, microcrystalline cellulose,
hydroxypropylcellulose, sodium starch glycollate, magnesium stearate,
titanium dioxide (E171), macrogol 400, macrogol 6000, polysorbate-80,
hypromellose E3, hypromellose E5.
What Tatig looks like and contents of the pack
Tatig are white, capsular shaped film-coated scored tablets coded with
‘ZLT-50’ on one side and ‘PFIZER’ on the other side.
Each blister pack contains 15 tablets and comes in boxes of 30 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Haupt Pharma Latina S.r.l : S.S. 156, Km
47, 600, Borgo San Michele, 04100 Latina, Italy and are procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0973

Tatig is a registered trademark of Pfizer Products Inc.
Revision date: 09/05/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

Sertraline ® 50mg Tablets

Ref:0973/090517/3/F

(sertraline hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Sertraline 50mg Tablets but will be referred to as
Sertraline throughout this Patient Information Leaflet. Please note that the
leaflet also contains information about other strengths of the medicine,
Sertraline 100mg.
What is in this leaflet
1 What Sertraline is and what it is used for
2 What you need to know before you take Sertraline
3 How to take Sertraline
4 Possible side effects
5 How to store Sertraline
6 Contents of the pack and other information

1

What Sertraline is and what it is used for

Sertraline contains the active substance sertraline. Sertraline is one of a
group of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs);
these medicines are used to treat depression and/or anxiety disorders.
Sertraline can be used to treat:
* Depression and prevention of recurrence of depression (in adults).
* Social anxiety disorder (in adults).
* Post traumatic stress disorder (PTSD) (in adults).
* Panic disorder (in adults).
* Obsessive compulsive disorder (OCD) (in adults and children and
adolescents aged 6-17 years old).
Depression is a clinical illness with symptoms like feeling sad, unable to
sleep properly or to enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety with symptoms like
being constantly troubled by persistent ideas (obsessions) that make you
carry out repetitive rituals (compulsions).
PTSD is a condition that can occur after a very emotionally traumatic
experience, and has some symptoms that are similar to depression and
anxiety. Social anxiety disorder (social phobia) is an illness linked to anxiety.
It is characterised by feelings of intense anxiety or distress in social
situations (for example: talking to strangers, speaking in front of groups of
people, eating or drinking in front of others or worrying that you might
behave in an embarrassing manner).
Your doctor has decided that this medicine is suitable for treating your
illness.
You should ask your doctor if you are unsure why you have been given
Sertraline.

2

What you need to know before you take Sertraline

Do not take Sertraline:
* If you are allergic to sertraline or any of the other ingredients of this
medicine (listed in section 6).
* If you are taking or have taken medicines called monoamine oxidase
inhibitors (MAOIs such as selegiline, moclobemide) or MAOI like drugs
(such as linezolid). If you stop treatment with sertraline, you must wait
until at least one week before you start treatment with a MAOI. After
stopping treatment with a MAOI, you must wait at least 2 weeks before
you can start treatment with sertraline.
* If you are taking another medicine called pimozide (a medicine for mental
disorders such as psychosis).
Warnings and precautions
Talk to your doctor or pharmacist before taking Sertraline.
Medicines are not always suitable for everyone. Tell your doctor before you
take Sertraline, if you suffer from or have suffered in the past from any of the
following conditions:
* If you have epilepsy (fit) or a history of seizures. If you have a fit
(seizure), contact your doctor immediately.
* If you have suffered from manic depressive illness (bipolar disorder) or
schizophrenia. If you have a manic episode, contact your doctor
immediately.
* If you have or have previously had thoughts of harming or killing yourself
(see below-Thoughts of suicide and worsening of your depression or
anxiety disorder).
* If you have Serotonin Syndrome. In rare cases this syndrome may occur
when you are taking certain medicines at the same time as sertraline.
(For symptoms, see section 4. Possible Side Effects). Your doctor will
have told you whether you have suffered from this in the past.
* If you have low sodium level in your blood, since this can occur as a
result of treatment with Sertraline. You should also tell your doctor if you
are taking certain medicines for hypertension, since these medicines may
also alter the sodium level in your blood.
* If you are elderly as you may be more at risk of having low sodium level
in your blood (see above).
* If you have liver disease; your doctor may decide that you should have a
lower dose of Sertraline.
* If you have diabetes; your blood glucose levels may be altered due to
Sertraline and your diabetes medicines may need to be adjusted.
* If you have suffered from bleeding disorders or have been taking
medicines which thin the blood (e.g. acetylsalicyclic acid (aspirin), or
warfarin) or may increase the risk of bleeding.
* If you are a child or adolescent under 18 years old. Sertraline should only
be used to treat children and adolescents aged 6-17 years old, suffering
from obsessive compulsive disorder (OCD). If you are being treated for
this disorder, your doctor will want to monitor you closely (see belowChildren and adolescents).
* If you are having electro-convulsive therapy (ECT).
* If you have eye problems, such as certain kinds of glaucoma (increased
pressure in the eye).
* If you have been told that you have an abnormality of your heart tracing
after an electrocardiogram (ECG) known as prolonged QT interval.
Restlessness/Akathisia:
The use of sertraline has been linked to a distressing restlessness and need
to move, often being unable to sit or stand still (akathisia). This is most likely
to occur during the first few weeks of treatment. Increasing the dose may be
harmful so if you develop such symptoms you should talk to your doctor.
Withdrawal reactions:
Side effects relating to stopping treatment (withdrawal reactions) are
common, particularly if the treatment is stopped suddenly (see section
3 If you stop taking Sertraline and section 4 Possible side effects). The risk
of withdrawal symptoms depends on the length of treatment, dosage, and
the rate at which the dose is reduced. Generally, such symptoms are mild to
moderate. However, they can be serious in some patients. They normally
occur within the first few days after stopping treatment. In general, such
symptoms disappear on their own and wear off within 2 weeks. In some
patients they may last longer (2-3 months or more). When stopping
treatment with sertraline it is recommended to reduce the dose gradually
over a period of several weeks or months, and you should always discuss
the best way of stopping treatment with your doctor.

Thoughts of suicide and worsening of your depression or anxiety
disorder:
If you are depressed and/or have anxiety disorders you can sometimes have
thoughts of harming or killing yourself. These may be increased when first
starting antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years
with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed
or have an anxiety disorder, and ask them to read this leaflet. You might ask
them to tell you if they think your depression or anxiety is getting worse, or if
they are worried about changes in your behaviour.
Children and adolescents:
Sertraline should not usually be used in children and adolescents less than
18 years old, except for patients with Obsessive Compulsive Disorder
(OCD). Patients under 18 have an increased risk of undesirable effects,
such as suicide attempt, thoughts of harming or killing themselves (suicidal
thoughts) and hostility (mainly aggressiveness, oppositional behaviour and
anger) when they are treated with this class of medicines. Nevertheless, it is
possible that your doctor decides to prescribe Sertraline to a patient under
18 if it is in the patient’s interest. If your doctor has prescribed Sertraline to
you and you are less than 18 years old and you want to discuss this, please
contact him/her. Furthermore, if any of the symptoms listed above appear or
worsen while you are taking Sertraline, you should inform your doctor. Also,
the long-term safety of Sertraline in regard to growth, maturation and
learning (cognitive) and behavioural development in this age group has not
yet been demonstrated.
Other medicines and Sertraline:
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines can affect the way Sertraline works, or Sertraline itself can
reduce the effectiveness of other medicines taken at the same time.
Taking Sertraline together with the following medicines may cause serious
side effects:
* Medicines called monoamine oxidase inhibitors (MAOIs), like moclobemide
(to treat depression) and selegiline (to treat Parkinson’s disease), the
antibiotic linezolid and methylene blue (to treat high levels of
methaemoglobin in the blood). Do not use Sertraline together with these
medicines.
* Medicines to treat mental disorders such as psychosis (pimozide). Do not
use Sertraline together with pimozide.
Talk to your doctor if you are taking the following medicines:
* Herbal medicine containing St. John’s Wort (Hypericum perforatum). The
effects of St. John’s Wort may last for 1-2 weeks.
* Products containing the amino acid tryptophan.
* Medicines to treat severe pain (e.g. tramadol).
* Medicines used in anaesthesia or to treat chronic pain (e.g. fentanyl,
mivacurium and suxamethonium).
* Medicines to treat migraines (e.g. sumatriptan).
* Blood thinning medicine (warfarin).
* Medicines to treat pain/arthritis (Non steroidal anti-inflammatory drug
(NSAID) such as ibuprofen, acetylsalicylic acid (aspirin)).
* Sedatives (diazepam).
* Diuretics (also called ‘water’ tablets).
* Medicines to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
* Medicines to treat diabetes (tolbutamide).
* Medicines to treat excessive stomach acid, ulcers and heartburn
(cimetidine, omeprazole, lanzoprazole, pantoprazole, rabeprazole).
* Medicines to treat mania and depression (lithium).
* Other medicines to treat depression (such as amitriptyline, nortriptyline,
nefazodone, fluoxetine, fluvoxamine).
Medicines
to treat schizophrenia and other mental disorders (such as
*
perphenazine, levomepromazine and olanzapine).
* Medicines used to treat high blood pressure, chest pain or regulate the
rate and rhythm of the heart (such as verapamil, diltiazem, flecainide,
propafenone).
* Medicines used to treat bacterial infections (such as rifampicin,
clarithromycin, telithromycin, erythromycin).
* Medicines used to treat fungal infections (such as ketoconazole,
itraconazole, posaconazole, voriconazole, fluconazole).
* Medicines used to treat HIV/AIDS and Hepatitis C (protease inhibitors
such as ritonavir, telaprevir).
* Medicines used to prevent nausea and vomiting after an operation or
chemotherapy (aprepitant).
* Medicines known to increase the risk of changes in the electrical activity
of the heart (e.g. some antipsychotics and antibiotics).
Sertraline with food, drink and alcohol:
Sertraline tablets can be taken with or without food.
Alcohol should be avoided whilst taking Sertraline.
Sertraline should not be taken in combination with grapefruit juice, as this
may increase the level of sertraline in your body.
Pregnancy, breast-feeding and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
The safety of sertraline has not fully been established in pregnant women.
Sertraline will only be given to you when pregnant if your doctor considers
that the benefit for you is greater than any possible risk to the developing
baby.
Make sure your midwife and/or doctor know you are on Sertraline. When
taken during pregnancy, particularly in the last 3 months of pregnancy,
medicines like Sertraline may increase the risk of a serious condition in
babies, called persistent pulmonary hypertension of the newborn (PPHN),
making the baby breathe faster and appear bluish. These symptoms usually
begin during the first 24 hours after the baby is born. If this happens to your
baby you should contact your midwife and/or doctor immediately.
Your newborn baby might also have other conditions, which usually begin
during the first 24 hours after birth. Symptoms include:
* trouble with breathing,
* a blueish skin or being too hot or cold,
* blue lips,
* vomiting or not feeding properly,
* being very tired, not able to sleep or crying a lot,
* stiff or floppy muscles,
* tremors, jitters or fits,
* increased reflex reactions,
* irritability,
* low blood sugar.
If your baby has any of these symptoms when it is born, or you are
concerned about your baby’s health, contact your doctor or midwife who will
be able to advise you.
There is evidence that sertraline passes into human breast milk. Sertraline
should only be used in women during breast-feeding, if your doctor
considers that the benefit exceeds any possible risk to the baby.
Some medicines like sertraline may reduce the quality of sperm in animal
studies. Theoretically, this could affect fertility, but impact on human fertility
has not been observed as yet.
Driving and using machines:
Psychotropic drugs such as sertraline may influence your ability to drive or
use machines. You should therefore not drive or operate machinery, until you
know how this medication affects your ability to perform these activities.

Ref:0973/090517/3/B

Sertraline ® 50mg Tablets
(sertraline hydrochloride)
3

How to take Sertraline

haemorrhage, sexual dysfunction, female sexual dysfunction,
* vaginal
menstrual irregularities, swelling in legs, chills, fever, weakness, thirst,

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults:
Depression and Obssessive Compulsive Disorder
For depression and OCD, the usual effective dose is 50 mg/day. The daily
dose may be increased in 50 mg increments and at intervals of at least
one week over a period of weeks. The maximum recommended dose is
200 mg/day.
Panic disorder, Social anxiety disorder and Post Traumatic Stress
Disorder:
For panic disorder, social anxiety disorder and post traumatic stress
disorder, treatment should be started at 25 mg/day, and increased to
50 mg/day after one week.
The daily dose then may be increased in 50 mg increments over a period
of weeks. The maximum recommended dose is 200 mg/day.
Use in children and adolescents:
Sertraline must only be used to treat children and adolescents suffering from
OCD aged 6-17 years old.
Obsessive Compulsive Disorder:
Children aged 6 to 12: the recommended starting dose is 25 mg daily.
After one week, your doctor may increase this to 50 mg daily. The
maximum dose is 200 mg daily.
Adolescents aged 13 to 17: the recommended starting dose is
50 mg daily.
The maximum dose is 200 mg daily.
If you have liver or kidney problems, please tell your doctor and follow the
doctor’s instructions.
Method of administration:
Sertraline tablets may be taken with or without food.
Take your medication once daily either in the morning or evening.
Your doctor will advise you on how long to take this medication for. This
will depend on the nature of your illness and how well you are responding
to the treatment. It may take several weeks before your symptoms begin to
improve. Treatment of depression should usually continue for 6 months after
improvement.
If you take more Sertraline than you should:
If you accidentally take too much Sertraline contact your doctor at once or
go to the nearest hospital casualty department. Always take the labelled
medicine package with you, whether there is any medication left or not.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid
heart rate, shaking, agitation, dizziness and in rare cases unconsciousness.
If you forget to take Sertraline:
Do not take a double dose to make up for a forgotten dose. If you forget to
take a dose, do not take the missed dose. Just take the next dose at the
right time.
If you stop taking Sertraline:
Do not stop taking Sertraline unless your doctor tells you to. Your doctor will
want to gradually reduce your dose of Sertraline over several weeks, before
you finally stop taking this medicine. If you suddenly stop taking this
medicine you may experience side effects such as dizziness, numbness,
sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick
and shaking. If you experience any of these side effects, or any other side
effects whilst stopping taking Sertraline, please speak to your doctor.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Nausea is the most common side effect. The side effects depend on the
dose and often disappear or lessen with continued treatment.
Tell your doctor immediately:
If you experience any of the following symptoms after taking this medicine,
these symptoms can be serious.
you develop a severe skin rash that causes blistering (erythema
* Ifmultiforme),
(this can affect the mouth and tongue). These may be signs of
a condition known as Stevens Johnson Syndrome, or Toxic Epidermal
Necrolysis (TEN). Your doctor will stop your treatment in these cases.
Allergic reaction or allergy, which may include symptoms such as an itchy
* skin
rash, breathing problems, wheezing, swollen eyelids, face or lips.
you experience agitation, confusion, diarrhoea, high temperature and
* Ifblood
pressure, excessive sweating and rapid heartbeat. These are
symptoms of Serotonin Syndrome. In rare cases this syndrome may occur
when you are taking certain medicines at the same time as sertraline. Your
doctor may wish to stop your treatment.
develop yellow skin and eyes which may mean liver damage.
* IfIf you
you experience depressive symptoms with ideas of harming or killing
* yourself
(suicidal thoughts).
start to get feelings of restlessness and are not able to sit or stand
* Ifstillyouafter
you start to take Sertraline. You should tell your doctor if you start
to feel restless.
have a fit (seizure).
* IfIf you
* you have a manic episode (see section 2 “Warnings and precautions”).
The following side effects were seen in clinical trials in adults.
Very common (may affect more than 1 in 10 people):
Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry
mouth, ejaculation failure, fatigue.
Common (may affect up to 1 in 10 people):
throat, anorexia, increased appetite,
* Sore
feeling strange, nightmare, anxiety, agitation, nervousness,
* depression,
decreased sexual interest, teeth grinding,
and tingling, shaking, muscle tense, abnormal taste, lack of
* numbness
attention,
disturbance, ringing in ears,
* visual
hot flush, yawning,
* palpitations,
pain, vomiting, constipation, upset stomach, gas,
* abdominal
increased sweating, muscle pain, erectile dysfunction, chest pain
* rash,
pain,
* joint
* malaise.
Uncommon (may affect up to 1 in 100 people):
cold, runny nose,
* Chest
* hypersensitivity,
thyroid hormones,
* low
feeling too happy, lack of caring, thinking abnormal,
* hallucination,
aggression,
involuntary muscle contractions, abnormal coordination,
* convulsion,
moving a lot, amnesia, decreased feeling, speech disorder, dizziness
while standing up, passing out, migraine,
pupils,
* enlarged
pain, fast heartbeat, high blood pressure, flushing,
* ear
difficulty, possible wheezing, shortness of breath, nose bleed,
* breathing
of the oesophagus, difficulty swallowing, haemorrhoids,
* inflammation
increased saliva, tongue disorder, burping,
swelling, purple spots on skin, face oedema, hair loss, cold sweat, dry
* eye
skin, hives, itching,
muscular weakness, back pain, muscle twitching,
* osteoarthritis,
urination, unable to urinate, increase in urination, increase in
* nighttime
frequency of urination, problem urinating, urinary incontinence,

increase in liver enzyme levels, weight decreased, weight increased.
Rare (may affect up to 1 in 1,000 people):
problem, ear infection, cancer, swollen glands, high cholesterol,
* Intestine
low blood sugar,
symptoms due to stress or emotions, drug dependence, psychotic
* physical
disorder, paranoia, suicidal thoughts, sleep walking, premature ejaculation,
allergic reaction,
* severe
abnormal movements, difficulty moving, increased sensation,
* coma,
sensory disturbance,
tear problem, spots in front of eyes, double vision, light
* glaucoma,
hurts eye, blood in the eye,
problems controlling blood sugar levels (diabetes),
* heart
attack, slow heart beat, heart problem, poor circulation of arms and
* legs, closing
up of throat, breathing fast, breathing slow, difficulty talking,
hiccups,
in stool, sore mouth, tongue ulceration, tooth disorder, tongue
* blood
problem, mouth ulceration, problems with liver function,
problem with blisters, hair rash, hair texture abnormal, skin odour
* skin
abnormal, bone disorder,
urination, urinary hesitation, blood in urine,
* decreased
vaginal bleeding, dry vaginal area, red painful penis and
* excessive
foreskin, genital discharge, prolonged erection, breast discharge,
hernia,
tolerance decreased, difficulty walking, semen abnormal,
* increasedrug
in blood cholesterol levels, injury, relaxation of blood vessels
procedure,
of suicidal ideation and suicidal behaviours have been
* Cases
reported during sertraline therapy or early after treatment
discontinuation (see section 2).
After marketing sertraline, the following side effects have been
reported:
in white blood cells, decrease in clotting cells, endocrine
* Decrease
problem, low blood salt, increase in blood sugar levels,
abnormal dreams, suicidal behaviour,
* terrifying
muscular
movement problems (such as moving a lot, tense muscles,
* difficulty walking
and stiffness, spasms and involuntary movements of
muscles), sudden severe headache (which may be a sign of a serious
condition known as Reversible Cerebral Vasoconstriction Syndrome
(RCVS)),
abnormal, unequal sized pupils, bleeding problems (such as
* vision
stomach bleeding), progressive scarring of lung tissue (Interstitial Lung
Disease), pancreatitis, serious liver function problems, yellow skin and
eyes (jaundice),
oedema, skin reaction to sun, muscle cramps, breast enlargement,
* skin
problems with clotting, abnormal laboratory tests, bedwetting.
fainting, or chest discomfort which could be signs
* Light-headedness,
of changes in the electrical activity (seen on electrocardiogram) or
abnormal rhythm of the heart.
Additional side effects in children and adolescents
In clinical trials with children and adolescents, the side effects were generally
similar to adults (see above). The most common side effects in children and
adolescents were headache, insomnia, diarrhoea and feeling sick.
Symptoms that can occur when treatment is discontinued
If you suddenly stop taking this medicine you may experience side effects
such as dizziness, numbness, sleep disturbances, agitation or anxiety,
headaches, feeling sick, being sick and shaking (see section 3. “If you stop
taking Sertraline”).
An increased risk of bone fractures has been observed in patients taking this
type of medicines.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard
5

How to store Sertraline

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip. If your doctor tells you to stop taking this medicine, return any
unused tablets to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to. If your tablets become discoloured or show
any other signs of deterioration, consult your pharmacist who will tell you
what to do.
Storing your medicine
OUT OF THE SIGHT AND REACH OF CHILDERN
* KEEP
not take your tablets out of the blister strip until it is time to take your
* Do
dose.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Contents of the pack and other information

What Sertraline contains
Each tablet contains sertraline hydrochloride equivalent to 50mg sertraline
as the active ingredient.
Other ingredients: calcium hydrogen phosphate, microcrystalline cellulose,
hydroxypropylcellulose, sodium starch glycollate, magnesium stearate,
titanium dioxide (E171), macrogol 400, macrogol 6000, polysorbate-80,
hypromellose E3, hypromellose E5.
What Sertraline looks like and contents of the pack
Sertraline are white, capsular shaped film-coated scored tablets coded with
‘ZLT-50’ on one side and ‘PFIZER’ on the other side.
Each blister pack contains 15 tablets and comes in boxes of 30 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Haupt Pharma Latina S.r.l : S.S. 156, Km
47, 600, Borgo San Michele, 04100 Latina, Italy and are procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0973

Sertraline is a registered trademark of Pfizer Products Inc.
Revision date: 09/05/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

Инструкция по применению Золофт импортный Pfizer (под названием Lustral) 50мг таблетки №28

Форма выпуска, упаковка и состав препарата Золофт®

Фармакологическое действие

Фармакокинетика

Показания препарата Золофт®

Режим дозирования

Побочное действие

Противопоказания к применению

Применение при беременности и кормлении грудью

Применение при нарушениях функции печени

Применение при нарушениях функции почек

Применение у детей

Применение у пожилых пациентов

Особые указания

Форма выпуска, упаковка и состав препарата Золофт^®

Таблетки, покрытые пленочной оболочкой белого цвета, овальные, двояковыпуклые, с гравировкой «Pfizer» на одной стороне и «ZLT» с цифрой «50», разделенные риской, на другой.

Вспомогательные вещества: кальция гидрофосфата дигидрат — 24 мг, целлюлоза микрокристаллическая (PH102) — 44.925 мг, гипролоза — 4.5 мг, карбоксиметилкрахмал натрия — 18.75 мг, магния стеарат — 1.875 мг.

Состав пленочной оболочки:
Опадрай белый — 4.125 мг (гипромеллоза — 2.465 мг, титана диоксид — 1.289 мг, макрогол 400 — 0.33 мг, полисорбат 80 — 0.041 мг).
Опадрай прозрачный — 0.375 мг (гипромеллоза — 0.341 мг, макрогол 400/8000 — 0.034.

В упаковке 28 таблеток.

Клинико-фармакологическая группа: Антидепрессант.

Фармако-терапевтическая группа: Антидепрессант.

Фармакологическое действие

Сертралин — антидепрессант, мощный селективный ингибитор обратного захвата серотонина (5-НТ) (СИОЗС). Оказывает очень слабое влияние на обратный захват норадреналина и дофамина. При применении в терапевтических дозах сертралин блокирует обратный захват серотонина в тромбоцитах человека. В контролируемых клинических исследованиях не было отмечено стимулирующего, седативного или антихолинергического действия, а также не было отмечено нарушения психомоторных функций у добровольцев. Сертралин не вызывает лекарственной зависимости, не вызывает увеличение массы тела при длительном применении.

На животных моделях показано, что благодаря селективному угнетению захвата 5-НТ, сертралин не усиливает катехоламиновую активность, не обладает сродством к мускариновым (холинергическим), серотонинергическим, дофаминергическим, адренергическим, гистаминергическим, ГАМК- или бензодиазепиновым рецепторам. На животных моделях было показано, что сертралин также не обладает кардиотоксическим действием. Длительное применение у животных было связано с регуляцией рецепторов норадреналина в головном мозге по типу отрицательной обратной связи, характерной для других антидепрессантов и противообсессивных препаратов.

Сертралин не приводит к злоупотреблению препаратом. В плацебо-контролируемом двойном слепом сравнительном исследовании, изучавшем способность сертралина, алпразолама и декстроамфетамина к развитию злоупотребления, для сертралина не было отмечено такой способности. В противоположность этому наблюдению, пациенты, получавшие алпразолам и декстроамфетамин, показали большую склонность к развитию злоупотребления препаратами, по сравнению с плацебо. Степень склонности к злоупотреблению основывалась на измерении таких показателей, как способность препарата вызывать положительные эмоции, эйфорию и злоупотребление. У резус-макак, приученных к самостоятельному введению кокаина, прием сертралина не действовал как положительный стимул, в отличие от фенобарбитала и декстроамфетамина.

Дети

Постмаркетинговое исследование безопасности SPRITES

Пострегистрационное наблюдательное исследование с участием 941 пациента в возрасте от 6 до 16 лет было проведено для оценки долгосрочной безопасности лечения сертралином (с психотерапией и без нее) по сравнению с психотерапией в отношении когнитивного, эмоционального, физического и пубертатного созревания продолжительностью до 3 лет. Данное исследование проводилось в условиях клинической практики у детей и подростков с первичными диагнозами обсессивно-компульсивное расстройство, депрессия или другие тревожные расстройства. В рамках исследования оценивались когнитивные способности (оценка проводилась при помощи теста Trails В и индекса метакогниции из Перечня Оценки Поведения Исполнительной Функции (ПОПИФ), поведенческой/эмоциональной регуляции (оценивается с помощью индекса регуляции поведения из ПОПИФ) и физического/пубертатного созревания (оценивается по стандартизированному индексу роста/веса/массы тела (ИМТ) и стадии Таннера)). Сертралин одобрен для использования в педиатрии только для пациентов в возрасте 6 лет и старше с ОКР (см. раздел «Показания»).

Стандартизация каждого критерия первичного исхода на основе норм пола и возраста показала, что общие результаты соответствуют нормальному развитию. Статистически значимых различий по основным критериям результата, за исключением веса, не наблюдалось. Статистически значимый результат для стандартизованного веса был обнаружен в сравнительных анализах, однако величина изменения веса была небольшой (среднее (стандартное отклонение) изменение стандартизованных z-значений <0.5 стандартного отклонения) и наблюдалась в основном при более высоких дозах.

Фармакокинетика

Всасывание

C_max и AUC пропорциональны дозе в пределах 50-200 мг, при этом выявляется линейный характер фармакокинетической зависимости. При применении сертралина в дозе от 50 мг до 200 мг 1 раз/сут в течение 14 дней C_max сертралина в плазме крови достигалась через 4.5-8.4 ч после приема. Абсорбция высокая, с медленной скоростью. Во время приема пищи биодоступность изменяется незначительно (на 25%).

Распределение

Приблизительно 98% сертралина связывается с белками плазмы крови.

Метаболизм

Сертралин подвергается активной биотрансформации при «первом прохождении» через печень. Основной путь метаболизма — N-деметилирование. Основной метаболит, обнаруженный в плазме, N-десметилсертралин, значительно уступает (примерно в 20 раз) сертралину по активности in vitro и фактически не активен на моделях депрессии in vivo. И сертралин, и N-десметилсертралин проходят окислительное дезаминирование и последующее сокращение, гидроксилирование и глюкуронирование. При введении меченного сертралина здоровым добровольцам в плазме крови отмечали менее 5% радиоактивного сертралина. Около 40-45% введенной дозы через 9 дней обнаруживалось в моче. Неизмененный сертралин не выводится через почки. За тот же период около 40-45% введенного сертралина обнаруживалось в фекалиях, включая 12-14% неизмененного сертралина.

AUC_{(0-24 ч)}, C_max и C_min десметилсертралина увеличиваются в зависимости от дозы и времени приблизительно в 5-9 раз от 1-го дня до 14-го.

Выведение

Средний Т_1/2 сертралина у молодых и пожилых пациентов составляет 22-36 ч. Соответственно конечному Т_1/2 наблюдается примерно двукратная кумуляция препарата до наступления равновесных концентраций через 1 неделю лечения (прием дозы 1 раз/сут). Т_1/2 N-десметилсертралина варьирует в пределах 62-104 ч. Сертралин и N-десметилсертралин активно биотрансформируются; образующиеся метаболиты выводятся в равных количествах почками и через кишечник. Сертралин в неизмененном виде выводится почками в незначительном количестве (<0.2%).

Фармакокинетика у особых групп пациентов

Применение у детей. Показано, что фармакокинетика сертралина у детей с ОКР сходна с таковой у взрослых (хотя у детей метаболизм сертралина является несколько более активным). Однако, учитывая более низкую массу тела у детей (особенно в возрасте 6-12 лет), препарат рекомендуется применять в меньшей дозе, чтобы избежать чрезмерных концентраций сертралина в плазме крови (см. раздел «Режим дозирования»).

Подростки и пожилые пациенты. Фармакокинетический профиль у подростков и пожилых пациентов не отличается от фармакокинетического профиля у пациентов в возрасте от 18 до 65 лет.

Применение при недостаточности функции печени. При многократном приеме сертралина у пациентов с циррозом печени легкого течения наблюдается увеличение Т_1/2 препарата и почти троекратное увеличение AUC и C_max по сравнению с таковыми у здоровых людей. Существенных различий в связывании с белками плазмы крови в 2 группах не отмечается. При применении сертралина у пациентов с нарушенной функцией печени необходимо обсудить целесообразность снижения дозы или увеличения интервала между приемом препарата.

Применение при почечной недостаточности. Сертралин подвергается активной биотрансформации, поэтому почками в неизмененном виде он выводится в незначительном количестве. У пациентов с легкой и умеренно выраженной почечной недостаточностью (КК 30-60 мл/мин) и пациентов с умеренной или тяжелой степенью почечной недостаточности (КК 10-29 мл/мин) фармакокинетические параметры (AUC_0-24 и C_max) сертралина при многократном его приеме существенно не отличались от группы контроля. Во всех группах Т_1/2 сертралина был одинаков, равно как не было различий в связывании с белками плазмы крови. Было установлено, что, как и ожидалось, с учетом незначительной почечной экскреции сертралина, коррекции его дозы в зависимости от выраженности почечной недостаточности не требуется.

Показания препарата Золофт^®

• большие депрессивные эпизоды;
• профилактика больших депрессивных эпизодов;

• обсессивно-компульсивные расстройства (ОКР) у взрослых и детей в возрасте 6 лет и старше;

• панические расстройства (с агорафобией или без нее);
• посттравматическое стрессовое расстройство (ПТСР);
• социальная фобия.

Режим дозирования

Препарат принимают внутрь, 1 раз/сут, утром или вечером, вне зависимости от приема пищи.

Начальная доза

Депрессия и ОКР: начальная доза — 50 мг/сут.

Панические расстройства, ПТСР и социальная фобия: лечение начинают с дозы 25 мг/сут, которую увеличивают через 1 неделю до 50 мг/сут. Применение препарата по такой схеме позволяет снизить частоту ранних нежелательных эффектов лечения, характерных для панического расстройства.

Подбор дозы

Депрессия, ОКР, панические расстройства, ПТСР и социальная фобия: при недостаточном эффекте применения сертралина в дозе 50 мг/сут, суточную дозу допускается повышать с шагом не более 50 мг/сут и интервалом не чаще чем 1 раз в неделю (принимая во внимание 24-часовой терминальный Т_1/2) до максимальной рекомендуемой дозы, составляющей 200 мг/сут.

Начальный терапевтический эффект может проявиться в течение 7 дней, однако полный эффект обычно достигается через 2-4 недели (или даже в течение более длительного времени при ОКР).

Поддерживающая терапия: поддерживающая доза при длительном лечении должна быть минимальной эффективной, с проведением соответствующей коррекции в зависимости от терапевтического эффекта.

При больших депрессивных эпизодах терапию следует продолжать не менее 6 месяцев. При ОКР и паническом расстройстве следует регулярно оценивать необходимость продолжения терапии, т.к. при этих состояниях профилактика рецидивов не показана.

Применение у детей

Безопасность и эффективность сертралина установлены у детей с ОКР (в возрасте от 6 до 17 лет).

Для подростков (в возрасте 13-17 лет) с ОКР начальная доза — 50 мг/сут.

Для детей (в возрасте 6-12 лет) терапию ОКР начинают с дозы 25 мг/сут, с последующим увеличением дозы через 1 неделю до 50 мг/сут. В дальнейшем, при недостаточном эффекте дозы 50 мг возможно дальнейшее повышение дозы в течение нескольких недель. Максимальная доза составляет 200 мг/сут. Не следует изменять дозу чаще, чем 1 раз в неделю. Было показано, что у пациентов с депрессией и ОКР в возрасте от 6 до 17 лет фармакокинетический профиль сертралина сходен с таковым у взрослых. Однако, чтобы избежать передозировки, при увеличении дозы более 50 мг необходимо принимать во внимание меньшую массу тела у детей по сравнению со взрослыми.

Безопасность и эффективность препарата у детей с большим депрессивным расстройством не выявлена.

Подбор дозы у детей и подростков

Т_1/2 сертралина составляет приблизительно 1 сут, поэтому изменение дозы должно происходить с интервалом не менее 1 нед.

Пациенты пожилого возраста

В пожилом возрасте препарат следует применять с осторожностью из-за повышенного риска развития гипонатриемии. Препарат применяют в том же диапазоне доз, что и у более молодых людей.

Пациенты с недостаточностью функции печени

У пациентов с печеночной недостаточностью следует применять меньшие дозы или увеличивать интервал между приемами препарата (см. раздел «Особые указания»). Не следует применять сертралин у пациентов с тяжелой печеночной недостаточностью (не имеется клинических данных).

Пациенты с недостаточностью функции почек

С учетом незначительной почечной экскреции сертралина, коррекция его дозы в зависимости от выраженности почечной недостаточности не требуется (см. раздел «Особые указания»).

Синдром отмены

Следует избегать резкой отмены препарата Золофт^®. При необходимости отменить терапию, следует постепенно снижать дозу сертралина в течение как минимум 1-2 недель с целью минимизации риска развития симптомов синдрома отмены. В случае возникновения непереносимых нежелательных реакций в течение периода снижения дозы или после отмены препарата, следует рассмотреть возможность возобновления терапии в прежней дозе. В дальнейшем врач может возобновить снижение дозы, но с более длительными интервалами.

Побочное действие

Наиболее частым побочным эффектом является тошнота. При лечении социальной фобии отмечали нарушение сексуальной функции (нарушение эякуляции) у мужчин в 14% случаев при применении сертралина, по сравнению с 0% на фоне применения плацебо. Эти нежелательные явления зависят от дозы и часто проходят при продолжении терапии. Нежелательные явления, наблюдавшиеся у пациентов с ОКР, паническим расстройством, ПТСР и социальной фобией не отличаются от таковых при большом депрессивном расстройстве.

В таблице 1 представлена информация о побочных реакциях, наблюдавшихся при применении сертралина, на основании данных, полученных во время постмаркетинговых (частота неизвестна) и плацебо-контролируемых клинических исследований (исследования проводили с участием 2542 пациентов, получающих сертралин, и 2145 пациентов, получающих плацебо). Данные исследования проводились у пациентов с депрессией, ОКР, паническим расстройством, ПТСР или социальной фобией.

Некоторые нежелательные реакции, перечисленные в таблице 1, при продолжении терапии могут уменьшаться по интенсивности и частоте и, в целом, не приводят к прекращению терапии.

Частота определяется следующим образом: очень часто (≥10%), часто (≥1% и <10%), нечасто (≥0.1% и <1%), редко (≥0.01% и <0.1%), очень редко (<0.01%), частота неизвестна (невозможно определить на основании имеющихся данных).

Таблица 1

При регистрации нежелательного явления у пациентов с депрессией, ОКР, паническим расстройством, ПТСР и социальным тревожным расстройством нежелательное явление относят к классу органов, который использовался для классификации данного нежелательного явления в рамках исследований у пациентов с депрессией.

⁺Сообщалось об одном случае развития новообразования по сравнению с пациентами из группы плацебо.

^* Данные побочные эффекты наблюдались также в постмаркетинговых исследованиях.

^§ Частота данных побочных эффектов ранжирована по верхней границе 95% доверительного интервала.

^** В качестве знаменателя используется количество пациентов, объединенных по группам в зависимости от пола: терапия сертралином (1118 мужчин, 1424 женщин), терапия плацебо (926 мужчин, 1219 женщин).

^*** Отмечали случаи появления суицидальных мыслей и суицидального поведения у пациентов, получающих терапию сертралином или в ранний период после отмены терапии (см. раздел «Особые указания»).

Класс-эффекты

Согласно эпидемиологическим исследованиям, проводившимся преимущественно с участием пациентов в возрасте 50 лет и старше, отмечался повышенный риск переломов костей у пациентов, принимавших СИОЗС и трициклические антидепрессанты. Механизм данного побочного эффекта неизвестен.

Синдром отмены

Прекращение лечения сертралином (в особенности резкое) часто приводит к развитию синдрома отмены. Наиболее часто сообщается о следующих симптомах: головокружение, нарушения чувствительности (включая парестезии), нарушения сна (включая бессонницу и яркие сны), ажитация или психомоторное возбуждение, тошнота и/или рвота, тремор и головная боль. В целом, эти симптомы носят легкий, умеренный и ограниченный характер; тем не менее, у некоторых пациентов они могут быть тяжелыми и длительно сохраняться. В связи с этим в случае, если пациент не нуждается в продолжении лечения сертралином, следует проводить постепенную отмену препарата путем плавного снижения дозы.

Пожилые пациенты

Применение СИОЗС или селективных ингибиторов обратного захвата норадреналина (СИОЗН), в т.ч. сертралина, в некоторых случаях было связано с развитием серьезной гипонатриемии у пожилых пациентов, для которых может быть характерен повышенный риск развития такого осложнения.

Дети

Профиль побочных реакций при применении сертралина у детей был в целом схожим с профилем безопасности у взрослых пациентов. В клинических исследованиях у детей отмечали следующие побочные реакции:

Очень часто (≥1/10): головная боль (22%), бессонница (21%), диарея (11%), тошнота (15%).

Часто (≥1/100 и <1/10): боль в грудной клетке, мания, пирексия, рвота, анорексия, аффективная лабильность, агрессивное поведение, ажитация, повышенная возбудимость, нарушение внимания, головокружение, гиперкинезия, мигрень, сонливость, тремор, нарушение зрения, сухость слизистой оболочки полости рта, диспепсия, кошмарные сновидения, повышенная утомляемость, недержание мочи, сыпь, акне, носовое кровотечение, метеоризм.

Нечасто (≥1/1000 и <1/100): удлинение интервала QT на ЭКГ, попытки суицида, судороги, экстрапирамидные расстройства, парестезия, депрессивные симптомы, галлюцинации, пурпура, гипервентиляция, анемия, нарушение функции печени, повышение активности АЛТ, цистит, простой герпес, отит, боль в ушах, боль в глазных яблоках, мидриаз, недомогание, гематурия, пустулезная сыпь, ринит, травмы, снижение массы тела, непроизвольные сокращения мышц, нетипичные сновидения, апатия, альбуминурия, поллакиурия, полиурия, боль в груди, нарушения менструального цикла, алопеция, дерматит, поражения кожи, изменение запаха кожи, крапивница, скрежет зубами во сне, «приливы» крови к коже лица.

Частота неизвестна: энурез.

Противопоказания к применению

• известная повышенная чувствительность к сертралину и другим компонентам препарата;
• детский возраст до 6 лет (при ОКР);
• возраст до 18 лет (для остальных показаний);
• одновременное применение сертралина с ингибиторами МАО необратимого действия в связи с риском развития серотонинового синдрома, проявляющегося ажитацией, тремором и гипертермией. Не следует начинать прием сертралина в течение 14 дней после отмены необратимых ингибиторов МАО, а терапию сертралином следует прекратить за 7 дней до начала терапии необратимыми ингибиторами МАО (см. разделы «Лекарственное взаимодействие» и «Особые указания»);
• одновременное применение с пимозидом (см. раздел «Лекарственное взаимодействие»).

С осторожностью

Следует соблюдать осторожность при применении сертралина у пациентов с органическими заболеваниями головного мозга (в т.ч. задержка умственного развития), эпилепсией, печеночной и/или почечной недостаточностью, выраженным снижением массы тела.

Также следует соблюдать осторожность при одновременном применении сертралина с другими препаратами, усиливающими серотонинергическую нейротрансмиссию (см. раздел «Лекарственное взаимодействие»).

Необходимо соблюдать осторожность при назначении СИОЗС в сочетании с препаратами, обладающими подтвержденной способностью влиять на функцию тромбоцитов (см. раздел «Особые указания»).

Необходимо соблюдать осторожность при одновременном применении сертралина и трициклических антидепрессантов (см. раздел «Лекарственное взаимодействие»).

Следует соблюдать осторожность при применении сертралина у пациентов с факторами риска удлинения интервала QT_c на ЭКГ или развития аритмии желудочковой тахисистолической типа «пируэт» (TdP).

Применение при беременности и кормлении грудью

Беременность

Контролируемых исследований применения сертралина у беременных женщин не проводилось, поэтому применять препарат у данной категории пациентов стоит только в том случае, если ожидаемая польза для матери превышает потенциальный риск для плода. Однако в значительном объеме данных не было обнаружено доказательств индукции врожденных пороков сертралином. Экспериментальные исследования на животных показали возможное влияние сертралина на репродуктивную функцию. Вероятно, это влияние связано с материнской токсичностью, вызванной фармакодинамическими эффектами сертралина на плод.

В ходе наблюдательных исследований были получены данные о повышенном риске (менее чем в 2 раза) послеродового кровотечения после применения СИОЗС, включая сертралин, особенно в течение месяца до родов.

У некоторых новорожденных, матери которых принимали сертралин во время беременности, наблюдались симптомы, сходные с реакциями отмены. Этот феномен наблюдался и при приеме других антидепрессантов группы СИОЗС.

Женщинам репродуктивного возраста, у которых предполагается применять сертралин, следует рекомендовать пользоваться эффективными средствами контрацепции.

Период лактации

В грудном молоке в небольшом количестве обнаруживается сертралин и его метаболит N-десметилсертралин. В основном, в плазме крови новорожденных обнаруживались незначительные количества сертралина, за исключением одного случая, когда в плазме крови новорожденного было обнаружено 50% от концентрации в плазме крови матери (без заметного эффекта на состояние здоровья новорожденного). Лечение этим препаратом во время грудного вскармливания не рекомендуется. Если же лечение все же необходимо, кормление грудью лучше прекратить.

У новорожденных, матери которых принимали препарат Золофт^® и другие СИОЗС или СИОЗН во время беременности, наблюдались осложнения, требующие дополнительной госпитализации, поддержки дыхательной системы и кормления через зонд. Следует тщательно наблюдать новорожденных, матери которых принимали сертралин на поздних стадиях беременности, в особенности в III триместре. У таких новорожденных могут наблюдаться следующие симптомы: респираторный дистресс, цианоз, апноэ, судороги, нестабильность температуры тела, затруднения при кормлении, рвота, гипогликемия, гипотонус, гипертонус, гиперрефлексия, тремор, подергивание мышц, повышенная возбудимость, летаргия, длительный плач, сонливость и трудности засыпания. Эти симптомы могут быть связаны с непосредственными серотонинергическими эффектами или могут являться симптомами отмены препарата. В большинстве случаев подобные осложнения начинаются непосредственно или вскоре (<24 ч) после рождения. Следует учитывать, что в некоторых случаях клиническая картина может быть похожа на симптомы серотонинергического синдрома.

У новорожденных, матери которых принимали СИОЗС во время беременности, также может быть повышен риск развития персистирующей легочной гипертензии новорожденных (ПЛГН). ПЛГН составляет 5 случаев на 1000 беременностей и составляет одну из причин заболеваемости и смертности новорожденных. Несколько недавних эпидемиологических исследований указывают на связь между приемом СИОЗС (в т.ч. препарата Золофт^®) и ПЛГН.

Фертильность

В одном из двух исследований на мышах было отмечено снижение фертильности при применении сертралина в дозе 80 мг/кг (это в 4 раза больше максимальной рекомендуемой дозы для человека при расчете мг/м²).

Согласно описанным клиническим случаям, прием некоторых СИОЗС оказывает влияние на качество спермы, но этот эффект обратим.

Применение при нарушениях функции печени

У пациентов с печеночной недостаточностью требуется коррекция дозы. Не следует применять сертралин у пациентов с тяжелой печеночной недостаточностью, в связи с отсутствием клинических данных.

Применение при нарушениях функции почек

Следует соблюдать осторожность при применении сертралина у пациентов с почечной недостаточностью, коррекции дозы не требуется.

Применение у детей

Противопоказано применение препарата в детском возрасте до 6 лет (при обсессивно-компульсивных расстройствах) и в возрасте до 18 лет (для остальных показаний).

Применение у пожилых пациентов

В пожилом возрасте препарат следует применять с осторожностью, коррекции дозы не требуется.

Особые указания

Сертралин не следует назначать совместно с ингибиторами МАО, в течение 14 дней до начала приема ингибиторов МАО и в течение 14 дней после их отмены.

Следует контролировать концентрацию трициклических антидепрессантов в крови с целью оценки необходимости коррекции дозы.

При одновременном применении сертралина и толбутамида необходимо контролировать концентрацию глюкозы крови (см. раздел «Лекарственное взаимодействие»).

Серотониновый синдром

При применении СИОЗС описаны случаи развития серотонинового синдрома (СС) и злокачественного нейролептического синдрома (ЗНС). Риск данных осложнений повышается при одновременном применении СИОЗС с другими серотонинергическими средствами (в т.ч. амфетаминами, триптанами и опиоидами (например, фентанилом и их аналогами, трамадолом, декстрометорфаном, тапентадолом, мепередином, метадоном, пентазоцином)), а также препаратами, влияющими на метаболизм серотонина (в т.ч. ингибиторами МАО), антипсихотическими средствами и другими антагонистами дофаминовых рецепторов. Проявлениями СС могут быть изменения психического статуса (в частности, ажитация, галлюцинации, кома), вегетативная лабильность (тахикардия, колебания АД, гипертермия), изменения нейромышечной передачи (гиперрефлексия, нарушение координации движений) и/или нарушения со стороны ЖКТ (тошнота, рвота и диарея). Некоторые проявления СС, в т.ч. гипертермия, ригидность мышц, вегетативная лабильность с возможными быстрыми колебаниями параметров жизненно важных функций, а также изменения психического статуса, могут напоминать симптоматику, развивающуюся при ЗНС. Необходимо наблюдать пациентов на предмет развития клинических проявлений СС и ЗНС.

Удлинение интервала QT_c или желудочковая тахисистолическая аритмия типа «пируэт» (torsade de pointes (TdP))

Во время постмаркетингового применения сертралина сообщалось о случаях удлинения интервала QT_c на ЭКГ и о развитии желудочковой тахисистолической аритмии типа «пируэт» (TdP). Большинство случаев отмечалось у пациентов с факторами риска развития таких сос

Добавьте отзыв об этом препарате: