Sertraline zentiva: detailed information

Package leaflet: Information for the user

Sertraline Zentiva, 25 mg, film-coated tablets
Sertralinum
Please read all of this leaflet carefully before 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 symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Sertraline Zentiva is and what it is used for
What you need to know before taking Sertraline Zentiva
How to take Sertraline Zentiva
Possible side effects
How to store Sertraline Zentiva
Contents of the pack and other information

1. What Sertraline Zentiva is and what it is used for

Sertraline Zentiva contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines are used to treat depression and (or) anxiety disorders.

Sertraline Zentiva may 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 in children and adolescents aged 6 to 17 years).

Depression is an illness characterised by symptoms such as sadness, sleep disturbances, and inability to feel joy in life.

Obsessive-compulsive disorder (OCD) and panic disorder are anxiety-related conditions, characterised by persistent worry due to intrusive thoughts (obsessions), which lead to repetitive rituals (compulsions).

Post-traumatic stress disorder (PTSD) is a condition that may occur after an exceptionally traumatic experience and is characterised by certain symptoms similar to depression and anxiety.

Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterised by intense fear or anxiety in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in public, or fear of potentially embarrassing behaviour).

Your doctor decides whether this medicine is suitable for treating the condition you have.

If you have any doubts about why this medicine has been prescribed for you, consult your doctor.

2. Important information before using Sertraline Zentiva

When not to use Sertraline Zentiva: if the patient is allergic to sertraline or to any of the other ingredients of this medicine
(listed in section 6);
if the patient is currently taking or has recently taken monoamine oxidase inhibitors (MAO inhibitors, e.g.
selegiline, moclobemide) or medicines similar to MAO inhibitors (e.g. linezolid). After stopping treatment with sertraline, at least one week must elapse before starting treatment with an MAO inhibitor. After stopping treatment with an MAO inhibitor, at least two weeks must elapse before starting treatment with sertraline;
if the patient is taking a medicine called pimozide (a medicine used to treat psychiatric disorders such as psychosis).

Warnings and precautions
Medicines are not always suitable for every person.
Before starting treatment with Sertraline Zentiva, tell your doctor or pharmacist if any of the following situations apply to you currently or have applied in the past:

If the patient has epilepsy or a history of seizures. If a seizure (convulsion) occurs, contact a doctor immediately.
A history of bipolar disorder (manic depression) or schizophrenia. If a manic episode occurs, contact a doctor immediately.
Current or past suicidal thoughts (see below – suicidal thoughts and worsening of depression or anxiety disorders).
If the patient has serotonin syndrome, a potentially life-threatening condition. In rare cases, this syndrome may occur in patients taking other medicines at the same time as sertraline (see Sertraline Zentiva and other medicines). (Symptoms, see section 4. Possible side effects). The doctor should inform the patient whether serotonin syndrome has occurred in the past.
Low sodium levels in the blood, which may occur as a result of taking Sertraline Zentiva. You should also inform your doctor if you are taking medicines used to treat high blood pressure, as these may also affect sodium levels in the blood.
If the patient is elderly, they may be more susceptible to low sodium levels in the blood (see above).
If the patient has liver disease; the doctor may decide to reduce the dose of Sertraline Zentiva.
If the patient has diabetes; Sertraline Zentiva may affect blood glucose levels, so a change in dosage of antidiabetic medicines may be necessary.
If the patient has bleeding disorders or if the patient is pregnant (see: “Pregnancy”) or has previously taken medicines that reduce blood clotting (e.g. acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding.
If the patient is under 18 years of age. Sertraline Zentiva may be used in children and adolescents aged 6 to 17 years only for the treatment of obsessive-compulsive disorder. Patients being treated for this condition should be closely monitored by a doctor (see below “Children and adolescents”).
If the patient is undergoing electroconvulsive therapy (ECT).
If the patient has eye problems, such as certain types of glaucoma (increased pressure in the eye).
If the patient has abnormalities on ECG, known as prolonged QT interval.
If the patient has heart disease, low potassium or magnesium levels, a family history of prolonged QTc interval, slow heart rate, or is taking other medicines that prolong the QTc interval.

Psychomotor agitation/akathisia
Sertraline has been associated with the development of a condition characterised by motor restlessness and an urge to move – often with an inability to sit or stand still (akathisia). This condition usually occurs during the first weeks of treatment. Contact your doctor if the dose of the medicine is increased, as this may be harmful in patients experiencing such symptoms.

Withdrawal symptoms
After stopping treatment, unwanted effects (withdrawal symptoms) often occur, especially if treatment is stopped abruptly (see section 3. Stopping Sertraline Zentiva and section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dose, and speed of dose reduction. These symptoms are usually mild or moderate in intensity, but in some patients may be severe. They usually occur within the first few days after stopping treatment. They usually resolve spontaneously within 2 weeks, but in some patients may persist longer (2–3 months or more). If a decision is made to discontinue sertraline treatment, gradual dose reduction over several weeks or months is recommended, and the best way to stop treatment should be discussed with a doctor.

Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such thoughts or behaviours may increase at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks to start working, sometimes longer.

The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

the patient has previously had suicidal thoughts or self-harm tendencies;
the patient is a young adult; clinical data indicate an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders who are being treated with antidepressants.

If the patient has suicidal thoughts or thoughts of self-harm, they should contact a doctor immediately or go to hospital. It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask for help from family or friends and ask them to inform the patient if they notice that depression or anxiety has worsened or if there are disturbing changes in behaviour.

Sexual dysfunction
Medicines such as Sertraline Zentiva (SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.

Children and adolescents
Sertraline should generally not be used in children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder (OCD). In patients under 18 years of age, an increased risk of adverse reactions such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostility (mainly aggressive, defiant and angry behaviours) has been observed during treatment with medicines from this group. However, a doctor may decide to prescribe Sertraline Zentiva to a patient under 18 years of age if it is in the patient's best interest. If a doctor prescribes Sertraline Zentiva and the patient is under 18 years of age, and the child's caregiver wishes to discuss this, contact the doctor. Furthermore, if any of the symptoms listed above appear or worsen during treatment with Sertraline Zentiva in a patient under 18 years of age, the doctor should be informed. In addition, the long-term safety of Sertraline Zentiva with regard to its effect on growth, maturation, learning (cognitive functions), and behaviour in this age group has not been established.

Sertraline Zentiva and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect the way Sertraline Zentiva works, or Sertraline Zentiva may reduce the effectiveness of other medicines taken at the same time.
Taking Sertraline Zentiva together with the following medicines may cause serious side effects:

Monoamine oxidase inhibitors (MAO inhibitors), e.g. moclobemide (used to treat depression), selegiline (used to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methemoglobin in the blood). Do not take Sertraline Zentiva together with MAO inhibitors.
Medicines used to treat psychiatric disorders such as psychosis (pimozide). Do not take Sertraline Zentiva together with pimozide.
Medicines used in opioid substitution therapy for opioid dependence (such as buprenorphine). Medicines containing buprenorphine may interact with Sertraline Zentiva and may lead to serotonin syndrome, a potentially life-threatening condition. The patient may experience symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle stiffness, body temperature above 38°C. If such symptoms occur, contact a doctor.

The patient should inform the doctor if they are taking any of the following medicines or herbal remedies:

Medicines containing amphetamine (used to treat ADHD – Attention Deficit Hyperactivity Disorder, narcolepsy and obesity).
Herbal remedies containing St John's wort (Hypericum perforatum). The effect of St John's wort may persist for 1–2 weeks.
Products containing the amino acid tryptophan.
Metamizole, a medicine used to treat pain and fever.
Medicines used to treat severe pain (e.g. tramadol).
Medicines used in anaesthesia or for treating chronic pain (fentanyl, mivacurium and suxamethonium).
Medicines used to treat migraine (e.g. sumatriptan).
Medicines that prevent blood clotting (warfarin).
Medicines used to treat joint pain/inflammation (non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, salicylic acid (aspirin)).
Sedatives (diazepam).
Diuretics (so-called water tablets).
Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines used to treat diabetes (tolbutamide).
Medicines used to treat excessive stomach acid secretion, peptic ulcer disease and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
Medicines used to treat mania and depression (lithium).
Other medicines used to treat depression (e.g. amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines used to treat schizophrenia and other psychiatric disorders (such as perphenazine, levomepromazine and olanzapine).
Medicines used to treat high blood pressure, chest pain or to regulate heart rate and rhythm (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 infection and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
Medicines used to prevent nausea and vomiting after chemotherapy (aprepitant).
Medicines that increase the risk of changes in the electrical activity of the heart (e.g. antipsychotics and antibiotics).

Sertraline Zentiva with food, drink and alcohol
Sertraline Zentiva can be taken with or without food.
During treatment with Sertraline Zentiva, alcohol should be avoided.
Do not take Sertraline Zentiva together with grapefruit juice, as this may lead to increased levels of sertraline in the body.

Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
The safety of sertraline use in pregnant women has not been fully established. The medicine may be used in pregnant women only if, in the doctor's opinion, the benefits to the mother outweigh the potential risks to the developing foetus. Women of childbearing potential who are taking sertraline should use a reliable method of contraception (e.g. oral contraceptive pill).

Taking Sertraline Zentiva towards the end of pregnancy may increase the risk of serious vaginal bleeding occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Sertraline Zentiva, she should inform her doctor or midwife so that appropriate advice can be given.
Inform the midwife or doctor about the use of Sertraline Zentiva. Taking medicines such as Sertraline Zentiva during pregnancy, particularly in the third trimester, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes faster and turns blue. These symptoms usually appear within the first day of life. If the baby shows any of the above symptoms, contact the midwife or doctor immediately.

Other conditions/complications may also occur in the newborn, which usually appear within the first 24 hours after birth. Symptoms may include:

difficulty breathing,
cold or hot skin,
blue lips,
vomiting or inability to suckle properly,
extreme tiredness, insomnia or constant crying,
increased or decreased muscle tone,
tremor, muscle twitching or convulsions,
increased reflexes,
irritability,
low blood sugar levels.

If the baby shows any of the above symptoms after birth, or if the mother has any doubts about the baby's health, contact a doctor or midwife immediately for appropriate advice.

There is evidence that sertraline passes into breast milk. The medicine may be used in women who are breastfeeding if, in the doctor's opinion, the benefits to the mother outweigh the potential risks to the infant.

Some medicines, such as sertraline, may reduce semen quality in animal studies. This may theoretically affect fertility, but no effect on fertility in humans has been demonstrated to date.

Driving and operating machinery
Psychotropic medicines such as sertraline may affect the ability to drive or operate machinery. Wait until you know how Sertraline Zentiva affects your ability before performing the above activities.

Sertraline Zentiva contains lactose and sodium
If the patient has been informed by a doctor that they have an intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Sertraline Zentiva

This medicine should always be taken exactly as prescribed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Recommended dose of Sertraline Zentiva:
Adults
Depression and obsessive-compulsive disorder (OCD)
The usual effective dose in the treatment of depression and OCD is 50 mg once daily. The daily dose may be increased gradually by 50 mg at intervals of at least one week over several weeks. The maximum recommended dose is 200 mg per day.
Panic disorder, social anxiety disorder, and post-traumatic stress disorder
Treatment of panic disorder, social anxiety disorder, and post-traumatic stress disorder should be initiated at a dose of 25 mg/day, increasing after one week to 50 mg once daily.
The daily dose may then be increased gradually by 50 mg at a time over several weeks. The maximum recommended dose is 200 mg per day.
Use in children and adolescents
Sertraline Zentiva may be used in the treatment of children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD).
Obsessive-compulsive disorder
Children aged 6 to 12 years: the recommended starting dose is 25 mg once daily. After one week, the doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.
Adolescents aged 13 to 17 years: the recommended starting dose is 50 mg once daily. The maximum dose is 200 mg per day.
Patients with liver or kidney disease should inform their doctor and follow medical advice.
Method of administration:
Take the medicine once daily, in the morning or evening. Sertraline Zentiva tablets may be taken with or without food.
Your doctor will inform you how long you should take the medicine. The duration of treatment depends on the type of illness and your response to treatment. Improvement may take several weeks. Treatment for depression should usually continue for 6 months after improvement is observed.
If you take more Sertraline Zentiva than you should
If you accidentally take too much Sertraline Zentiva, contact your doctor immediately or go to the nearest hospital. Take the medicine packaging with you, regardless of whether any medicine remains.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremor, agitation, dizziness, and rarely loss of consciousness.
If you forget to take Sertraline Zentiva
Do not take a double dose to make up for a missed dose.
If you miss a dose, do not take the missed tablet. Take the next tablet at the usual time.
Stopping Sertraline Zentiva
Do not stop taking Sertraline Zentiva without first consulting your doctor.
Your doctor should gradually reduce the dose of Sertraline Zentiva over a period of several weeks before stopping completely.
Suddenly stopping the medicine may cause unwanted effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and muscle tremors (see section 2, withdrawal symptoms). If you experience any of these or other unwanted effects while discontinuing Sertraline Zentiva, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most commonly occurring adverse reaction is nausea. Adverse reactions depend on
dose and often subside as treatment continues.
You should inform your doctor immediately if any of the following symptoms occur in the patient
after taking this medicine, as they may be serious:
If the patient develops a severe skin rash causing blisters (erythema multiforme; blisters may appear
in the mouth and on the tongue). These may be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN – toxic epidermal necrolysis). In such cases, the doctor will discontinue treatment.
If the patient experiences an allergic reaction or allergy, with symptoms such as: itchy skin rash,
breathing difficulties, wheezing, eyelid, facial or lip swelling.
If the patient experiences: agitation, confusion, diarrhoea, high body temperature and high blood pressure, excessive sweating and rapid heartbeat. These are symptoms of serotonin syndrome. In rare cases, this syndrome may occur when the patient is taking certain medicines at the same time as sertraline. The doctor may then discontinue the patient's treatment.
If the patient develops yellowing of the skin and eyes, which may indicate liver damage.
If the patient experiences symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
If, after starting treatment with Sertraline Zentiva, the patient begins to feel inner restlessness and is unable to sit or stand still. If the patient starts to feel restless, they should inform their doctor.
If the patient experiences a seizure.
If the patient experiences manic episodes (see section 2. Warnings and precautions).
Following the introduction of sertraline into clinical use, the following adverse reactions have been observed in clinical studies in adult patients:
Very common (may occur in more than 1 in 10 patients):

insomnia, dizziness, somnolence, headache, diarrhoea, nausea, dry mouth, ejaculation disorders, fatigue.

Common (may occur in 1 in 10 patients):
common cold, sore throat, nasal congestion;
loss of appetite, increased appetite;
anxiety, depression, nervous agitation, decreased interest in sex, nervousness, unusual feelings, nightmares, teeth grinding;
tremor, muscle movement problems (such as increased mobility, increased muscle tension, difficulty walking and stiffness, twitching (muscle contractions without affecting normal movement), involuntary muscle movements)*, tingling and numbness, difficulty concentrating, taste disturbances;
visual disturbances;
tinnitus;
palpitations;
hot flushes;
yawning;
gastrointestinal discomfort, constipation, abdominal pain, vomiting, flatulence,
increased sweating, skin rash;
back pain, joint pain, muscle pain;
irregular menstruation, erectile dysfunction;
general malaise, chest pain, weakness, fever;
weight gain,
injuries.
Uncommon (may occur in 1 in 100 patients):
intestinal disorders, ear infection;
tumour,
hypersensitivity, seasonal allergy;
decreased blood concentration of thyroid hormones;
suicidal thoughts, suicidal behaviour*, psychotic disorders, thought disturbances,
unwarrantable worry, hallucinations, aggression, euphoria, paranoia;
memory loss, emotional blunting, involuntary muscle contractions, fainting, increased mobility,
migraine, seizures, dizziness upon standing, coordination disturbances, speech disorders,
dilated pupils;
ear pain,
rapid heartbeat, heart problems,
bleeding (such as gastrointestinal bleeding)*, high blood pressure, hot flushes,
blood in urine;
shortness of breath, nosebleeds, breathing difficulties, possible wheezing;
blood in stool, dental disorders, oesophagitis, tongue disorders, haemorrhoids,
increased salivation, difficulty swallowing, belching, difficulty moving the tongue;
eyelid swelling, urticaria, hair loss, itching, purpuric skin spots, skin disorders with blister formation, dry skin, facial swelling, cold sweats,
osteoarthritis, muscle tremor, muscle cramps*, muscle weakness,
increased frequency of urination, urinary difficulties, inability to urinate, urinary incontinence, increased urine output, nocturnal urination,
sexual disorders, increased menstrual bleeding, vaginal bleeding, sexual dysfunction in women;
leg swelling, chills, difficulty walking, thirst;
increased liver enzyme activity, weight loss.
Cases of suicidal thoughts and behaviours have been reported during treatment with sertraline or shortly after discontinuation (see section 2).
Rare (may occur in 1 in 1000 patients):
diverticulitis, lymph node swelling, decreased platelet count*,
decreased white blood cell count*;
severe allergic reaction;
endocrine disorders*;
elevated cholesterol levels, difficulty controlling blood glucose levels
(diabetes), decreased glucose levels, increased blood glucose levels*,
decreased blood sodium levels*;
physical symptoms caused by stress or emotions, frightening nightmares*,
drug dependence, sleepwalking, premature ejaculation;
coma, abnormal movements, difficulty moving, increased sensory sensitivity, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome, RCVS)*, sensory disturbances;
visual scotoma*, glaucoma*, double vision*, light-induced eye pain*,
blood in the eye*, unequal pupil size*, visual disturbances*, tearing problems*;
myocardial infarction, dizziness, fainting or chest discomfort, which may be symptoms of changes in the heart's electrical activity (visible on electrocardiogram) or abnormal heart rhythm*, bradycardia;
circulatory disorders in arms and legs;
rapid breathing, progressive lung tissue fibrosis (interstitial lung disease)*,
throat obstruction, speech difficulties, slowed breathing, hiccups;
oral ulceration, pancreatitis*, blood in stool, tongue ulceration, oral pain,
liver function disorders, severe liver dysfunction*, yellowing of the skin and whites of the eyes (jaundice)*,
skin reaction to sunlight*, skin swelling*, abnormal hair structure, abnormal skin odour, scalp rash;
rhabdomyolysis*, bone disorders,
inability to continuously pass urine, reduced urine output;
nipple discharge, vaginal dryness, vaginal discharge, penile and foreskin pain and redness, breast enlargement*, prolonged penile erection;
hernia, decreased drug tolerance;
increased blood cholesterol levels, abnormal laboratory test results*,
abnormal semen analysis results, blood clotting problems*,
blood vessel dilation.
Frequency not known (cannot be estimated from available data):
bruxism*,
nocturnal enuresis*,
partial loss of vision*,
colitis (causing diarrhoea),
severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy" in section 2.
* Adverse reactions reported after sertraline was placed on the market.
Additional adverse reactions in children and adolescents
In clinical studies involving children and adolescents, adverse reactions were generally similar
to those occurring in adults (see above). The most commonly occurring adverse reactions in children and adolescents were: headache, insomnia, diarrhoea and nausea.
Symptoms occurring after discontinuation
After abrupt discontinuation of the medicine, adverse reactions such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and muscle tremors may occur (see section 3. Discontinuing treatment with Sertraline Zentiva).
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Sertraline Zentiva

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Sertraline Zentiva coated tablets contain

The active substance is sertraline. Sertraline Zentiva 25 mg, coated tablets: Each coated tablet contains sertraline hydrochloride equivalent to 25 mg of sertraline.
Other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose (PH-102), povidone K-30, sodium croscarmellose, magnesium stearate. Coating: hypromellose 2910/5, macrogol 400, titanium dioxide (E171), talc.

What Sertraline Zentiva looks like and contents of the pack
Sertraline Zentiva 25 mg, coated tablets: white or almost white, round, biconvex coated tablets with a diameter of 6.0 mm ± 0.5 mm.
The tablets are packed in transparent PVC/PVDC/Aluminium blisters, placed in a cardboard box.
Pack sizes: 28, 30, 98, 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer
Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
S.C. Zentiva S.A., B-dul Theodor Pallady nr. 50, sector 3, Bucharest, 032266, Romania

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark, Czech Republic, Sweden: Sertralin Zentiva
Poland, Slovakia: Sertraline Zentiva
Romania: Sertralină Zentiva

For further information about this medicinal product, please contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 (22) 375 92 00