Sertraline Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sertralina Zentiva 50 mg film-coated tablets, 100 mg film-coated tablets

Generic medicine
Please 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, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Sertralina Zentiva is and what it is used for.
2. What you need to know before taking Sertralina Zentiva.
3. How to take Sertralina Zentiva.
4. Possible side effects.
5. How to store Sertralina Zentiva.
6. Contents of the pack and other information.

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

The name of this medicine is Sertralina Zentiva 50 mg and 100 mg film-coated tablets, referred to as sertraline in the package leaflet. Sertralina Zentiva contains the active substance sertraline. Sertraline belongs to a group of medicines known as Selective Serotonin Re-uptake Inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.
Sertralina Zentiva can be used to treat the following conditions:

• 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 a clinical illness with symptoms such as feeling sad, inability to sleep properly, or to enjoy life as you used to.
OCD and Panic Disorder are anxiety-related illnesses with symptoms such as persistent, intrusive thoughts (obsessions) that lead you to perform ritualistic actions (compulsions).
PTSD is a condition that may occur after a strongly traumatic emotional experience, and some symptoms of this condition are similar to those of depression and anxiety. Social Anxiety Disorder (social phobia) is an anxiety-related illness. It is characterized by intense feelings of anxiety or distress in social situations (e.g. speaking to strangers, speaking in public, eating or drinking in front of others, or fear of behaving in an embarrassing way).
Your doctor has determined that this medicine is suitable for treating your condition.
Ask your doctor if you are unsure why Sertralina Zentiva has been prescribed for you.

2. What you should know before taking Sertralina Zentiva

Do not take Sertralina Zentiva if
you are allergic to sertraline or to any of the other ingredients of this medicine (listed in
section 6).
you are taking or have taken monoamine oxidase inhibitors (MAOIs) (e.g. selegiline,
moclobemide) or medicines with MAOI-like activity (such as linezolid). If you stop
treatment with sertraline, you must wait 1 week before restarting treatment with an
MAOI. After stopping treatment with an MAOI, you must wait at least 2 weeks before
starting treatment with sertraline.
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 Sertralina Zentiva.
Medicines are not always suitable for everyone. Talk to your doctor before taking Sertralina Zentiva if
you suffer or have previously suffered from any of the following conditions:
If you have epilepsy (seizures) or a history of convulsions. If you experience a seizure, contact
your doctor immediately.
If you have suffered from manic-depressive disorders (bipolar disorders) or schizophrenia. If you
experience a manic episode, contact your doctor immediately.
If you are thinking or have ever thought about harming yourself or committing suicide (see below –
suicidal thoughts and worsening of depression or anxiety disorder).
If you suffer from serotonin syndrome. In rare cases, this syndrome may occur when certain
medicines are taken together with sertraline and could be fatal (for symptoms, see section 4 and
“Other medicines and Sertralina Zentiva”). Your doctor will inform you if you have previously
experienced this condition.
If you have low levels of sodium in your blood, as this condition may occur as a result of
treatment with Sertralina Zentiva. You should also inform your doctor if you are taking certain
medicines for high blood pressure, as these medicines may also alter sodium levels in the
blood.
If you are elderly, as you are at higher risk of low sodium levels in the blood (see above).
If you have liver disease; your doctor may decide to prescribe you a lower dose of Sertralina
Zentiva.
If you have diabetes; glucose levels in the blood may be altered due to treatment with
Sertralina Zentiva, and it may be necessary to adjust the dose of your diabetes medicines.
If you have a history of bleeding problems (tendency to bruise easily), or if you are pregnant (see
“Pregnancy, breastfeeding and fertility”) or if you have taken medicines that thin the blood (e.g.
acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding.
Children or adolescents under 18 years of age. Sertralina Zentiva should only be used to treat
children and adolescents aged between 6 and 17 years who suffer from obsessive-compulsive
disorder (OCD). If the child or adolescent is being treated for this disorder, the doctor will want
to monitor them closely (see below “Children and adolescents”).
If you are undergoing electroconvulsive therapy (ECT).
If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
If you have been told you have an abnormality in your heart’s electrical pattern after an
electrocardiogram (ECG), known as QT interval prolongation.
If you have heart disease, have low potassium or magnesium levels, have a family history
of QT interval prolongation, have a slow heart rate, or are taking concomitant medicines
that prolong the QT interval.

Restlessness/Akathisia
Use of sertraline has been associated with distressing restlessness and an urge to move, often
accompanied by an inability to sit or remain still (akathisia). This condition is more likely to occur
during the first few weeks of treatment. Increasing the dose may be harmful for patients who develop
these symptoms; therefore, discuss this with your doctor.

Withdrawal reactions
Undesirable effects related to stopping treatment (withdrawal reactions) are common,
particularly if treatment is stopped suddenly (see section 3 “If you stop taking Sertralina Zentiva” and
section 4 Possible side effects). The risk of withdrawal reactions depends on the duration of treatment,
the dosage, and the extent of dose reduction.
Generally, these symptoms are mild to moderate in intensity; however, in some patients they may be
severe. They usually occur in the first few days after stopping treatment. Generally, these symptoms
resolve spontaneously within 2 weeks. In some patients, they may last longer (2-3 months or more).
When stopping treatment with sertraline, it is recommended to gradually reduce the dose over a period
of several weeks or months, and you should always discuss with your doctor the best way to stop
treatment.

Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you may sometimes think about harming yourself or
committing suicide.
These thoughts may worsen when you first start taking antidepressants, as all these
medicines take time to become effective, usually about 2 weeks but sometimes longer.
You are more likely to have such thoughts if:
you have previously thought about killing yourself or harming yourself.
you are a young adult. Available data from clinical trials have shown an increased risk of suicidal
behaviour in adults under 25 years of age with psychiatric conditions treated with an antidepressant.
If at any time you think about harming yourself or committing suicide, contact your doctor
or go immediately to the nearest hospital.
It may help to inform a close relative or friend that you are depressed or have an anxiety disorder
and ask them to read this leaflet. You may ask them to let you know if they think your depression
or anxiety disorder is worsening, or if they are concerned about changes in your behaviour.

Sexual problems
Medicines such as Sertralina Zentiva (so-called selective serotonin reuptake inhibitors (SSRIs) and
serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see
section 4). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents
Sertraline should not normally be used in children and adolescents under 18 years of age, except for
patients with OCD. Patients under 18 years of age have a higher risk of adverse effects, such as suicide
attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostile behaviour (mainly aggression,
oppositional behaviour and anger) when treated with this class of medicines. However, your doctor
may decide to prescribe Sertralina Zentiva to a patient under 18 years of age if this is in the patient’s best
interest. If your doctor has prescribed Sertralina Zentiva for you and you are under 18 years of age and
wish to discuss this decision, please contact your doctor. Furthermore, if any of the symptoms listed
above occur or worsen while you are being treated with Sertralina Zentiva, you must inform your doctor.
The long-term safety of Sertralina Zentiva on growth, maturation, learning ability (cognitive development),
and behavioural development has been evaluated in a long-term study involving more than 900
children aged 6 to 16 years who were monitored for a period of 3 years. Overall, the study results showed
that children treated with sertraline had normal development, except for a slight increase in weight in
those treated with a higher dose.

Other medicines and Sertralina Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Some medicines may affect the activity of Sertralina Zentiva, or Sertralina Zentiva may reduce the
effectiveness of other medicines taken at the same time.
Taking Sertralina Zentiva with the following medicines may cause serious side effects:

• Medicines called monoamine oxidase inhibitors (MAOIs), such as 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 Sertralina Zentiva with these medicines.
• Medicines for the treatment of mental disorders such as psychosis (pimozide). Do not use Sertralina Zentiva together with pimozide.

Tell your doctor if you are taking any of the following medicines:

• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Herbal medicines 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.
• Metamizole, a medicine used to treat pain and fever.
• Medicines for the treatment of severe or chronic pain (opioids such as tramadol, fentanyl).
• Medicines used for anaesthesia (e.g. fentanyl, mivacurium, and suxamethonium).
• Medicines for the treatment of migraine (e.g. sumatriptan).
• Medicines to thin the blood (warfarin).
• Medicines for the treatment of pain/arthritis (e.g. metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics (water tablets).
• Medicines for the treatment of epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines for the treatment of diabetes (tolbutamide).
• Medicines for the treatment of excess stomach acid, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines for the treatment of mania and depression (lithium).
• Other medicines for the treatment of depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines for the treatment of schizophrenia and other mental 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 and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medicines known to increase the risk of changes in the heart’s electrical activity (such as certain antipsychotics and antibiotics).

Serotonin syndrome
Taking certain medicines (e.g. other antidepressants or buprenorphine) together with
sertraline may cause symptoms such as involuntary rhythmic muscle contractions, including
muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating,
tremor, increased reflexes, increased muscle contraction, and fever above 38°C.
Contact your doctor if you experience such symptoms.

Sertralina Zentiva with food, drinks and alcohol
Sertralina Zentiva tablets may be taken with or without food.
Alcohol consumption should be avoided during treatment with Sertralina Zentiva.
Sertraline must not be taken together with grapefruit juice, as this may increase the level of sertraline in the body.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor before taking this medicine.
The safety of sertraline in pregnant women has not been fully established. Sertralina Zentiva will be
prescribed during pregnancy only if your doctor considers that the benefit to you outweighs any possible
risk to the unborn baby.
If you take Sertralina Zentiva near the end of pregnancy, there may be an increased risk of heavy vaginal
bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed easily). Inform
your doctor or midwife that you are taking Sertralina Zentiva so they can advise you on what to do.
Medicines such as Sertralina Zentiva, when taken during pregnancy, particularly during the last 3 months,
may increase the risk in newborns of a serious condition called persistent pulmonary hypertension of the
newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually begin
within the first 24 hours after birth. If this happens to your baby, you must contact the midwife and/or
doctor immediately.
The newborn baby may also experience other conditions that usually begin within the first 24 hours after
birth.
Symptoms include:

• Difficulty breathing,
• Bluish skin or being too hot or cold,
• Bluish lips,
• Vomiting or difficulty feeding,
• Being very tired, unable to sleep or crying excessively,
• Stiff or floppy muscles,
• Tremors, agitation or seizures,
• Increased reflexes,
• Irritability,
• Low blood sugar.

If your baby has any of these symptoms at birth or if you are concerned about your baby’s health,
contact your doctor or midwife for advice.
There is evidence that sertraline passes into breast milk. Sertralina Zentiva should only be used during
breastfeeding if your doctor considers that the benefit outweighs any possible risk to the baby.
In animal studies, some medicines such as sertraline may reduce sperm quality. In theory, this could
affect fertility, but the impact on human fertility has not yet been observed.

Driving and using machines
Psychotropic medicines such as Sertralina Zentiva may affect your ability to drive or use machinery.
Therefore, do not drive or use machinery until you are certain that this medicine does not affect your
ability to perform these activities.

Sertralina Zentiva contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Sertraline Zentiva

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, please consult your doctor or pharmacist.

Recommended dose:

Adults

• Depression and Obsessive-Compulsive Disorder (OCD): For depression and OCD, the usual effective dose is 50 mg/day. The daily dose may be increased by 50 mg at intervals of at least 1 week over several weeks. The maximum recommended dose is 200 mg/day.
• Panic Disorder, Social Anxiety Disorder and Post-Traumatic Stress Disorder (PTSD): For panic disorder, social anxiety disorder and PTSD, treatment should start at a dose of 25 mg/day, which should then be increased to 50 mg/day after 1 week. The daily dose may then be increased in increments of 50 mg over several weeks. The maximum recommended dose is 200 mg/day.

Children and adolescents
Sertraline Zentiva should only be used for the treatment of children and adolescents aged 6–17 years with Obsessive-Compulsive Disorder (OCD).

• Obsessive-Compulsive Disorder (OCD): Children aged 6–12 years: The recommended starting dose is 25 mg/day. After 1 week, your doctor may increase the dose to 50 mg/day. The maximum dose is 200 mg/day. Adolescents aged 13–17 years: The recommended starting dose is 50 mg/day. The maximum dose is 200 mg/day.

If you have liver or kidney problems, inform your doctor and follow the instructions provided by your doctor.

Method of administration
Sertraline Zentiva tablets may be taken with or without food.
Take the medicine once daily, in the morning or in the evening.
Your doctor will tell you how long you should take this medicine. This will depend on the nature of your condition and how well you respond to treatment. It may take several weeks before symptoms begin to improve. Treatment for depression should usually continue for 6 months after symptoms have improved.

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 emergency department. Always take the medicine pack with you, whether or not it still contains medicine.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and in rare cases, loss of consciousness.

If you forget to take Sertraline Zentiva
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. Take the next dose at the usual time.

If you stop taking Sertraline Zentiva
Do not stop taking Sertraline Zentiva unless your doctor tells you to. Your doctor may want to gradually reduce your dose of Sertraline Zentiva over several weeks before stopping completely. If you stop taking this medicine suddenly, you may experience unwanted effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and tremors. If you experience any of these unwanted effects, or any other unwanted effects during discontinuation of Sertraline Zentiva, speak to your doctor.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Nausea is the most common side effect. Side effects depend on the dose and often disappear or decrease with continued treatment.
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as these symptoms may be serious.

• If you develop a severe skin reaction causing blistering (erythema multiforme) (which may affect the mouth and tongue). These could be signs of a condition known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). In such cases, your doctor will stop treatment.
• Allergic reactions or allergies, which may include symptoms such as itchy rash, breathing problems, wheezing, swelling of the eyelids, face or lips.
• If you experience agitation, confusion, diarrhoea, high fever and high blood pressure, excessive sweating and rapid heartbeat. These are symptoms of Serotonin Syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline. Your doctor may decide to stop treatment.
• If you develop yellowing of the skin and eyes, which may indicate liver damage.
• If you develop depressive symptoms with thoughts of harming yourself or suicide (suicidal thoughts).
• If you start feeling restless and are no longer able to sit or stand still after starting treatment with Sertraline Zentiva. You must inform your doctor if you start feeling restless.
• If you have seizures (fits).
• If you experience episodes of mania (see section 2 “Warnings and precautions”).

The following side effects have been observed in clinical studies conducted in adult patients and after marketing authorization:

Very common (may affect more than 1 in 10 people):

• Insomnia,
• dizziness, drowsiness, headache,
• diarrhoea, feeling unwell, dry mouth,
• absence of ejaculation,
• fatigue.

Common (may affect up to 1 in 10 people):

• Bronchitis, sore throat, runny nose.
• Decreased appetite, increased appetite.
• Anxiety, depression, agitation, reduced sexual interest, nervousness, feeling strange, nightmares, teeth grinding.
• Tremor, muscle movement problems (such as frequent movements, tense muscles, difficulty walking, stiffness, spasms and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of attention, abnormal taste;
• Vision disturbances.
• Ringing in the ears.
• Palpitations.
• Hot flushes.
• Yawning.
• Stomach discomfort, constipation, abdominal pain, vomiting, gas in the stomach.
• Increased sweating, skin rash.
• Back pain, joint pain, muscle pain.
• Menstrual irregularities, erectile dysfunction.
• Malaise, chest pain, weakness, fever.
• Weight gain.
• Injuries.

Uncommon (may affect up to 1 in 100 people):

• Gastroenteritis, ear infection.
• Tumour.
• Hypersensitivity, seasonal allergy.
• Low thyroid hormone.
• Suicidal thoughts, suicidal behaviour*, psychotic disorders, altered thinking, lack of self-care, hallucinations, aggression, excessive feeling of happiness, paranoia.
• Amnesia, reduced sensations, involuntary muscle contractions, fainting, excessive movements, migraine, seizures, dizziness upon standing, coordination disturbances, speech disorders;
• Pupil dilation.
• Ear pain.
• Rapid heartbeat, heart problems.
• Bleeding problems (such as stomach bleeding)*, high blood pressure, facial flushing, blood in urine.
• Shortness of breath, nosebleeds, breathing difficulties, possible wheezing,
• Tarry stools, dental problems, oesophagitis, tongue problems, haemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders.
• Swelling of the eyes, urticaria, hair loss, itching, development of red spots on the skin, skin problems with blister formation, dry skin, facial oedema, cold sweats.
• Osteoarthritis, muscle contractions, muscle cramps*, muscle weakness;
• Increased frequency of urination, difficulty urinating, inability to urinate, urinary incontinence, increased urine volume, nocturnal urination.
• Sexual dysfunction, excessive vaginal bleeding, vaginal haemorrhage, female sexual dysfunction.
• Swelling of the legs, chills, difficulty walking, thirst.
• Increased liver enzymes, weight loss.
• Cases of suicidal ideation and suicidal behaviour have been reported in patients treated with sertraline or immediately after discontinuation of treatment (see section 2).

Rare (may affect up to 1 in 1000 people):

• Diverticulitis, swollen lymph glands, reduction in the number of blood clotting cells *, reduction in white blood cell count *.
• Severe allergic reaction. Endocrine problems*.
• Elevated cholesterol levels, problems controlling blood sugar levels, low blood sugar, increased blood sugar*, low blood sodium levels*.
• Physical symptoms due to stress or emotions, altered frightening dreams*, drug dependence, sleepwalking, premature ejaculation.
• Coma, abnormal movements, difficulty moving, increased sensations, sudden severe headaches (which may be a sign of a serious condition such as Reversible Cerebral Vasoconstriction Syndrome (RCVS)*, disturbances of consciousness.
• Formation of spots on the eye, glaucoma, double vision, light sensitivity, presence of blood in the eye, unequal pupil size*, altered vision, tear production problems.
• Heart attack, sensation of empty head, fainting, heart problems, or chest pain, which may be signs of changes in heart activity (as seen on electrocardiogram) or abnormal heart rhythm*, slow heartbeat.
• Poor blood circulation to arms and legs.
• Rapid breathing, progressive scarring of lung tissue (Interstitial Lung Disease)*, closure of the throat, difficulty speaking, slow breathing, hiccups.
• A form of lung disease in which eosinophils (a type of white blood cell) appear in greater numbers in the lungs (eosinophilic pneumonia).
• Mouth ulceration, pancreatitis*, blood in stools, ulceration of the tongue, mouth pain.
• Liver function problems, severe liver function problems*, yellowing of the skin and eyes (jaundice)*;
• Skin reaction to sunlight*, cutaneous oedema*, alteration in hair structure, change in skin odour, inflammation of hair follicles.
• Rupture of muscle tissue*, bone disorders;
• Urinary hesitation; reduced urine output,
• Breast secretion, vaginal dryness, genital discharge, red and painful penis and foreskin, breast enlargement*, prolonged erection.
• Hernia, reduced drug tolerance.
• Increased blood cholesterol levels,
• Changes in laboratory test results*, alteration of seminal fluid.
• Coagulation disorders.
• Procedure of blood vessel relaxation.

Not known (frequency cannot be estimated from the available data):

• Jaw locking*;
• Bed-wetting*.
• Partial loss of vision;
• Inflammation of the colon (causing diarrhoea)*;
• Heavy vaginal bleeding immediately after childbirth (post-partum haemorrhage); see section 2 "Pregnancy, breastfeeding and fertility" for further information.
• Muscle weakness and severe muscle pain, which may be signs of a disorder similar to multiple acyl-coenzyme A dehydrogenase deficiency (MADD).

* Side effect reported after marketing authorization.
Additional side effects in children and adolescents
In clinical studies in children and adolescents, side effects were generally similar to those observed in adults (see above). The most common side effects in children and adolescents were headache, insomnia, diarrhoea and nausea.
Symptoms that may occur when treatment is stopped
If you stop taking this medicine abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, feeling unwell or sick, and restlessness (see section 3 “If you stop taking Sertraline Zentiva”).
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sertralina Zentiva

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Sertralina Zentiva after the expiry date stated on the packaging under "Exp.". The
expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sertralina Zentiva contains
Sertralina Zentiva tablets contain 50 mg or 100 mg of sertraline as the active substance.
The other components are: Monohydrate lactose, microcrystalline cellulose, povidone, sodium
croscarmellose, magnesium stearate, hypromellose, titanium dioxide (E 171), talc and propylene glycol.

Description of the appearance of Sertralina Zentiva and package contents
Sertralina Zentiva 50 mg film-coated tablets
Film-coated tablets of size 10 × 5 mm, white, oval, biconvex, with a score line on one side and an engraved "L" on the opposite side. The tablet can be divided into equal doses.

Sertralina Zentiva 100 mg film-coated tablets
Film-coated tablets of size 10 mm, white, round, biconvex, with a score line on one side and a "C" engraved on the opposite side. The score line is not intended for breaking the tablet.

This medicine is packaged in blisters containing 7, 14, 15, 20, 28, 30, 50, 60, 98 and 100 tablets.
Single-unit blisters containing 28, 30, 50, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturers
Marketing Authorization Holder
Zentiva Italia S.r.l., Via P. Paleocapa, 7, 20121 Milano, Italy

Manufacturer
S.C ZENTIVA S.A., 50 Theodor Pallady Blvd., district 3, code 032266 Bucharest, Romania

This medicinal product is authorized in the European Economic Area countries under the following names:

This leaflet was updated in November 2025