Patient Information Leaflet: Information for the User

Sertralina EG STADA 50 mg film-coated tablets, 100 mg film-coated tablets

Generic Medicine
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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Sertralina EG STADA is and what it is used for

Sertralina EG STADA contains the active substance sertraline. Sertraline belongs to a group of
medicines known as Selective Serotonin Reuptake Inhibitors (SSRIs); these medicines
are used to treat depression and/or anxiety disorders.
Sertralina EG STADA 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 one used to.
OCD and panic disorder are anxiety-related illnesses with symptoms such as persistent, intrusive worries (obsessions) leading to ritualistic behaviours (compulsions).
PTSD is a condition that may occur following an emotionally traumatic experience, and some of its symptoms resemble those of depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterised by intense anxiety or stress 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 EG STADA has been prescribed for you.

2. What you need to know before taking Sertralina EG STADA

Do not take Sertralina EG STADA:

If you are allergic (hypersensitive) to sertraline or to any of the other ingredients of this medicine (listed in section 6).
If you are currently taking, or have recently taken, medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide), or medicines with MAOI-like activity (such as linezolid). If you stop treatment with sertraline, you must wait one week before starting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least 2 weeks before starting treatment with sertraline.
If you are taking another medicine called pimozide (a medicine used for mental disorders such as psychosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sertralina EG STADA.
Medicines are not always suitable for everyone. Inform your doctor before taking Sertralina EG STADA if you suffer or have previously suffered from any of the following conditions:

If you suffer from serotonin syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline (for symptoms, see section 4. Possible side effects). Your doctor will tell 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 EG STADA. 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 may be at increased risk of low sodium levels in the blood (see above).
If you suffer from liver disease: your doctor may decide to prescribe you a lower dose of Sertralina EG STADA.
If you suffer from diabetes: blood glucose levels may be altered due to treatment with Sertralina EG STADA, and it may be necessary to adjust the dose of your diabetes medicines.
If you suffer from epilepsy (seizures) or have a history of seizures. If you experience a seizure, contact your doctor immediately.
If you have suffered from bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
If you are having or have ever had thoughts of harming or killing yourself (see below – Suicidal thoughts and worsening of depression or anxiety disorder).
If you have a history of bleeding problems (tendency to bleed or bruise easily), or if you are taking medicines that thin the blood (e.g. acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
Children or adolescents under 18 years of age. Sertralina EG STADA 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 found to have an abnormality in your heart trace on an electrocardiogram (ECG) known as QT interval prolongation.
If you have heart disease, low potassium or magnesium levels, a family history of QT interval prolongation, slow heart rate, or are taking other medicines that prolong the QT interval.

Restlessness/Akathisia
The use of sertraline has been associated with akathisia (distressing restlessness and a need to move, often associated with an inability to sit still). 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 reaction
Withdrawal reactions that occur when stopping the medicine are common, particularly if treatment is stopped suddenly (see section 3 If you stop taking Sertralina EG STADA and section 4 Possible side effects). The risk of withdrawal reactions depends on the duration of treatment, the dose, 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. In general, these symptoms resolve on their own 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 several weeks or months, depending on the individual patient’s needs.
Always talk to your doctor to determine 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 have thoughts of harming or killing yourself. These thoughts may worsen when starting 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 have thoughts of harming or killing yourself, contact your doctor or go immediately to the nearest hospital.
It may be helpful to inform a close family member or friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them to monitor whether your depression or anxiety disorder is worsening, or whether they are concerned about changes in your behaviour.
Sexual problems:
Medicines such as Sertralina EG STADA (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have been observed to persist after discontinuation of treatment.
Children and adolescents
Sertraline should not normally be used in children and adolescents under 18 years of age, except for patients with Obsessive-Compulsive Disorder (OCD). Patients under 18 years of age have an increased 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 EG STADA to a patient under 18 years of age if this is in the patient’s best interest. If your doctor has prescribed Sertralina EG STADA to you and you are under 18 years of age and wish to discuss this decision with your doctor, please contact them. In addition, if any of the symptoms listed above develop or worsen while a patient under 18 years of age is being treated with Sertralina EG STADA, you must inform the doctor.
Finally, the long-term safety of Sertralina EG STADA on growth, maturation, learning ability (cognitive development), and behavioural development was evaluated in a long-term study involving more than 900 children aged between 6 and 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 EG STADA
Inform your doctor if you are taking or have recently taken any other medicines, including those without a prescription.
Some medicines may affect the activity of Sertralina EG STADA, or Sertralina EG STADA may reduce the effectiveness of other medicines taken at the same time.
Taking Sertralina EG STADA with the following medicines may cause serious adverse events:

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 EG STADA together with these medicines.
Medicines for the treatment of mental disorders such as psychosis (pimozide). Do not use Sertralina EG STADA together with pimozide.

Inform 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. Discuss this with your doctor.
Products containing the amino acid tryptophan.
Medicines for the treatment of severe or chronic pain (opioids such as tramadol, fentanyl).
Medicines used in 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 (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
Sedatives (diazepam).
Diuretics.
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).
Metamizole, a medicine used to treat pain and fever.
Medicines used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, and 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 (e.g. certain antipsychotics and antibiotics).

Sertralina EG STADA with food, drinks and alcohol
Sertralina EG STADA tablets may be taken with or without food.
Alcohol consumption should be avoided during treatment with Sertralina EG STADA.
Sertraline should not be taken with grapefruit juice, as this may increase levels 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 or pharmacist before taking this medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline should only be given to pregnant women if your doctor considers that the benefit to the mother outweighs any possible risk to the developing baby. Women of childbearing potential should use an adequate method of contraception while being treated with sertraline.
Ensure that your midwife and/or doctor know that you are taking Sertralina EG STADA. If taken during pregnancy, particularly during the last 3 months of pregnancy, medicines like Sertralina EG STADA may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you take Sertralina EG STADA 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 EG STADA so they can advise you on what to do.
Your baby may also experience other conditions, which usually begin within the first 24 hours after birth.
Symptoms include:

Breathing difficulties,
Bluish skin or being too hot or too cold,
Bluish lips,
Vomiting or feeding difficulties,
Being very tired, unable to sleep or crying excessively,
Stiff or floppy muscles,
Tremors, nervousness, jerks,
Increased reflex responses,
Irritability,
Low blood sugar.

If your baby shows any of the symptoms listed above at birth, or if you have any concerns about your baby’s health, contact your doctor or midwife, who will be able to advise you.
There is evidence that sertraline is excreted in human breast milk. Sertraline should only be used during breastfeeding if your doctor considers that the benefit to the mother outweighs any possible risk to the baby.
Fertility
In animal studies, some medicines like 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 sertraline may affect your ability to drive or use machinery. Therefore, do not drive or operate machinery until you know how this medicine affects your ability to perform these activities.
Sertralina EG STADA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Sertralina EG STADA

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:
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 one week over several 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
start at a dose of 25 mg/day, then increased to 50 mg/day after one week.
The daily dose may then be increased by 50 mg over several weeks. The maximum
recommended dose is 200 mg/day.
Use in children and adolescents:
Sertralina EG STADA should only be used to treat children and adolescents aged
6 to 17 years with Obsessive-Compulsive Disorder (OCD).
Obsessive-Compulsive Disorder:
Children aged 6-12 years: the recommended initial dose is 25 mg/day.
After one 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 initial 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 given by your doctor.
Method of administration
Sertralina EG STADA tablets can 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 continue taking this medicine. This depends on the duration of
the illness and your response to treatment. It may take several weeks before symptoms
begin to improve. Treatment for depression should usually continue for 6 months after improvement is observed.
If you take more Sertralina EG STADA than you should
If you accidentally take too much Sertralina EG STADA, contact your doctor immediately or go to the
nearest emergency room. Always take the medicine pack with you, whether or not it still contains tablets.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat,
tremor, agitation, dizziness, and in rare cases, loss of consciousness.
If you forget to take Sertralina EG STADA
If you forget to take a dose, do not take the missed dose. Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
If you stop taking Sertralina EG STADA
Do not stop taking Sertralina EG STADA unless your doctor tells you to.
Your doctor may wish to gradually reduce the dose of Sertralina EG STADA over
several weeks before stopping treatment 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 side effects during treatment with Sertralina EG STADA, talk to your
doctor.
If you have any questions about how to use Sertralina EG STADA, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
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 they may be serious:

If you develop a severe skin reaction causing blistering (erythema multiforme), which may affect the mouth and tongue. These may be signs of a condition known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis. In such cases, your doctor will stop treatment.
Allergic reactions or allergies, which may include symptoms such as an itchy rash, breathing difficulties, 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 of suicide (suicidal thoughts).
If you start feeling restless and unable to sit or stand still after starting treatment with Sertralina EG STADA. You must inform your doctor if you begin to feel restless.
If you have seizures.
If you experience a manic episode (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 side effects (may affect more than 1 in 10 people):
Insomnia, dizziness, drowsiness, headache, diarrhoea, feeling unwell (nausea), dry mouth, absence of ejaculation, fatigue.

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

bronchitis, sore throat, runny nose,
anorexia, increased appetite, decreased appetite,
depression, feeling strange, nightmares, anxiety, agitation, nervousness, reduced sexual desire, teeth grinding,
numbness and tingling, tremors, movement disorders (such as frequent movements, tense muscles, difficulty walking and stiffness, spasms and involuntary muscle movements)*, muscle tension, altered taste, lack of attention,
visual disturbances,
ringing in the ears,
palpitations,
hot flushes,
yawning,
abdominal pain, vomiting, constipation, stomach discomfort, gas in the stomach,
rash, increased sweating,
muscle pain, back pain, joint pain,
sexual dysfunction, erectile dysfunction, menstrual irregularities,
chest pain, malaise, weakness, fever,
weight gain,
injuries.

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

cold chest,
intestinal problems,
cancer,
hypersensitivity, seasonal allergy,
low levels of thyroid hormones,
suicidal thoughts, suicidal behaviour*, psychotic disorders, hallucinations, euphoric mood, lack of personal care, altered thinking, paranoia, aggression,
seizures, involuntary muscle contractions, coordination disturbances, fainting, excessive movements, amnesia, reduced sensations, speech disorders, dizziness upon standing, migraine,
pupil dilation,
ear infections and ear pain,
rapid heartbeat, heart problems,
bleeding problems (such as stomach bleeding)*, high blood pressure, facial flushing, blood in urine,
difficulty breathing, possible wheezing, shortness of breath, nosebleeds, oesophageal problems, difficulty swallowing, haemorrhoids, increased salivation, tongue disorders, burping, dental problems, tarry stools,
eye swelling, development of purplish spots on the skin, skin problems with blister formation, itching, hair loss, cold sweats, dry skin, hives, facial oedema,
osteoarthritis, muscle weakness, muscle contractions, muscle cramps*,
nocturnal urination, inability to urinate, increased urine volume, increased frequency of urination, urinary problems, urinary incontinence,
vaginal bleeding, excessive vaginal bleeding, female sexual dysfunction,
leg swelling, chills, thirst,
weight loss, increased liver enzyme levels. 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 side effects (may affect up to 1 in 1,000 people):

diverticulitis, swollen glands, reduced number of blood clotting cells*, reduced number of white blood cells*,
severe allergic reaction,
endocrine problems*,
high blood cholesterol levels, problems controlling blood sugar levels (diabetes), low blood sugar levels, increased blood sugar levels*, low blood sodium levels*,
physical symptoms due to stress or emotions, disturbing nightmares*, drug dependence, sleepwalking, premature ejaculation,
coma, abnormal movements, difficulty moving, increased sensations, sudden severe headaches (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS))*, disturbances of consciousness,
development of spots on the eye, glaucoma, double vision (diplopia), discomfort caused by light (photophobia), blood collection in the anterior chamber of the eye (hyphaema), unequal pupil size*, altered vision*, tearing problems,
heart attack, feeling dizzy, fainting or chest pain, which could be signs of changes in the heart's electrical activity (as seen on electrocardiogram) or abnormal heart rhythm*, slow heartbeat,
poor blood circulation to arms and legs,
throat closure, rapid breathing, progressive scarring of lung tissue (Interstitial Lung Disease)*, slow breathing, difficulty speaking, hiccups,
a form of lung disease in which eosinophils (a type of white blood cells) are present in increased numbers in the lungs (eosinophilic pneumonia),
blood in stools, pancreatitis*, ulceration of the tongue, tongue problems, mouth ulceration, mouth pain,
liver function problems, severe liver function problems*, yellowing of the skin and eyes (jaundice)*,
skin reaction to sunlight*, skin oedema*, inflammation of hair follicles, changes in hair structure, altered skin odour,
muscle tissue breakdown*, bone disorders,
reduced urination, urinary hesitation,
dryness of the vaginal area, red and painful penis and foreskin, genital discharge, prolonged erection,
breast secretion, breast enlargement*,
hernia, reduced drug tolerance, changes in laboratory test results*, coagulation problems*, alteration of seminal fluid, blood vessel relaxation procedure.

Side effects not known (frequency cannot be estimated from available data):

jaw locking*,
enuresis*,
partial loss of vision,
inflammation of the colon (causing diarrhoea)*,
heavy vaginal bleeding shortly after childbirth (postpartum 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.

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 suddenly, you may experience side effects such as dizziness, tingling, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and tremor (see section 3 “If you stop taking Sertralina EG STADA”).

Other side effects
An increased risk of bone fractures has been observed in patients taking this type of medicine.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Sertraline EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
If taking half a 50 mg tablet, the unused half must be stored in the blister pack for use the following day.
This medicine requires no special storage conditions.
Do not dispose of any medicine 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 EG STADA contains:
The active substance is sertraline (as sertraline hydrochloride).
Each 50 mg tablet contains 55.95 mg of sertraline hydrochloride (equivalent to 50 mg of sertraline).
Each 100 mg tablet contains 111.90 mg of sertraline hydrochloride (equivalent to 100 mg of sertraline).
The other components are: calcium hydrogen phosphate, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate. Film-coating components: titanium dioxide (E171), hypromellose E3, hypromellose E5, macrogol 400, macrogol 6000, polysorbate 80.

Description of the appearance of Sertralina EG STADA and pack contents
Pack size: 30 film-coated tablets of 50 mg and 100 mg.
The 50 mg tablets are divisible.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan, Italy

Manufacturer responsible for batch release
DOPPEL FARMACEUTICI S.r.l., Via Volturno, 48 – Quinto de’ Stampi, 20089 Rozzano (MI)
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A., Via Grignano 43 – 24041 Brembate (BG)

This patient information leaflet was last approved on

Sertraline Eg Stada