Package leaflet: Information for the user

Sertraline Aurobindo 50 mg film-coated tablets, 100 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start using 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Sertralina Aurobindo 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 Aurobindo 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 between
6 and 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 conditions with symptoms such as persistent, intrusive worries (obsessions) leading to ritualistic behaviors (compulsions).
PTSD is a condition that may occur following a strongly traumatic 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 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 Aurobindo has been prescribed for you.

2. What you should know before taking Sertraline Aurobindo

Do not take Sertraline Aurobindo: If you are allergic to sertraline or to any of the other ingredients of this medicine (see
section 6).
If you are taking or have 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 at least 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 for mental disorders such as psychosis).

Warnings and precautions: Talk to your doctor or pharmacist before taking Sertraline Aurobindo.
Medicines are not always suitable for everyone. Ask your doctor or pharmacist before using Sertraline Aurobindo if you have or have previously had any of the following conditions:
If you suffer from epilepsy or have a history of seizures. In case of a seizure (convulsion), contact your doctor immediately.
If you have suffered from manic-depressive disorders (bipolar disorders) or schizophrenia. In case of a manic episode, contact your doctor immediately.
If you have or have previously had suicidal thoughts (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 taking certain medicines together with sertraline (for symptoms, see section 4 Possible side effects). Your doctor will inform you if you have previously experienced this condition.
If you are taking medicines containing buprenorphine. The use of these medicines together with Sertraline Aurobindo may lead to serotonin syndrome, a condition that can be fatal (see “Other medicines and Sertraline Aurobindo”).
If you have low levels of sodium in the blood, as this condition may occur as a result of treatment with Sertraline Aurobindo. You should also inform your doctor if you are taking certain medicines for hypertension, 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 have liver disease: your doctor may decide to prescribe a lower dose of Sertraline Aurobindo.
If you have diabetes: blood glucose levels may be affected by treatment with Sertraline Aurobindo, and the dose of your diabetes medicines may need to be adjusted.
If you have a history of bleeding problems (tendency to bruise easily), or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”) 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.
Children or adolescents under 18 years of age. Sertraline Aurobindo should only be used to treat children and adolescents aged 6 to 17 years who suffer from obsessive-compulsive disorder (OCD). If a child or adolescent is being treated for this disorder, the doctor will monitor them closely (see below Use in 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 trace after 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 concomitant medicines that prolong the QT interval.

Sexual problems:
Medicines such as Sertraline Aurobindo (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 discontinuation of treatment.

Restlessness/Akathisia:
The use of sertraline has been associated with an anxious restlessness and urge to move, often associated with an inability to sit still or remain motionless (akathisia). This condition is more likely to occur during the first weeks of treatment. Increasing the dose may be harmful; if you develop these symptoms, speak to your doctor.

Withdrawal reaction:
Undesirable effects that occur when stopping the medicine are common, especially if treatment is stopped abruptly (see section 3 If you stop taking Sertraline Aurobindo and section 4 Possible side effects). The risk of withdrawal symptoms 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 a period of several weeks or months, and you should always discuss the best way to discontinue treatment with your doctor.

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 increase 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 think about harming yourself or committing suicide, contact your doctor or go immediately to the nearest hospital.
It may be helpful to inform a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them to observe whether your depression or anxiety disorder is worsening, or whether they are concerned about changes in your behaviour.

Children and adolescents:
Sertraline should not usually 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, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when treated with this class of medicines. However, your doctor may decide to prescribe Sertraline Aurobindo to a patient under 18 years of age if it is in the patient’s best interest. If your doctor has prescribed Sertraline Aurobindo to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor. Furthermore, if any of the symptoms listed above occur or worsen while a patient under 18 years of age is being treated with Sertraline Aurobindo, you must inform the doctor. The long-term safety of Sertraline Aurobindo 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 Sertraline Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the activity of Sertraline Aurobindo, or Sertraline Aurobindo may reduce the effectiveness of other medicines taken at the same time.
Taking Sertraline Aurobindo with the following medicines may cause serious adverse events:
Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for treating depression), selegiline (for treating Parkinson’s disease), the antibiotic linezolid, and methylene blue (for treating high levels of methaemoglobin in the blood). Do not use Sertraline Aurobindo together with these medicines.
Medicines for treating mental disorders such as psychosis (pimozide). Do not use Sertraline Aurobindo together with pimozide.
Some medicines may worsen the side effects of Sertraline Aurobindo and sometimes cause very serious reactions. Do not take other medicines during treatment with Sertraline Aurobindo without first consulting your doctor, especially medicines containing buprenorphine.
These medicines may interact with Sertraline Aurobindo and may cause symptoms such as involuntary and 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.

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 medicine containing St. John’s wort (Hypericum perforatum). The effects of St. John’s wort may last for at least 1–2 weeks.
Products containing the amino acid tryptophan.
Medicines for treating severe or chronic pain (opioids such as tramadol, fentanyl) and opioid dependence (buprenorphine).
Medicines used in anaesthesia (fentanyl, mivacurium, and suxamethonium).
Medicines for treating migraine (e.g. sumatriptan).
Medicines to thin the blood (warfarin).
Medicines for treating pain/arthritis (e.g. metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
Sedatives (diazepam).
Diuretics.
Medicines for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines for treating diabetes (tolbutamide).
Medicines for treating excess stomach acid, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
Medicines for treating mania and depression (lithium).
Other medicines for treating depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines for treating schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
Medicines used to treat 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 fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole).
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 during chemotherapy (aprepitant).
Medicines known to increase the risk of changes in the heart’s electrical activity (e.g. certain antipsychotics and antibiotics).
Metamizole, a medicine used to treat pain and fever.

Sertraline Aurobindo with food and drinks:
Sertraline Aurobindo tablets can be taken with or without food.
Alcohol consumption should be avoided during treatment with Sertraline Aurobindo.
Sertraline must not be taken together with grapefruit juice, as this may increase the level of sertraline in your 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 fetus.
If you take Sertraline Aurobindo 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 Sertraline Aurobindo so they can advise you on what to do. Medicines such as Sertraline Aurobindo, if taken during pregnancy, particularly during the last 3 months of pregnancy, may increase the risk of a serious condition in newborns 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 occurs with your baby, you must contact your midwife and/or doctor immediately.
Your newborn may also have other conditions, which usually begin within the first 24 hours after birth. Symptoms include:

difficulty breathing,
bluish, too hot, or too cold skin,
blue lips,
vomiting or feeding problems,
being very tired, unable to sleep, or crying a lot,
swollen or floppy muscles,
tremors, agitation, or seizures,
increased reflex responses,
irritability,
low blood sugar.

If your baby shows any of these symptoms at birth, or if 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 is excreted in 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 infant.
In animal studies, some medicines such as sertraline may reduce sperm quality. In theory, this could affect fertility, but an 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 you.

Sertraline Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Sertraline Aurobindo

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, 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 one 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, 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.
Children and adolescents:
Sertraline Aurobindo 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 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 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 given by your doctor.
Method of administration:
Sertraline Aurobindo 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 take this medicine. This will depend 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.
If you take more Sertraline Aurobindo than you should:
If you accidentally take too much Sertraline Aurobindo, contact your doctor immediately or go to the nearest emergency department. Always carry 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 Aurobindo:
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 forgotten dose.
If you stop taking Sertraline Aurobindo:
Do not stop taking Sertraline Aurobindo unless instructed by your doctor. Your doctor may wish to gradually reduce the dose of Sertraline Aurobindo 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, feeling unwell, and tremors. If you experience any of these unwanted effects, or any other side effects during treatment, stop taking Sertraline Aurobindo and 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.
Tell your doctor immediately:
If you experience any of the following symptoms after taking this medicine, these symptoms may be serious.

If you develop a severe skin rash 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 (TEN). In these 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 taking certain medicines 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 can no longer sit still or remain motionless after starting treatment with Sertralina Aurobindo. You must inform your doctor if you start feeling restless.
If you have seizures.
If a manic episode occurs (see section 2 “Warnings and precautions”).

The following side effects have been observed in clinical studies conducted in adult patients and after marketing authorisation:
Very common (may affect more than 1 in 10 people):

insomnia, dizziness, drowsiness, headache, diarrhoea, feeling unwell, dry mouth, ejaculation failure, fatigue.

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

bronchitis, sore throat, runny nose;
decreased appetite, increased appetite;
anxiety, depression, agitation, reduced sexual desire, nervousness, feeling strange, nightmares, teeth grinding;
tremor, movement disorders (such as frequent movements, tense muscles, difficulty walking, stiffness, spasms and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of attention, altered taste;
visual 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):

bowel problems, ear infections;
tumour;
hypersensitivity, seasonal allergy;
low levels of thyroid hormones;
suicidal thoughts, suicidal behaviour*, psychotic disorders, abnormal thoughts, lack of self-care, hallucinations, aggression, euphoric mood, paranoia;
amnesia, reduced sensations, involuntary muscle contractions, fainting, excessive movements, migraine, seizures, dizziness when standing up, coordination disturbances, speech disorders;
dilated pupils;
ear pain;
rapid heartbeat, heart problems;
bleeding problems (such as stomach bleeding)*, high blood pressure, hot flushes, blood in urine;
shortness of breath, nosebleeds, difficulty breathing, possible wheezing;
tarry stools, dental problems, oesophagitis, tongue disorders, haemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders;
eye swelling, hives, hair loss, itching, development of purplish spots on the skin, skin problems with blistering, dry skin, facial oedema, cold sweats;
osteoarthritis, muscle contractions, muscle cramps*, muscle weakness;
increased frequency of urination, problems urinating, inability to urinate, urinary incontinence, increased urine volume, nocturnal urination;
sexual dysfunction, excessive vaginal bleeding, vaginal haemorrhage, female sexual dysfunction;
leg swelling, chills, difficulty walking, thirst;
increased liver enzyme levels, 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 1,000 people):

diverticulitis, swollen glands, reduced number of platelets (cells involved in blood clotting)*, reduced number of white blood cells*;
severe allergic reaction;
endocrine disorders*;
elevated cholesterol levels, problems controlling blood sugar levels (diabetes), low blood sugar levels, increased blood sugar levels*, low sodium levels in blood*;
physical symptoms due to stress or emotions, disturbing nightmares*, drug dependence, sleepwalking, premature ejaculation;
coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headaches (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, disturbance of consciousness;
development of spots on the eye*, glaucoma*, double vision (diplopia)*, discomfort caused by light (photophobia)*, blood accumulation in the anterior chamber of the eye (hyphaema)*, pupils of unequal size*, abnormal vision*, altered tear production*;
heart attack, feeling faint, 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;
rapid breathing, progressive scarring of lung tissue (pulmonary interstitial disease)*, throat closure, difficulty speaking, slow breathing, hiccups;
a form of lung disease in which eosinophils (a type of white blood cell) are present in increased numbers in the lungs (eosinophilic pneumonia);
mouth ulceration, pancreatitis*, blood in stools, tongue ulceration, mouth pain;
liver function problems, severe liver function problems*, yellowing of the skin and eyes (jaundice)*;
skin reaction to sunlight*, cutaneous oedema*, changes in hair structure, altered skin odour, inflammation of hair follicles;
muscle tissue breakdown*, bone disorders;
initial difficulty urinating, reduced urination;
breast discharge, dryness of the vaginal area, genital discharge, red and painful penis and foreskin, breast enlargement*, prolonged erection;
hernia, reduced tolerance to the medicine;
increased blood cholesterol, changes in laboratory test results*, altered semen, coagulation problems*;
procedure for relaxing blood vessels.

Not known (frequency cannot be estimated from the 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 authorisation.
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, tingling, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and tremor (see section 3 “If you stop taking Sertralina Aurobindo”).
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 effect, 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 . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sertralina Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after "Exp.".
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Store in the original packaging.
Do not use this medicine if you notice any visible signs of deterioration.
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 Aurobindo contains
The active substance is sertraline.
Each film-coated tablet contains 50 mg of sertraline (as sertraline hydrochloride).
Each film-coated tablet contains 100 mg of sertraline (as sertraline hydrochloride).
The excipients are:
Tablets: microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropylcellulose, calcium hydrogen phosphate dihydrate, magnesium stearate.
Coating: hypromellose, Macrogol 400, polysorbate 80, and titanium dioxide (E171).

Description of the appearance of Sertralina Aurobindo and package contents
Film-coated tablets.
Sertralina Aurobindo 50 mg film-coated tablets are white, biconvex, capsule-shaped, film-coated tablets with an "A" engraved on one side and a line between the digits "8" and "1" on the other side. The tablet can be divided into two equal doses.
Sertralina Aurobindo 100 mg film-coated tablets are white, biconvex, capsule-shaped, film-coated tablets with an "A" engraved on one side and "82" on the other side.

Sertralina Aurobindo 50 mg / Sertralina Aurobindo 100 mg film-coated tablets are available in packs containing 10, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 98, and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

Responsible person for batch release
APL Swift Services (Malta) Limited,
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG3000
Malta
Orion Corporation, Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation, Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
Generis Farmaceutica, S.A.
Rua Joao De Deus N 19 Venda Nova,
Amadora 2700-487, Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
CZ: Sertralin Vipharm 50 mg/100 mg potahované tablety
DE: Sertralin Aurobindo 50 mg/100 mg Filmtabletten
DK: Sertralin Orion 50 mg/100 mg filmovertrukne tabletter
IT: Sertralina Aurobindo 50 mg/100 mg compresse rivestite con film
NL: Sertraline Aurobindo 50 mg/100 mg filmomhulde tabletten
PT: Sertralina Aurobindo 50 mg/100 mg comprimidos revestidos por película
SE: Oralin 50 mg/100 mg filmdragerade tabletter