Sertraline Teva Pharma B.V.

Package leaflet: Information for the user

Sertralina Teva Pharma B.V. 50 mg film-coated tablets, 100 mg film-coated tablets

Sertraline
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 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 adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Sertralina Teva Pharma B.V. is and what it is used for

Sertralina Teva Pharma B.V. 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 Teva Pharma B.V. can be used to treat:
Depression and prevention of recurrence of depression (in adults);
Social anxiety disorder (in adults);
Post-traumatic stress disorder (PTSD) (in adults);
Panic disorder (in adults);
Obsessive-compulsive disorder (OCD) in adults and 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 behaviours (compulsions).
PTSD is a condition that may occur following a strongly traumatic experience, and some of its symptoms are similar to those of depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterised by feelings of intense anxiety or stress (for example: speaking to strangers, speaking in public, eating or drinking in the presence 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 Teva Pharma B.V. has been prescribed for you.

2. What you need to know before taking Sertraline Teva Pharma B.V.

Do not take Sertraline Teva Pharma B.V. if:

• You are allergic to sertraline or any of the excipients of this medicine (listed in section 6).
• You are taking or have recently taken monoamine oxidase inhibitors (MAOIs), e.g. selegiline, moclobemide, or medicines with a similar action to MAOIs (such as linezolid). If you stop treatment with sertraline, you must wait one week before restarting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least two weeks before starting treatment with sertraline.
• 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 Sertraline Teva Pharma B.V.
Medicines are not always suitable for everyone. Talk to your doctor before taking Sertraline Teva Pharma B.V. 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 (convulsions), contact your doctor immediately.
• If you have suffered from bipolar disorder (manic-depressive illness) or schizophrenia. In case of a manic episode, contact your doctor immediately.
• If you have thoughts of harming yourself or of suicide, or have had such thoughts in the past (see below “Suicidal thoughts and worsening of your depression or anxiety disorder”);
• Serotonin Syndrome/Neuroleptic Malignant Syndrome. In rare cases, these syndromes may occur when taking certain medicines together with sertraline (for symptoms, see section 4 “Possible side effects”). Your doctor will advise you if you have previously experienced this condition.
• If you have low levels of sodium in the blood, as this condition may occur as a result of treatment with Sertraline Teva Pharma B.V. You should also inform your doctor if you are taking certain medicines for high blood pressure, as these medicines may also affect sodium levels in the blood.
• If you are elderly, as you are 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 Teva Pharma B.V.
• If you have diabetes; blood glucose levels may be affected by treatment with Sertraline Teva Pharma B.V., and the dose of your diabetes medicines may need to be adjusted.
• If you have had bleeding problems or if you are taking medicines that thin the blood (e.g. acetylsalicylic acid or warfarin) or that may increase the risk of bleeding.
• Children or adolescents under 18 years of age. Sertraline Teva Pharma B.V. should only be used to treat children and adolescents aged 6 to 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 receiving electroconvulsive therapy (ECT).
• If you have eye problems such as certain types of glaucoma (increased pressure in the eye).
• If, after an electrocardiogram (ECG), you were told you have an abnormal heart trace known as QT interval prolongation.
• If you have heart disease, low potassium or low magnesium levels, a family history of QT interval prolongation, slow heart rate, or are taking concomitant medicines that prolong the QT interval.

Effects on urine drug screening tests
If you undergo urine drug screening, taking Sertraline Teva Pharma B.V. may result in false positive results for benzodiazepines. False positives may occur for many days after discontinuation of Sertraline Teva Pharma B.V. If this occurs, a more specific test can be performed.

Restlessness/akathisia
Use of sertraline has been associated with distressing restlessness and a need to move, often accompanied by an inability to sit still or remain motionless (akathisia). This condition is most likely to occur during the first weeks of treatment. Increasing the dose may be harmful; therefore, if you develop these symptoms, consult your doctor.

Withdrawal reaction
Side effects that occur when stopping the medicine (withdrawal reactions) are common, especially if treatment is stopped abruptly (see section 3 “If you stop taking Sertraline Teva Pharma B.V.” 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 two 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 to discuss with your doctor the best way to discontinue 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 yourself or of suicide.
These thoughts may worsen when starting antidepressants, as all these medicines take time to become effective, usually about two 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 family member or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder is worsening, or whether they are concerned about changes in your behaviour.

Children and adolescents
Sertraline should not routinely 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 Sertraline Teva Pharma B.V. to a patient under 18 years of age if this is in the patient’s best interest. If your doctor has prescribed Sertraline Teva Pharma B.V. and you are under 18 years of age and wish to discuss this decision with your doctor, please contact them.
Furthermore, if any of the symptoms listed above develop or worsen while you are being treated with Sertraline Teva Pharma B.V., you must inform your doctor.
Finally, the long-term safety of Sertraline Teva Pharma B.V. on growth, maturation, learning ability (cognitive development), and behavioural development in this age group has not been established.

Other medicines and Sertraline Teva Pharma B.V.
Inform 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 Teva Pharma B.V., or Sertraline Teva Pharma B.V. may reduce the effectiveness of other medicines taken at the same time.
Taking Sertraline Teva Pharma B.V. with the following medicines may cause serious adverse events:

• Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression), selegiline (used to treat Parkinson’s disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methaemoglobin in the blood). Do not use Sertraline Teva Pharma B.V. together with these medicines.
• Medicines used to treat mental disorders such as psychosis (pimozide). Do not use sertraline together with pimozide.

Consult 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 1–2 weeks.
• Products containing the amino acid tryptophan.
• Medicines used to treat severe pain (e.g. tramadol).
• Medicines used in anaesthesia or for treating chronic pain (fentanyl, mivacurium, and succinylcholine).
• Medicines used to treat migraine (e.g. sumatriptan).
• Medicines used to thin the blood (warfarin).
• Medicines used to treat pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and acetylsalicylic acid).
• Sedatives (diazepam).
• Diuretics.
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excess stomach acid, ulcers, and heartburn (e.g. 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 mental disorders (e.g. perphenazine, levomepromazine, and olanzapine).
• Medicines used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (e.g. verapamil, diltiazem, flecainide, and propafenone).
• Medicines used to treat bacterial infections (e.g. rifampicin, clarithromycin, telithromycin, erythromycin).
• Medicines used to treat fungal infections (e.g. 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).

Sertraline Teva Pharma B.V. with food, drinks, and alcohol:
The film-coated tablets of Sertraline Teva Pharma B.V. can be taken with or without food.
Alcohol consumption should be avoided during treatment with Sertraline Teva Pharma B.V.
Sertraline Teva Pharma B.V. should 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 or pharmacist before taking this medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline Teva Pharma B.V. should be given to pregnant women only if your doctor considers that the benefit to the mother outweighs any possible risk to the unborn child.
Inform your midwife and/or doctor that you are taking Sertraline Teva Pharma B.V.
If taken during pregnancy, especially during the last three months of gestation, medicines such as Sertraline Teva Pharma B.V. may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to appear bluish and breathe faster. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.
The newborn may also have other symptoms, which usually appear within the first 24 hours after birth. Symptoms include:

• Breathing difficulties,
• Bluish skin or perception of excessive heat or cold,
• Bluish lips,
• Vomiting or poor feeding,
• Extreme tiredness, inability to sleep, or excessive crying,
• Stiff or floppy muscles,
• Tremors, nervousness, or seizures,
• Increased reflex responses,
• Irritability,
• Low blood sugar levels.
  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 Teva Pharma B.V. should be used during breastfeeding only if your doctor considers that the benefit outweighs any possible risk to the infant.
  In animal studies, some medicines like sertraline may reduce sperm quality.
  In theory, this could affect fertility, but no impact on human fertility has been observed.

Driving and using machines
Psychotropic medicines such as sertraline may affect your ability to drive or use machines. Therefore, you should not drive or operate machinery until you know whether this medicine affects your ability to perform these activities.

Sertraline contains sodium
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 Teva Pharma B.V.

Always take this medicine exactly as instructed by your doctor. Contact your doctor or pharmacist if you are unsure.

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 a time, 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 post-traumatic stress disorder, treatment should start at a dose of 25 mg/day, which should then be increased to 50 mg/day after one week.
The daily dose may then be increased by 50 mg at a time over several weeks. The maximum recommended dose is 200 mg/day.

Use in children and adolescents:
Sertraline Teva Pharma B.V. should only be used for the treatment of children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD).

Obsessive-compulsive disorder (OCD)
Children aged 6–12 years: The recommended starting dose is 25 mg daily. After one week, your doctor may increase this to 50 mg/day. The maximum dose is 200 mg daily.

Adolescents aged 13–17 years: The recommended starting dose is 50 mg/day. The maximum dose is 200 mg daily.

If you have problems with your liver or kidneys, inform your doctor and follow the instructions given by your doctor.

Method of administration
The Sertraline Teva Pharma B.V. 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 duration of your illness and your response to treatment. It may take several weeks before your symptoms improve. Generally, once improvement has been achieved, treatment for depression should continue for a further 6 months.

If you take more Sertraline Teva Pharma B.V. than you should
If you accidentally take too much Sertraline Teva Pharma B.V., contact your doctor immediately or go to the nearest emergency department. Always take the medicine packaging with you, whether or not it still contains the 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 Teva Pharma B.V.
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 Teva Pharma B.V.
Do not stop taking Sertraline Teva Pharma B.V. unless your doctor tells you to do so.
Before completely stopping this medicine, your doctor may want to gradually reduce the dose of Sertraline Teva Pharma B.V. over several weeks. 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 treatment with Sertraline Teva Pharma B.V., talk to your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Nausea is the most common side effect. Side effects are dose-dependent and often disappear or diminish 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 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. In such cases, your doctor will discontinue 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, high blood pressure, excessive sweating, and rapid heartbeat. These are symptoms of Serotonin Syndrome/Neuroleptic Malignant Syndrome. In rare cases, these syndromes may occur when certain medicines are taken together with sertraline. Your doctor may decide to discontinue treatment.
• If you develop yellowing of the skin and eyes, which may indicate liver damage.
• If you develop depressive symptoms and have thoughts of harming yourself or committing suicide (suicidal thoughts).
• If you begin to feel restless and unable to sit or stand still after starting sertraline. If you start feeling restless, inform your doctor.
• If you have a seizure (convulsion).
• 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 in post-marketing experience:

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

• Insomnia, dizziness, drowsiness, headache;
• diarrhoea, nausea, 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;
• tremors, movement disorders (such as excessive movement, muscle tension, difficulty walking and stiffness, spasms and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of attention, taste disturbances;
• visual disturbances;
• ringing in the ears;
• palpitations;
• hot flush;
• yawning;
• stomach discomfort, constipation, abdominal pain, vomiting, gas in the stomach;
• increased sweating, 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;

• allergic reaction, seasonal allergy;

• low levels of thyroid hormone;

• suicidal thoughts, suicidal behaviour *, psychotic disorders, altered thinking, lack of personal care, hallucinations, aggression, euphoria, paranoia;

• amnesia, reduced sensations, involuntary muscle contractions, fainting, excessive movements, migraine, seizures, dizziness upon standing, coordination disorders, language disorders;

• dilated pupils;

• ear pain;

• rapid heartbeat, heart problem;

• bleeding problems (such as stomach bleeding)*, high blood pressure, flushing, blood in urine;

• shortness of breath, nosebleeds, breathing difficulties, possible wheezing;

• dark stools, dental problems, inflammation of the oesophagus, tongue problems, haemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders;

• swelling around the eyes, hives, hair loss, itching, red spots on the skin, blistering skin condition, dry skin, facial swelling, 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;

• leg swelling, chills, difficulty walking, thirst;

• increased liver enzyme levels, weight loss.

• Cases of suicidal ideation and suicidal behaviour have been reported during treatment with sertraline or immediately after discontinuation of treatment (see section 2).

Rare (may affect up to 1 in 1,000 people)

• Diverticulitis, swollen lymph nodes, decreased platelet count*, decreased white blood cell count*;
• severe allergic reaction;
• endocrine disorders*;
• high cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, increased blood sugar levels*, low levels of salts in the blood*;
• physical symptoms due to stress or emotions, terrifying abnormal dreams*, drug dependence, sleepwalking, premature ejaculation;
• coma, abnormal movements, movement difficulties, increased sensitivity, sudden severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances;
• spots appearing before the eyes, glaucoma, double vision, light sensitivity, blood in the eyes, unequal pupil size*, abnormal vision *, tear production problems;
• heart attack, sensation of emptiness in the head, fainting or chest discomfort which could be signs of changes in electrical activity (seen on electrocardiogram) or abnormal heart rhythm*, slow heartbeat;
• poor circulation in arms and legs;
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat closure, difficulty speaking, slow breathing, hiccups;
• mouth ulcers, pancreatitis*, blood in stools, tongue ulceration, inflamed mouth;
• liver function problems, severe liver function problems*, yellowing of the skin and eyes (jaundice)*;
• skin reaction to sunlight*, skin oedema*, abnormal hair texture, abnormal skin odour, rash;
• muscle tissue breakdown*, bone disorder;
• difficulty in urinary voiding, decreased urination;
• breast discharge, dryness of the vaginal area, genital discharge, red and painful penis and foreskin, breast enlargement*, prolonged erection;
• hernia, reduced drug tolerance;
• increased cholesterol levels in blood, abnormal laboratory tests*, abnormal semen, coagulation problems*;
• relaxation of blood vessels.

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

• Jaw/mouth locking *Nocturnal enuresis*

* Side effects reported after marketing

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 stopping treatment
If you stop treatment suddenly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremor (see section 3. "If you stop taking Sertralina Teva Pharma B.V.").
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
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sertraline Teva Pharma B.V.

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 packaging after "EXP". The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Contents of the pack and other information

What Sertralina Teva Pharma B.V. contains:
50 mg

• The active substance is sertraline. Each film-coated tablet contains 50 mg of sertraline (as hydrochloride).
• The other components are: Core: Microcrystalline cellulose, dibasic calcium phosphate dihydrate, povidone K-30, croscarmellose sodium, magnesium stearate. Tablet coating: Hypromellose, titanium dioxide (E171), macrogol 6000, polysorbate 80, indigo carmine (E132).

100 mg

• The active substance is sertraline. Each film-coated tablet contains 100 mg of sertraline (as hydrochloride).
• The other components are: Core: Microcrystalline cellulose, dibasic calcium phosphate dihydrate, povidone K-30, croscarmellose sodium, magnesium stearate. Tablet coating: Titanium dioxide (E171), partially hydrolysed polyvinyl alcohol (E1203), macrogol 4000 (E1521), talc (E553b), yellow iron oxide (E172), black iron oxide (E172).

Description of the appearance of Sertralina Teva Pharma B.V. and contents of the pack
50 mg
Film-coated blue, elliptical tablets, with one side divided by a score line and marked with the numbers “9” and “3” on either side of the break line. The number “7176” is engraved on the opposite side of the tablet.
Transparent and opaque white PVC/PVdC-aluminum blister.
Sertralina Teva Pharma B.V. 50 mg is available in packs of 7, 10, 15, 20, 28, 30, 50, 60, 98, 100, 105, 200, 294 or 300 film-coated tablets.
HDPE bottle with tamper-evident screw cap
Sertralina Teva Pharma B.V. 50 mg is available in packs of 100, 250 and 500 film-coated tablets.
Not all pack sizes may be marketed.

100 mg
100 mg film-coated tablets are light yellow, coated, elliptical tablets, with one side divided by a score line and marked with the numbers “9” and “3” on either side of the break line. The number “7177” is engraved on the opposite side of the tablet.
Transparent and opaque white PVC/PVdC-aluminum blister
Sertralina Teva Pharma B.V. 100 mg is available in packs of 15, 20, 28, 30, 50, 60, 98, 100, 105 or 200 film-coated tablets.
HDPE bottle with tamper-evident screw cap
Sertralina Teva Pharma B.V. 100 mg is available in packs of 100 and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA PHARMA B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Manufacturers
TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG (United Kingdom)
Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, The Netherlands
Teva Pharmaceutical Works Private Limited Company - Pallagi út 13 - 4042 Debrecen, Hungary
Teva Operations Poland Sp. Z.o.o., Mogilska 80 Str., 31-546 Krakow, Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Sertraline Teva filmomhulde tabletten
Czech Republic: Sertralin - Teva
Denmark: Sertralin Teva filmovertrukne tabletter
Estonia: Sertraline-Teva
Finland: Sertralin Teva tabletti, kalvopäällysteinen
Ireland: Sertraline Teva Film-coated Tablets
Italy: Sertralina Teva Pharma B.V. compresse rivestite con film
Lithuania: Sertraline – Teva plėvele dengtos tabletės
Netherlands: Sertraline PCH, filmomhulde tabletten
Portugal: Sertralina Teva Comprimidos revestidos por película
Sweden: Sertralin Teva filmdragerad tablett
United Kingdom: Sertraline Film-coated Tablets