SERTRALINA 50 mg Film-Coated Tablets

Зміст інструкції

1. Sertralina Teva Pharma B.V. 50 mg film-coated tablets, 100 mg film-coated tablets
   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. Package contents and other information

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

Sertralina

Generic medicine

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 ingredient sertraline. Sertraline belongs to a
group of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs); these
medicines are used to treat depression and/or anxiety disorders.

Sertralina Teva Pharma B.V.can be used totreat:
Depression and prevention of depressive relapses (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 illnesses related to anxiety with symptoms such as being
constantly worried about persistent thoughts (obsessions) that make you perform ritual actions
(compulsions).
PTSD is a condition that can occur after an emotionally strong traumatic experience and
some symptoms of this condition are similar to depression and anxiety. Social anxiety disorder
(social phobia) is an illness related to anxiety. 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 other people or the
worry of behaving embarrassingly).
Your doctor has decided that this medicine is suitable to treat your condition.
Ask your doctor if you are not sure why you have been prescribed Sertralina Teva Pharma B.V.

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

Do not takeSertralina Teva Pharma B.V.:

• If you are allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
• If you are taking or have taken monoamine oxidase inhibitors (MAOIs) e.g. selegiline, moclobemide) or drugs with a similar action to MAOIs (such as linezolid). If you stop treatment with sertraline, you must wait one week before starting treatment with an MAOI again. After stopping treatment with an MAOI, you must wait at least two 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 Teva Pharma B.V.
Medicines are not always suitable for everyone. Talk to your doctor before taking Sertralina Teva

Pharma B.V.if you suffer from or have previously suffered from any of the following conditions:

• If you have epilepsy or a history of seizures. If you have an epileptic seizure (convulsions), 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 think you have or have previously thought about harming yourself or committing suicide (see below “Suicidal thoughts and worsening of your depression or anxiety disorder”);
• Serotonin Syndrome/Neuroleptic Malignant Syndrome. In rare cases, these syndromes can occur when taking certain medicines together with sertraline (for symptoms, see section 4 “Possible side effects”). Your doctor will tell you if you have suffered from this condition in the past.
• If you have low levels of sodium in your blood, because this condition can occur as a result of treatment with Sertralina Teva Pharma B.V.. You should also tell your doctor if you are taking certain medicines for high blood pressure, because these medicines can also alter sodium levels in the blood.
• If you are elderly because you are at greater risk of low sodium levels in the blood (see above).
• If you have a liver disease: your doctor may decide to prescribe you a lower dose of Sertralina Teva Pharma B.V..
• If you have diabetes; blood glucose levels may be altered due to treatment with Sertralina Teva Pharma B.V.and it may be necessary to adjust the dose of your diabetes medications.
• If you have suffered from bleeding problems or if you have taken medicines that make your blood more fluid (e.g. acetylsalicylic acid or warfarin) or that can increase the risk of bleeding.
• Children or adolescents under the age of 18. Sertralina Teva Pharma B.V.should only be used to treat children and adolescents between the ages of 6 and 17 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 carefully (see below “Children and adolescents”).
• If you are undergoing electroconvulsive therapy (ECT).
• If you suffer from eye problems such as certain types of glaucoma (increased pressure in the eye).
• If, after an electrocardiogram (ECG), you have been told that you have an abnormality in your cardiac trace known as prolongation of the QT interval.
• If you have heart disease, low levels of potassium or low levels of magnesium, a family history of prolonged QT interval, slow heart rate and concomitant use of drugs that prolong the QT interval.

Effects on urine drug screening tests
If you are undergoing urine screening, taking Sertralina Teva Pharma B.V.may result in
false positives for benzodiazepines. False positives can occur for many days after
stopping Sertralina Teva Pharma B.V..If this happens, a more specific test may be performed.

Restlessness/akathisia
The use of sertraline has been associated with distressing restlessness and a need to move, often
associated with the inability to sit still or remain motionless (akathisia). This condition is more likely to occur in the early weeks of treatment. An increase in dose may be harmful,
therefore if you develop these symptoms you should contact your doctor.

Drug discontinuation reaction
Side effects that develop when taking the medicine is stopped (discontinuation reactions) are common, particularly if treatment is stopped suddenly (see
section 3 “If you stop taking Sertralina Teva Pharma B.V.” and section 4 “Possible
side effects”). The risk of discontinuation reactions depends on the duration of treatment, the
dose and the extent of the dose reduction. Generally these symptoms are mild to
moderate in intensity. However, in some patients they can 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 have a longer duration (2-3 months or more).
When stopping treatment with sertraline, it is recommended to reduce the dose gradually
over a period of several weeks or months, and to 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 wanting to harm yourself or kill yourself.
These thoughts may worsen when you take antidepressants for the first time, because
all these medicines take time to become effective, usually about two weeks but
sometimes even longer.

You are more likely to have thoughts of this kind if:
You have previously thought about wanting to kill yourself or harm yourself.
If you are a young adult. Available information from clinical studies has shown a
greater risk of suicidal behavior in adults under the age of 25 with psychiatric conditions treated with an antidepressant.
If at any time you should think about wanting to harm yourself or kill yourself, contact your
doctor or go to the nearest hospital immediately.
It may be helpful to tell a relative or close friendthat you are depressed or have an
anxiety disorder and that you are feeling worse, or if they are concerned about
changes in your behavior.

Children and adolescents
Sertraline should not be routinely used in children and adolescents under the age of
18, except for patients with Obsessive-Compulsive Disorder (OCD). Patients under the age of
18 have an increased risk of side effects, such as attempting suicide, having thoughts of harming themselves or killing themselves (suicidal thoughts) and hostile behavior (mainly
aggression, oppositional behavior and anger) when treated with this class of medicines.
However, your doctor may decide to prescribe Sertralina Teva Pharma B.V.to a patient
under the age of 18 if this is in the patient's best interest. If your doctor has prescribed Sertralina Teva

Pharma B.V.and you are under 18 and want to talk to your doctor about this decision, please
contact them.
Also, if any of the above symptoms occur or worsen while you are being treated with

Sertralina Teva Pharma B.V., you should tell your doctor.
Finally, the long-term safety of Sertralina Teva Pharma B.V.on growth, maturation, learning ability (cognitive development) and behavioral development in this age group has not
been demonstrated.

Other medicines andSertralina Teva Pharma B.V.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Some medicines can affect the activity of Sertralina Teva Pharma B.V., or Sertralina

Teva Pharma B.V.can reduce the effectiveness of other medicines you are taking at the same time.

TakingSertralina Teva Pharma B.V.with the following medicines can 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 metahemoglobin in the blood). Do not use Sertralina Teva Pharma B.V.together with these medicines.
• Medicines for treating 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 for the treatment of attention deficit hyperactivity disorder (ADHD), narcolepsy and obesity).
• Herbal medicine containing St John's wort ( Hypericum perforatum). The effects of St John's wort can last 1-2 weeks.
• Products containing the amino acid tryptophan.
• Medicines for the treatment of severe pain (e.g. tramadol).
• Medicines used in anesthesia or for the treatment of chronic pain (fentanyl, mivacurium and succinylcholine).
• Medicines for the treatment of migraine (e.g. sumatriptan).
• Medicines for thinning the blood (warfarin).
• Medicines for the treatment of pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and acetylsalicylic acid).
• 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 acid in the stomach, ulcers and heartburn (e.g. cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines for the treatment of mania and depression (lithium).
• Other medicines for the treatment of depression (e.g. amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines for the treatment of 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 (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. some antipsychotics and antibiotics).

Sertralina Teva Pharma B.V.with food, drinks and alcohol:
The film-coated tablets of Sertralina Teva Pharma B.V.can be taken with or without
food.
Consumption of alcohol should be avoided during treatment with Sertralina Teva Pharma B.V..

Sertralina Teva Pharma B.V.should not be taken in combination with grapefruit juice,
as this may increase the level of sertraline in the body.

Pregnancy, breastfeeding and fertility:
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
The safety of sertraline has not been fully established in pregnant women. Sertralina
Teva Pharma B.V. should only be administered to pregnant women if the doctor considers that the
benefit to the mother is greater than any possible risk to the development of the child.
Inform your midwife and/or doctor who is following you that you are taking Sertralina Teva Pharma B.V..
If taken during pregnancy, especially in the last 3 months of gestation, medicines like

Sertralina Teva Pharma B.V.can increase the risk of a serious illness in newborns, called
persistent pulmonary hypertension of the newborn, due to which the baby turns a
bluish color and breathes more rapidly. These symptoms generally begin during the first 24 hours after
the baby's birth. If this should happen to your child, contact your midwife and/or
doctor immediately.
The newborn may also have other symptoms, which usually appear within the first 24 hours after
birth. The symptoms include:
breathing problems,
bluish skin color or perception of excessive heat or cold,
blue lips,
vomiting or inadequate feeding,
appears very tired, unable to sleep or cries a lot,
stiff or floppy muscles,
tremors, nervousness or convulsions,
increased reflex reactions,
irritability,
low blood sugar levels.
If your baby, at birth, shows any of these symptoms, or if you are worried 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. Sertralina Teva Pharma B.V.must
be used during breastfeeding only if the doctor considers that the benefit is greater than
any possible risk to the child.
In animal studies, some drugs like sertraline can reduce sperm quality.
In theory, this could affect fertility, but the impact on human fertility has not yet been
observed.

Driving and operating machinery
Psychotropic medicines like sertraline can affect the ability to drive vehicles and
operate machinery. Therefore, you should not drive vehicles or operate machinery until you
have ascertained whether this medicine alters 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 Sertralina Teva Pharma B.V.

Always take this medicine exactly as your doctor has told you. Contact your doctor or pharmacist if you are not sure.

The recommended dose is:
Adults
Depression and obsessive-compulsive disorder
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
For panic disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should begin 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 at a time over several weeks. The maximum recommended dose is 200 mg/day.

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

Obsessive-compulsive disorder
Children aged 6 - 12 years:the recommended starting dose is 25 mg per day.
After one week, your doctor may increase it to 50 mg/day. The maximum dose is 200 mg per day.

Adolescents aged 13 - 17 years:the recommended starting dose is 50 mg/day.
The maximum dose is 200 mg per day.
If you have liver or kidney problems, tell your doctor and follow the instructions they give you.

Method of administration
The tablets of Sertralina Teva Pharma B.V.can be taken with or without food.
Take the medicine once a day, in the morning or evening.
Your doctor will tell you how long you will need to take this medicine. This will depend on the duration of the illness and your response to treatment. It may take several weeks to see an improvement in your symptoms. Generally, once an improvement has been achieved, treatment for depression should continue for another 6 months.

If you take moreSertralina Teva Pharma B.V.than you should
If you accidentally take an overdose of Sertralina Teva Pharma B.V., contact your doctor immediately or go to the nearest emergency room. Always take a pack of the medicine with you, whether it contains medicine or not.
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 takeSertralina Teva Pharma B.V.
Do not take a double dose to make up for a missed 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 takingSertralina Teva Pharma B.V.
Do not stop taking Sertralina Teva Pharma B.V.unless your doctor has told you to.
Before stopping this medicine completely, your doctor may want to gradually reduce the dose of Sertralina Teva Pharma B.V.over several weeks. If you stop using this medicine suddenly, you may experience undesirable effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and tremors. If you experience any of these undesirable effects, or any other undesirable effects during treatment with Sertralina Teva Pharma B.V.., talk to your doctor.
If you have any doubts about using 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 lessen as therapy continues.

Immediately inform your doctor:
If you experience any of the following symptoms after taking this medicine, these
symptoms may be serious.

• If you develop a severe skin rash that causes blistering (multiforme erythema) (may affect the mouth and tongue). These may be signs of a condition known as Stevens Johnson Syndrome or Toxic Epidermal Necrolysis. In these cases, your doctor will stop treatment.
• Allergic reactions or allergies, which may include symptoms such as a itchy rash, breathing problems, wheezing, swelling of eyelids, face or lips.
• If you experience agitation, confusion, diarrhea, high fever and high blood pressure, excessive sweating and a rapid heartbeat. These are the symptoms of Serotonin Syndrome/Neuroleptic Malignant Syndrome. In rare cases, these syndromes can occur when taking certain medicines together with sertraline. Your doctor may want to stop treatment.
• If you develop a yellowing of the skin and eyes, which may be indicative of liver damage.
• If you develop depressive symptoms and think about harming yourself or committing suicide (suicidal thoughts).
• If you start to feel restless and are unable to sit or stand still after starting sertraline. If you start to feel restless, tell your doctor.
• If you have an epileptic seizure (convulsions).
• If you have a manic episode (see section 2. “Warnings and precautions”).

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

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

• Insomnia, dizziness, drowsiness, headache;
• diarrhea, 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, decreased sexual interest, nervousness, feeling strange, nightmares, teeth grinding;
• tremors, muscle movement problems (such as restlessness, muscle tension, difficulty walking and stiffness, spasms and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of attention, altered taste;
• vision disturbances;
• ringing in the ears;
• palpitations;
• hot flashes;
• yawning;
• stomach discomfort, constipation, abdominal pain, vomiting, gas in the stomach;
• increased sweating, rash;
• back pain, joint pain, muscle pain;
• irregular menstrual cycle, erectile dysfunction;
• feeling unwell, chest pain, weakness, fever;
• weight gain;
• wounds.

Uncommon (may affect up to 1 in 100 people)

• gastroenteritis, ear infection;
• tumor;
• allergic reaction, seasonal allergy;
• low levels of thyroid hormone;
• suicidal thoughts, suicidal behavior *, altered thoughts, lack of self-care, hallucinations, aggression, euphoria, paranoia;
• amnesia, reduced sensations, involuntary muscle contractions, fainting, excessive movements, migraine, dizziness when getting up, coordination problems, speech disorders;
• dilated pupils;
• ear pain;
• fast heartbeat, heart problem;
• bleeding problems (such as stomach bleeding)*, high blood pressure, flushing, blood in urine;
• shortness of breath, bleeding from the nose, difficulty breathing, possible wheezing;
• dark stools, dental problems, inflammation of the esophagus, problems with the tongue, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders;
• swelling of the eyes, hives, hair loss, itching, red spots on the skin, skin problem with blisters, dry skin, swelling of the face, cold sweat;
• 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 hemorrhage, female sexual dysfunction;
• swelling of the legs, chills, difficulty walking, thirst;
• increased levels of liver enzymes, weight loss.
• Cases of suicidal ideation and suicidal behavior have been reported during therapy 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 cells involved in coagulation*, decreased white blood cells*;
• severe allergic reaction;
• endocrine problems*;
• high cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, increased blood sugar levels*, low salt levels in the blood*;
• physical symptoms due to stress or emotions, terrifying abnormal dreams*, drug dependence, sleepwalking and premature ejaculation;
• coma, abnormal movements, difficulty moving, increased sensitivity, severe sudden headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances;
• formation of spots in front of the eyes, glaucoma, double vision, discomfort in the light, blood in the eyes, pupils of unequal size*, abnormal vision *, problems with tearing;
• heart attack, feeling of emptiness in the head, fainting or chest discomfort that may be signs of changes in electrical activity (seen on electrocardiogram) or irregular heartbeat*, slow heartbeat;
• poor circulation in arms and legs;
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, closure of the throat, difficulty speaking, slow breathing, hiccups;
• ulcerations in the mouth, pancreatitis*, blood in the stool, ulceration of the tongue, inflamed mouth,
• problems with liver function, severe problems with liver function*, yellow skin and eyes (jaundice)*;
• skin reaction to the sun*, skin edema*, abnormal hair texture, abnormal skin odor, rash;
• muscle tissue rupture*, bone disorder;
• difficulty urinating, decreased urination;
• breast secretion, vaginal dryness, genital secretion, red and painful penis and prepuce, breast enlargement*;
• hernia, reduced tolerance to the drug
• increased levels of cholesterol in the blood, abnormal laboratory tests*, abnormal sperm, coagulation problems*;
• relaxation of blood vessels.

Not known (frequency cannot be estimated based on available data)

• Jaw/mandible locking *Nocturnal enuresis*

* side effects reported after marketing

Additional side effects in children and adolescents
In clinical studies on 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, diarrhea and nausea.

Symptoms that may occur when stopping treatment
If you suddenly stop therapy, you may develop 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
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 Sertralina Teva Pharma B.V.

Keep this medicine out of 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 any medicine in 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

Contents of packSertralina Teva PharmaB.V.:
50 mg

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

100 mg

• The active ingredient is sertraline. Each film-coated tablet contains 100 mg of sertraline (in the form of hydrochloride).
• The other ingredients are: Core:Microcrystalline cellulose, dibasic calcium phosphate dihydrate, povidone K-30, sodium croscarmellose, 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 ofSertralina Teva Pharma B.V.and contents of the pack
50 mg
Film-coated tablets, light blue in colour, elliptical in shape, with one side divided by a score line and with the number “9” and the number “3” imprinted on either side of the fracture line. The number “7176” is imprinted on the opposite side of the tablet.

Transparent and opaque white PVC/PVdC aluminium blister.

Sertralina Teva Pharma B.V.50 mg is available in pack sizes of 7, 10, 15, 20, 28, 30, 50, 60, 98, 100, 105, 200, 294 or 300 film-coated tablets.

Bottle (HDPE) with tamper-evident screw cap

Sertralina Teva Pharma B.V.50 mg is available in pack sizes 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 in shape, with one side divided by a score line and with the number “9” and the number “3” imprinted on either side of the fracture line. The number “7177” is imprinted on the opposite side of the tablet.

Transparent and opaque white PVC/PVdC aluminium blister

Sertralina Teva Pharma B.V.100 mg is available in pack sizes of 15, 20, 28, 30, 50, 60, 98, 100, 105 or 200 film-coated tablets.

Bottle (HDPE) with tamper-evident screw cap

Sertralina Teva Pharma B.V.100 mg is available in pack sizes 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 (Netherlands)

Manufacturer
TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
(United Kingdom)
Pharmachemie B.V, Swensweg 5, Postbus 552, 2003 RN Haarlem (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 Member States of the European Economic Area 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