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SERTRALINE 50 mg and 100 mg FILM-COATED TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you

start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1.    What Sertraline is and what it is used for

2.    Before you take Sertraline

3.    How to take Sertraline

4.    Possible side effects

5.    How to store Sertraline

6.    Further information

OWHAT SERTRALINE IS AND WHAT IT IS USED FOR

Sertraline contains the active ingredient sertraline. Sertraline is one of a group of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

Sertraline can be used to treat:

•    depression and to prevent recurrence of depression (in adults)

•    panic disorder with or without agoraphobia (fear of open spaces) in adults

•    Obsessive Compulsive Disorder (OCD) in adults and in children and adolescents aged 6-17 years old

•    Social anxiety disorder (in adults)

•    Post-Traumatic Stress Disorder (PTSD) in adults.

Depression is a clinical illness with symptoms like feeling sad, unable to sleep properly or to enjoy life as you used to.

OCD and Panic disorders are illnesses linked to anxiety with symptoms like being constantly troubled by persistent ideas (obsessions) that make you carry out repetitive rituals (compulsions).

PTSD is a condition that can occur after a very emotionally traumatic experience and has some symptoms that are similar to depression and anxiety. Social anxiety disorder (social phobia) is an illness linked to anxiety. It is characterised by feelings of intense anxiety or distress in social situations (for example talking to strangers, speaking in front of groups of people, eating or drinking in front of others or worrying that you might behave in an embarrassing manner).

Your doctor has decided that this medicine is suitable for treating your illness. Talk to your doctor if you are unsure why you have been given Sertraline.

^ BEFORE YOU TAKE SERTRALINE

DO NOT take Sertraline if you:

•    are allergic (hypersensitive) to sertraline hydrochloride or any of the other ingredients (see section 6)

•    are taking or have taken in the past two weeks, monoamine oxidase inhibitors (MAOIs such as moclobemide and selegiline) or MAOI-like drugs (such as linezolid). If you stop treatment with sertraline, you must wait until at least one week before you start treatment with a MAOI. After stopping treatment with a MAOI, you must wait at least 2 weeks before you can start treatment with sertraline.

•    are taking another medicine called pimozide (an antipsychotic medicine).

Take special care with Sertraline

Medicines are not always suitable for everyone. Tell your doctor before you take Sertraline, if you suffer from or have suffered in the past from any of the following conditions:

•    Epilepsy or a history of seizures. If you have a fit (seizure), contact your doctor immediately.

•    If you have suffered from manic depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, contact your doctor immediately.

•    If you have or have previously had thoughts of harming or killing yourself (see below - Thoughts of suicide and worsening of your depression or anxiety disorder)

•    Serotonin Syndrome. In rare cases, this syndrome may occur when you are taking certain medicines at the same time as sertraline. (For symptoms, see section 4 Possible Side Effects). Your doctor will have told you whether you have suffered from this in the past.

•    Neuroleptic malignant syndrome. In rare cases, this syndrome may occur when you are taking certain medicines at the same time as sertraline. (For symptoms, see section 4 Possible Side Effects). Your doctor will have told you whether you have suffered from this in the past.

•    If you have low sodium level in your blood, since this can occur as a result of treatment with Sertraline. You should also tell your doctor if you are taking certain medicines for hypertension, since these medicines may also alter the sodium level in your blood.

•    Take special care if you are elderly as you may be more at risk of having low sodium level in your blood (see above)

•    Liver disease; your doctor may decide that you should have a lower dose of Sertraline

•    Diabetes; your blood glucose levels may be altered due to Sertraline and your diabetes medicines may need to be adjusted

•    If you have suffered from bleeding disorders or have been taking medicines which thin the blood (e.g. acetylsalicylic acid (aspirin), or warfarin) or may increase the risk of bleeding

•    If you are a child or adolescent under 18 years old. Sertraline should only be used to treat children and adolescents aged 6-17 years old, suffering from Obsessive Compulsive Disorder. If you are being treated for this disorder, your doctor will want to monitor you closely (see Use in children and adolescents below).

•    If you are having electro-convulsive therapy (ECT)

•    If you are suffering from increased eye pressure or have a previous history of increased eye pressure.

Restlessness/Akathisia:

The use of sertraline has been linked to a distressing restlessness and need to move, often being unable to sit or stand still (akathisia). These problems are more likely to occur in the first few weeks of treatment. Increasing the dose may be harmful, so you should tell your doctor if you experience these symptoms, so the best decision can be made as to how to continue your treatment.

Withdrawal reactions:

Side effects relating to stopping treatment (withdrawal reactions) are common, particularly if the treatment is stopped suddenly (see section 3 If you stop taking Sertraline and section 4 Possible side effects). The risk of withdrawal symptoms depends on the length of treatment, dosage and the rate at which the dose is reduced. Generally, such symptoms are mild to moderate. However, they can be serious in some patients. They normally occur within the first few days after stopping treatment. In general, such symptoms disappear on their own and wear off within 2 weeks. In some patients, they may last longer (2-3 months or more).

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When stopping treatment with Sertraline, it is recommended to reduce the dose gradually over a period of several weeks or months, and you should always discuss the best way of stopping treatment with your doctor.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this if you:

•    have previously had thoughts about killing or harming yourself

•    are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse or if they are worried about changes in your behaviour.

Use in children over 6 years old and adolescents under 18 years old:

Sertraline should normally not be used for children and adolescents under 18 years, except for patients with Obsessive Compulsive Disorder (OCD). Also, you should know that patients under 18 have an increased risk of side effects such as suicide attempt, thoughts of harming or killing themselves (suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Sertraline for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Sertraline for a patient under 18 years and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms above develop or worsen when patients under 18 are taking Sertraline. Also, the long-term safety effects concerning growth, maturation and learning (cognitive) and behavioural development of Sertraline in this age group have not yet been demonstrated.

False-positive urine tests for benzodiazepines (drugs used to prevent mental problems) have been reported in patients taking sertraline. False-positive test results may be expected for several days following discontinuation of sertraline therapy.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines can affect the way Sertraline works, or Sertraline itself can reduce the effectiveness of other medicines taken at the same time.

Taking Sertraline together with the following medicines may cause serious side effects:

•    Medicines called monoamine oxidase inhibitors (MAOIs) e.g. moclobemide (to treat depression), selegiline (to treat Parkinson's disease) and the antibiotic linezolid. Do not use Sertraline together with MAOIs.

•    Medicines to treat mental disorders such as psychosis (pimozide). Do not use Sertraline together with pimozide.

Talk to your doctor if you are taking the following medicines:

•    Herbal medicine containing St. John's

Wort (Hypericum perforatum).The effects of St. John's Wort may last for 1-2 weeks. Talk to your doctor.

•    Medicines containing the amino acid, tryptophan

•    Medicines to treat severe pain (e.g. tramadol)

•    Medicines to treat migraines (e.g. sumatriptan)

•    Blood thinning medicine (warfarin)

•    Medicines to treat pain/arthritis (Non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen, acetylsalicylic acid (aspirin))

•    Sedatives (diazepam)

•    Diuretics (also called 'water' tablets)

•    Medicines to treat epilepsy (phenytoin, phenobarbital, carbamazepine)

•    Medicines to treat diabetes (tolbutamide)

•    Medicines to treat excessive stomach acid and ulcers (e.g. omeprazole, lansoprazole, pantoprazole, rabeprazole, cimetidine)

•    Medicines to treat mania and depression (lithium)

•    Other medicines to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine)

•    Medicines to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine and olanzapine)

•    Medicines used to regulate the rate and rhythm of the heart (such as flecainide, propafenone)

•    Fentanyl (painkiller)

•    Medicines used to treat fungal infection (e.g. ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole)

•    Medicines used to treat bacterial infection (e.g. clarithromycin, telithromycin, erythromycin, rifampicin)

•    Medicines used to treat high blood pressure (e.g. verapamil and diltiazem)

•    Aprepitant (used to treat sickness).

Taking Sertraline with food and drink

•    Sertraline tablets can be taken with or without food

•    Alcohol should be avoided whilst taking Sertraline

•    Sertraline tablets should not be taken in combination with grapefruit juice.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking this medicine.

The safety of Sertraline has not been fully established in pregnant women. Sertraline should only be given to pregnant women if the doctor considers that the benefit to the mother is greater than any possible risk to the developing baby. Women of childbearing potential should use a reliable method of contraception (such as the contraceptive pill) if taking Sertraline.

Make sure your midwife and/or doctor know you are on Sertraline. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Sertraline may increase the risk of a serious condition in babies, called Persistent Pulmonary Hypertension of the Newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.

Some medicines like Sertraline may reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.

There is evidence that sertraline is excreted in human breast milk. Sertraline should only be used in women during lactation, if the doctor considers that the benefit for the mother exceeds any possible risk to the baby.

Driving and using machines

Psychotropic drugs such as Sertraline may influence your ability to drive or use machines. You should therefore, not drive or operate machinery, until you know how this