PACKAGE LEAFLET: INFORMATION FOR THE USER

Sertraline 50mg or 100mg Film-Coated Tablets

Sertraline (as hydrochloride)

You are at risk of having suicidal thoughts while taking this medicine. Take special care with Sertraline Film-Coated Tablets if you have a

history of suicide attempts or suicidal thoughts or feelings.

See section 2 ‘Take special care with Sertraline Film-Coated Tablets:’.

When you stop taking this medication you may experience withdrawal symptoms. This is most likely if you stop taking your medicine suddenly.

See section 4 ‘Withdrawal symptoms’.

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 gets 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 film-coated tablets

3.    How to take sertraline film-coated tablets

4.    Possible side effects

5.    Storing sertraline film-coated tablets

6.    Further Information

1. What Sertraline Film-Coated Tablets are and what they are used for

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 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 children and adolescents aged 6-17 years old).

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.

You should ask your doctor if you are unsure why you have been given Sertraline.

2. Before you take Sertraline Film-Coated Tablets

Do not take Sertraline Film-Coated Tablets

•    if you are allergic (hypersensitive) to sertraline or any of the other ingredients of Sertraline Film-Coated Tablets;

•    if you are taking, or have taken within the last seven days, any monoamine oxidase inhibitors (MAOinhibitors). These are medicines used to treat depression or Parkinson’s disease (e.g. selegiline, moclobemide or linezolid);

•    if you are taking pimozide

•    if you have severe liver problems.

•    for depression if you are under 18 years old

•    if you are under six years old

Take special care with Sertraline Film-Coated Tablets:

Certain life-threatening conditions have been reported with the use of sertraline. The risk for these conditions is increased with concomitant use of serotonergic drugs including triptans. If you are concerned you should consult your doctor or pharmacist.

If any of the following apply to you discuss it with your doctor or pharmacist BEFORE taking Sertraline Film-Coated Tablets.

•    if you are diabetic;

•    if you suffer from epilepsy;

•    if you have a history of bleeding disorders;

•    if you suffer from liver or kidney problems;

•    if you suffer from manic phases;

•    if you are having electric shock treatment;

•    if you suffer from major depressive disorder or any other psychiatric disorder;

•    if you are elderly or a child

•    if you have a history of suicide attempts or suicidal thoughts or feelings.

•    if you have suffered with Serotonin syndrome.

Use in children and adolescents under 18 years of age: Patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour an anger) when they take this class of medicines. Sertraline Film-Coated Tablets should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes (in combination with psychological therapy) and it should not be sued in other indications.

Additionally, only limited information concerning the long-term safety of Sertraline Film-Coated Tablets on growth, puberty, mental, emotional and behavioural development in this age group is available. Despite this, your doctor may prescribe

Sertraline Film-Coated Tablets for patients under 18 for moderate to severe major depressive episodes in combination with psychological therapy because he/she decides that this is in their best interests. If your doctor has prescribed Sertraline Film-Coated Tablets fora patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Sertraline Film-Coated Tablets.

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.

-    If you 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.

Taking other medicines

Do not take Sertraline Film-Coated Tablets in combination with:

•    any monamine oxidase inhibitors (MAO-inhibitors) or if you have taken these in the last two weeks. See Section 2 ‘Do not take Sertraline Film-Coated Tablets’;

•    tramadol (to treat pain);

•    pimozide (to treat schizophrenia);

•    fenfluramine (an appetite suppressant).

Tell your doctor or pharmacist if you are taking any of the following:

•    lithium (to treat manic-depressive illness); tryptophan (amino acid), taken together you may experience weakness, unusually increased reflexes, muscular inco-ordination, confusion, anxiety and agitation;

•    tricyclic antidepressants or any other antidepressants;

•    drugs to treat abnormal heart rhythm such as propafenone and flecanide;

•    warfarin or aspirin (used to thin the blood);

•    propafenone (antiarrhythmic);

•    diazepam, a drug used for epilepsy, anxiety or as a muscle relaxant;

•    tolbutamide (diabetes medicine);

•    cimetidine (to treat heartburn and gastric ulcers);

•    any other centrally active medication (e.g. medication which affects your mood or nerves);

•    any plasma protein bound medication (your doctor or pharmacist can tell you this);

•    the herbal medicine St John’s Wort. If you already take St John’s Wort preparations, stop taking St John’s Wort and mention it to your doctor at your next visit;

•    tranquillizers (e.g. benzodiazepines);

•    any non-steroidal anti-inflammatory drugs (NSAIDs);

•    diuretics (or if you have trouble staying hydrated);

•    phenytoin;

•    sumatriptan (used to treat migraines). Taken together you may experience weakness, unusually increased reflexes, muscular uncoordination, confusion, anxiety and agitation.

You may have to have blood tests if you are taking lithium or warfarin at the same time as sertraline film-coated tablets.

It is important that you consult your doctor or pharmacist if you are taking any other medicine as he/she may need to monitor you or adjust your dose. Please tell your doctor or pharmacist if you are taking or have recently taken anyother medicines, including medicines obtained without a prescription.

Taking Sertraline Film-Coated Tablets with food and drink

The tablets may be taken with or without food. Do not take alcohol while taking this medicine.

Pregnancy

Ask your doctor or pharmacist for advice before taking any medicine. You should discuss with your doctor if you wish to become pregnant.

Make sure your midwife and/or doctor knowyou are on sertraline film-coated tablets. When taken during pregnancy, particularly in the last three months of pregnancy, medicines like sertraline film-coated tablets may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (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.

Breast-feeding

You should not breast-feed while taking sertraline film-coated tablets.

Fertility

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.

Driving and using machines

Do not drive or use any tools or machines if you feel that your abilities are affected. Medicines for the treatment of mental illnesses may decrease your ability to perform tasks requiring precision or close attention.

Important information about some of the ingredients of Sertraline Film-Coated Tablets

Sertraline 50mg Film-Coated Tablets contain approximately 0.3mg of sodium per tablet and Sertraline 100mg Film-Coated Tablets contain approximately 0.6mg of sodium per tablet. This needs to be taken into consideration if you are on a controlled sodium diet.

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3. How to take Sertraline Film-Coated Tablets

Always take your tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults:

Depression - The usual starting dose is 50mg daily, increasing over a period of weeks to a maximum of 200mg daily if necessary.

Obsessive Compulsive Disorder (OCD) - The usual starting dose is 50mg daily which may increase to 200mg daily, if necessary, over a period of weeks.

Post Traumatic Stress Disorder (PTSD) - The usual starting dose is 25mg daily, increased to 50mg daily after a week, and to a maximum of 200mg daily, if necessary, over a period of weeks.

Elderly:

The usual adult doses may be used.

Children and adolescents:

Obsessive Compulsive Disorder (OCD) - The dose will be decided by a doctor.

It is very important that you follow your doctor’s instructions as to the dosage of sertraline and for how long you should continue to take your tablets.

Even when you start to feel better it is important for you to keep taking them for as long as your doctor tells you.

If you take more sertraline film-coated tablets than you should:

If you have taken too large a dose of thismedicine, contact your doctor or hospital immediately.

Symptoms of overdose may include feeling or being sick, drowsiness, dizziness, anxiety, rapid heart beat and shaking. Take this leaflet and any tablets you have left to show the doctor or pharmacist.

If you forget to take sertraline film-coated tablets:

If you forget to take a dose, take it as soonas you remember. However, if it is nearly timefor the next dose, miss the forgotten dose altogether and continue with the rest of the tablets as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking sertraline film-coated tablets

Do not stop taking the medicine without talking to your doctor first.

Occasionally side effects may occur even when treatment with sertraline is stopped. For this reason when your doctor decides you should stop taking the tablets he/she may choose to reduce the dose gradually over at least 1 to 2 weeks to reduce the risk of side effects.

If you experience side effects when the dose is reduced, your doctor may decide to reduce the dose more slowly (see Section 4 ‘Possible side effects - Withdrawal symptoms’).

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Withdrawal symptoms

When you stop taking this medication you may experience withdrawal symptoms. This is most likely if you stop taking your medicine suddenly. Withdrawal symptoms include dizziness,tingling, numbness, difficulty in sleeping, vivid dreams, agitation, headache, tremor, feeling or being sick and anxiety. You should not stop taking the tablets abruptly, and should discuss stopping takingthis medication with your doctor.

•    if you experience depressive symptoms with ideas of harming or killing yourself (suicidal thoughts);

•    excessive sleepiness;

•    visual disturbances;

•    menstrual irregularities;

•    milk production;

•    inability to orgasm;

•    feeling like you are losing contact with reality.

You may

experience some of the following side effects. Speak to your doctor or

pharmacist if you are concerned about any of these side effects:

•    tumours (neoplasms)

•    bleeding from vagina or womb

•    fall in number of white cells in blood

•    weight gain or weight loss

•    low blood sugar

•    bleeding into stomach or gut. Black stools

•    bedwetting in children

•    forgetfulness;

•    nervousness;

•    difficulties in sleeping, drowsiness;

•    numbness;

•    reduced sensation to touch, strange skin sensations, abnormal coordination;

•    stiffness;

•    sweating;

•    not feeling like yourself, feelinguncomfortable;

•    feeling or being sick;

•    stomach ache;

•    loss of appetite, and other eating disorders, weight changes;

•    diarrhoea, vomitting, flatulence, or constipation;

•    dry mouth;

•    yawning and fatigue;

•    an increased risk of bone fractures;

•    nightmares, decreased libido, mood swings, drug dependency, paranoia or depression;

•    visual disturbances;

•    tinnitus, ear pain;

•    trouble breathing, hyperventilation

You may also have thoughts of harming orkilling yourself whilst taking sertraline film-coated tablets, or soon after your doctor tells you to stop taking sertraline film-coated tablets, (read the section of this leaflet “Thoughts of suicide and worsening of your depression or anxiety disorder” for further information). If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

In children treated for Obsessive Compulsive Disorder, the most common side-effects reported are headache, loss of appetite,shaking, not being able to sleep and agitation.

If you suffer from any of the side effects listed above and they are severe or prolonged orif you experience any other side effects not mentioned in this leaflet, please inform your doctor or pharmacist immediately.

5. How to store Sertraline Film-Coated Tablets

4. Possible Side Effects

Like all medicines, Sertraline Film-Coated Tablets can cause side effects, although not everybody gets them.

•    Keep out of the reach and sight of children.

•    Do not use sertraline film-coated tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

•    Do not take sertraline film-coated tablets if you notice they are discoloured (they should be white).

•    Do not store above 25°C.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

If you experience any of the following side effects, stop taking your tablets and either tell your doctor immediately or go to your nearest hospital. You may be experiencing an allergic reaction to the tablets:

•    swelling of the hands, feet, ankles, face, lips, mouth or throat;

•    problems with swallowing or breathing.

•    rash or itching

There is a risk of low blood salt (sodium) - with a higher risk in the elderly.

Stop taking your tablets and see a doctor as soon as possible if you experience any of the following:

•    if you have a manic episode with symptoms including diminishing self-esteem, talkativeness, easily being distracted andother manic tendencies;

•    hallucinations;

•    aggression;

•    if you have a fit (seizure);

•    your blood fails to clot as quickly as usual;

•    unexplained bruising or bleeding;

•    if you develop yellow skin and eyes which may mean liver damage;

•    difficulty in passing water;

•    inflammation of the pancreas (pain in the middle of your abdomen);

•    cramps;

•    acid indigestion;

•    if you develop a severe skin rash that causes blistering (erythema multiforme), (this can affect the mouth and tongue). These may be signs of a condition known as Stevens Johnson Syndrome, or Toxic Epidermal Necrolysis (TEN). Your doctor will stop your treatment in these cases;

•    hair loss;

•    allergic reaction or allergy, which may include symptoms such as an itchy skin rash, breathing problems, wheezing, swollen eyelids, face or lips;

•    aching or swollen joints or muscles, muscular weakness, back pain and muscle twitching;

•    arthritis, bone disorder, and involuntary muscle contractions;

•    if you start to get feelings of restlessness and are not able to sit or stand after you start to take Sertaline. You should tell your doctor if you start to feel restless;

•    if you experience agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating and rapid heartbeat. These are symptoms of Seratonin syndrome;

•    anxiety or panic;

•    headache, dizziness, shaking, or coordination problems;

6. Further information

What Sertraline Film-Coated Tablets contain

The active substance is sertraline. Each tablet contains 50mg or 100mg of sertraline (as hydrochloride).

The other ingredients are:

microcrystalline cellulose, dibasic calcium phosphate dihydrate, hydroxy-propylcellulose, sodium starch glycolate, magnesium stearate, deionised water, Opadry White YS-1R-7003 and Opadry Clear YS-1R-7006

What Sertraline Film-Coated Tablets look like and the contents of the pack

Sertraline 50mg film-coated tablets are white film-coated oblong, biconvex tablets, scored on one side. Sertraline 100mg film-coated tablets are white film-coated oblong, biconvex tablets. They are available in blister packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer:

CP Pharmaceuticals Limited,Ash Road North, Wrexham, LL13 9UF, UK.

Other formats:

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0800 198 5000 (UK Only).

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This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in: October 2012

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