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The product codes for this leaflet are: PL 29831/0184, PL 29831/0183

 

Sertraline 50mg or 100mg Tablets (Wockhardt UK Ltd)

Company Details

Wockhardt UK Ltd


Ash Road NorthWrexham Industrial EstateWrexhamLL13 9UF
Telephone:
Fax:
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PACKAGE LEAFLET

Sertraline 50mg or 100mg Tablets

Sertraline hydrochloride

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 further questions, please ask your doctor or your pharmacist.
  • This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours

In this leaflet:

  • 1. What sertraline is and what it is used for
  • 2. Before you take sertraline tablets
  • 3. How to take sertraline tablets
  • 4. Possible side effects
  • 5. Storing sertraline tablets

The active substance in the tablets is sertraline hydrochloride

The other ingredients are microcrystalline cellulose, dibasic calcium phosphate dihydrate, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, deionised water, Opadry White YS-1R-7003 and Opadry Clear YS-1R-7006

Sertraline 50mg and 100mg Tablets are manufactured by the Marketing Authorisation holder

Wockhardt UK
Ash Road North
Wrexham
LL13 9UF
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1. WHAT SERTRALINE IS AND WHAT IT IS USED FOR

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

Sertraline belongs to a group of antidepressant or antiobsessional medicines called the Selective Serotonin Re-uptake Inhibitors (SSRIs)

Sertraline tablets are used to treat depression, Obsessive Compulsive Disorder (OCD) or Post Traumatic Stress Disorder (PTSD).

Sertraline tablets should not be used to treat depression in children and adolescents under the age of 18 years but are used to treat OCD in children of six years and over.

The tablets are not sleeping tablets or tranquillisers.

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2. BEFORE YOU TAKE SERTRALINE TABLETS

You should not take sertraline tablets:

  • if you are hypersensitive (allergic) to sertraline hydrochloride or any of the other ingredients of sertraline tablets
  • if you are taking a monoamine oxidase inhibitor (MAOI) for depression or have taken it within the last two weeks
  • if you have severe liver problems
  • if you are taking another medicine called pimozide
  • for depression if you are under 18 years old
  • if you are under six years old

Tell your doctor:

  • if you have liver or kidney problems
  • if you have diabetes
  • if you have epilepsy
  • if you are being treated with electroconvulsive therapy (ECT)
  • if you have suffered from manic depressive illness
  • if you have suffered from bleeding disorders or are taking other medicines which thin the blood
  • if you are elderly or a child
  • if you have or have ever had suicidal thoughts. You should talk to your doctor immediately.
  • If you are taking medicines as follows; most tricyclic antidepressants such as amitriptyline; aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen; or you are taking another stronger painkiller called tramadol

Use in children and adolescents under 18 years of age:

Sertraline tablets should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe sertraline tablets for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed sertraline tablets for a 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 tablets. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of sertraline tablets in this age group have not yet been demonstrated.

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

The herbal remedy St John’s Wort (hypericum perforatum) should not be taken at the same time as this medicine. 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.

It is important that you tell your doctor everything about your condition and of any problems that you may have had in the past. Tell him if you have ever reacted badly to sertraline.

Taking sertraline tablets with food and drink:

It does not matter when you take your sertraline tablets in relation to food. You should avoid alcohol while you are taking sertraline tablets.

Pregnancy

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

You should also discuss with your doctor if you wish to become pregnant.

Breast-feeding

You should not breast-feed while taking sertraline tablets.

Driving and using machines:

Sertraline tablets should not affect your ability to drive or use machines. However, if you are affected do not drive or operate machinery.

Important information about some of the ingredients of sertraline tablets:

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

Taking other medicines:

Taking another medicine while you are taking sertraline tablets can affect how it or the other medicine works. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those you may have bought yourself without a prescription. Please check with your doctor if you are taking any of the following (or any other medication):

  • monoamine oxidase inhibitors (MAOIs) or have taken them within the last two weeks
  • other medication for your illness such as lithium, or a tricyclic antidepressant, such as amitriptyline
  • pimozide, a drug used to treat schizophrenia
  • tramadol, a painkiller
  • sumatriptan, a drug used for migraine
  • fenfluramine, a drug used to suppress appetite
  • aspirin or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) such as ibuprofen
  • the herbal remedy St John’s Wort
  • diazepam, a drug used for epilepsy, anxiety or as a muscle relaxant
  • tolbutamide, a drug used to treat Type 2 diabetes
  • warfarin, a drug used to thin the blood (you may need to have extra blood tests on starting and stopping sertraline)
  • cimetidine, used for stomach ulcers
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3. HOW TO TAKE SERTRALINE TABLETS

The usual starting dose in the treatment of depression in adults is 50mg daily, increasing over a period of weeks to a maximum of 200mg daily if necessary.

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

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

The dose for the treatment of OCD in children aged 6-17 years will be decided by a doctor.

Your doctor will decide the dose that is best for you. Always follow your doctor's instructions completely. Also, follow any instructions or warnings that appear on the label that the pharmacist has put on the pack. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

To obtain a tablet, press on the tablet from the blister (or bubble) side, pushing it through the foil. Do not remove the tablet from the blister until you are ready to take it.

Unless told otherwise, take your tablets with water preferably at the same time of day, with or without food. Do not crush or chew the tablet. Keep taking your tablets every day. The dose will usually not be changed more frequently than once a week.

You may need to take your tablets for two to four weeks (longer if you are suffering from OCD) before you feel better. Your doctor will monitor your progress during this time. You should keep taking your tablets even if you feel better and always see your doctor before your tablets run out. Do not stop taking your tablets without seeing your doctor.

If you take more sertraline tablets than you should:

If you or anybody else takes too many tablets, you should contact your doctor, pharmacist or nearest hospital casualty department immediately. Take this leaflet and any tablets you have left to show the doctor or pharmacist.

If you forget to take sertraline tablets:

If you occasionally forget to take a dose do not worry, just take the next dose when it is due. Never double the next dose to make up for the one missed. Do not stop taking the medicine without talking to your doctor first. When it is time to stop taking sertraline tablets the dose should be reduced gradually.

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4. POSSIBLE SIDE EFFECTS

Like all medicines, sertraline tablets can have side effects. These include feeling sick, diarrhoea, upset stomach, loss of appetite, indigestion, feeling shaky (tremor), dizziness, not being able to sleep, feeling sleepy, sweating, dry mouth and a change in sex function (ejaculatory delay in males).

Occasionally other effects have been reported which include problems with your blood pressure causing vomiting, stomach pain, rapid heart beat and dizziness on standing, problems with vision; loss of memory, headache, drowsiness, uncontrollable twitching or jerking movements, tingling, numbness, confusion, feeling agitated or aggressive, hallucinations, mania, nervousness, panic attacks, personality changes, feeling depressed, anxiety; fits; joint or muscle pain; inflammation of the pancreas and liver problems including hepatitis, jaundice, and liver failure; not being able to pass water; irregular periods, lack of orgasm and discharge of milk from the nipples; rash, easy bruising, itching and sensitivity to light; blood problems and abnormal bleeding; feeling unwell.

When you stop taking the tablets you may experience withdrawal effects such as dizziness, tingling, sleep disturbances, agitation and anxiety, headache, shaking, nausea and vomiting. These should disappear within a few days.

Very rarely patients have experienced suicidal thoughts and thoughts of self-harm. PLEASE TELL YOUR DOCTOR IMMEDIATELY IF YOU DO.

Rarely allergic reactions can occur. You should tell your doctor immediately if you experience wheezing, difficulty breathing, swelling, rash or itching.

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.

Most undesirable effects are usually mild and tend to wear off as you continue to take the tablets. If they continue check with your doctor or pharmacist.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

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5. STORING SERTRALINE TABLETS

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use after the expiry date stated on the carton.

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

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This leaflet was last approved in October 2005


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