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DOSULEPIN CAPSULES 25 mg AND DOSULEPIN TABLETS 75 mg

PACKAGE LEAFLET: INFORMATION FORTHE 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 you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

IN THIS LEAFLET:

1.    What Dosulepin is and what it is used for

2.    Before you take Dosulepin

3.    How to take Dosulepin

4.    Possible side effects

5.    How to store Dosulepin

6.    Further information

OWHAT DOSULEPIN IS AND WHAT IT IS USED FOR

Pharma code 1600

Dosulepin belongs to a group of medicines called “ antidepressants. Dosulepin is used to treat — depression and can also help reduce feelings of anxiety.This medicine will only be used when other medicines have been found to be unsuitable. Please askyour doctor or pharmacist if you need more information.

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BEFORE YOUTAKE DOSULEPIN

DO NOT take Dosulepin tablets/capsules and

speak to your doctor if:

*    you know that you are allergic (hypersensitive) to dosulepin or any of the other ingredients (listed in section 6 of this leaflet) in Dosulepin tablets and capsules

*    you have an irregular heart beat or any other heart problems

*    you have liver problems

*    you have an eye condition known as glaucoma

*    you are a man that has prostate problems (difficulty in passing water)

*    you have been diagnosed as having mania (feeling over-excited with unusual behaviour)

*    you have fits (epilepsy).

Dosulepin should not be given to children,

Take special care with Dosulepin if:

* you are going to have general or dental surgery, tell your surgeon you are taking Dosulepin. It may affect the anaesthetic used.

*    A medicine used to treat depression called a mono-amine oxidase inhibitor (MAOI).You should not take Dosulepin tablets/capsules at the same time as MAOIs or within 14 days of stopping them.

*    Other medicines used to treat depression called SSRIs (selective serotonin re-uptake inhibitors)

*    Any medicines given to you for treating high blood pressure (hypertension)

*    Any hay fever/allergy medicines which contains terfenadine or astemizole

*    Sotalol (a medicine for heart or blood pressure problems) or halofantrine (a medicine for malaria)

*    Any medicines called barbiturates (e.g. phenobarbital for fits, amylobarbitone for sleeplessness) or methylphenidate (used to treat behavioural problems)

*    Any medicine that contains an opioid (these include codeine, morphine, co-proxamol and co-dydramol)

*    Medicines called sympathomimetic agents -these include ephedrine, pseudoephedrine, adrenaline and noradrenaline (these may be found in medicines used to treat heart problems and asthma as well as some decongestants and cough/cold remedies).

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

Pregnancy and breast-feeding

If you are or think you might be pregnant or you plan to become pregnant, or if you are breast-feeding you must tell your doctor before you take this medicine.Your doctor will decide if you can take this medicine.

Driving and using machines

These tablets/capsules can make you feel drowsy. Do not drive, operate machinery or do anything that requires you to be alert until you know how the tablets/capsules will affect you. Feeling drowsy in the day can improve with time, but if drowsiness becomes a problem, you should tell your doctor.

If you drink alcohol with these tablets/capsules, this can make the feeling of drowsiness worse.

Important information about some of the ingredients of Dosulepin tablets and capsules

Dosulepin tablets contain a sugar called sucrose and Dosulepin capsules contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Dosulepin tablets also contain a colour called sunset yellow which may cause allergic reactions.

HOWTO TAKE DOSULEPIN

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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.

Your doctor will tell you how many tablets/capsules to take and when you should take them. This will also be on the carton label. Ask your pharmacist or doctor for help if you are not sure how to take your tablets/capsules or if you want more information.The following information is given as a guide only:

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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 (less than 25 years old) 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 askthem 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

You should tell your doctor if you are taking or have taken any of the following medicines as they may affect how your Dosulepin tablets/capsules work:

The tablets/capsules should be swallowed whole with a drink of water. Do not chew the tablets/capsules as you may get a bitter taste in your mouth and a temporary numbness of your tongue.

It may take two to four weeks of treatment before you begin to see an improvement in your mood although you might feel there is an improvement in your anxiety symptoms before then. It is important that you keep taking this medicine until your doctor tells you to stop.

The usual dose is:

Adults:

The usual starting dose is 1 tablet or 3 capsules a day. Your doctor may ask you to increase this.

Your doctor will tell you if you should take the tablets/capsules as separate doses throughout the day, or a single dose each evening, usually a couple of hours before you go to bed. Normally, not more than 3 tablets or 9 capsules should be taken each day.

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Elderly:

The usual starting dose is 1 tablet or between 1 and 3 capsules a day.

If you stop taking Dosulepin Do not stop taking these tablets/capsules just because you feel better. If you stop taking this medicine too soon, your condition may get worse. If your doctor wants you to stop taking these tablets/capsules, your doctor will ask you to stop gradually.

If you forget to take Dosulepin

Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not take a double dose to make up for a forgotten tablet/capsule. If you are unsure, check again with your doctor or pharmacist.

If you take more tablets/capsules than you should

You should only ever take the number of tablets/capsules that your doctor has told you to take. Do not change the dose yourself. If you think your tablets/capsules are not working well enough, speak to your doctor to see if the dose can be increased.

These tablets/capsules may seriously harm you and may be life threatening if you take too many. You should seek immediate help if a child takes any tablets/capsules or if you or anybody else accidentally takes too many tablets/capsules. Remember to take the pack with you, even if it is empty.

Q POSSIBLE SIDE EFFECTS

Like all medicines, Dosulepin tablets/capsules can cause side effects, although not everybody gets them.

If you get any of the following symptoms after taking these tablets/capsules, you should contact your doctor immediately:

*    a fever (high temperature, sweating, shivering)

*    discomfort around the right lower rib cage

*    hepatitis (damage to the liver causing dark urine, jaundice (yellowing of the skin or whites of the eyes), nausea and fever).

The most common side effects (that affect less than 1 person in 10) are:

*    dry mouth

*    blurred vision

*    changes in the heart beat

*    constipation and difficulty in passing water.

These side effect tend to improve with time.

Other side effects you may also experience are:

*    drowsiness

*    increased sweating

*    skin rashes

*    tremor (shaking)

*    changes in sexual function

*    low blood pressure, which may cause dizziness or fainting.

Rare side effects (that affect less than 1 person in 1000) are:

*    changes in the blood and changes in hormone levels (these will be found if you have blood tests)

*    severe mood changes such as extreme excitability

*    fits.

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, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via theYellow Card Scheme at: www. m h ra.g ov. u k/y el lowca rd

By reporting side effects you can help provide more information on the safety of this medicine.

HOWTO STORE DOSULEPIN

Keep these tablets/capsules in the original container, and in a safe place (preferably a locked cupboard) where children cannot see or reach them.Your medicine could seriously harm them.

Do not take this product after the 'use by' date shown on the carton.

If your doctor decides to stop the treatment, you must return any left over tablets to your pharmacist. Only keep the tablets/capsules if your doctor tells you to.

Q FURTHER INFORMATION

What Dosulepin contains

*    The active substance in both tablets and capsules is dosulepin hydrochloride.

*    The other ingredients in the tablets are calcium phosphate, maize starch, povidone, sodium carboxymethylcellulose, magnesium stearate (E572), hydrolysed gelatin, sucrose and talc (E553). The coating of the tablets also contains small amounts of sucrose, shellac, carnauba wax, beeswax, sodium benzoate, titanium dioxide (E171), ponceau red (E124), sunset yellow (E110) and indigotine (E132). The printing ink contains shellac, black iron oxide (El72) and propylene glycol (E1520).

*    The other ingredients in the capsules are lactose monohydrate, maize starch, povidone, sodium starch glycolate and magnesium stearate (E572). The capsule shell contains gelatin, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), erythrosine (E127) and titanium dioxide (E171).The printing ink contains shellac, black iron oxide (E172) and propylene glycol (E1520).

What Dosulepin looks like and contents of the pack

Dosulepin tablets are red coded with APS' or plain on one side and '75/1129' on the reverse. Dosulepin capsules are brown/pink printed '3D2 25'.

Dosulepin Capsules are available in pack sizes of 10, 14, 20 and 28.

DosulepinTablets are available in pack sizes of 14 and 28.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Company responsible for manufacture is

TEVA UK Limited Eastbourne East Sussex BN229AG United Kingdom

This leaflet was last revised: May 2015

PL 00289/0108 PL 00289/0158

TEUZD

TEVA UK LIMITED

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