PATIENT INFORMATION LEAFLET

TRIMIPRAMINE 10MG AND 25MG TABLETS

READ ALL OF THIS LEAFLET CAREFULLY

BEFORE YOU START USING 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.

THE LEAFLET CONTAINS INFORMATION ON:

1.    What Trimipramine Tablets are and what they are used for

2.    Before you take Trimipramine Tablets

3.    How to take Trimipramine Tablets

4.    Possible side effects

5.    How to store Trimipramine Tablets

6.    Further information

1. WHAT TRIMIPRAMINE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Trimipramine 10mg or 25mg Tablets (called trimipramine throughout this leaflet). Trimipramine belongs to a group of medicines called antidepressants and can be used to treat depression. In particular it is used to treat depression in people who also have the following symptoms - problems sleeping, anxiety or are feeling irritable and restless (agitation).

2. BEFORE YOU TAKE TRIMIPRAMINE TABLETS

Do not take trimipramine and tell your doctor if you:

•    are allergic (hypersensitive) to trimipramine maleate or any of the other ingredients of the tablets (listed in Section 6 Further information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

•    have recently had a heart attack

•    have any other heart problems including slow or uneven heart beat

•    have severe liver problems

•    have mania (signs include very high mood, energy and unusual behaviour)

•    are pregnant or breast-feeding.

Do not take trimipramine if the above apply to you. If you are not sure, talk to your doctor or pharmacist.

Take special care and check with your doctor or pharmacist before you take trimipramine if you:

•    are elderly

•    have an enlarged prostate gland

•    have glaucoma (a increased pressure in the eye)

•    have a history of epilepsy

•    have thyroid problems.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking trimipramine.

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 mav be more likelv 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

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because trimipramine can affect the way some other medicines work.

Also some medicines can affect the way trimipramine works.

In particular, tell your doctor if you are taking any of the following medicines:

•    MAOI (Mono Amine Oxidase Inhibitors) medicines such as tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson’s disease). Tell your doctor or pharmacist if you are taking them now or have taken them in the last 2 weeks

•    Sedatives such as tranquilizers or sleeping pills

•    Medicines used to treat high blood pressure such as guanethidine, debrisoquine and bethanidine

•    Adrenaline, noradrenaline, ephedrine or isoprenaline - used in an emergency

•    Medicines, including some cough and cold medicines, containing ephedrine, pseudoephedrine or adrenaline.

Anaesthetics

If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking trimipramine.

Taking trimipramine with food and drink

You should avoid drinking alcohol while taking trimipramine. This is because trimipramine can change the way alcohol affects you.

Pregnancy and breast-feeding

Do not take and tell your doctor before taking trimipramine if you are:

•    pregnant, might become pregnant, or think you may be pregnant

•    breast-feeding.

Driving and using machines

Trimipramine may make you feel sleepy or less alert. If this happens do not drive or use any tools or machines.

Important information about some of the ingredients of trimipramine

Trimipramine tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE TRIMIPRAMINE TABLETS

Always take trimipramine exactly as your doctor has told you. The dose of trimipramine will depend on your needs and the illness being treated. Check with your doctor or pharmacist if you are not sure.

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Taking this medicine

•    Swallow the tablets whole with a drink of water

•    If trlmlpramine Is taken only once each day, you should take it before going to bed

•    Your doctor may decide you should take trimipramine more than once each day

•    It may take 7 to 10 days before you feel the full benefit of the medicine.

How much to take Adults:

•    The usual starting dose of trimipramine is 50mg to 75mg each day

•    Your doctor may then increase the dose to between 150mg and 300mg each day depending on your condition

•    Once you start to feel better, the usual daily dose then stays the same at 75mg to 150mg each day.

Elderly:

•    The usual starting dose of trimipramine is 10mg to 25mg three times each day

•    Your doctor will then increase this slowly

•    Once you start to feel better, the usual daily dose then stays the same at 35mg to 75mg each day.

Children:

Do not give trimipramine to children.

If you take more trimipramine than you should

If you take more trimipramine than you should, tell a doctor or go to a hospital casualty department straight away. Take the carton and any tablets left with you. This is so the doctor knows what you have taken. The following effects may happen: convulsions, collapse and falling into a coma.

If you forget to take trimipramine

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten dose.

If you stop taking trimipramine

•    Keep taking trimipramine until your doctor tells you to stop. Do not stop taking trimipramine just because you feel better. This is because your illness may come back.

•    When your doctor tells you to stop taking these tablets he/she will help you stop taking them gradually.

•    Stopping your medicine too quickly could cause sleep problems, leave you feeling more irritable than usual and cause you to sweat more than usual.

•    Convulsions

•    Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin.

Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days:

•    Feeling drowsy or sleepy

•    Constipation

•    Dry mouth

•    Tremor (shaking)

•    Blurred vision

•    Rapid heartbeat

•    Sweating more than usual

•    Feeling dizzy or light-headed on standing or sitting up quickly

•    Sexual problems

•    Delay when starting to pass water (urine)

•    Skin rash.

An increased risk of bone fractures has been observed in patients taking this type of medicines.

If any of the side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE TRIMIPRAMINE TABLETS

•    Keep out of the reach and sight of children.

•    Do not store above 25°C.Store in the original packaging.

•    Do not use trimipramine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.

•    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.

6. FURTHER INFORMATION

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4. POSSIBLE SIDE EFFECTS

Like all medicines, trimipramine can cause side

effects, although not everybody gets them.

Stop taking trimipramine and see a doctor or

go to a hospital straight away if:

*    You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty swallowing or breathing. You could also notice an itchy, lumpy rash known as urticaria or hives. This may mean you are having an allergic reaction to trimipramine.

Talk to your doctor straight away if you notice

the following side-effects:

*    Yellowing of the eyes or skin. This could be a liver problem (such as jaundice)

*    Overactive behaviour or thoughts (mania or hypomania)

*    Numbness or weakness in the arms and legs

*    Feeling unable to trust people or things, for no reason. This could be a sign of a mental problem called paranoia

*    Getting infections more easily than usual. This could be because of a blood disorder (low white blood cell numbers)

What trimipramine contains

Each Trimipramine 10mg Tablet contains 13.948mg of timipramine maleate, equivalent to 10mg of trimipramine.

Each Trimipramine 25mg Tablet contains 34.87mg of trimipramine maleate, equivalent to 25mg of trimipramine.

The other ingredients are lactose monohydrate, sodium lauryl sulphate, maize starch, calcium hydrogen phosphate dehydrate, magnesium stearate.

What trimipramine looks like and contents of the pack

Trimipramine 10mg and 25mg Tablets are white coloured round tablets.

Trimipramine 10mg and 25mg tablets are supplied in blister packs of 28 and 84 tablets.

Marketing Authorisation Holder

Focus Pharmaceuticals Limited,

Capital House, 85 King William Street,

London, EC4N 7BL, UK

Manufacturer

Primegen Limited,

Unit 15 Moorcroft Harlington Road,

Uxbridge, UB8 3HD UK

This leaflet was last revised in February 2016

103642-43/LF/334/02

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