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PACKAGE LEAFLET: INFORMATION FOR THE USER Amitriptyline 10mg Film-Coated Tablets Amitriptyline 25mg Film-Coated Tablets Amitriptyline 50mg Film-Coated Tablets (referred to as Amitriptyline Tablets in this leaflet)

Read all of this leaflet carefully before you start to take this medicine.

-    Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please 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 Amitriptyline Tablets are and what they are used for

2.    Before you take Amitriptyline Tablets

3.    How to take Amitriptyline Tablets

4.    Possible side effects

5.    How to store Amitriptyline Tablets

6.    Further information

Do not take Amitriptyline Tablets if you:

•    are allergic (hypersensitive) to amitriptyline or to any of the other ingredients in Amitriptyline Tablets (see section 6, Further information)

•    are taking drugs called Monoamine Oxidase Inhibitors (MAOls) for depression or have taken them within the last two weeks

•    are recovering from a heart attack

•    have an abnormal heart rhythm or irregular heart block (slow conduction of the electrical impulses which make the heart beat)

•    suffer from mania (feeling high or over-excited)

•    have severe liver disease

•    are breast feeding

Amitriptyline Tablets should not be used in children under 6 years.

Amitriptyline Tablets are not recommended for the treatment of depression in children under 16 years of age. Talk to your doctor before taking Amitriptyline Tablets if you:

•    suffer from or have a history of epilepsy

•    suffer from liver problems

•    have diabetes

•    have problems passing water

•    have an enlarged prostate

•    have increased pressure in your eyes (e.g. glaucoma)

•    suffer from heart disease

•    have an overactive thyroid gland

•    suffer from schizophrenia or manic-depression

•    receive electroconvulsive therapy (ECT)

•    have hiatus hernia (a weakness of the diaphragm causing heartburn)

•    have phaeochromocytoma (a rare tumour of the adrenal gland)

•    have porphyria (a disease of blood proteins affecting the skin, gut and nervous system)

•    are due to have surgery in the near future

•    smoke

Special care should be taken with elderly patients.

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 toll 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, including medicines obtained without a prescription. It is important you do this as some medicines when taken in combination with Amitriptyline Tablets can cause very serious side effects such as paralytic ileus (this is when the small bowel ceases to function for a time), heart problems including a life-threatening irregular heart beat and changes to the blood clotting process. The following medicines can affect or be affected by treatment with Amitriptyline Tablets:

•    antidepressants called monoamine oxidase inhibitors (MAOls) - you should wait at least 14 days after stopping an MAOl before starting amitriptyline

•    medicines used to treat high blood pressure (e.g. guanethidine, debrisoquine, betanidine, clonidine)

•    astemizole and terfenadine, used in hayfever and other allergic conditions

•    drugs used to treat severe allergic reactions and shock such as adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine

•    drugs used to control irregular heart rhythm, such as amiodarone, disopyramide, procainamide and quinidine

•    anaesthetics

•    nitrates, such as glyceryl trinitrate, used to treat angina

•    sotalol, a beta-blocker, used in heart disease

•    medicines used as sedatives to treat sleep problems (e.g. ethchlorvynol) and tranquillisers

•    barbiturates and other drugs which slow down brain function

•    carbamazepine and sodium valproate to treat epilepsy

•    methylphenidate, a drug used to treat hyperactivity

•    anticholinergic drugs, such as trihexyphenidyl hydrochloride and benzatropine mesylate, and selegiline, used in the treatment of Parkinson’s Disease

•    nefopam and morphine, used for pain relief

•    rifampicin, used to treat bacterial infections

•    warfarin and other drugs used to thin the blood

•    fluconazole, used to treat fungal infections

•    diuretics (water tablets)

•    disulfiram (used to treat alcoholism)

•    ritonavir (used to treat HIV infection)

•    cimetidine (used to treat problems with stomach acid)

•    oral contraceptives ("the pill")

•    thyroxine, used to treat an underactive thyroid gland

•    sertindole, pimozide, thioridazine and phenothiazine, used to treat mental illness

•    Fluoxetine, reboxetine and St John's Wort used to treat depression Taking Amitriptyline Tablets with food and drink

As with all medicines that act on the central nervous system (the brain and spinal cord), it is advised that you do not drink alcohol while taking this medicine.

Pregnancy and breast-feeding

You should not use this medicine if you are pregnant unless your doctor specifically recommends it. Tell your doctor straight away if you think you may be pregnant or wish to become pregnant.

You should not take Amitriptyline Tablets if you are breast feeding.

Driving and using machinery

Amitriptyline Tablets may cause drowsiness and reduced alertness, do not drive or operate machinery while taking this medicine.

Important information about some of the ingredients in Amitriptyline Tablets

Amitriptyline 25mg Tablets contain tartrazine aluminium lake (E102) and sunset yellow FCF (E110), which may cause allergic reactions.

3. HOW TO TAKE AMITRIPTYLINE TABLETS

Always take Amitriptyline Tablets as your doctor has told you. Your doctor will decide the right dose for you; this will be on the pharmacist’s label. Check this carefully, it will tell you how much of this medicine to take and how often to take it. This medicine should be swallowed. The usual doses are as follows:

Depression

Adults

•    usual starting dose is 75mg given twice or as one dose before bedtime

•    this may be increased to 150mg a day, with the additional doses being given in the late afternoon or before bedtime

•    usual daily maintenance dose is 50mg - 100mg

•    when an improvement is seen in your condition, your doctor will reduce the dose

102530/6

Elderly

•    elderly patients may need a lower starting dose of 10mg to 25mg three times a day and a maintenance dose of 50mg a day

Not recommended in children under 16 years of age.

Bed-wetting

•    children aged 6-10 years may receive 10-20mg a day

•    children aged 11-16 years may need 25mg a day

•    treatment should be no longer than 3 months Not for use in children under 6 years.

If you take more Amitriptyline Tablets than you should If you (or anybody else, including a child), takes more Amitriptyline Tablets than you should you should contact your doctor or nearest hospital casualty department immediately. Always take the leaflet and any tablets you have left with you.

If you forget to take Amitriptyline Tablets

If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

If you stop taking Amitriptyline Tablets

Do not stop taking Amitriptyline Tablets unless you have been told to do so by your doctor. If you suddenly stop your treatment you may experience effects such as nausea, chills, headache, sweating, anxiety, agitation, jerky uncontrollable movements, irregular heart rhythm, mania (persistent extremely elevated mood and sometimes psychosis), hypomania (mild form of mania), vivid dreams and sleep disturbances and general feeling of unwell.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Amitriptyline Tablets can cause side effects, although not everybody gets them. As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, seek medical help immediately:

•    rash, itching, swelling of the face and tongue, difficulty breathing, increased sensitivity to sunlight Side effects that have been reported with Amitriptyline Tablets are:

Heart and Blood Vessel disorders

•    high blood pressure

•    fainting

•    low blood pressure resulting in dizziness (particularly on standing)

•    palpitations Nervous System disorders

•    confusion

•    disorientation

•    drowsiness

•    excitement

•    delusions

•    sleep disturbance

•    involuntary movements, jerking, uncontrolled shaking

•    headache

•    problems with coordination and balance

•    speech problems

•    Neuroleptic Malignant Syndrome (fever, muscle cramps, delirium)

Eye problems

•    blurred vision

•    enlarged pupils Gastrointestinal System

•    dry mouth

•    sore mouth

•    paralysis of the gut

•    stomach pains

•    weight gain

•    unpleasant taste in mouth Skin and Hair problems

•    sensitivity to sunlight

•    increased sweating

•    hair loss

Kidney and Urinary complaints

•    problems passing water Liver complaints

•    liver problems Muscle and Bone complaints

•    painful joints

•    weakness Other complaints

•    altered sex drive

•    delayed ejaculation, delayed orgasm in women

•    swelling of testicles

•    mi k production

•    increase in breast tissue (in men and women)

•    problems with bone marrow and blood cell production

•    severe reduction in number of white blood cells, which makes infections more likely

•    reduction in blood platelets, which increases risk of bleeding or bruising

When used for the treatment of bed wetting in children, the side effects are less frequent. The most common side effects are drowsiness, blurred vision, dilated pupils, constipation, sweating, itching and dry mouth. Changes in behaviour have also occurred in children receiving amitriptyline.

Some babies bom to mothers who have taken amitriptyline shortly before delivery have had heart problems, breathing difficulty, muscle spasm, irritability, fits or difficulty passing urine.

You may also have thoughts of harming or killing yourself whilst taking amitriptyline tablets, or soon after your doctor tells you to stop taking amitriptyline 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.

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 AMITRIPTYLINE TABLETS

Keep out of the reach and sight of children.

•    Do not store above 25°C.

•    Amitriptyline Tablets should not be taken after the expiry date on the label and carton; the expiry date refers to the last day of the month.

•    Do not take this medicine if the tablets show signs of "going off' such as discolouration.

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 protect the environment.

6. FURTHER INFORMATION

What Amitriptyline Tablets contain

The active ingredient is: amitriptyline hydrochloride. The tablets are available in three strengths, 10mg, 25mg and 50mg. Amitriptyline 10mg Tablets also contain: Calcium hydrogen phosphate dihydrate, sodium starch glycollate, maize starch, microcrystalline cellulose, magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol and indigo carmine aluminium lake (E132).

Amitriptyline 25mg Tablets also contain: Calcium hydrogen phosphate dihydrate, sodium starch glycollate, maize starch, microcrystalline cellulose, magnesium stearate, hypromellose (E464), titanium dioxide (El 71), macrogol, tartrazine aluminium lake (E102) and sunset yellow FCF (E110).

Amitriptyline 50mg Tablets also contain: calcium hydrogen phosphate dihydrate, sodium starch glycollate, maize starch, microcrystalline cellulose, magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol, iron oxide yellow (E172), iron oxide black (E172) and iron oxide red (E172).

What Amitriptyline Tablets look like and the contents of the pack

Amitriptyline 10mg Tablets are pale blue, film coated, circular tablets marked A on one face and 10 on the reverse. Amitriptyline 25mg Tablets are yellow, film coated, circular tablets marked A on one face and 25 on the reverse. Amitriptyline 50mg Tablets are buff, film coated, circular tablets marked A on one face and 50 on the reverse. Amitriptyline Tablets are available in containers of 100 and 500 tablets or blister packs containing 28 tablets. 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:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only). Please be ready to give the following information:

Product name	Reference number
Amitriptyline 10mg Film-Coated Tablets	PL 29831/0007
Amitriptyline 25mg Film-Coated Tablets	PL 29831/0008
Amitriptyline 50mg Film-Coated Tablets	PL 29831/0009

This is a service provided by the Royal National Institute of Blind People. The leaflet was last revised in: 04/2015

Twockhardt