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PACKAGE LEAFLET: INFORMATION FOR THE USER

AMITRIPTYLINE 25 mg TABLETS BP

(Amitriptyline 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 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 signs of illness 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.

What is in this leaflet

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

2.    What you need to know before you you take Amitriptyline Tablets

3.    How to take Amitriptyline Tablets

4.    Possible side effects

5.    How to store Amitriptyline Tablets

6.    Contents of the pack and other information

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

Amitriptyline belongs to a group of drugs called tricyclic antidepressants (TCADs).It prolongs the effects of noradrenaline and serotonin (substance which transmit nerve impulses). Amitriptyline is used:-

•    To treat depression

•    For the relief of night bed-wetting in children

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMITRIPTYLINE TABLETS

Do not take Amitriptyline tablets and tell your doctor if you or your child (if they are the patient):-

•    Are allergic (hypersensitive) to Amitriptyline, other tricyclic antidepressants or any of the other ingredients (see Section 6).

•    Suffer from any liver or heart problems (e.g. abnormal heart rhythm).

•    Have you suffered a heart attack within the last three months.

•    Are taking monoamine oxidase inhibitors (MAOI) or you have taken MAOIs within the previous 14 days for depression.

•    Are you pregnant, trying to become pregnant, or breastfeeding

•    If the child is under 7 years old.

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 young 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 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.

Warnings and Precautions

Check with your doctor or pharmacist before taking Amitriptyline tablets if you or your child (if they are the patient):

•    Have any blood disorders

•    Have difficulty in passing water

•    Have you had prostate trouble

•    Have an overactive thyroid gland

•    Have a history of epilepsy or suffered recently from convulsions

•    Suffer from any mental illness other than depression

•    Have porphyria

•    Have increased pressure in the eye (glaucoma)

If you are to undergo any surgery or receive anaesthetics (even at the dentist) or have electroconvulsive therapy (ECT), you should make the doctor or dentist treating you aware that you are taking amitriptyline.

If you experience symptoms such as drowsiness, confusion or fits, tell your doctor immediately because this may indicate a low sodium level in the blood.

Other medicines and Amitriptyline Tablets Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, especially:-

•    Other medicines used to treat depression including monoamine oxidase inhibitors (MAOIs), herbal remedy St John’s Wort

•    Drugs that depress the central nervous system including barbiturates (e.g. phenobarbitone)

•    Sedatives (medicines that relieve anxiety and have a calming effect)

•    Thyroid harmone therapy

•    Altretamine a drug used for the treatment of advanced ovarian cancer

•    apraclonidine and brimonidine (to treat glaucoma ; a condition characterised by increased intraoccular pressure)

•    Baclofen a drug used for muscle spasm resulting from disorders such as multiple sclerosis

•    Disulfiram (to treat alcoholism)

•    Certain painkillers, including nefopam and tramadol

•    Medicines to treat irregular heart rhythm, such as amiodarone, disopyramide, procainamide, propafenone, quinidine and sotalol

•    Medicines used in the treatment of angina

•    Rifampicin (an antibiotic)

•    Medicines used to treat epilepsy

•    Medicines used to relieve: asthma, gastrointestinal upset (e.g.vomiting or cramps) and allergies (antihistamines e.g. terfenadine)

•    Any medicines to treat high blood pressure such as guanethidine, debrisoquine, bethanidine, clonidine or methyldopa or diuretics (water tablets)

•    Medicines used to treat mental illness, including thioridazine and pimozide

•    Cimetidine (a medicine used to treat ulcers)

•    Methylphenidate, a drug used to treat sleeping problems

•    Ethchlorvynol (to help you sleep)

•    Entacapone or selegiline (to treat Parkinson’s disease)

•    Oral contraceptives

•    Sibutramine, a medicine used for weight loss

•    Medicines such as adrenaline, ephedrine, phenylephrine, or phenylpropanolamine. These may be present in many medicines for colds and nasal stuffiness. Tell your pharmacist that you are taking amitriptyline before buying such products

•    Ritonavir (to treat HIV)

•    Fluconazole (to treat fungal infections)

Amitriptyline Tablets with food, drink and Alcohol

You are advised not to drink alcohol with this medicine

Pregnancy, breast-feeding and fertility

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

•    Amitriptyline tablets should not be taken in the first 3 months and last 3 months of pregnancy. If taken in the last three months, the newborn may have withdrawal symptoms.

•    Do not take Amitriptyline tablets if you are breast feeding Driving and using machines

If you feel dizzy or drowsy when you start taking this medicine, do not drive or operate machinery until these effects wear off. Amitriptyline Tablets contains Lactose and Sunset Yellow

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.

The 25mg tablets also contain a colour called “sunset yellow” which may cause allergic reactions.

3. HOW TO TAKE AMITRIPTYLINE TABLETS

Always take Amitriptyline tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets with a glass of water

You are advised not to drink alcohol with this medicine.

You may not notice any improvement in your symptoms for up to 4 weeks after starting treatment.

Doses

Depression:-

Adults - 50-75mg a day either in divided doses or a single night time dose increasing to 150-200mg a day. A maintenance dose of 50-100mg at night should be given to lessen the chances of relapse. Adolescents and elderly - 25-50mg a day either in divided doses or as a single night time dose. A maintenance dose of 25-50mg may be sufficient.

Nightly bedwetting:-

Children only (for no longer than 3 months)

11-16 years - 25-50mg at night 7-10 years - 10-20mg at night Under 7 years - not recommended Treatment should not exceed three months.

Not recommended for treatment of depression in children under 16 years of age.

•    Amitriptyline tablets are not suitable for children under 7 years.

•    This medicine should only be used for up to 3 months to treat night bed-wetting.

•    If you are elderly you will be advised by your doctor specifically on how many and how often to take the tablets.

•    This medicine is not suitable for the treatment of depression in children under 12 years

If you take more than you should

If you or the patient (or someone else) swallows a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department, or tell your doctor immediately.

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time.

If you stop taking the tablets

Talk to your doctor before you stop taking the tablets and follow their advice as you may experience unwanted effects such as nausea, headache or weakness

4. POSSIBLE SIDE EFFECTS

Like all medicines, Amitriptyline Tablets can cause side effects,

although not everybody gets

them.

Stop taking Amitriptyline tablets and contact your doctor straight away if you have:

•    an allergic reaction. Signs may include a skin rash, which may be itchy, sensitivity to the sun or sun lamps, puffy, swelling of your face, lips, throat or tongue, which may be severe causing shortness of breath, swelling, shock and collapse.

•    a serious effect on your blood, such as low sodium levels. Signs may include fever or chills, sore throat, ulcers in your mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruises.

If you notice any of these, tell your doctor straight away.

Serious side effects: tell your doctor straight away

•    If you feel more depressed, including thinking about suicide. Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

•    Effects on your blood:

bone marrow depression or reduction in some blood cells (you may experience a sore throat, mouth ulcers and recurring infections, bleeding or bruising easily)

•    Effects on your hormones:

disturbances in sexual function or sex drive, breast swelling in men and women, swelling of the testicles, production or overproduction of breast milk, changes in blood sugar levels, increased appetite and weight gain. Inappropriate secretion of the hormone ADH (antidiuretic hormone), which may make you urinate more frequently.

•    Effects on your brain and central nervous system:

dizziness, tiredness or sleepiness, weakness, headache, difficulty concentrating, confusion, difficulty sleeping, nightmares, slight hyperactivity, exaggerated behaviour, delusions, seeing things that are not there (hallucinations), anxiety, excitement, disorientation (not knowing where you are), restlessness, numbness or tingling or pins and needles (particularly in the hands and feet), lack of co-ordination, shaky movements, tremor, fits, unconsciousness, slow or slurred speech.

•    Effects on your heart:

feeling faint when getting up (postural hypotension), change in blood pressure, fast/racing heart, palpitations, heart attack, stroke, irregular or slow heart-beats.

•    Effects on your stomach and intestines:

feeling or being sick, diarrhoea, change in appetite, irritation and a nasty taste in your mouth, swollen saliva glands, abdominal pains, black tongue, dry mouth, fever, constipation, blockage of your small intestine.

•    Effects on your liver:

hepatitis, including changes in liver function (as seen in blood tests), jaundice (yellowing of the skin and/or whites of the eyes)

•    Effects on your ears:

Buzzing or ringing in the ears.

•    Effects on your eyesight:

blurred or double vision, changes in eyesight.

•    General effects:

headache, dizziness, weakness, tiredness, change in weight, drowsiness, increased sweating, hair loss, widely dilated pupils, difficulty passing water (urine).

•    Effects on the skin:

skin rashes, skin rash due to sunlight.

•    Withdrawal symptoms: feeling sick, malaise and headache, dream and sleep disturbances, irritability and restlessness. Mania or hypomania (exaggerated mood and/or elation) may occur 2-7 days after stopping the tablets.

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

When used for children, the side effects are less frequent but may still happen. The most common reported effects amongst children are drowsiness, dry mouth, blurred eyesight, increased pressure in the eye, changes in eyesight, constipation, fever and difficulty in passing water (urine). There have also been rare reports of mild sweating and itching.

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. Store in the original container. Keep the container tightly closed.

•    Do not use this medicine after the expiry date which is stated on the label or carton (EXP:). The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Amitriptyline tablets contain

•    The active substance (the ingredient that makes the tablets work) is Amitriptyline Hydrochloride. Each tablet contains 25mg of the active ingredient.

•    The other inactive ingredients are Lactose Monohydrate, Povidone, Magnesium Stearate, Stearic Acid, Maize Starch, Calcium Carbonate, Talc, Acacia, Sucrose, Polyvinyl acetate Phthalate, Yellow Carnauba Wax,White Besswax,Shellac and the colours Titanium Dioxide, Quinoline Yellow Aluminium Lake (E104) and Sunset Yellow Aluminium Lake. The sugar coat contains the preservative Sodium Benzoate (E211).

What Amitriptyline tablets look like and contents of the pack

•    Amitriptyline 25mg Tablets are pale yellow, circular, deep convex sugar-coated tablets.

•    They are available in packs of 50, 100, 250 & 500 tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Name and Address:

Bristol Laboratories Ltd

Unit 3, Canalside, Northbridge Road, Berkhamsted, HP4 1EG.

Telephone:    0044 (0) 1442 200922

Fax:    0044 (0) 1442 873717

E-mail:    info@bristol-labs.co.uk

Amitriptyline 25mg Tablets; PL 17907/0342

This leaflet was last revised in August 2014

To request a copy of this leaflet in Braille, large print or audio

format, please contact the licence holder at the address (or

telephone, fax, email) above.