PACKAGE LEAFLET: INFORMATION FOR USER

AMITRIPTYLINE 10 MG, 25 MG AND 50 MG FILM-COATED TABLETS Amitriptyline Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    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 only. 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 is and what it is used for

2.    What you need to know before you take Amitriptyline

3.    How to take Amitriptyline

4.    Possible side effects

5.    How to store Amitriptyline

6.    Contents of the pack and other information

1. What Amitriptyline is and what it is used for

Amitriptyline belongs to a group of drugs called tricyclic antidepressants (TCADs). These medicines alter the levels of chemicals in the brain to relieve the symptoms of depression.

Amitriptyline may be used:

•    to treat the symptoms of depression.

•    for the relief of bed-wetting at night by children.

2. What you need to know before you take Amitriptyline

Do not take Amitriptyline and tell your doctor if you

•    are allergic (hypersensitive) to amitriptyline, other tricyclic antidepressants or any of the other ingredients in these tablets (listed in section 6).

•    are taking monoamine oxidase inhibitors (MAOI), or you have stopped taking these medicines within the last14 days.

•    have heart disease including irregular heart beats, heart block, heart failure, coronary artery disease or have had a recent heart attack.

•    suffer from periods of increased and exaggerated behaviour (mania).

•    are pregnant or breast-feeding.

•    have severe liver disease.

•    are under 16 years old.

Warnings and precautions

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.

Talk to your doctor or pharmacist before taking Amitryptiline if you or your child:

•    have any blood disorders (you may bruise easily, frequently suffer from infections or be anaemic).

•    have any psychiatric (mental) disorder (eg schizophrenia or manic depression).

•    are not able to pass water.

•    have been told you have an enlarged prostate gland.

•    suffer from porphyria (a deficiency of specific enzymes within the body, causing an increase of substances called porphyrins).

•    have a diseased thyroid gland

•    have a history of epilepsy.

•    suffer from narrow-angle glaucoma (increased pressure in the eye resulting in loss of vision).

•    are being given electroconvulsive therapy (ECT)

•    are planning to have surgery (including dental), as Amitriptyline may need to be stopped before you have a general anaesthetic.

If you are elderly, you are more likely to suffer from certain side effects (see section 4).

You may not see an improvement in your depression during the first month of treatment. Your doctor may want to monitor you during this time.

Other medicines and Amitriptyline

Do not take Amitriptyline in combination with, or if you have taken in the last 14 days

•    antidepressants known as MAOIs (e.g. moclobemide or phenelzine).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription in particular the following:

•    altretamine (used to treat cancer of ovary)

•    anticholinergics e.g. atropine or hyoscine

•    apraclonidine and brimonidine (used to treat glaucoma)

•    baclofen (a muscle relaxant)

•    disulfiram (used to treat alcohol addiction)

•    painkillers (such as nefopam, tramadol,)

•    medicines to treat an irregular heart beat(such as amiodarone, diltiazem, disopyramide, procainamide, propafenone, quinidine, sotalol, verapamil)

•    medicines to treat angina that you spray or dissolve under your tongue (eg glyceryl trinitrate “GTN”, isosorbide dinitrate)

•    rifampicin (to treat infections)

•    antidepressants or medicines used to treat some mental illnesses such as, clozapine, pimozide, fluoxetine

•    carbamazepine or barbiturates (e.g. Phenobarbital or amobarbital) (to treat epilepsy)

•    terfenadine, cetirizine, loratidine (to treat allergies and hayfever)

•    methylphenidate (used to treat attention deficit/hyperactivity disorder (ADHD))

•    any medicines to treat high blood pressure (such as guanethidine, debrisoquine, bethanidine or clonidine)

•    cimetidine (to treat ulcers)

•    ethchlorvynol (to help you sleep)

•    diuretics (“water” tablets, e.g. furosemide, bendroflumethiazide, amiloride, triamterene)

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

•    oral contraceptives (“the pill”)

•    sibutramine (anti-obesity drug)

•    sympathomimetic medicines such as adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (these may be present in many cough and cold remedies, tell your pharmacist that you are taking amitriptyline before buying such products)

•    ritonavir (used to treat HIV).

•    levacetylmethadol (used to treat drug dependence)

•    thyroid hormones (e.g.levothyroxine)

•    electroconvulsive therapy (ECT)

Amitriptyline with food, drink and alcohol

DO NOT drink alcohol with this medicine as it may increase the sedative effects of these tablets

Pregnancy, breast-feeding and fertility

If you are pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before taking any medicine.

Do not take Amitriptyline film-coated tablets if you are breast-feeding. Amitriptyline should not be taken in the first three months and the last three months of pregnancy. If taken in the last three months, the newborn may have withdrawal symptoms.

Driving and using machines

Amitriptyline may impair your alertness. Do not drive or operate machinery if you are affected.

Amitriptyline film-coated tablets contain Lactose.

If you or your child has been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Amitriptyline

Always take Amitriptyline exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed with a glass of water. The usual dose is:

Depression:

Children and adolescents: Not recommended for children and adolescents under 16 years.

Adults: The usual starting dose is 75 mg daily, either in divided doses or as a single night time dose, gradually increased if necessary. A maintenance dose of 50-100 mg at night should be given to lessen the chances of relapse.

Elderly: The usual dose is 10-25 mg three times a day initially, which may be gradually increased if necessary. The dosage may be taken as divided doses, or as a single dose, preferably in the evening or at bedtime.

Nightly bed-wetting:

Children only (for no longer than 3 months treatment):

11-16 years:    25-50 mg taken at night.

7-10 years:    10-20 mg taken at night.

Under 7 years:    Not recommended.

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

If you take more Amitriptyline than you should

If you (or somebody else) accidentally swallow 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. Take any remaining tablets and the container with you.

Symptoms of an overdose include fast or irregular heartbeat, low blood pressure, dilated pupils, drowsiness, low body temperature, fits, coma, agitation, muscle rigidity, being sick or fever,squint, problems passing water, difficulty in controlling movements, involuntary eye movement, low blood pressure, vomiting, breathing problems

If you forget to take Amitriptyline

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 Amitriptyline

Do not stop taking these tablets suddenly. You should continue to take them for as long as your doctor tells you.

Talk to your doctor before you stop taking the tablets and follow their advice as you may experience withdrawal symptoms (feeling sick, malaise and headache.) Gradual withdrawal is associated with reports of symptoms including dream and sleep disturbances, irritability and restlessness;excitement and hyperactivity during the first two weeks

of dosage reduction. Feeling elated or over-excited has been rarely reported when stopping long term treatment with this type of drug. These symptoms are transient and are not a sign of addiction.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

_4. Possible side-effects_

Like all medicines, Amitriptyline can cause side-effects, although not everybody gets them.

Stop taking Amitriptyline and tell your doctor immediately or go to the casualty department at your nearest hospital

•    if you experience an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives). This is a serious but rare side effect. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

•    Effects on the blood:

Blood disorders which may be characterised by fever or chills, sore throat, ulcers in your mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruising. Tell your doctor immediately if you notice any of these symptoms.

•    Effects on the heart, circulation and blood:

High or low blood pressure, fainting, dizziness,changes in heart rhythm, heart attack, stroke.

•    Effects on the nervous system:

Tiredness, headache, weakness, confusion,disturbed concentration, disorientation, delusions,hallucinations, elevated mood and hyperactivity,excitement, anxiety, restlessness, drowsiness, dream and sleep disturbances, numbness, pins and needles, loss of co-ordination, uncontrolled shaking, abnormal muscle movements, slurred speech, ringing in the ears, coma, and fits.

•    Effects on the anti-cholinergic system:

Dry mouth, blurred vision, eye problems,increased pressure in the eye, constipation, bowel problems, problems passing urine, increased urine production, high body temperature.

•    Allergic reactions:

Skin rash, sensitivity to light, swelling of the face and tongue and urticaria (hives).

•    Effects on the digestive system:

Nausea (feeling sick), stomach discomfort,vomiting, loss of appetite, diarrhoea, abdominal pains, an unpleasant taste, black tongue,swelling of the area around the ear, soreness of the mouth and rarely hepatitis (inflammation ofthe liver), including liver enzyme abnormalities and jaundice characterised by yellowing of the skin and whites of the eyes.

•    Effects on the hormone system:

Testicular swelling, breast enlargement in both men and women, milk production by women even if they are not breast-feeding, and sexual problems, changes in blood sugar levels and low blood sodium levels.

Other adverse effects include, dizziness, weakness, fatigue, headache, fluid retention, needing to passwater often, increased perspiration, hair loss,increased appetite, and weight gain (may be due to the drug or as a result of the relief of depression).

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

There have also been reports of breathing problems and agitation in babies whose mothers took this type of drug.

If you are elderly, you are more likely to experience effects of agitation, confusion, lowblood pressure on standing causing dizziness,light-headedness or fainting, or to develop low blood levels of sodium, which can cause tiredness,confusion, muscle twitching and fits

Other side effects:

If taken to treat bed-wetting: drowsiness, mild sweating, itching, changes in behaviour and anticholinergic effects.

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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on safety of this medicine.

5. How to store Amitriptyline

Keep out of the sight and reach of children.

Do not store above 30⁰C. Store in the original package (blister) in order to protect from moisture and light.

Do not use Amitriptyline film-coated tablets after the expiry date which is stated on the carton or blister after ‘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 dispose of medicines you no longer use.These measures will help protect the environment.

6. Contents of the pack and other information

What Amitriptyline film-coated tablets contain

The active substance is amitriptyline hydrochloride. Each tablet contains either 10mg, 25mg or 50mg of the active ingredient.

The other ingredients are: lactose monohydrate, crospovidone, maize starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate and talc.

The 10 mg tablet also contains: hypromellose, macrogol 6000, talc, titanium dioxide (E171), indigo carmine Al Lake (E132).

The 25 mg tablet also contains: hypromellose, macrogol 6000, talc, titanium dioxide (E171), quinoline yellow (E104).

The 50 mg tablet also contains: hypromellose, macrogol 6000, talc, titanium dioxide (E171), ferric oxide red (E172), quinoline yellow (E104).

What Amitriptyline film-coated tablets look like and contents of the pack

Amitriptyline 10 mg film-coated tablets are pale blue coloured, circular biconvex film-coated tablets with “BL” embossed on one side and “10” on the other side.

Amitriptyline 25 mg film-coated tablets are yellow coloured, circular biconvex film-coated tablets with “BL” embossed on one side and plain on the other side.

Amitriptyline 50 mg film-coated tablets are buff coloured, circular biconvex film-coated tablets with “BL” embossed on one side and plain on the other side.

Amitriptyline film-coated tablets are available in a pack sizes of 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160 or 168 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP41EG, UK

Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

E-mail:    info@bristol-labs.co.uk

Amitriptyline 10 mg film-coated tablets; PL 17907/0131 Amitriptyline 25 mg film-coated tablets; PL 17907/0132 Amitriptyline 50 mg film-coated tablets; PL 17907/0133

This leaflet was last revised in September 2013

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, e-mail) above.