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Amitriptyline 10mg Tablets

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Metwest

Pharmaceuticals


PACKAGE LEAFLET: INFORMATION FOR THE USER

AMITRIPTYLINE 10 mg & 25 mg TABLETS

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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.

THIS LEAFLET CONTAINS

1.    What Amitriptyline is for

2.    Before you take Amitriptyline

3.    How to take Amitriptyline

4.    Possible side effects

5.    How to store Amitriptyline

6.    Further information

1. WHAT AMITRIPTYLINE IS FOR

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

Amitriptyline can be used to treat:

•    the symptoms of depression

•    bed-wetting at night by children

If you are not sure why you have been prescribed these tablets then please ask your doctor.

2. BEFORE YOU TAKE AMITRIPTYLINE

Do not take Amitriptyline and tell your doctor if you:

•    are allergic to Amitriptyline or any of the other ingredients in the tablets (listed in section 6 of this leaflet)

•    have heart problems such as irregular heartbeats, heart block or have recently had a heart attack

•    have severe liver problems

•    are taking other medicines to treat depression known as Monoamine Oxidase Inhibitors (MAOIs) or you have taken MAOIs within the last 14 days

•    suffer from mania (feeling over-excited, which causes unusual behaviour)

•    are pregnant, planning a pregnancy or are breast-feeding

•    have an inherited iron disorder (porphyria)

Amitriptyline should not be given to children under 7 years of age.

Take special care with Amitriptyline

Tell your doctor before you take this medicine if you:

•    have epilepsy

•    have a mental health problem such as schizophrenia or manic depression

•    have problems with your liver or heart

•    have increased pressure in your eye (glaucoma)

•    cannot pass urine or have an enlarged prostate gland

•    have an overactive thyroid gland or are taking medicines to treat thyroid problems

•    are having electroconvulsive therapy (ECT)

•    have a tumour called phaeochromocytoma, which is usually near the kidney and can cause high blood pressure

Tell your doctor or dentist that you are taking Amitriptyline if you are going to have an anaesthetic for an operation or dental treatment.

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 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

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Amitriptyline tablets work:

•    medicines to treat depression known as Monoamine Oxidase Inhibitors (MAOIs) such as moclobemide or you have taken MAOIs within the last 14 days

•    other medicines to treat depression such as fluoxetine, duloxetine or the herbal remedy St John's Wort

•    medicines to treat mental health problems such as lithium, clozapine, pimozide, thioridazine, chlorpromazine or prochlorperazine

•    medicines to treat high blood pressure such as moxonidine, guanethidine, debrisoquine, bethanidine or clonidine

•    medicines to treat chest pain such as glyceryl trinitrate, nicorandil, diltiazem or verapamil

•    medicines to treat an irregular heart beat such as amiodar-one, dronedarone, disopyramide, flecainide, procainamide, propafenone or sotalol

•    sympathomimetic agents such as adrenaline, apraclonidine, brimonidine, ephedrine, isoprenaline, noradrenaline, phenylephrine or phenylpropanolamine (these may be found in medicines to treat heart problems and asthma as well as cough or cold remedies)

•    painkillers such as codeine, nefopam or tramadol

•    medicines to help you sleep such as ethchlorvynol

•    medicines to treat epilepsy such as carbamazepine, phenytoin or barbiturates for example phenobarbital

•    medicines to treat Parkinson's disease such as entacapone, rasagiline or selegiline

•    medicines to stop blood clots from forming such as coumarins for example warfarin

•    anticholinergic drugs such as atropine to treat spasms, shaking, stiffness or movement disorders

•    atomoxetine or methylphenidate to treat Attention Deficit Hyperactivity Disorder (ADHD)

•    disulfiram to treat alcohol addiction

•    pentamidine isetionate to treat pneumonia

•    moxifloxacin to treat bacterial infections

•    ritonavir or saquinavir to treat viral infections

•    artemether and lumefantrine to treat malaria

•    cimetidine to treat stomach ulcers

•    medicines to treat thyroid problems

•    sibutramine for weight loss.

AVOID ALCOHOL whilst taking Amitriptyline Pregnancy and breast-feeding

Amitriptyline should not be taken if you are pregnant or planning a pregnancy, unless your doctor has told you to.

Do not take Amitriptyline if you are breast-feeding.

Driving and using machines

Amitriptyline may make you feel less alert. If you are affected in this way, do not drive or operate machinery.

Important information about some of the ingredients of Amitriptyline

Amitriptyline 10 mg and 25 mg tablets contain lactose. If you know you have an intolerance to some sugars, contact your doctor before taking this medicine.

Amitriptyline 25 mg tablets also contain sunset yellow (E110), which may cause allergic reactions.

3. HOW TO TAKE AMITRIPTYLINE

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 whole with a glass of water.

It may take two to four weeks of treatment before you notice an improvement in your symptoms.

Dosage

Depression:

Adults: The usual dose is 75 mg a day, either as a single dose at night or split into smaller doses over the day. Your doctor may increase this to a maximum of 150-200 mg a day.

For long term treatment the usual dose is 50-100 mg a day as a single dose at night. As your condition improves you will be prescribed the lowest effective dose necessary to treat your symptoms.

Elderly: Your doctor will start you on a lower dose (typically 10-25 mg three times a day) and then gradually increase your dose, as you may be more sensitive to the effects of this medicine.

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

Bed-wetting at night

Children (for no longer than 3 months treatment):

Under 7 years: Not recommended 7-10 years: 10-20 mg at night 11-16 years: 25-50 mg at night

If you take more Amitriptyline than you should

Contact your doctor or go to the nearest hospital immediately. Take this leaflet and the package with you.

Symptoms of an overdose may include fast or irregular heartbeats, difficulty breathing, low blood pressure, coma, fits, muscle rigidity, agitation, dry mouth, dilated pupils, hallucinations, disturbed concentration, confusion, drowsiness, vomiting, a fall in body temperature or fever.

If you forget to take Amitriptyline

Don't worry, just take it as soon as you remember. However, if it is nearly time for your next scheduled dose, skip the missed dose. Do not take a double dose (two doses at the same time) to make up for the missed one.

If you stop taking Amitriptyline

DO NOT STOP taking Amitriptyline unless your doctor tells you to. If you stop taking it abruptly, you may experience withdrawal symptoms such as headache, nausea or general illness. Your doctor will gradually reduce your dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Amitriptyline can cause side effects, although

not everybody gets them.

STOP TAKING Amitriptyline and see a doctor straight away if

you have:

•    an allergic reaction, symptoms of which may include skin rash, itching, red and raised lumps (hives), sensitivity to sunlight, swelling of your face or tongue leading to difficulty in breathing or swallowing

•    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. The doctor may wish to test your blood.

Serious side effects: Tell a doctor straight away if you:

•    feel more depressed or have thoughts of harming or killing yourself.

If you get any of the following side effects, see your doctor as

soon as possible:

•    Effects on your heart: feeling faint or dizzy when standing up, high blood pressure, fast or irregular heartbeats, palpitations, heart attack, heart block, stroke, very low blood pressure or altered electrocardiogram (ECG).

•    Effects on your brain and nervous system: confusion, disorientation (not knowing where you are), difficulty concentrating, difficulty sleeping, nightmares, delusions, hallucinations (hearing and seeing things that are not there), feeling hyperactive, excited, anxious or restless, numbness or tingling or pins and needles (particularly in the hands and feet), difficulty co-ordinating movements, shaking, fits or fainting.

•    Effects on your liver: hepatitis, including changes in liver function (as seen in blood tests) or yellowing of the skin or whites of your eyes (jaundice).

•    Effects on your hormones: changes in sexual function or sex drive, breast swelling in men and women, swelling of your testicles, production of breast milk, increased or decreased blood sugar levels or inappropriate secretion of Antidiuretic Hormone (ADH), which may make you urinate more frequently.

Tell your doctor if you get any of these side effects:

•    Effects on your ears: ringing in your ears

•    Effects on your stomach and intestines: nausea, vomiting, diarrhoea, constipation, blockage of your small intestine, pains in your stomach area (the abdomen), change in appetite, dry mouth, inflammation or irritation in your mouth sometimes causing mouth ulcers, taste disturbances, swollen salivary glands or black tongue.

•    Effects on your eyes: blurred vision, changes in eyesight, dilated pupils or glaucoma.

•    General effects: headache, fever, weakness, tiredness, drowsiness, increased sweating, difficulty in passing urine, weight gain or hair loss.

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

Withdrawal symptoms: As your doctor gradually reduces your dose you may experience irritability, restlessness or dream and sleep disturbances. Mania or hypomania (feeling elated or over-excited) may occur 2-7 days after stopping the tablets.

Bed-wetting at night by children: The side effects are less frequent but may still occur. The most common side effects are drowsiness, dry mouth, blurred vision, glaucoma, changes in eyesight, constipation, fever and difficulty in passing urine. There have also been rare reports of mild sweating and itching, as well changes in behaviour.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE AMITRIPTYLINE

Keep out of the reach and sight of children.

Store below 25°C and away from light. Store in the original package or container and keep the container tightly closed.

Do not use these tablets after the expiry date, which is stated on the package or container. 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

What Amitriptyline tablets contain

The active ingredient in Amitriptyline 10 mg and 25 mg tablets is amitriptyline hydrochloride. The other ingredients are lactose monohydrate, calcium hydrogen phosphate dihydrate, maize starch, microcrystalline cellulose, colloidal anhydrous silica, stearic acid, magnesium stearate, hypromellose, ethylcellulose, diethyl phthalate, hydroxypropyl cellulose (E463) and titanium dioxide (E171).

The 10 mg tablets also contain indigo carmine (E132). The 25 mg tablets also contain quinoline yellow (E104) and sunset yellow (E110).

What Amitriptyline tablets look like and contents of the pack

Amitriptyline 10 mg tablets are round, blue, film-coated tablets with the marking MP49 on one side.

Amitriptyline 25 mg tablets are round, yellow, film-coated tablets with the marking MP50 on one side and 25 mg on the other.

The tablets come in blister packs of 28 tablets and containers of 28, 100 and 500 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Metwest Pharmaceuticals Limited,

15 Runnelfield, Harrow on the Hill,

Middlesex HA1 3NY

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road,

London SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 05/2012

M0049-50/O/PIL/G002