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Amitriptyline 25mg Tablets Bp

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PATIENT INFORMATION LEAFLET

AMITRIPTYLINE 25 mg TABLETS BP

THIS LEAFLET PROVIDES A SUMMARY OF THE INFORMATION AVAILABLE ON YOUR MEDICINE: PLEASE READ IT CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE IF YOU HAVE ANY QUESTIONS OR ARE NOT SURE OF ANYTHING ASK YOUR DOCTOR OR PHARMACIST.

What is in this Medicine?

Amitriptyline 25mg tablets are pale yellow, circular, sugar coated tablets. Each tablet contains Amitriptyline Hydrochloride 25mg, the active ingredient.

The tablets also contain the inactive ingredients lactose monothydrate, maize starch, povidone, magnesium stearate, stearic acid, calcium carbonate, talc, acacia, sucrose, polyvinylacetate phthalate, yellow carnauba wax, white beeswax, shellac and the colours titanium dioxide (E171), quinoline yellow aluminium lake (E104) and sunset yellow aluminium lake (E110). The sugar coat contains the preservative sodium benzoate (E211).

Pack sizes: 50, 100, 250 and 500 tablets.

What is Amitriptyline?

Amitriptyline belongs to a group of drugs called tricyclic antidepressants (TCADs). It prolongs the effect of noradrenaline and serotonin (substances which transmit nerve impulses)

Who makes this medicine?

MA Holder and Manufacturer:

Pharmvit Ltd, 177 Bilton Road, Perivale,

Greenford, Middlesex UB6 7HQ.

What is this medicine for?

Amitriptyline is used to treat depression. It is also used to treat night bedwetting in children.

What do you need to know before taking this medicine?

I the answer to any of the following questions is YES,

DO NOT take this medicine without consulting your doctor

•    Have you previously suffered an allergic reaction to a medicine containing Amitriptyline or other antidepressant medicines?

•    Are you allergic to any of the other ingredients? (See ‘’What is in this medicine?’’ above)

•    Do you suffer from any liver or heart problems (e.g. abnormal heart rhythm)?

•    Have you had glaucoma (increased pressure in the eyes)

•    Do you have difficulty in passing water?

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

•    Are you taking or have you recently taken (within the last 14 days) any other medicines for depression, particularly monoamine oxidase inhibitors (MAOIs)?

•    Are you pregnant, trying to become pregnant or breast feeding?

•    Do you have a history of epilepsy or suffered recently from convulsions?

•    Do you have an overactive thyroid gland?

•    Do you suffer or have you ever suffered from any mental illness other than depression?

•    Have you had prostate trouble?

•    Do you have porphyria?

•    Are you allergic to any other ingredients? This medicine contains sunset yellow, which can cause allergic type reactions. Allergy is more common in those who are allergic to aspirin. This product also contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you feel dizzy or drowsy when you start taking this medicine, do not drive or operate machinery until these effects wear off.

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.

Are you taking any other medicine?

You should consult your doctor BEFORE taking any other medicines, including:

•    Other medicines used to treat depression including monoamine oxidase inhibitors (MAOIs).

•    Medicines used to lower blood pressure (e.g. guanethidine, debrisoquine, bethanidine, methyldopa and clonidine).

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

•    Methylphenidate, a drug used to treat sleeping problems.

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

•    Thyroid hormone therapy.

•    Medicines used to treat Parkinson’s disease, including entacapone and selegiline.

•    Disulfiram (a medicine used to treat alcoholism).

•    Cimetidine (a medicine used to treat ulcers).

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

•    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, a drug used for HIV infection.

•    Sibutramine, a medicine used for weight loss.

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

•    Certain painkillers, including nefopam and tramadol.

•    Medicines used to treat irregular heart rhythm, including amiodarone, disopyramide, procainamide, propafenone, quinidine and sotalol.

•    Rifampicin (an antibiotic)

•    Medicines used to treat epilepsy.

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

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

•    Medicines used in the treatment of angina.

•    Oral contraceptives.

Avoid alcohol while taking this medicine as it may affect you more than usual.

How much of this medicine should you take?

You should take your medicines as directed by your doctor.

The pharmacist’s label should tell you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist.

Adults:

The usual dose is one tablet 3 times daily or alternatively three tablets at bedtime. If necessary, your doctor may increase the dose to a total of 150mg (6 tablets) per day. Children: (for night bedwetting)

6-10 years: One tablet 30 minutes before bedtime

11-16 years: One or two tablets 30 minutes before bedtime.

•    Amitriptyline tablets are not suitable for children under 6 years.

•    The tablets should be swallowed with a drink of water.

•    This medicine should only be used for up to 3 months to treat night bedwetting.

•    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.

•    You should keep taking your medicine until your doctor tells you to stop. This medicine may take up to four weeks to be fully effective.

•    Do not stop taking your medicine suddenly, unless your doctor tells you to, as this may lead to unwanted effects such as nausea, headache or weakness.

What if you have taken too many tablets?

If you or anyone else has swallowed a lot of the tablets all together contact your nearest hospital casualty department or doctor immediately.

If you forget to take a dose, take the next dose at the usual time. Do not take two doses together.

What unwanted effects can this medicine have?

This medicine, like most other medicines, may cause side effects in some people.

If you experience any of the following tell your doctor IMMEDIATELY.

•    Palpitations or unusually rapid heartbeat.

•    Dizziness or fainting when you stand up.

•    Development of a skin rash or itching.

•    Any yellowing of your skin or the whites of your eyes.

•    Epileptic fits or convulsions.

There have been reports of blood disorders which may be characterized by fever or chills, sore throat, ulcers in your mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruises.

Part of the intestine may become paralysed and this may lead to constipation, a swollen stomach, fever and vomiting.

Tell your doctor immediately, if you notice any of these symptoms.

The following side effects are often mild and may wear off after a few days treatment. If they are severe or last more than a few days, tell your doctor.

•    Dry mouth, blurred vision, constipation or difficulty in passing water.

•    Fatigue, dizziness, drowsiness, headache or confusion.

•    Nausea, vomiting and diarrhea.

•    Shakiness of the hands, increased perspiration or hot flushes.

•    Increased appetite/weight gain.

Other side effects which may occur include hallucinations, excitement, feeling anxious, restlessness, sleeping problems, nightmares, numbness or pins and needles, a ringing in the ears, speech impairment, abnormal muscle movements or twitching, unsteadiness, coma, eye problems, dilated pupils, abdominal pain, sensitivity to light, swollen face or tongue, loss of appetite, weight loss, sore mouth, black tongue, unpleasant taste, swollen testicles, breast swelling, impotence and other sexual problems, secretion of milk from the breast, high or low blood sugar, having to pass water frequently and hair loss. High doses or over dosage may lead to heart problems. Mood changes after stopping treatment have been reported rarely.

If your child is being treated with Amitriptyline for night bedwetting you may notice a change in his/her behavior. If any of the side effects gets serious, or if you noticed any side effects not listed in this leaflet, please tell your doctor.

How should you store this medicine?

This medicine should not be used after the expiry date stated on the pack.

Do not store above 25°c. Store in the original container. Keep the Container tightly closed.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

Remember: This medicine has been prescribed for you. DO NOT give it to anybody else even if their symptoms appear to be the same as yours, since it may be harmful to them.

Pharmvit Ltd. PL04556/0039

Last revision date: August 2010__

Reference: 00390810/OL    |POM