Package Leaflet: Information for the User. Amitriptyline 25 mg Film-coated Tablets

Transcription

1 Package Leaflet: Information for the User Amitriptyline 25 mg Film-coated Tablets 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 symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effect 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 1. What Amitriptyline Tablets are and what they are used for Amitriptyline belongs to a group of medicines called tricyclic antidepressant drugs. These medicines alter the levels of chemicals in the brain to relieve the symptoms of depression. Amitriptyline is used to treat the symptoms of depression. 2. Before you take Amitriptyline Tablets Do not take Amitriptyline if you: Are allergic (hypersensitive) to amitriptyline, other tricyclic antidepressants or any of the other ingredients of Amitriptyline Tablets (see section 6, further information) Have suffered a heart attack recently or you have abnormal heart rhythm Are taking or have recently taken (within the last 14 days) any other medicines for depression, particularly monoamine oxidase inhibitors (MAOIs) Suffer from any mental illness other than depression Have severe liver disease Are breast-feeding This medicine is not suitable for the treatment of depression in children and adolescents under 18 years. Take special care with Amitriptyline and tell your doctor or pharmacist if you: Have liver or cardiovascular disease Suffer from glaucoma (increased pressure in the eyes) Have difficulty passing water or you have problems with your prostate gland Are undergoing Electroconvulsive Therapy

2 Have a history of epilepsy or have you suffered recently from convulsions Have thyroid problems or are you taking thyroid medicines Are due to have surgery, including dental, that involves an anaesthetic Have 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 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 especially important to tell your doctor if you are taking any of the following: Other drugs used to treat depression, including monoamine oxidase inhibitors (MAOIs) Drugs used to manage abnormal heart rhythm (e.g. disopyramide, procainamide and quinidine). Antipsychotic drugs (e.g. sertindole, pimozide and thioridazine). Astemizole and terfenadine(antihistamines) Medicines used to lower blood pressure (e.g. guanethidine, debrisoquine, bethanidine, methyldopa and sotalol) Drugs that depress the central nervous system, including barbiturates (e.g. phenobarbital) and ethchlorvynol Anticholinergic and sympathomimetic drugs, which act on a variety of conditions; examples of these are adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine. These may be present in treatments for common colds and nasal stuffiness and allergies Disulfiram (a medicine used to treat alcoholism) Cimetidine (a medicine used to treat ulcers) Antifungal drugs (e.g. fluconazole) Thyroid medicines. Taking Amitriptyline with food or drink You should avoid alcohol while you are taking this medicine. Pregnancy and breast-feeding You should consult with your doctor before taking this medicine if you are pregnant or planning to become pregnant. You must not take amitriptyline if you are breast-feeding and you should consult with your doctor.

3 Driving and using machines When you start to take this medicine it may make you feel dizzy or drowsy. If affected do not drive or operate machinery until these effects wear off. Important information about some of the ingredients of Amitriptyline Amitriptyline tablets contain lactose monohydrate. If you have been told by your doctor that you have intolerance to certain sugars, please contact your doctor before taking this medicinal product. 3. How to take Amitriptyline Tablets Always take Amitriptyline tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with a drink of water. You may not notice any improvement in your symptoms for up to 4 weeks after starting treatment. Adults The usual starting dose is 75 mg daily which can be taken in divided doses three times daily or as a single dose at night. If necessary, your doctor may increase the dose to a total of 150mg per day. The maintenance dose of amitriptyline is usually mg daily which is best taken in the evening or at bedtime. When a satisfactory improvement is noticed the dose should be reduced to the lowest dose which will still relieve symptoms. Treatment should be continued for three months or longer in order to lessen the chances of a relapse. Elderly If you are elderly your doctor may prescribe a lower dose. An initial dose of mg daily in divided doses may be prescribed. This dose may be increased slowly. A dose of 50 mg daily may be sufficient for elderly patients. Children Depression: This medicine is not suitable for the treatment of depression in children and adolescents under 18 years. If you take more Amitriptyline than you should If you take too many tablets, go to your nearest hospital casualty department or tell your doctor straight away. Take the pack of Amitriptyline with you. If you forget to take Amitriptyline If you forget to take a dose, take the next dose at the usual time. Do not take two doses together. Taking your medicine at the same time each day may help you to remember to take it regularly.

4 If you stop taking Amitriptyline Do not stop taking amitriptyline until your doctor tells you to. It is important that you keep taking your medicine. You may notice the following effects when you stop taking Amitriptyline: sickness, headache or tiredness. If amitriptyline therapy is stopped gradually, sleep and dream disturbance can occur during the first two weeks of reduced dosage. There have been rare reports of mania occurring within 2-7 days of stopping long-term therapy. 4. Possible side effects This medicine may occasionally cause unwanted effects in some people. You should contact your doctor IMMEDIATELY if you experience any of the following: Problems with your circulatory system; fast or irregular heartbeat, heart attack, palpitations, fainting or stroke. High or low blood pressure (symptoms of which are dizziness or fainting particularly when you stand up). Development of an allergic reaction, symptoms of which are skin rash, itching or increased sensitivity of the skin to sunlight. More severe cases can result in fever, swelling of the lips, face, tongue and/or throat which may result in difficulty in breathing or swallowing. Inflammation of the liver, altered liver function and jaundice (the symptoms of which are yellowing of your skin or the whites of your eyes) can occur. Blood disorders resulting in symptoms such as unusually sore throat, recurrent infection, bleeding from the gums or into the skin or bruising easily. Confusion, loss of concentration, disorientation, hallucinations (i.e. hearing voices or seeing faces), delusions, mood elevation, anxiety, restlessness, drowsiness, sleep disturbance, numbness, tingling, pins and needles, loss of feeling, ringing in the ears, irregular and jerky movements, abnormal involuntary movements, stammering, tremor and coma. Alteration of electrical activity in the brain or convulsions. Effects on the digestive system including dry mouth, trapped wind, abdominal pain, nausea, vomiting, diarrhoea or constipation, increased appetite or loss of appetite, weight gain or loss, sore mouth, unpleasant taste, swelling of the salivary glands and blackening of the tongue. Swelling of the testicles in men, breast enlargement in both men and women, unusual excretion of milk from the breast and changes in sexual behaviour. Changes in blood sugar levels. Other effects include blurred vision, eye pain and changes in vision, difficulty in urinating and changes in urinary flow, high temperature, sweating, tiredness, dizziness, headache, weakness, hair loss and swelling due to accumulation of body fluid. Some patients taking amitriptyline have complained of rheumatoid arthritis like symptoms. It is not known however if these symptoms were caused by amitriptyline.

5 An increased risk of bone fractures has been observed in patients taking these types of medicines. 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. FREEPOST, Pharmacovigilance Section, Irish Medicines Board, Kevin O Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland Tel : Fax : Website : imbpharmacovigilance@imb.ie 5. How to store Amitriptyline Tablets Keep out of the reach and sight of children. Do not take Amitriptyline after the expiry date which is stated on the pack. Do not store above 25 C. 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 contains The active substance is Amitriptyline as amitriptyline hydrochloride. Each tablet contains 25 mg amitriptyline hydrochloride. The other ingredients are Lactose monohydrate, maize starch, povidone, microcrystalline cellulose, purified talc, colloidal anhydrous silica and magnesium stearate. The film-coat contains hypromellose, propylene glycol, titanium dioxide (E171), talc, iron oxide yellow (E172) and quinoline yellow aluminium lake (E104). What Amitriptyline looks like and contents of the pack Amitriptyline 25 mg tablets are pale yellow, circular, biconvex film-coated tablets. Each tablet contains amitriptyline hydrochloride 25mg. Pack sizes In PVC/Al transparent blisters: 50, 100 and 250 tablets. In polypropylene tubes with low density polyethylene caps: 50, 100, 250, 500 and 1,000 tablets.

6 Not all pack sizes may be marketed. Marketing authorisation holder and Manufacturer Clonmel Healthcare Ltd Waterford Road Clonmel Co. Tipperary Ireland This leaflet was last approved in September 2013.