Country: Арменија
Језик: Енглески
Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
amitriptyline (amitriptyline hydrochloride)
Accord Healthcare Limited
N06AA09
amitriptyline (amitriptyline hydrochloride)
25mg
tablets film-coated
(28/2x14/), in blister
Prescription
Registered
2015-12-17
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,pharmacist or nurse. - 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 you doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Amitriptyline Tablets are and what they are used for 2. What you need to know before 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 medicines called tricyclic antidepressant drugs. These medicines alter the levels of chemicals in the brain to relieve the symptoms of depression. Amitriptyline tablets are used in following conditions : • to treat the symptoms of depression. • for the relief of bed-wetting at night by children known as nocturnal enuresis. 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 PATIENTS): • are allergic (hypersensitive) to amitriptyline, other tricyclic antidepressants or any of the other ingredients of Amitriptyline Tablets (see section 6). The 25mg tablets contain sunset yellow (E110), which may cause allergic-type reactions including asthma. Allergy is more common in people who are allergic to aspirin. An allergic reaction can include a rash, itching or shortness of breath. • have heart disease such as irregular heartbeats, heart block or failure, coronary artery disease or have recently had a heart attack • suffer from periods of increased and exaggerated behaviour (mania) • hav Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amitriptyline 25mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Amitriptyline HCl 25.00mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Yellow coloured, round, biconvex, film-coated tablet plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS -Symptoms of depression (especially where sedation is required). -Nocturnal enuresis where organic pathology is excluded. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: Initially 50-75mg daily in divided doses or as a single dose at night, increasing to 150-200mg daily according to clinical response. Maintenance dose 50-100mg at night which should be continued for at least three months to lessen chances of relapse. Adolescents and the elderly: 25-50mg daily in divided doses or as a single dose at night. Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response. Children: For nocturnal enuresis only. The maximum period of treatment (including gradual withdrawal) should not exceed three months. A further course of treatment should not be started until a full physical examination, including an ECG, has been made. (11-16 years): 25-50mg daily. (7-10 years): A more suitable dosage form should be used for this age group. (Under 7 years): Not recommended for this age group. Method of Administration For oral administration. 4.3. CONTRAINDICATIONS • Hypersensitivity to tricyclic antidepressants or to any of the ingredients in the tablets • Patients who are taking mono-amine oxidase inhibitors (MAOIs) or who have received them within the last 14 days ; • prior sensitisation to amitriptyline; • history of myocardial infarction; arrhythmias; particularly heart block of any degree, congestive heart failure, coronary artery insufficiency; • mania; • severe liver disease, porphyria, • children under 7 years. • Breast feeding (See also “Use in pregnancy” Прочитајте комплетан документ