Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amitriptyline hydrochloride
Genesis Pharmaceuticals Ltd
N06AA09
Amitriptyline hydrochloride
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100; GTIN: 5060014441652
MARKETING AUTHORISATION HOLDER AND MANUFACTURER Relonchem Limited, Cheshire House, Gorsey lane, Widnes, WA8 0RP, United Kingdom. Date leaflet revised: October 2018 AMITRIPTYLINE 25MG TABLETS Amitriptyline hydrochloride PATIENT INFORMATION LEAFLET 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. • • 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: 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 DO NOT TAKE AMITRIPTYLINE TABLETS IF YOU: • Prolonged QT interval A heart problem called "prolonged QT interval" (which is shown on your electrocardiogram, ECG) and heart rhythm disorders (rapid or irregular heart beat) have been reported with Amitriptyline Tablets. Tell your doctor if you: 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: • Depression in adults (major depressive episodes) • Neuropathic pain in adults • Chronic tension type headache prophylaxis in adults • Migraine prophylaxis in adults • • have slow heart rate, • • are taking any other medication that may cause heart problems, or • have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood. • • have an over active thyroid gland or receive thyroid medication. THOUGHTS OF SUICIDE AND WORSENING OF YOUR DEPRESSION You may be more likely to think like this: • If you have previously had thoughts about killing or harming yourself. If you have thoug Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amitriptyline Tablets Bp 25mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25mg Amitriptyline Hydrochloride. Excipient with known effect: Each tablet contains 42.00mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, circular, biconvex, film-coated tablets, impressed “C” on one face and the identifying letters “AB” on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amitriptyline is indicated for: • The treatment of major depressive disorder in adults • The treatment of neuropathic pain in adults • The prophylactic treatment of chronic tension type headache (CTTH) in adults • The prophylactic treatment of migraine in adults • The treatment of nocturnal enuresis in children aged 6 years and above when organic pathology, including spina bifida and related disorders, have been excluded and no response has been achieved to all other non-drug and drug treatments, including antispasmodics and vasopressin- related products. This medicinal product should only be prescribed by a healthcare professional with expertise in the management of persistent enuresis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _Posology _ _ Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths. The appropriate formulation/strength should be selected for the starting doses and any subsequent dose increments. _MAJOR DEPRESSIVE DISORDER_ Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerability. _ _ _Adults _ Initially 25 mg 2 times daily (50 mg daily). If necessary, the dose can be increased by 25 mg every other day up to 150 mg daily divided into two doses. The maintenance dose is the lowest effective dose. _ _ _Elderly patients over 65 years of age and patients with cardiovascular disease_ Initially 10 mg – 25 mg daily. The daily dose may be incr Belgenin tamamını okuyun