Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nortriptyline hydrochloride
Alliance Healthcare (Distribution) Ltd
N06AA10
Nortriptyline hydrochloride
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100
SAME SIZE ARTWORK LEAFLET SIZE: 120 mm x 670 mm 670 mm PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NORTRIPTYLINE 10 MG FILM-COATED TABLETS NORTRIPTYLINE 25 MG FILM-COATED TABLETS NORTRIPTYLINE 50 MG FILM-COATED TABLETS Nortriptyline hydrochloride 120 mm FONT TYPE: TIMES NEW ROMAN FONT SIZE: 9 PT DATE: 08-03-2019 VERSION: 01 (NL) Variation No. NL/H/4630/001-003/IA/001 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. - 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 your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Nortriptyline Tablets are and what they are used for 2. What you need to know before you take Nortriptyline Tablets 3. How to take Nortriptyline Tablets 4. Possible side effects 5. How to store Nortriptyline Tablets 6. Contents of the pack and other information 1. WHAT NORTRIPTYLINE TABLETS ARE AND WHAT ARE THEY USED FOR Nortriptyline Tablets contain the active ingredient nortriptyline hydrochloride, which is a tricyclic antidepressant. Nortriptyline Tablets are used to treat major depression in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTRIPTYLINE TABLETS DO NOT TAKE NORTRIPTYLINE TABLETS IF: ● you are ALLERGIC (hypersensitive) to nortriptyline or any of the other ingredients of Nortriptyline Tablets (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue; ● you have had a RECENT HEART ATTACK or heartbeat disorder, heart block or coronary artery disease; ● you are taking, or have stopped taking within the last 14 days, a monoamine oxidase inhibitor (e.g. PHENELZINE, ISOC Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nortriptyline 50 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 50mg tablet contains nortriptyline hydrochloride equivalent to 50 mg nortriptyline base. Excipients with known effect: Each 50 mg tablet contains 60 mg Lactose Monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet 50mg White to off white, round shaped, film coated, biconvex tablets, debossed with ‘Y374’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nortriptyline is indicated for the treatment of Major Depressive Episodes in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS: The usual adult dose is 25mg three or four times daily. Dosage should begin at a low level e.g. 10mg three or four times daily, and be increased as required. Alternatively, the total daily dose may be given once a day, usually given at night. When doses above 100mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150ng/ml. Doses above 150mg per day are not recommended. Lower than usual dosages are recommended for elderly patients. Lower dosages are also recommended for outpatients than for hospitalised patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission. If a patient develops minor side-effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur. THE ELDERLY: 30 to 50mg/day in divided doses. Dosage should begin at a low level (10 – 20 mg daily) and be increased as required to the maximum dose of 50mg. If it is considered necessary to use hig Прочитайте повний документ