Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nortriptyline hydrochloride
DE Pharmaceuticals
N06AA10
Nortriptyline hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NORTRIPTYLINE10MG AND 25MG TABLETS Nortriptyline hydrochloride 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. – 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 THEY ARE USED FOR Nortriptyline tablets contain the active ingredient Nortriptyline hydrochloride, which is a tricyclic antidepressant. Nortriptyline tablets are indicated for the treatment of major depressive disorders in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTRIPTYLINE TABLETS DO NOT TAKE NORTRIPTYLINE TABLETS: – If you are ALLERGIC to Nortriptyline hydrochloride or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue If 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, ISOCARBOXAZID OR TRANYLCYPROMINE ). If you are taking moclobemide you must stop this at least 24 hours before starting nortriptyline – you have to stop treatment with Nortriptyline and wait for 14 days before you start treatment with a monoamine oxidase inhibit Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nortriptyline 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains nortriptyline hydrochloride equivalent to nortriptyline 10mg Excipient with known effect Each tablet contains 43.06mg of lactose monohydrate. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet White to off-white round biconvex tablets, debossed ‘NO’ on one side and ‘10’ 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 (50mg once daily or 25mg 2-3 times daily). If necessary, dose could be gradually increased in 25mg increments no more rapidly than every other day to be added to the morning dose. When doses above 100mg daily are administered, monitoring of plasma levels of nortriptyline should be considered 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. The maintenance dose should be the same as the optimal therapeutic dose. 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. 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 higher dosing Lugege kogu dokumenti