Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Nortriptyline hydrochloride
Chanelle Medical Unlimited Company
N06AA; N06AA10
Nortriptyline hydrochloride
25 milligram(s)
Film-coated tablet
Non-selective monoamine reuptake inhibitors; nortriptyline
Not marketed
2019-10-24
ID: PL 208M / 209M (IE/H/0587/001-002/DC) VERSION: 06 REVISION DATE: 15/02/2022 Page 7 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER NORTRIPTYLINE CHANELLE MEDICAL 10 MG FILM-COATED TABLETS NORTRIPTYLINE CHANELLE MEDICAL 25 MG FILM-COATED TABLETS nortriptyline (as 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. THE NAME OF THIS MEDICINE IS NORTRIPTYLINE CHANELLE MEDICAL 10 MG/25 MG FILM-COATED TABLETS. _In the rest of the leaflet Nortriptyline Chanelle Medical 10 mg/25 mg Film-Coated Tablet is _ _called Nortriptyline film-coated tablets. _ WHAT IS IN THIS LEAFLET 1. What Nortriptyline film-coated tablets are and what they are used for 2. What you need to know before you take Nortriptyline film-coated tablets 3. How to take Nortriptyline film-coated tablets 4. Possible side effects 5. How to store Nortriptyline film-coated tablets 6. Contents of the pack and other information 1. WHAT NORTRIPTYLINE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Nortriptyline film-coated tablets contain the active ingredient nortriptyline hydrochloride, which is a tricyclic antidepressant. Nortriptyline film-coated tablets is indicated for the treatment of major depressive episodes in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTRIPTYLINE FILM-COATED TABLETS YOU SHOULD NOT TAKE NORTRIPTYLINE TABLETS UNTIL YOU ARE SURE IT IS SAFE FOR YOU TO DO SO. NORTRIPTYLINE TABLETS ARE FOR ADULTS ONLY. DO NOT TAKE NORTRIPTYLINE FILM-COATED TABLETS: - If you are allergic to nortriptyline hydrochloride or any of the other ingredients Les hele dokumentet
Health Products Regulatory Authority 11 January 2023 CRN00D8ZX Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nortriptyline Chanelle Medical 25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg nortriptyline (as hydrochloride). Excipient(s) with known effect: Lactose, 146.05 mg per tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. The 25 mg tablets are white, film-coated, circular, with “C2” on one side and plain on the other side. They are approximately 8 mm in diameter. 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 25 mg three or four times daily. Dosage should begin at a low level and be increased as required. Alternatively, the total daily dose may be given once a day usually at night. When doses above 100 mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150 ng/ml. Doses above 150 mg 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 50 mg/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 co Les hele dokumentet