国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nortriptyline hydrochloride
Waymade Healthcare Plc
N06AA10
Nortriptyline hydrochloride
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100
It may still be all right for you to be given Nortriptyline Tablets. Your doctor will be able to decide what is suitable for you. PREGNANCY AND BREAST-FEEDING Do not take Nortriptyline Tablets if you are breast- feeding. The safety of nortriptyline for use during pregnancy has not been established. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. DRIVING AND USING MACHINES Nortriptyline hydrochloride may affect alertness. Use caution when driving or operating heavy machinery until you’re aware of how this drug affects you. If you feel Nortriptyline Tablets affect your ability to drive or use machines, tell your doctor immediately. NORTRIPTYLINE TABLETS CONTAIN LACTOSE If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. NORTRIPTYLINE 25MG TABLETS CONTAIN SUNSET YELLOW (E110) Sunset yellow (E110) may cause allergic reactions. 3. HOW TO TAKE NORTRIPTYLINE TABLETS Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. DOSAGE ADULTS: The usual adult dose is 25mg three or four times daily or the dose may be given once a day, usually at night. The dose should begin at a low level, 10mg, 3-4 times daily, for example and be increased gradually as required. The maximum dose is 150mg per day. THE ELDERLY: The usual dose is 30 to 50mg/day in divided doses. Treatment may start with 10mg three times a day. ADOLESCENT PATIENTS: The usual dose is 30 to 50mg/day in divided doses. Treatment may start with 10mg three times a day. Lower dosages are recommended for outpatients than for patients in hospital who will be under close supervision. NORTRIPTYLINE 25MG TABLETS Package leaflet: information for the user (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 nee 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nortriptyline 25mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains nortriptyline hydrochloride equivalent to nortriptyline 25mg Excipient with known effect The tablet also contains 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 ‘25’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nortriptyline is indicated for the treatment of Major Depressive Episodes. 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 in an elderly pat 阅读完整的文件