国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nortriptyline hydrochloride
Medreich Plc
N06AA10
Nortriptyline hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100; GTIN: 05060292741192
6-7 20-25 44-55 10 8-11 25-35 55-77 10-20 Over 11 35-54 77-119 25-35 AGE (YEARS) WEIGHT DOSE (MG) KG LB years with psychiatric conditions who were treated with an antidepressant. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour. If any of these points apply to you, tell your doctor or pharmacist. TAKING OTHER MEDICINES You should tell your doctor if you are taking or have taken any medicines, including medicines obtained without a prescription. The following medicines may interact with your Nortriptyline Tablets: • guanethidine, debrisoquine, bethanidine, clonidine (used to treat high blood pressure); • barbiturates (used for anxiety or to make you feel sleepy); • alcohol (you should not drink alcohol); • fluoxetine (another antidepressant); • cimetidine (for heartburn and ulcers); • phenothiazines (for mental illness); • carbamazepine (for epilepsy); • propafenone, flecainide, encainide, quinidine (for heartbeat disorders). • Valproic acid (medicine used for the treatment of epilepsy and bipolar disorder) 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. DRIVING AND USING MACHINES Nortriptyline Tablets 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. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF NORTRIPTYLINE TABLETS Nortriptyline Tablets contain lactose. If you are lactose intolerant, contact your doctor before taking this medicine. Nortriptyline 25 mg Tablets contain 阅读完整的文件
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 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 ‘10’ 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