Country: Միացյալ Թագավորություն
language: անգլերեն
source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nitrazepam
Accord-UK Ltd
N05CD02
Nitrazepam
5mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010100; GTIN: 5012617009609
PACKAGE LEAFLET: INFORMATION FOR THE USER NITRAZEPAM 5MG TABLETS Nitrazepam 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 Nitrazepam Tablet is and what it is used for 2. What you need to know before you take Nitrazepam Tablets 3. How to take Nitrazepam Tablets 4. Possible side effects 5. How to store Nitrazepam Tablets 6. Contents of the pack and other information 1. WHAT NITRAZEPAM TABLET IS AND WHAT IT IS USED FOR Nitrazepam Tablets belongs to a group of medicines known as benzodiazepines, which are tranquillisers (medicines that have a calming effect). Nitrazepam Tablets shortens the time taken to fall asleep and lengthens the duration of sleep. Nitrazepam Tablets are used for the short term treatment of sleeplessness (also known as insomnia) when it is severe. Nitrazepam Tablets help you to sleep but do not cure the underlying cause of your insomnia, which you should discuss with your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITRAZEPAM TABLETS DO NOT TAKE NITRAZEPAM TABLETS IF YOU: • are allergic (hypersensitive) to nitrazepam or any of the other ingredients of Nitrazepam Tablets (these are listed in section 6, “Contents of the pack and other information”). • are allergic (hypersensitive) to any medicine known as a benzodiazepine (e.g. flurazepam, diazepam, chlordiazepoxide or temazepam). • suffer from lung disease. • suffer from difficulty breathing while awake or asleep. • suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily). read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nitrazepam 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of nitrazepam. Excipient with known effect: Each nitrazepam 5 mg tablet contains 95 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off white round, flat, bevel edged tablets, debossed with ‘DM’ on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term treatment of insomnia when it is severe, disabling or subjecting the individual to unacceptable distress, where daytime sedation is acceptable. An underlying cause for insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief. Benzodiazepines are not recommended for the primary treatment of psychotic illness. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: ADULTS 5 mg before retiring. This dose may, if necessary, be increased to 10 mg. ELDERLY _Elderly or debilitated patients_: the elderly or patients with impaired renal and/or hepatic function will be particularly susceptible to the adverse effects of Nitrazepam tablets. Doses should not exceed half those normally recommended. If organic brain changes are present, the dosage of Nitrazepam tablets should not exceed 5 mg in these patients. OTHER POPULATIONS In patients with chronic pulmonary insufficiency and in patients with chronic renal or hepatic disease, the dosage may need to be reduced. PAEDIATRIC POPULATION Nitrazepam tablets are contraindicated for use in children. Dosage should be adjusted on an individual basis. Treatment should, if possible, be on an intermittent basis. Treatment should be as short as possible and should be started with the lowest recommended dose. The maximum dose should not be exceeded. Generally the duration of treatment varies from a few days to two weeks with a maximum of four weeks; including the tapering off process. Patients who have taken benzodiazepines for a prolonged time may requi read_full_document