Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nitrazepam
A A H Pharmaceuticals Ltd
N05CD02
Nitrazepam
5mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010100; GTIN: 5012252103458
MEASURE BAR SHOULD BE 150MM AT 100% SCALE Customer Description Item Code Profile Size Min. Point Size Market Language Proof By Proof No. Date Artwork No. Pharma Code Colours Used Wockhardt UK Limited Nitrazepam leaflet 105232/4 n-a 128 x 420mm matt.pirie-scott 1 26/08/2015 591904 n-a Process Black Keylines (non-printing) artwork.leicester@MULTIPKG.com CLEARLY MARK ANY AMENDMENTS ON ONE PROOF AND RETURN TO MPS WARNING! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clientʼs brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT. UK English 8pt (main body) / 8pt (variables) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Nitrazepam Tablets are and what they are used for 2. Before you take Nitrazepam Tablets 3. How to take Nitrazepam Tablets 4. Possible side effects 5. How to store Nitrazepam Tablets 6. Further information 1. What Nitrazepam Tablets are and what they are used for The name of your medicine is Nitrazepam Tablets. The active ingredient in your medicine is nitrazepam. Nitrazepam Tablets belong to a group of medicines called benzodiazepines which are used as sedatives. Nitrazepam Tablets are used to treat severe sleeplessness problems (insomnia) and the worry such sleeping problems may cause. 2. Before you take Nitrazepam Tablets DO NOT TAKE NITRAZEPAM TABLETS IF YOU • are allergic (hypersensitive) to nitrazepam, or other benzodiazepines, or to any of the other ingredients in Lesen Sie das vollständige Dokument
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 tablet contains 445 mg of Lactose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets. Uncoated white flat bevel edged tablets with breakline on one face and stamped “SPN5” on the other. 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: 5mg before retiring. This dose may, if necessary, be increased to 10mg. 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. Doses should not exceed half those normally recommended. If organic brain changes are present, the dosage of Nitrazepam should not exceed 5mg 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 require a longer period during which doses Lesen Sie das vollständige Dokument