Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nitrazepam
Viatris UK Healthcare Ltd
N05CD02
Nitrazepam
5mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010100
PATIENT INFORMATION LEAFLET REMNOS NITRAZEPAM 5 MG TABLETS PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF REMNOS. IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION. _WHAT IS IN YOUR MEDICINE?_ The name of this medicine is REMNOS. Each tablet contains Nitrazepam BP 5 mg together with the following ingredients: lactose, maize starch, pregelatinised maize starch, ethylcellulose, magnesium stearate. Your tablets are round, white, flat tablets with bevelled edges and a breakline. They are engraved REMNOS 5. REMNOS is available in containers of 100 and 500 tablets. The Product Licence holder of REMNOS is Chelonia Healthcare Limited, Boumpoulinas 11, 3 rd Floor, Nicosia, P.C. 1060, Cyprus. The manufacturer of REMNOS is DDSA Pharmaceuticals Ltd., Chatfield Road, off York Road, London SW11 3SE. _HOW DOES REMNOS WORK?_ REMNOS belongs to a group of medicines known as the benzodiazepine hypnotics (medicines used in the treatment of insomnia). _WHY HAVE YOU BEEN PRESCRIBED REMNOS?_ Nitrazepam is used in the short term treatment of insomnia only when it is severe, disabling or subjecting the patient to extreme distress. _BEFORE TAKING YOUR MEDICINE_ Before you start treatment with REMNOS study this section of the leaflet carefully so you can be sure this medicine is suitable for you. Before taking these tablets, tell your doctor if you have ever had any unusual or allergic reactions to Nitrazepam or other medicines belonging to the same benzodiazepine group. Also tell your doctor or pharmacist if you are allergic to any of the other ingredients listed under “What is in your medicine?” above, or any other substances such as food, preservatives or dyes. It is important to tell your doctor if you are pregnant or likely to become pregnant. Do not use Nitrazepam if you have suffered or suffer from: • a lung or other respiratory problem • a disorder known as ‘myasthenia gravi Read the complete 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 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 Read the complete document