দেশ: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
NITRAZEPAM
Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
N05CD02
NITRAZEPAM 5 mg
TABLET
NITRAZEPAM 5 mg
POM
PSYCHOLEPTICS
Authorised
2007-06-04
PATIENT INFORMATION LEAFLET MOGADON 5 MG TABLETS Nitrazepam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE - 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 experience any side effect and this becomes serious, tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET: 1. What Mogadon tablets are and what they are used for 2. What you need to know before you take Mogadon tablets 3. How to take Mogadon tablets 4. Possible side effects 5. How to store Mogadon tablets 6. Further information 1. WHAT MOGADON TABLETS ARE AND WHAT THEY ARE USED FOR Mogadon belongs to a group of medicines known as benzodiazepines, which are tranquillisers (medicines that have a calming effect). Mogadon shortens the time taken to fall asleep and lengthens the duration of sleep. Mogadon Tablets are used for the short term treatment of sleeplessness (also known as insomnia) when it is severe. Mogadon Tablets help you to sleep but do not cure the underlying cause of your insomnia, which you should discuss with your doctor 2. BEFORE YOU TAKE MOGADON TABLETS DO NOT TAKE MOGADON TABLETS IF YOU: • are allergic (hypersensitive) to nitrazepam or any of the other ingredients of Mogadon Tablets (these are listed in section 6, ˝Further 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). • are suffering from a psychiatric illness or a personality disorder (severe mental problems). • have a severe liver condition. Mogadon Tablets are not for use in anyone under 18 years of age. Take special care with Mogadon Ta সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mogadon 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of nitrazepam. There is 301 mg lactose per tablet. For the full list of excipients, See section 6.1 3 PHARMACEUTICAL FORM Tablets Round, white tablets with “ V ” MOG 5 imprinted on one face with a single break bar on the other. The tablet can be divided into equal doses. 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 Mogadon. Doses should not exceed half those normally recommended. If organic brain changes are present, the dosage of Mogadon 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 Mogadon 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 সম্পূর্ণ নথি পড়ুন