国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Clonazepam
Rosemont Pharmaceuticals Ltd
N03AE; N03AE01
Clonazepam
2 mg/5ml
Oral solution
Product subject to prescription which may not be renewed (A)
Benzodiazepine derivatives; clonazepam
Marketed
2012-02-24
CLONAZEPAM 0.5MG/5ML ORAL SOLUTION MODULE 1.3.1 LEAFLET - IE VERSION: AUGUST 2017 PAGE 1 PACKAGE LEAFLET: INFORMATION FOR THE USER 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 Clonazepam Rosemont 0.5mg/5ml Oral Solution is and what it is used for 2. What you need to know before you take Clonazepam Rosemont Oral Solution 3. How to take Clonazepam Rosemont Oral Solution 4. Possible side effects 5. How to store Clonazepam Rosemont Oral Solution 6. Contents of the pack and other information The name of your medicine is Clonazepam Rosemont 0.5mg/5ml Oral Solution (called Clonazepam in this leaflet). Clonazepam belongs to a group of medicines called benzodiazepines. It is used to treat epilepsy in adults. It lowers the number of fits (seizures) that you have. Any fits that you do have will be less serious. DO NOT TAKE CLONAZEPAM ROSEMONT ORAL SOLUTION, IF YOU ARE ALLERGIC TO: clonazepam or any of the other ingredients of this medicine listed in Section 6 other benzodiazepine medicines. These include diazepam, flurazepam and temazepam. An allergic reaction can include a rash, itching or shortness of breath. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Clonazepam. DO NOT TAKE THIS MEDICINE IF: you have breathing problems or lung disease your breathing stops when you are asleep (sleep apnoea) you have severe liver problems 1. WHAT CLONAZEPAM ROSEMONT ORAL SOLUTION IS AND WHAT IT IS USED 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clonazepam Rosemont 2mg/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains 2mg Clonazepam Excipients with known effects: Ethanol – 100mg/5ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution A clear, pale straw coloured oily solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clonazepam Rosemont Oral Solution is indicated in all clinical forms of epileptic disease and seizures in adults, especially absence seizures (petit mal) including atypical absence; primary or secondarily generalised tonic-clonic (grand mal), tonic or clonic seizures; partial (focal) seizures with elementary or complex symptomatology; various forms of myoclonic seizures, myoclonus and associated abnormal movements. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The 0.5mg/5ml oral solution may facilitate the administration of lower daily doses in the initial stages of treatment or treatment for the elderly. The 2mg/5ml oral solution should be used for maintenance and maximum dosage regimens. _Adults_ Initial dosage should not exceed 1mg/day. The maintenance dosage for adults normally falls within the range 4 to 8mg. _Elderly_ The elderly are particularly sensitive to the effects of centrally depressant drugs and may experience confusion. It is recommended that the initial dosage of clonazepam should not exceed 0.5mg/day. These are total daily dosages which should be divided into 4 doses taken at intervals throughout the day. If necessary, larger doses may be given at the discretion of the physician, up to a maximum of 20mg daily. The maintenance dose should be attained after 2 to 4 weeks of treatment. _Paediatric Population_ Due to the presence of ethanol in the formulation, this product is not indicated for paediatric use. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 阅读完整的文件