Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Zopiclone
Meda Health Sales Ireland Limited
N05CF; N05CF01
Zopiclone
7.5 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Benzodiazepine related drugs; zopiclone
Marketed
1987-10-06
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZIMOVANE7.5 MG FILM-COATED TABLETS Zopiclone 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. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Zimovane 7.5mg Film-Coated Tablets, which will be called Zimovane tablets through out this leaflet. WHAT IS IN THIS LEAFLET: 1. What Zimovane tablets are and what they are used for 2. What you need to know before you take Zimovane tablets 3. How to take Zimovane tablets 4. Possible side effects 5. How to store Zimovane tablets 6. Contents of the pack and further information 1. WHAT ARE ZIMOVANE TABLETS AND WHAT THEY ARE USED FOR The active ingredient in these tablets is zopiclone. This belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep. The tablets are normally used for the short term treatment of severe sleeping difficulties in adults. 2. WHAT YOU NEED TO KNOW BEFORE TAKING ZIMOVANE TABLETS DO NOT TAKE ZIMOVANE TABLETS ‐ If you are allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6). ‐ If you suffer from myasthenia gravis (a condition where the muscles easily tire and become weak) ‐ If you have any severe breathing problems, if your lungs do not work properly (e.g. respiratory failure) ‐ If you suffer from severe sleep apnoea syndrome ‐ If the patient is under 18 years of age ‐ If you suffer from severe liver problems WARNINGS AND PRECAUTIONS Tell your doctor or pharmacist before taking Zimovane if any of the following apply: ‐ If you are pregnant or think you migh Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zimovane 7.5 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.5mg of zopiclone. Excipients: Each tablet also contains 31.57mg of lactose monohydrate For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet. White, elliptical film-coated tablet with a score line on one side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term treatment of insomnia in adults Benzodiazepines and benzodiazepine-like agents are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be as short as possible. Generally the duration of treatment varies from a few days to two weeks with a maximum, including tapering off of four weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so it should not take place without re-evaluation of the patient's status. The product should be taken just before retiring for the night. Dose The recommended dose for adults is 7.5mg. This dose should not be exceeded. Treatment of the elderly and patients with impaired liver function or chronic respiratory insufficiency should be initiated on a dose of 3.75mg and if necessary increased to 7.5mg. Although in case of renal insufficiency no accumulation of zopiclone or of its metabolites has been detected, it is recommended that patients with impaired renal function should start treatment with 3.75mg. _Paediatric population:_ Zopiclone should not be used in children and adolescents aged less than 18 years. The safety and efficacy of zopiclone in children and adolescents aged less than 18 years have not been established. 4.3 CONTRAINDICATIONS Myasthenia gravis Hypersensitivity to zopiclone Severe respiratory insufficiency Severe sleep apnoea syndrome Severe hepatic insufficiency Use in children. H E A L T H P R O D U C T S R E G U L Read the complete document