Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
zaleplon
Meda AB
N05CF03
zaleplon
Psycholeptics
Sleep Initiation and Maintenance Disorders
Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.
Revision: 13
Withdrawn
1999-03-12
32 B. PACKAGE LEAFLET Medicinal product no longer authorised 33 PACKAGE LEAFLET: INFORMATION FOR THE USER Zerene 5 mg hard capsules zaleplon 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. 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Zerene is and what it is used for 2. Before you take Zerene 3. How to take Zerene 4. Possible side effects 5. How to store Zerene 6. Further information 1. WHAT ZERENE IS AND WHAT IT IS USED FOR Zerene belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions. Zerene will help you to sleep. Sleeping problems do not usually last long, and most people only need a short course of treatment. The duration of treatment should usually vary from a few days to two weeks. If you still have problems sleeping after you have finished your capsules, contact your doctor again. 2. BEFORE YOU TAKE ZERENE Do not take Zerene if you have • hypersensitivity (an allergy) to zaleplon or to any other ingredients of Zerene • sleep apnoea syndrome (stopping breathing for short periods while asleep) • severe kidney or liver problems • myasthenia gravis (very weak or tired muscles) • severe breathing or chest problems If you are in any doubt about whether you have any of these conditions, do ask your doctor. Children under 18 years of age must not take Zerene. Take special care with Zerene • Never drink alcohol while you are being treated with Zerene. Alcohol can increase the undesirable effects of any medicine taken to help you sleep. • Use with extreme caution if you have ever been addicted to medicines or alco Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Zerene 5 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg of zaleplon. Excipient: Lactose monohydrate 54 mg. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. Capsules have an opaque white and opaque light brown hard shell with gold band, “W” and the strength “5 mg”. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 Posology and method of administration For adults, the recommended dose is 10 mg. Treatment should be as short as possible with a maximum duration of two weeks. Zerene can be taken immediately before going to bed or after the patient has gone to bed and is experiencing difficulty falling asleep. As administration after food delays the time to maximal plasma concentration by approximately 2 hours no food should be eaten with or shortly before intake of Zerene. The total daily dose of Zerene should not exceed 10 mg in any patient. Patients should be advised not to take a second dose within a single night. Elderly Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose of Zerene. Paediatric patients Zerene is contraindicated in children (see section 4.3). Hepatic impairment As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Zerene 5 mg. For severe hepatic impairment see section 4.3. Medicinal product no longer authorised 3 Renal impairment No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Zerene pharmacokinetics is not altered in such patients. Severe renal impairment is contraindicated (see section 4.3.). 4.3 Contraindications Hypersensitivity to the active Læs hele dokumentet