Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
zaleplon
Meda AB
N05CF03
zaleplon
Psycholeptics
Sleep Initiation and Maintenance Disorders
Sonata 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: 19
Withdrawn
1999-03-12
34 B. PACKAGE LEAFLET Medicinal product no longer authorised 35 PACKAGE LEAFLET: INFORMATION FOR THE USER Sonata 5 mg hard capsules zaleplon 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. 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 Sonata is and what it is used for 2. What you need to know before you take Sonata 3. How to take Sonata 4. Possible side effects 5. How to store Sonata 6. Contents of the pack and other information 1. WHAT SONATA IS AND WHAT IT IS USED FOR Sonata belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions. Sonata 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SONATA DO NOT TAKE SONATA if you are allergic to zaleplon or any of the other ingredients of this medicine (listed in section 6). if you have sleep apnoea syndrome (stopping breathing for short periods while asleep). if you have severe kidney or liver problems. if you have myasthenia gravis (very weak or tired muscles). if you have severe breathing or chest problems. If you are in any doubt about whether you have any of these conditions, do ask your doctor. Children and adolescents under 18 years of age must not take Sonata. WARNINGS AND PRECAUTIONS Talk to your doctor Прочитайте повний документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Sonata 5 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg of zaleplon. Excipient with known effect: Lactose monohydrate 54 mg. For the 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 the strength “5 mg”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sonata 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 . Sonata 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 Sonata. The total daily dose of Sonata 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 Sonata. Paediatric patients Sonata is contraindicated in children and adolescents under 18 years of age (see section 4.3). Hepatic impairment As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Sonata 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 Sonata pharmacokinetics is not altered in such patients. Severe renal impairment is contraindicated (see section 4.3.). 4.3 CONTRAINDICA Прочитайте повний документ