Country: Իսրայել
language: անգլերեն
source: Ministry of Health
ZOPICLONE
SANOFI ISRAEL LTD
N05CF01
FILM COATED TABLETS
ZOPICLONE 7.5 MG
PER OS
Required
SANOFI WINTHROP INDUSTRIE, FRANCE
ZOPICLONE
ZOPICLONE
Imovane is indicated for the short-term treatment of insomnia in adults
2021-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only IMOVANE FILM-COATED TABLETS 7.5 MG Composition: Each tablet contains: Zopiclone 7.5 mg For information about inactive and allergenic ingredients in the preparation: see section 2 “Important information about some of the ingredients of the medicine” and section 6 “Further information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. This medicine is not intended for children and adolescents under 18 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? Imovane is intended for treatment of the following conditions of severe sleep disorders: a. transient insomnia. b. short-term insomnia. THERAPEUTIC GROUP: Hypnotic and sedative from the cyclopyrrolone group. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • you are sensitive (allergic) to zopiclone or to any of the additional ingredients contained in the medicine (see section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue. • you suffer from a problem that causes severe muscle weakness (myasthenia gravis). • you suffer from a problem in lung function (respiratory failure). • you suffer from a problem in which you stop breathing for short periods at night (sleep apnoea). • you suffer from severe liver problems. • you are under the age of 18. The safety and efficacy of Imovane in children and adolescents aged less than 18 years have not been established. • you have ever experienced sleepwalking or any other unusual behavior (such as driving, eating, making a phone call or having sex, etc.) while you a read_full_document
IMOV-PO-7.5MG-SPC-24.1 SUMMARY OF PRODUCT CHARACTERISTICS IMOVANE 1 . NAME OF THE MEDICINAL PRODUCT Imovane 2 . QUALITATIVE AND QUANTITATIVE COMPOSITION Zopiclone 7.5 mg Excipient(s) with known effect: Lactose Wheat starch (containing gluten) (see section 4.4) For the full list of excipients, see section 6.1. 3 . PHARMACEUTICAL FORM Film coated tablet . White, elliptical film-coated tablets with a score-line on one side. The tablet can be divided into equal halves. 4 . CLINICAL PARTICULARS 4.1 Therapeutic indications Imovane is indicated for the short-term treatment of insomnia in adults. 4.2 Posology and method of administration Dose Use the lowest effective dose. Imovane should be taken in a single intake and not be re- administered during the same night. As with all hypnotics, long-term use of zopiclone is not recommended Treatment should be as short as possible, and should not exceed four weeks, including the period of tapering-off. Extension beyond the maximum treatment period should not take place without re-evaluation of the patient’s status, since the risk of abuse and dependence increases with the duration of treatment (see Section 4.4). The product should be taken just before retiring for the night. _Adults_ _:_ The recommended dose is one Imovane tablet (7.5mg zopiclone) by the oral route shortly before retiring. _Elderly patients_ _:_ A lower dose of 3.75mg zopiclone should be employed to start treatment in the elderly. Depending on effectiveness and acceptability, the dosage subsequently may be increased if clinically necessary. _Paediatric p_ _opulation_ _:_ Zopiclone should not be used in children and adolescents less than 18 years. The safety and efficacy of zopiclone in children and adolescents aged less than 18 years have not been Page 2 established. _Patients with hepatic insufficiency_ _:_ As elimination of zopiclone may be reduced in patients with hepatic dysfunction, a lower dose of 3.75mg zopiclone nightly is recommended. The standard dose of 7.5mg zopiclone may be used with caution in so read_full_document