Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ZOPICLONE
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
ZOPICLONE
20Tablet Tablets; 14 Tablets
Opella Healthcare International SAS
_ _ 1 _ _ _Consumer Medication Information Leaflet (RiMUP) _ IMOVANE ® TABLET Zopiclone (7.5 mg) WHAT IS IN THIS LEAFLET 1. What Imovane is used for 2. How Imovane works 3. Before you use Imovane 4. How to use Imovane 5. While you are using it 6. Side effects 7. Storage and Disposal of Imovane 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IMOVANE IS USED FOR Imovane is used for short term treatment of sleep problems (insomnia) such as: • Difficulty falling asleep • Waking in the middle of the night • Waking too early • Severe or upsetting sleep problems that are caused by your mood or mental health problems Do not take Imovane as long-term treatment. Treatment should be as short as possible because the risk of dependence increases with the duration of treatment. Ask your doctor for advice if you are unsure. HOW IMOVANE WORKS Imovane tablets are sleeping pills (hypnotics) which work by acting on the brain to cause sleepiness. BEFORE YOU USE IMOVANE _- When you must not use it _ Do not take Imovane if you: • are allergic (hypersensitive) to zopiclone or any of the other ingredients in the tablet (see section PRODUCT DESCRIPTION ). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. • have severe liver problems • suffer from breathing problems whilst sleeping (sleep apnoea syndrome) • suffer from severe muscle weakness (myasthenia gravis) • have severe breathing problems These tablets are not recommended for use in children and pregnant women. _- Before you start to use it _ Warnings: Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling) which can occur as early as the first time the product is taken. Complex sleep-related behaviors which may include sleep-driving, making phone calls, preparing and eating food while asleep. Check with your doctor or pharmacist before taking Imovane tablets if you: • have any kidney or liver problems. • have a history o Lugege kogu dokumenti
MY/IMO/0822/CCDS V12 IMOVANE ® 7.5 MG Zopiclone film-coated scored tablets 1. NAME OF THE MEDICINAL PRODUCT Imovane 7.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 7.5 mg zopiclone. Excipient(s) with known effect: Lactose Wheat starch (containing gluten) (see section 4.4 Special warnings and precautions for use). 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) White, elliptical, biconvex 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 Short term treatment of insomnia in adults, including difficulties in falling asleep, nocturnal awakening and early awakening, transient, situational or chronic insomnia, and insomnia secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is causing severe distress for the patient. Long term continuous use is not recommended. A course of treatment should employ the lowest effective dose. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Use the lowest effective dose. Imovane should be taken in a single intake and not be re- administered during the same night. _Adults _ The recommended dose is one Imovane tablet (7.5 mg zopiclone) by the oral route shortly before retiring. _Elderly patients _ A lower dose of 3.75 mg 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 population _ 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 established. _Patients with hepatic insufficiency _ As elimination of zopiclone may be reduced in patients with hepatic dysfunction, a lower dose of 3.75 mg zopiclone nightly is recommended. The standard dose of 7.5 mg zopiclone may be used with caution in some cases, depending on effectiveness and acceptability. _Renal insufficiency _ MY/IMO/082 Lugege kogu dokumenti