Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
ZOPICLONE
UNIPHARM LTD, ISRAEL
N05CF01
TABLETS
ZOPICLONE 7.5 MG
PER OS
Required
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
ZOPICLONE
ZOPICLONE
Hypnotic when the disorder of insomnia is severe and disabling.
2013-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only. NOCTURNO 3.75 NOCTURNO FORTE 7.5 TABLETS COMPOSITION: Each NOCTURNO 3.75 tablet contains: Zopiclone 3.75 mg Each NOCTURNO FORTE 7.5 tablet contains: Zopiclone 7.5 mg For a list of inactive ingredients, please see section 6: ”Further Information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. Keep this leaflet; you may need to read it again. This leaflet contains concise information about the medicine. 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 usually intended for children and adolescents below the age of 18. If a side effect worsens or if a side effect not mentioned in this leaflet occurs, please refer to a doctor or pharmacist. If you have further questions, refer to the doctor or pharmacist. 1. WHAT IS THE MEDICINE INTENDED FOR? NOCTURNO IS INTENDED for the treatment of the following 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 to zopiclone or to any of the other ingredients of NOCTURNO (see section 6: “Further Information”). Signs of allergic reaction include: rash, problems with swallowing or breathing, swelling of the lips, face, throat or tongue. • You suffer from a disease that causes severe muscle weakness (myasthenia gravis). • You suffer from a problem in lung function (respiratory insufficiency). • You suffer from a disease in which you stop breathing for short periods at night (sleep apnea). • You suffer from severe liver problems. You are below the age of 18. This is because the efficacy and safety of NOCTURNO in children and adolescents under the age of 18 have not yet been determined. SPECIAL W Prečítajte si celý dokument