Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
zopiclone
Apotex Pty Ltd
Zopiclone
Registered
CHEMMART ZOPICLONE _Zopiclone_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about zopiclone. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Zopiclone is used to help people with sleeping difficulties (insomnia). It helps you fall asleep and reduces the number of times you wake up during the night. It is used for short term treatment (2-4 weeks) of insomnia. It is not recommended for use for more than 4 weeks at a time. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine should not be used in children. The safe and effective dose of this medicine in children and adolescents under 18 years of age has not been established. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • zopiclone • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • cough, shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the skin • fainting • hay fever-like symptoms. DO NOT TAKE THIS MEDICINE IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • sleep apnoea • myasthenia gravis • severe liver problems • severe lung problems. • stroke DO NOT TAKE THIS MEDICINE IF YOU RECENTLY HAD ALCOHOL OR BE Przeczytaj cały dokument
1 AUSTRALIAN PRODUCT INFORMATION –CHEMMART ZOPICLONE (ZOPICLONE) TABLETS 1 NAME OF THE MEDICINE Zopiclone 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.5 mg of the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM The tablets are white to off white oval film coated tablets with breakline on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short term treatment of insomnia (2 to 4 weeks). 4.2 DOSE AND METHOD OF ADMINISTRATION USE IN ADULTS 7.5 mg by oral administration shortly before retiring for a maximum of 2-4 weeks. This dose should not be exceeded. Depending on clinical response, the dose may be lowered to 3.75 mg. Zopiclone is not recommended for long term use (i.e. periods of more than 4 weeks). If used for long periods, treatment should be withdrawn gradually. (See ‘4.4 Special warnings and precautions for use’) USE IN THE ELDERLY In the elderly and/or debilitated patient an initial dose of 3.75 mg is recommended. The dose may be increased to a maximum of 7.5 mg if the starting dose does not offer adequate therapeutic effect, but in clinical trials, 25% of elderly patients treated with zopiclone experienced CNS side-effects at the higher dose. Zopiclone should be used with caution in these patients. (See also ‘4.4 Special warnings and precautions for use’). USE IN CHILDREN Zopiclone is contraindicated in children. Dosage has not been established. USE IN PATIENTS WITH RENAL IMPAIRMENT In patients with renal insufficiency: although no accumulation of zopiclone or of its metabolites has been detected in cases of renal insufficiency, it is recommended that patients with impaired renal function should start treatment with 3.75 mg. 2 USE IN PATIENTS WITH HEPATIC IMPAIRMENT The recommended dose is 3.75 mg depending on acceptability and efficacy. Up to 7.5 mg may be used with caution in appropriate cases. ALTERNATIVE THERAPY For long term t Przeczytaj cały dokument