Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
zolpidem tartrate
Arrow Pharma Pty Ltd
zolpidem tartrate
Registered
STILDEM- Consumer Medicine Information Page 1 of 4 STILDEM _ _ _Zolpidem tartrate_ _ _ _ _ CONSUMER MEDICINE INFORMATION (CMI) WARNING: ZOLPIDEM MAY BE ASSOCIATED WITH UNUSUAL AND POTENTIALLY DANGEROUS BEHAVIOURS WHILST APPARENTLY ASLEEP. THESE HAVE INCLUDED SLEEP WALKING, DRIVING MOTOR VEHICLES AND OTHER BIZARRE BEHAVIOURS. SOME MEDICINES MAY INTERACT WITH ZOLPIDEM AND PARTICULAR CAUTION IS NEEDED WITH OTHER DRUGS THAT MAY ALSO ACT ON THE BRAIN; BEFORE YOU TAKE ZOLPIDEM REFER TO THE "TAKING OTHER MEDICINES" SECTION BELOW OR ASK YOUR DOCTOR OR PHARMACIST. YOU MUST NOT DRINK ALCOHOL WHEN YOU TAKE ZOLPIDEM. DO NOT TAKE ZOLPIDEM FOR MORE THAN 4 WEEKS. IF YOUR SLEEP PROBLEMS CONTINUE, CONSULT YOUR DOCTOR. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about STILDEM It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking STILDEM against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT STILDEM IS USED FOR STILDEM is used to initiate and maintain sleep in those with sleeping difficulties, also called insomnia. STILDEM works by binding to special sites in the brain which produce sleep. It has a different chemical structure to other sleeping tablets. In general, sleeping tablets such as STILDEM are not recommended for use for more than 4 weeks at a time. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY STILDEM WAS PRESCRIBED FOR YOU. STILDEM is only available with a prescription. BEFORE YOU TAKE IT _ _ _WHEN YOU MUST NOT TAKE_ _ _ _STILDEM _ _ _ DO NOT TAKE STILDEM IF YOU ARE ALLERGIC TO ZOLPIDEM OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips Soma hati kamili
AUSTRALIAN PI – STILDEM (ZOLPIDEM) ZOLPIDEM MAY BE ASSOCIATED WITH POTENTIALLY DANGEROUS COMPLEX SLEEP-RELATED BEHAVIOURS WHICH MAY INCLUDE SLEEP WALKING, SLEEP DRIVING AND OTHER BIZARRE BEHAVIOURS. ZOLPIDEM IS NOT TO BE TAKEN WITH ALCOHOL. CAUTION IS NEEDED WITH OTHER CNS DEPRESSANT DRUGS. LIMIT USE TO FOUR WEEKS MAXIMUM UNDER CLOSE MEDICAL SUPERVISION. 1 NAME OF THE MEDICINE Zolpidem 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zolpidem tartrate is a white to off-white colourless, hygroscopic, crystalline powder, slightly soluble in water. STILDEM tablets come in one strength and contain 10 mg of zolpidem tartrate. The tablets contain lactose monohydrate. For full list of excipients, see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM White film coated, capsule-shaped tablet, with a break line on both faces and engraved with ‘Z’ and ‘10’ on either side of the break line on both faces. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Short-term treatment of insomnia in adults (see section 4.2 DOSE AND METHOD OF ADMINISTRATION). 4.2 D OSE AND METHOD OF ADMINISTRATION Zolpidem acts rapidly and should therefore be taken immediately before retiring. As with all hypnotics, long-term use is not recommended. Treatment should be as short as possible and should not exceed four weeks. DISCONTINUATION OF TREATMENT. See section 4.8 ADVERSE EFFECTS. WITHDRAWAL EFFECTS. See section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. RECOMMENDED DOSAGE. ADULTS. 10 mg to be taken at night. ELDERLY OR DEBILITATED PATIENTS. Since elderly or debilitated patients may be especially sensitive to the effects of zolpidem, 5 mg to be taken at night is recommended. This dose should not be exceeded. HEPATIC IMPAIRMENT. As clearance and metabolism of zolpidem is reduced in hepatic impairment, dosage of 5 mg to be taken at night is recommended, with particular caution being exercised in elderly patients. In adults less than 65 years the dosage may be increased if the clinical response is inadequate and the drug is well tolerated. Soma hati kamili