Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
zolpidem tartrate, Quantity: 10 mg
Arrotex Pharmaceuticals Pty Ltd
zolpidem tartrate
Tablet, film coated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate; hypromellose; magnesium stearate; titanium dioxide; macrogol 400
Oral
3 blister packs of 10 tablets, 1 blister pack of 10 tablets, 2 blister packs of 14 tablets, 1 blister pack of 7 tablets, 1 blister pack of 14 tablets
(S4) Prescription Only Medicine
Short-term treatment of insomnia in adults.
Visual Identification: White, oval, bi-convex, film coated tablets, scored on both sides and embossed with "ZIM 10" on one side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2007-07-23
STILDEM 1 STILDEM CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING STILDEM? STILDEM contains the active ingredient zolpidem tartrate. STILDEM is used to initiate and maintain sleep in those with sleeping difficulties, also called insomnia in patients over 18 years of age. For more information, see Section 1. Why am I using STILDEM? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE STILDEM? Do not use if you have ever had an allergic reaction to zolpidem or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, HAVE BEEN DRINKING ALCOHOL, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use STILDEM? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with STILDEM and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE STILDEM? • In Adults: Usual dose is one 10 mg tablet taken just before bedtime. • In people over 65 years of age: The dose is one 5 mg tablet taken just before bedtime. More instructions can be found in Section 4. How do I use STILDEM? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING STILDEM? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using STILDEM. • If you become pregnant or suspect that you are pregnant while you are taking this medicine, stop taking it and tell your doctor or pharmacist immediately. THINGS YOU SHOULD NOT DO • Do not take STILDEM if you have sleep apnoea, myasthenia gravis, severe liver problems, acute and / or severe lung problems or if you have previously experienced complex sleep behavi Les hele dokumentet
AUSTRALIAN PRODUCT INFORMATION – STILDEM (ZOLPIDEM TARTRATE) TABLETS 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 tartrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each STILDEM tablet contains zolpidem tartrate 10 mg Excipients with known effect: Lactose monohydrate For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM STILDEM _(AUST R 131917) _10 mg tablets are white, oval, biconvex, film-coated tablets, scored on both sides and embossed with "ZIM" and "10" on one side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS STILDEM is indicated for the short-term treatment of insomnia in adults (see section 4.2 DOSE AND METHOD OF ADMINISTRATION). 4.2 D OSE AND METHOD OF ADMINISTRATION STILDEM acts rapidly and should therefore be taken immediately before retiring, or in bed. STILDEM should be taken in a single intake and not be re-administered during the same night. As with all hypnotics, long-term use is not recommended, and a course of treatment should be as short as possible and not exceed four weeks. For oral use only. Discontinuation of treatment: see section 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS). Withdrawal effects: see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. DOSAGE: Adults: 10 mg to be taken at night. The lowest effective daily dose of STILDEM should be used and must not exceed 10 mg. RENAL IMPAIRMENT No dosage adjustment is necessary in these patients, although they should be closely monitored. HEPATIC IMPAIRMENT As clearance and metabolism of Zolpidem is reduced in hepatic impairment, a 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 i Les hele dokumentet