Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ZOLPIDEM HEMITARTRATE
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
ZOLPIDEM HEMITARTRATE
20Tablet Tablets
SANOFI WINTHROP INDUSTRIE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ STILNOX ® Zolpidem tartrate 10 mg _ _ 1 _ _ WHAT IS IN THIS LEAFLET 1. What Stilnox is used for 2. How Stilnox works 3. Before you use Stilnox 4. How to use Stilnox 5. While you are using it 6. Side effects 7. Storage and disposal of Stilnox 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT STILNOX IS USED FOR This medicine belongs to a group of medicines called benzodiazepines. It is used as short-term treatment for insomnia in adults. Due to a lack of data, the use of this medicine is not recommended in children and adolescents under 18 years of age. HOW STILNOX WORKS Stilnox tablets are sleeping pills (hypnotics) which work by acting on the brain to help you sleep. Stilnox is not meant to be used every day for long periods of time. Ask your doctor for advice if you are unsure BEFORE YOU USE STILNOX - _When you must not use it _ Do not take Stilnox and tell your doctor if: • You are allergic (hypersensitive) to zolpidem tartrate, the family of medicines that belong to the benzodiazepine group or any of the other ingredients in the tablet • Signs of an allergic reaction may include: a rash, swallowing or breathing problems, swelling of the face, lips, throat or tongue. • You have serious respiratory failure. • You have serious liver disease (serious liver failure). • Your lungs do not work properly (respiratory failure) • You have sleep apnea syndrome (condition where you stop breathing for short periods in your sleep). • You have myasthenia (muscle disease). • You have been told by a doctor that you cannot tolerate lactose • You are under the age of 18 - _Before you start to use it _ Talk to your doctor or pharmacist before taking Stilnox 10 mg tablets. - _Taking other medicines _ Tell your doctor or pharmacist if you are taking or have recently taken any other medicine including medicines obtained without a prescription. Stilnox tablets can affect the way some other medicines work. Also some med Lue koko asiakirja
STILNOX® COMPOSITION Each scored film -coated tablet contains: Zolpidem tartrate.......................................................................... 10 mg PHARMACEUTICAL FORM Scored film -coated tablets. CLINICAL PARTICULARS Therapeutic indications Indications are limited to treatment of severe sleep disorders in adults with : Transient insomnia Short -term insomnia Posology and method of administration Posology Dose The treatment should be taken as a sin gle dose and not be re -administered during the same night. The recommended daily dose for adults is 10 mg to be taken immediately at bedtime. Treatment should be started at the lowest effective dose and the maximum do se must not exceed 10 mg. Elderly or debilitated subjects As elderly or debilitated patients are especially sensitive to the effects of zolpidem, the recommended dose i n this population is 5 mg (i.e. 1/2 a tablet). Liver failure As the clearance and metabolism of zolpidem are reduced in liver failure, treatment should begin at 5 mg per day in these patients, with particular caution being exercised in elderly patients. Under no circumstances should the daily dose exceed 10 mg. Stilnox may be prescribed for use continuously or as required, depending on the signs and symptoms. Pediatric population The safety and efficacy of zolpidem in children and adolescents unde r 18 years of age have not been demonstrated. Therefore, use of zolpidem is not recommended in this population. The available evidence from placebo -controlled clinical trials is presented in section Pharmacodynamic properties . Duration As with all hypnoti cs, long -term use of zolpidem is not recommended. Treatment should be as short as possible, and should not exceed four weeks, including the tapering -off period (see section Special warnings and special precautions for us e). Lue koko asiakirja