Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ZOLPIDEM TARTRATE
DUOPHARMA (M) SDN. BHD.
ZOLPIDEM TARTRATE
100Tablet Tablets
DUOPHARMA (M) SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1 SOMIDEM TABLET Zolpidem Tartrate (10 mg) WHAT IS IN THIS LEAFLET 1. What SOMIDEM is used for 2. How SOMIDEM tablet works 3. Before you use SOMIDEM tablet 4. How to use SOMIDEM 5. While you are using it 6. Side effects 7. Storage and Disposal of SOMIDEM 8. Product description 9. Manufacturer 10. P ro d u c t Registration Holder 11. Date of revision WHAT SOMIDEM IS USED FOR SOMIDEM is used to initiate and maintain sleep for short term in those with sleeping difficulties, also called insomnia. It is limited to 7 to 10 days of use and re- evaluation by the doctor is recommended if insomnia fails to remit after this period. HOW SOMIDEM WORKS SOMIDEM contains the active ingredient zolpidem tartrate. SOMIDEM belongs to a group of medicines called hypnotics. SOMIDEM has a different chemical structure to other sleeping tablets. SOMIDEM works by acting on your brain to help you sleep. BEFORE YOU USE SOMIDEM - _When you must not use it_ _ _ Do not take SOMIDEM if you have: • Been drinking alcohol or you believe that you may have alcohol in your bloodstream • Sleep apnoea (a condition where you temporarily stop breathing while you sleep) • Myasthenia gravis (a condition in which the muscles become weak and tired easily) • Severe liver problem • Severe lung problems Do not take SOMIDEM if you are allergic to Zolpidem or any of the ingredients listed at the end of this leaflet (see section PRODUCT DESCRIPTION ). _Children and adolescent_ Do not give SOMIDEM to a child or adolescent. There is no experience with its use in children or adolescents under 18 years of age. _Pregnancy and breastfeeding_ _ _ Do not take it if you pregnant or intend to become pregnant. It may affect your developing baby i f y o u t a k e i t d u r i n g pregnancy. Do not take it if you are breastfeeding or planning to breast-feed. SOMIDEM passes into breast milk and there is a possibility your baby may be affected. Tell your doctor if you are pregnant, planning to be pregnant, breastfeeding Baca dokumen lengkap