מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ZOLPIDEM TARTRATE
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
ZOLPIDEM TARTRATE
100tablet Tablets; 30 Tablets
TORRENT PHARMACEUTICALS LTD
TORZOLP TABLETS _ _ Zolpidem Tartrate (10mg) _ _ _ _ 1 _ _ _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is Torzolp used for. 2. How Torzolp works. 3. Before you use Torzolp. 4. How to use Torzolp. 5. While you are using it. 6. Side effects. 7. Storage and Disposal of Torzolp. 8. Product Description. 9. Manufacturer and Product Registration Holder. 10. Date of revision. 11. Serial Number WHAT TORZOLP IS USED FOR Torzolp is used for temporary sleep problems that are causing you severe distress or that are affecting your everyday life. This includes sleep problems such as: • Difficulty falling asleep. • Waking in the middle of the night. • Waking too early. HOW TORZOLP WORKS Torzolp contains a medicine called zolpidem tartrate. This belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep. BEFORE YOU USE TORZOLP - _When you must not use it _ Do not take Torzolp: • If you are allergic (hypersensitive) to zolpidem tartrate or any of the other ingredients of Torzolp. • Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Torzolp. _Pregnancy and lactation_ Do not take Torzolp if you are pregnant or plan to become pregnant or think you might be pregnant. Do not take Torzolp if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start use it _ Check with your doctor or pharmacist before taking your medicine if: • You have a history of alcohol or drug abuse. • You have liver problems. • You have depression or have had another mental illnesses in the past. • You have recently taken Torzolp or other similar medicines for more than four weeks. • You are elderly. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Torzo קרא את המסמך השלם
For the use of a Registered Medical Practitioner or a Hospital or a Laboratory PRODUCT NAME : ITEM / PACK : DESIGN STYLE : CODE : DIMENSIONS (MM) : ART WORK SIZE : DATE : Reviewed By NO. OF COLORS: 1 COUNTRY : Malaysia Front-Back Torzolp Insert S/S 150 x 240 xxxxxxxxxx-5253 xxxxxxxx-5253 Black 18-03-2020 PANTONE SHADE NOS.: ACTIVITIES DEPARTMENT NAME SIGNATURE DATE Prepared By PKG.DEV PKG.DEV LOCATION : Indrad QUALITY Approved By COMPOSITION Each film coated tablet contains Zolpidem Tartrate U.S.P. 10 mg Excipients q.s. Colour: Ferric oxide red, Ferric oxide yellow and Titanium dioxide DESCRIPTION Yellow coloured, capsule shaped tablets with ‘Torrent logo’ debossing on one side and ‘10 MG’ debossing on another side. CLINICAL PHARMACOLOGY PHARMACODYNAMICS: Subunit modulation of the GABA A receptor chloride channel macromolecular complex is hypothesized to be responsible for sedative, anticonvulsant, anxiolytic, and myorelaxant drug properties. The major modulatory site of the GABA A receptor complex is located on its alpha ( α ) subunit and is referred to as the benzodiazepine (BZ) or omega ( ω ) receptor. At least three subtypes of the ( ω ) receptor have been identified. Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, pyrrolopyrazines, pyrazolopyrimidines or other drugs with known hypnotic properties, it interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem _in vitro_ binds the (BZ 1 ) receptor preferentially with a high affinity ratio of the alpha 1 /alpha 5 subunits. The (BZ 1 ) receptor is found primarily on the Lamina IV of the sensorimotor cortical regions, substantia nigra (pars reticulata), cerebellum molecular layer, olfactory bulb, ventral thalamic complex, pons, inferior colliculus, and globus pallidus. This selective binding of קרא את המסמך השלם