Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
tramadol hydrochloride
Medis Pharma Pty Ltd
Tramadol hydrochloride
Registered
GA TRAMADOL CAPSULES _Tramadol hydrochloride_ Page 1 of 3 GA Tramadol V2 100528 CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about GA Tramadol. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking GA Tramadol against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT GA TRAMADOL IS USED FOR GA Tramadol is used to relieve moderate to severe pain and belongs to a group of medicines called analgesics (pain relievers). Your doctor may have prescribed GA Tramadol for another reason. Ask your doctor why GA Tramadol has been prescribed for you. This medicine is available only with a doctor's prescription. GA Tramadol is not normally addictive although some cases have been reported. BEFORE YOU USE GA TRAMADOL _When you must not use it _ _ _ Do not use GA Tramadol if: • YOU HAVE A KNOWN ALLERGY TO GA TRAMADOL OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include skin rash, itching, difficulty breathing and swelling of the face (including lips, tongue, throat etc) • YOU ARE TAKING MEDICINE FOR DEPRESSION CONTAINING A "MONOAMINE OXIDASE INHIBITOR" (SUCH AS NARDIL, PARNATE), OR HAVE TAKEN ONE WITHIN THE PAST TWO WEEKS. DO NOT USE GA TRAMADOL AFTER THE EXPIRY DATE PRINTED ON THE PACK. If you take this medicine after the expiry date has passed, it may not work as well. DO NOT USE GA TRAMADOL IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. DO NOT GIVE GA TRAMADOL TO CHILDREN. There is no experience with the use of GA Tramadol in children. If you are not sure whether you should be using GA Tramadol, talk to your doctor. _ _ _Before you use it _ _ _ YOU MUST TELL YOUR DOCTOR IF: 1. you have a known allergy to G Lesen Sie das vollständige Dokument
GA Tramadol V3 140916 Page 1 of 12 PRODUCT INFORMATION GA TRAMADOL 50 MG CAPSULES NAME OF THE MEDICINE The product, GA Tramadol 50 mg capsules, contains tramadol hydrochloride as the active ingredient. The chemical structure of tramadol hydrochloride is: CAS number: 36282-47-0 DESCRIPTION AND COMPOSITION The chemical name of tramadol hydrochloride is (1 _RS_ ,2 _RS_ )-2- [(dimethylamino)methyl)]-1-(3-methoxyphenyl)cyclohexanol hydrochloride. Molecular formula: C 16 H 25 NO 2 .HCl. MW: 299.84. Tramadol hydrochloride is an odourless, white to off white crystalline powder that is readily soluble in both water and ethanol and has a pKa of 9.41. The water/n-octanol partition coefficient is 1.35 at pH 7. The excipients contained in the product include croscarmellose sodium, povidone, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, gelatin, titanium dioxide, quinoline yellow, iron oxide yellow, Brilliant Blue FCF. CLINICAL PHARMACOLOGY PHARMACODYNAMICS: Tramadol is a centrally acting synthetic analgesic of the aminocyclohexanol group with opioid-like effects. It is not derived from natural sources, nor is it chemically related to opiates. GA Tramadol V3 140916 Page 2 of 12 Although the mode of action is not completely understood, at least two complementary mechanisms appear applicable: binding to _µ_ -opioid receptors and inhibition of re-uptake of noradrenaline and serotonin. The opioid like activity of tramadol derives from low affinity binding of the parent compound to _µ_ -opioid receptors and higher affinity binding of the principal active metabolite, mono O- desmethyl tramadol, denoted M1, to _µ_ -opioid receptors. In animal models, M1 is up to six times more potent than tramadol in producing analgesia and 200 times more potent in _µ_ -opioid binding. The contribution of tramadol to human analgesia, relative to M1, is unknown. Both human and animal studies have shown that antinociception induced by tramadol is only partially antagonised by the opiate antagonist naloxone. In addition Lesen Sie das vollständige Dokument