Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paracetamol; TRAMADOL HYDROCHLORIDE
HEALOL PHARMACEUTICALS SDN. BHD.
Paracetamol; TRAMADOL HYDROCHLORIDE
3 x 10 Tablets; 10tablet Tablets; 10 x 10 Tablets; 3 x 10 Tablets; 10 x 10 Tablets
M/S MICRO LABS LIMITED
BIDOL _Consumer Medication Information Leaflet (RiMUP)_ (Tramadol Hydrochloride 37.5mg and Paracetamol 325mg Tablets) 1 WHAT IS IN THIS LEAFLET 1. What BIDOL is used for 2. How BIDOL works 3. Before you use BIDOL 4. How to use BIDOL 5. While you are using it 6. Side effects 7. Storage and Disposal of BIDOL 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IS BIDOL USED FOR BIDOL tablets are used to treat moderate to severe pain when your doctor recommends that a combination of tramadol hydrochloride and paracetamol is needed. HOW BIDOL WORKS BIDOL tablets contain two different medicines called Tramadol and Paracetamol. Tramadol is an opioid analgesic that acts on the central nervous system. The other active component (Paracetamol) analgesic properties of paracetamol may involve central and peripheral effects. BEFORE YOU USE BIDOL -When you must not use it If you are hypersensitive or have had an allergic reaction (for instance skin rash, swelling of the face, wheezing or difficulty breathing) to tramadol, paracetamol or any of the other ingredients in BIDOL In cases of acute alcohol poisoning If you are taking sleeping pills, pain relievers or medicines that affect mood and emotions If you are also taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the last 14 days before treatment with BIDOL tablets. MAOIs are used in the treatment of depression or Parkinson’s disease If you have a severe liver disorder If you have epilepsy that is not adequately controlled by your current medicine If you are less than 12 years old If you have slow or shallow breathing, or other breathing problems If you are pregnant If you are breastfeeding Do not take BIDOL tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking BIDOL tablets. -Before you start to use it Talk to your doctor or pharmacist before taking this medicine if you: Take other medicines con Прочитайте повний документ
_Cytochromes P450 (CYP) 2D6 Ultra Rapid Metabolism_ Some individuals may be CYP2D6 ultra-rapid metabolisers. These individuals convert tramadol more rapidly than other people into its more potent opioid metabolites O-desmethyltramadol (M1). This rapid conversion could result in higher than expected opioid-like side effects including life- threatening respiratory depression. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese, Japanese and Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data are not available for other ethnic groups. Tramadol hydrochloride and Paracetamol tablets should be used with caution in opioid dependent patients, or in patients with cranial trauma, in patients prone to convulsive disorder, biliary tract disorders, in a state of shock, in an altered state of consciousness for unknown reasons, with problems affecting the respiratory centre or the respiratory function, or with an increased intracranial pressure. Paracetamol in over dosage may cause hepatic toxicity in some patients. At therapeutic doses, tramadol has the potential to cause withdrawal symptoms. Rarely, cases of dependence and abuse have been reported. Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal may occur. In one study, use of tramadol during general anaesthesia with enflurane and nitrous oxide was reported to enhance intra-operative recall. Until further information is available, use of tramadol during light planes of anaesthesia should be avoided. _Respiratory Depression: _Administer Bidol Tablet cautiously in patients at risk for respiratory depression, including patients with substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression, as in these patients, even therapeutic doses of Bidol Tablet may decrease respiratory drive to the point of apnea. In these patients, alternative non-opioid analgesics should be considered. When Прочитайте повний документ