Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TRAMADOL HYDROCHLORIDE
DUOPHARMA (M) SDN. BHD.
TRAMADOL HYDROCHLORIDE
10 x 10s Tablets
DUOPHARMA (M) SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 ACUGESIC TABLET Tramadol hydrochloride (50mg) WHAT IS IN THE LEAFLET 1. What ACUGESIC tablet is used 2. How ACUGESIC tablet works 3. Before you use ACUGESIC tablet 4. How to use ACUGESIC tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of ACUGESIC tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ACUGESIC TABLET IS USED FOR ACUGESIC tablet is a painkiller used for treatment of severe acute and chronic pain. ACUGESIC tablet is a medicine for relief of pain, eg. in wound pain, fractures, severe nerve pain, tumor pain, heart attack. It should not be used for minor pain. The effect sets in quickly and lasts for some hours. HOW ACUGESIC TABLET WORKS ACUGESIC tablet contains active substance called Tramadol. Tramadol is a painkiller belonging to the class of the opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain. BEFORE YOU USE ACUGESIC TABLET - _When you must not use it _ Do not use ACUGESIC tablet if you have or have had any of the following condition: • You are less than 12 years old. • You have slow or shallow breathing, or other breathing problems. • You are pregnant. • You are breastfeeding. • You have recently taken large amounts of alcohol, hypnotics (sleeping pills), analgesics (painkillers) or other medicines that act on the brain and spinal cord. • You are hypersentitive to, or have had an allergic reaction to tramadol, other opioids or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body, rash itching or hives on the skin; fainting or hay fever like symptoms. If you think you are having an allergic reaction, stop taking the medicine and contact your doctor immediately or go to the nearest hospital. - _Before you Przeczytaj cały dokument
[DUOPHARMA (M) SDN BHD] [Page 1/3] _ _ [Revision Date: 08.08.2019] ACUGESIC DESCRIPTION: ACUGESIC TABLET 50 MG is a 7 mm square shape, apple green in colour tablet scored with marking 'duo 861' on one side and plain on the other side. ACUGESIC CAPSULE 50 MG is a black/green capsule with marking 'DUO 861'. COMPOSITION: ACUGESIC TABLET 50 MG : Each tablet contains Tramadol Hydrochloride 50 mg. ACUGESIC CAPSULE 50 MG: Each capsule contains Tramadol Hydrochloride 50 mg. Gelatin for Hard Capsule: Bovine source certified with Malaysia’s Halal certification PHARMACODYNAMICS: The side effects of opioid therapy, manifested as respiratory depression and the development of dependence, which limit the application of potent analgesics, continue to impose on the therapist the difficult task of estimating the benefit-risk relation. Since it has not yet been possible to separate the therapeutically exploitable activity and the undesirable side effects of potent analgesics, it was assumed that the activity and side-effects of potent analgesics were traceable to a common principle of action. Increasing knowledge suggests however that it is possible to distinguish between the therapeutic effects and side effects. Tramadol (INN) (±)-trans-2-(dimethylaminomethyl)-1-(methoxy-phenyl)-cyclohexanol hydrochloride) is classified as a potent centrally active analgesic. Its structure is related to opiate alkaloids (eg. codeine) and to synthetic opiate analgesics. Preclinical and clinical studies have shown that the analgesic action derives from the reaction of the drug with the specific opioid receptors of the pain processing system. Animal experiments led to the assumption that tramadol hydrochloride is a substance in which the therapeutic effects and side effects can to a great extent be differentiated. In tramadol HCl, with its favourable side effect / analgesic action relation, we now have available for the first time an opioid for the therapy of severe pain with a minimized abuse and dependence potential, and which in therapeutic dos Przeczytaj cały dokument