País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paracetamol; TRAMADOL HYDROCHLORIDE
Generic Health Sdn. Bhd.
Paracetamol; TRAMADOL HYDROCHLORIDE
10tablet Tablets; 30 Tablets
LUPIN LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ TRABEST 37.5MG/325MG FILM COATED TABLETS Tramadol/Paracetamol (37.5mg/325mg) 1 WHAT IS IN THE LEAFLET 1. What Trabest Tablet is used for 2. How Trabest Tablet works 3. Before you take Trabest Tablet 4. How to take Trabest Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Trabest Tablet 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision WHAT TRABEST TABLET IS USED FOR This medicine is intended for the management of moderate to severe pain when your doctor recommends that a combination of tramadol and paracetamol is needed. This medicine should only be taken by adults and adolescents over 16 years of age. HOW TRABEST TABLET WORKS Trabest is a combination of two analgesics, Tramadol and Paracetamol, which act together to relieve your pain. BEFORE YOU TAKE TRABEST TABLET - _When you must not take it _ • If you are allergic or have had an allergic reaction (such as skin rash, swelling of the face, wheezing or difficulty breathing) to paracetamol, tramadol or any of the other ingredients of this medicine (listed in section 6). • 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 starting treatment with Trabest. 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. - _Before you start to take it _ Follow all instructions given to you by your doctor carefully, even if they differ from the information contained in this leaflet. - _Taking other medicines _ Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Your doctor will tell you which medicines Llegiu el document complet
XXXX XXXXXX Each film coated tablet contains: Tramadol Hydrochloride …...37.5 mg Paracetamol .…………….…..325 mg PHARMACEUTICAL DOSAGE FORM AND DESCRIPTION Film Coated Tablet Pale yellow, capsule shaped, film-coated tablet, debossed with "TP" on one side and plain on the other side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Tramadol and Paracetamol tablets are indicated for the management of moderate to severe pain. POSOLOGY AND METHOD OF ADMINISTRATIONS Posology: Tramadol and Paracetamol should under no circumstances be administered for longer than is strictly necessary. If repeated use or long term treatment with Tramadol and Paracetamol is required as a result of the nature and severity of the illness, then careful, regular monitoring should take place (with breaks in the treatment, where possible), to assess whether continuation of the treatment is necessary. _Adults and Children Over 16 Years _ The maximum single dose of Tramadol and Paracetamol is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. Tramadol and Paracetamol can be administered without regard to food. _Pediatric (Children Below 16 Years): _ The effective and safe use of Tramadol and Paracetamol has not been established in children below the age of 16 years. Treatment is therefore not recommended in this population. _Elderly (Geriatric) patients: _ The usual dosages may be used, although it should be noted that in volunteers aged over 75 years, the elimination half life of tramadol was increased by 17% following oral administration. In patients over 75 years old, it is recommended that the minimum interval between doses should be not less than 6 hours, due to the presence of tramadol. Method of administration: Oral use. Tablets must be swallowed whole, with a sufficient quantity of liquid. They must not be broken or chewed. CONTRA-INDICATIONS Hypersensitivity to tramadol, paracetamol or to any of the excipients of the medicinal product. Acute intoxication with alcohol, hypnotic dru Llegiu el document complet