Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIROXICAM-B-CYCLODEXTRIN
GERMAX SDN. BHD.
PIROXICAM-B-CYCLODEXTRIN
20Tablet Tablets
CHIESI FARMACEUTICI SPA
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ BREXIN ® TABLET Piroxicam (20mg) ___________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Brexin Tablet is used for 2. How Brexin Tablet works 3. Before you use Brexin Tablet 4. How to use Brexin Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Brexin Tablet 8. Product Description 9. Manufacturer & Product Registration Holder 10. Date of revision WHAT BREXIN TABLET IS USED FOR Brexin Tablet is an anti- inflammatory and anti-pain drug, used to relieve some symptoms caused by rheumatic disease like rheumatoid arthritis, osteoarthritis (degenerative joint disease) and ankylosing spondylitis. However it should not be the first choice treatment in these conditions. HOW BREXIN TABLET WORKS Piroxicam is a nonsteroidal anti- inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain and inflammation. BEFORE YOU USE BREXIN TABLET - _When you must not use it _ Do not take Brexin Tablet: - If you are allergic (hypersensitive) to piroxicam or to any of the excipients of Brexin Tablet. - If you currently or previously had a stomach or intestinal ulcer, bleeding or perforation. - If you previously had a serious allergic drug reaction to piroxicam, other NSAIDs and other medications, especially serious skin reactions (regardless of severity) such as multiform erythema, exfoliative dermatitis (intense reddening of skin, with skin peeling off in scales or layers), vesiculo-bullous reactions: Stevens-Johnson syndrome, a condition with red blistered, eroded, bloody or crusted skin, and toxic epidermal necrolysis, a disease with blistering and peeling of the top layer of skin. - If you are or suspect to be pregnant. - If you are breast-feeding. - If you are aged less than 18 years. - If you have a severe liver disease. - If you have a severe kidney disease. - If you have severe blood alterations. - If you have haemorrhagic diathesis (predisp Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS BREXIN 20MG TABLET NAME OF THE MEDICINAL PRODUCT BREXIN 20mg Tablets QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains Piroxicam β-cyclodextrin 191.2 mg (equivalent to piroxicam 20 mg). Excipients with known effect: Lactose (102.8 mg/tablet). PRODUCT DESCRIPTION Tablets for oral use. Pale yellow, hexagonal tablets with deep median scoring line. INDICATIONS For the symptomatic relief of pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. However, it should not be the first choice of non-steroidal anti-inflammatory drug (NSAID) treatment in these conditions. RECOMMENDED DOSAGE 1 tablet (equivalent to 20 mg of piroxicam) per day. In elderly patients, the dosage must be carefully decided by the physician and it may be necessary to reduce the dosage (half a tablet) and limit the duration of treatment. A prolonged administration of doses higher than 30mg/day increases the risk of gastro-intestinal side effects. After assessing the risk/benefit ration in each individual patient, the lowest effective dose for the shortest possible duration should be used. METHOD OF ADMINISTRATION Oral administration. 1 tablet per day. The tablet must be swallowed whole during a meal with a big glass of water. CONTRAINDICATIONS Piroxicam should not be prescribed to patients who are more likely to develop side effects, such as those with history of gastrointestinal disorders associated with bleeding or those who have had skin reactions to other medicines. Piroxicam should not be prescribed in association with any other NSAID or an anticoagulant. This medicine is contraindicated in the following situations: • Pregnancy, from the 6 th month onwards (beyond 24 weeks of amenorrhea) (see FERTILITY, PREGNANCY AND LACTATION) • Hypersensitivity to the active substance or to any of the excipients in BREXIN tablet, past history of skin reaction (however serious it was) to Piroxicam, to other NSAIDs and other medication • Past history of asthma tr Pročitajte cijeli dokument