Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MELOXICAM
APEX PHARMACY MARKETING SDN. BHD.
MELOXICAM
50Tablet Tablets
DELORBIS PHARMACEUTICALS LTD.
AVEGESIC TABLET Meloxicam (7.5mg, 15mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Avegesic Tablet is used for 2. How Avegesic Tablet works 3. Before you use Avegesic Table 4. How to use Avegesic Tablet 5. While you are using it 6. Side Effects 7. Storage and Disposal of Avegesic Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT AVEGESIC TABLET IS USED FOR Avegesic Tablet is used for: Symptomatic treatment of painful osteoarthritis (degenerative joint disease). Symptomatic treatment of rheumatoid arthritis (systemic inflammatory disorder that affects joints). Symptomatic treatment of ankylosing spondylitis (chronic inflammatory disease of the skeleton). HOW AVEGESIC TABLET WORKS Avegesic Tablet contains a substance called meloxicam. It belongs to a group of medicines called nonsteroidal anti- inflammatory drugs (NSAIDs) which are used to reduce inflammation, pain and fever. BEFORE YOU USE AVEGESIC TABLET - _When you must not use it _ You are pregnant, planning to become pregnant or if you are breast feeding. You are allergic to meloxicam or to any of the other ingredients listed. You are allergic to aspirin or other anti-inflammatory medicines. You have ever suffered from wheezing, nasal polyps (nasal obstruction due to swellings in the lining in your nose) along with a runny nose, swelling of the skin, urticaria (nettle rash) when taking aspirin or other anti-inflammatory medicines. You have or have ever had a gastrointestinal ulcer or perforation (ulcer of the stomach or intestines). You have any kind of bleeding disorder or have ever suffered from gastrointestinal bleeding (bleeding in the stomach or intestines) or cerebrovascular bleeding (bleeding in the brain). You have serious liver disease. You have serious kidney disease and are not undergoing dialysis. You have severe heart failure. - _Before you start to take it _ Inform your doctor if: You Olvassa el a teljes dokumentumot
COMPOSITION : AVEGESIC TABLET 7.5MG : Meloxicam 7.5 mg/ tablet AVEGESIC TABLET 15MG : Meloxicam 15 mg/ tablet PRODUCT DESCRIPTION AVEGESIC TABLET 7.5MG : Light yellow, round, flat tablet, 8mm diameter, cross- scored on one side. AVEGESIC TABLET 15MG : Light yellow, round, concave tablet, 10mm diameter, scored on one side. PHARMACODYNAMICS Non- steroidal anti- inflammatory agent (M; locomotor system). Meloxicam is a non- steroidal anti- inflammatory drug (NSAID) of the oxicam family, with anti- inflammatory, analgesic and antipyretic properties. The anti- inflammatory activity of meloxicam has been proven in classical models of inflammation. As with other NSAIDs, its precise mechanism of action remains unknown. However there is at least one common mode of action shared by all NSAIDs (including meloxicam): inhibition of the biosynthesis of prostaglandins, known inflammation mediators. PHARMACOKINETICS The bioavailability of meloxicam following oral administration is on the average 89%. With the doses of 7.5 and 15 mg, plasma concentrations are proportional to dose: 0.4 to 1.0 mg/lt for 7.5 mg and 0.8 to 2.0 mg/lt for 15 mg, on average (Cmin and Cmax at steady state). Meloxicam is very strongly bound to plasma proteins, essentially albumin (99%). Meloxicam is extensively metabolized, chiefly by oxidation of the methyl radical attached to the thiazolyl ring. Elimination is unchanged form accounts for 3% of the dose. Half of the substance is eliminated in urine and the other half in faeces. The mean elimination half-life of the order of 20 hours. Steady state is reached in 5 days. In terminal renal failure, the volume of distribution is increased and a daily dose of 7.5 mg must not be exceeded. Plasma clearance is on average 8 ml/min. Clearance is decreased in the elderly. Volume of distribution is low, on average 11 litres. Inter individual variation is the order of 30 – 40%. INDICATION - symptomatic treatment of painful osteoarthritis ( - arthrosis, degenerative joint disease). - symptomatic treatment of rheumatoi Olvassa el a teljes dokumentumot