Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MELOXICAM
Y.S.P. INDUSTRIES (M) SDN BHD
MELOXICAM
500Tablet Tablets; 100Tablet Tablets; 500Tablet Tablets; 1000Tablet Tablets; 100Tablet Tablets; 500Tablet Tablets; 1000Tablet Tablets; 1000 Tablets; 500 Tablets
Y.S.P. INDUSTRIES (M) SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1 | MELOCAM TABLET Meloxicam (7.5mg) WHAT IS IN THIS LEAFLET 1. What MELOCAM TABLET is used for 2. How MELOCAM TABLET works 3. Before you use MELOCAM TABLET 4. How to use MELOCAM TABLET 5. While you are using MELOCAM TABLET 6. Side effects 7. Storage and disposal of MELOCAM TABLET 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT MELOCAM TABLET IS USED FOR MELOCAM TABLET is used for relief of pain and inflammation in rheumatic disease; exacerbation of osteoarthritis (arthrosis, degenerative joint disease) and ankylosing spondylitis (chronic inflammatory diseases of the skeleton). HOW MELOCAM TABLET WORKS Meloxicam is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation. BEFORE YOU USE MELOCAM TABLET _-When you must not use it _ Do not use MELOCAM TABLET: - if you have had asthma, angioedema (swelling of your skin), urticarial (itching or hives), nasal polyps and the symptoms become worsen caused by Aspirin or NSAIDs. - if you have active stomach ulceration. - if you have severe liver or kidney problem. - if you are hypersensitivity to NSAIDs. - if you are under 15 years old. - if you are pregnant or breastfeeding. _-Before you start to use it _ Please consult with your doctor: - if you have ulceration, bleeding or perforation of your stomach or intestinal - if you are elderly - if you have kidney or liver diseases - if you are dehydrated - if you have heart failure or heart disease - if you need to undergo major surgical procedures which lead to hypovolaemia (decreased volume of circulating blood in the body) - if you are suffering from dyspepsia (discomfort at the epigastric region due to digestion problem). Meloxicam may cause severe skin reactions, e.g. exfoliative dermatitis, toxic epidermal necrolysis, Steven-Johnson Syndrome. Symptoms may include skin rash, blisters and peel off. These could be signs of a serious condition. I Perskaitykite visą dokumentą
ATTACHMENT 1 204406-03 260X110 MELOCAM TABLET 7.5MG INGREDIENT(S): Each tablet contains: Meloxicam …………...........................................................………........….. 7.5mg PHARMACOLOGY: PHARMACODYNAMICS: Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) of the enolic acid class that has shown anti-inflammatory, analgesic and antipyretic properties in animals. Meloxicam inhibits biosynthesis of prostaglandins, the known mediators of inflammation. Comparison of the ulcerogenic dose and the anti-inflammatory effective dose in the rat adjuvant arthritis confirmed a superior therapeutic margin in animals over standard NSAIDs. The selective inhibition of COX-2 relative to COX-1 by Meloxicam has been demonstrated _ in vitro_ on various cell systems. Clinical studies demonstrated a lower incidence of gastrointestinal adverse events with the recommended doses of Meloxicam than standard doses of other NSAIDs. PHARMACOKINETICS: Meloxicam is well absorbed following oral administration (89%). The absorption is not affected by concomitant food intake. Steady-state conditions are achieved in 3- 5 days. In plasma, >99% is bound to plasma proteins. Once-daily dosing leads to drug plasma concentrations with a relatively small peak-trough fluctuation in the range of 0.4-1 mcg/mL for 7.5mg doses (C min and C max at steady state, respectively). Meloxicam penetrates well into synovial fluid to give concentrations approximately 1/2 those in plasma. Meloxicam is extensively metabolized and <5% of the daily dose is excreted unchanged in faeces, while only traces of the unchanged compound are excreted in the urine. The mean elimination half-life of Meloxicam is 20 hours. Neither hepatic, mild or moderate renal insufficiency do substantially affect meloxicam pharmacokinetics. Plasma clearance is on average 8mL/min. Clearance is decreased in the elderly. Volume of distribution is low, on average 11L. INDICATION(S): Pain and inflammation in rheumatic disease; exacerbation of osteoarthritis (arthrosis, dege Perskaitykite visą dokumentą