Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ETORICOXIB
GENPHARMA SDN. BHD
ETORICOXIB
30 Tablets; 100 Tablets
Alembic Pharmaceuticals Limited
ERICOX TABLETS _ _ Etoricoxib (60mg, 90mg, 120mg) _ _ _ _ 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What ERICOX Tablet is used for 2. How ERICOX Tablet works 3. Before you use ERICOX Tablet 4. How to use ERICOX Tablet 5. While you are using it 6. Side effects 7. Storage and disposal of ERICOX Tablet 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT ERICOX TABLET IS USED FOR It helps to reduce the pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. It is also use for the treatment of acute pain, including that related to menstrual pain and minor dental procedures. _What is osteoarthritis? _ Osteoarthritis is a disease of the joints. It results from the gradual breakdown of cartilage that cushions the ends of the bones. This causes swelling (inflammation), pain, tenderness, stiffness and disability. _What _ _is _ _rheumatoid _ _arthritis? _ Rheumatoid arthritis is a longterm inflammatory disease of the joints. It causes pain, stiffness, swelling, and increasing loss of movement in the joints it affects. It may also cause inflammation in other areas of the body. _What is gout? _ Gout is a disease of sudden, recurring attacks of very painful inflammation and redness in the joints. It is caused by deposits of mineral crystals in the joint. _What _ _is _ _ankylosing _ _spondylitis? _ Ankylosing spondylitis is an inflammatory disease of the spine and large joints. HOW ERICOX TABLET WORKS Etoricoxib is one of a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti- inflammatory drugs (NSAIDs), that exhibits anti-inflammatory, analgesic, and antipyretic activities. BEFORE YOU USE ERICOX TABLET _When you must not use it _ You must not use ERICOX Tablet if you: • if you are allergic (hypersensitive) to etoricoxib or any of the other ingredients of ERICOX Tablet • i Lugege kogu dokumenti
NAME OF THE MEDICINAL PRODUCT _ERICOX 60mg Tablets_ _ERICOX 90mg Tablets_ _ERICOX 120mg Tablets_ NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Etoricoxib 60mg Etoricoxib 90mg Etoricoxib 120mg PRODUCT DESCRIPTION Ericox 60mg Tablet: Green, round, biconvex, film-coated tablets debossed with ‘444’ on one side and ‘L’ on other side. Ericox 90mg Tablet: White to off-white, round, biconvex, film-coated tablets debossed with ‘445’ on one side and ‘L’ on other side. Ericox 120mg Tablet: Pale-green, round, biconvex, film-coated tablets debossed with ‘446’ on one side and ‘L’ on other side. DOSAGE FORM Tablet PHARMACODYNAMICS Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non- steroids, coxibs, ATC code: M01AH05 Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor within the clinical dose range. Across clinical pharmacology studies, Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis and had no effect on platelet function. Cyclooxygenase is responsible for generation of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function). It may also play a role in ulcer healing. COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established. PHARMACOKINETICS _Absorption_ Orally administered etoricoxib is well absorbed. The absolute bioavailability is approximately 100%. Following 120 mg once-daily dosing to steady state, the peak plasma concentrat Lugege kogu dokumenti