Land: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Etoricoxib
DCH AURIGA (MALAYSIA) SDN. BHD.
Etoricoxib
10x10 Tablets; 3x10 Tablets
TEVA Gyogyszergyar Zrt.
_ Consumer Medication Information Leaflet (RiMUP)_ COXETA FC TABLETS _ _ Etoricoxib (60mg, 90mg, 120mg) 1 WHAT IS IN THIS LEAFLET 1. What Coxeta is used for 2. How Coxeta work 3. Before you use Coxeta 4. How to take Coxeta 5. While you are using Coxeta 6. Side Effects 7. Storage and Disposal of Coxeta 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT COXETA IS USED FOR Coxeta helps to reduce the pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. Coxeta is also used for the short term treatment of moderate pain including that related to dental surgery and menstrual pain. HOW COXETA WORK Coxeta is a member of a group of medicines called selective COX- 2 inhibitors that are used to reduce pain and inflammation. BEFORE YOU USE COXETA _-When you must not take it _ Do not take Coxeta if you: • are allergic to etoricoxib and any of its ingredients • have had heart failure, a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries) • have increased risk of heart disease such as a stroke. Etoricoxib may slightly increase your risk of heart attack and stroke and this is why it should not be used in those who have already had heart problems or stroke. • have high blood pressure that has not been controlled by treatment. • are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors • have a current stomach ulcer or bleeding in your stomach or intestines • have serious kidney disease • are or could be pregnant or are breast-feeding • have inflammatory bowel disease If you think any of these are relevant to you, do not take the tablets until you have consulted your doctor. _ _ PREGNANCY AND BREAST-FEEDING Pregnancy Coxeta must not be taken during pregnancy. If you are pregnant or think you may be pregnant, or if you are planning to have a bab Lestu allt skjalið
COXETA FC TABLETS PRODUCT NAME Coxeta FC tablets 60mg Coxeta FC tablets 90mg Coxeta FC tablets 120mg NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Etoricoxib 60mg Etoricoxib 90mg Etoricoxib 120mg PRODUCT DESCRIPTION 60 mg: Dark green, round, biconvex film-coated tablet, debossed “60” on one side and plain on the other. Dimension: Approx. 8 mm diameter. 90 mg: White, round, biconvex film-coated tablet, debossed “90” on one side and plain on the other. Dimension: Approx. 9 mm diameter. 120 mg: Pale-green, round, biconvex film-coated tablet, debossed “120” on one side and plain on the other. Dimension: Approx. 10 mm diameter. PHARMACODYNAMICS Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs, ATC code: M01AH05 _Mechanism of Action_ Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor within the clinical dose range. Etoricoxib produce 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_ Etoricoxib is well absorbed from the gastrointestinal tract after oral doses. The mean oral bioavailability is approximately 100%. Peak plasma concentrations occur in about 1 hour in fasted adu Lestu allt skjalið