Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CELECOXIB
HEALOL PHARMACEUTICALS SDN. BHD.
CELECOXIB
3 x 10capsule Capsules; 10x10 Capsules
GRACURE PHARMACEUTICALS LTD.
_Consumer Medication Information Leaflet (RiMUP) _ GELOXIB-200 (CELECOXIB 200MG CAPSULES) Celecoxib (200mg) 1 WHAT IS IN THIS LEAFLET 1. What GELOXIB-200 is used for 2. How GELOXIB-200 works 3. Before you use GELOXIB-200 4. How to use GELOXIB-200 5. While you are using it 6. Side effects 7. Storage and Disposal of GELOXIB-200 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS GELOXIB-200 USED FOR GELOXIB-200 is used for the management of acute pain, chronic pain and inflammation in adults. It is indicated in menstrual pain, arthritic pain, ankylosing spondylitis and lower back pain. HOW GELOXIB-200 WORKS The active ingredient in GELOXIB- 200 which is Celecoxib, selectively inhibits an enzyme called cyclooxygenase-2 (COX-2) which is involved in the process of inflammation in the body. BEFORE YOU USE GELOXIB-200 -When you must not use it Do not take GELOXIB-200 if you are pregnant, trying to get pregnant or think you may be pregnant. Breastfeeding mothers should not take this medication too. Please ask your doctor or pharmacist for advice before taking this medicine. You must not use GELOXIB-200 if you are at known risk of heart disease such as a stroke or ischemic heart disease. Do not use GELOXIB-200 if you have experienced asthma, itching of skin or other allergic type reactions after taking other painkillers such as aspirin or medicines in the group of Non-Steroidal Anti Inflammatory Drugs (NSAIDs). -Before you start to use it Tell your doctor if any of the following are true for you, as patients with these conditions should not take GELOXIB-200 • If you are allergic to Celecoxib or any other ingredients in this medicine. • If you are allergic to a group of medicines called ‘sulphonamides’ • If you currently have an ulcer in your digestive tract or bleeding in your digestive tract • If you are allergic to a group of drugs called NSAIDs (Non-Steroidal Anti- Inflammatory Drugs) • If you have severe liver disease • If you have sever Prečítajte si celý dokument
WARNING RISK OF GI ULCERATION, BLEEDING AND PERFORATION WITH NSAID Serious GI toxicity such as bleeding, ulceration and perforation can occur at any time, with or without warning symptoms. in patients treated with NSAID therapy. Although minor upper GI problems (e.g. dyspepsia) are common, usually developing early in therapy, prescribers should remain alert for ulceration and bleeding in patients treated with NSAIDs even in the absence of previous GI tract symptoms. Studies to date have not identified any subset of puberty not at risk of developing peptic ulceration and bleeding. Patients with prior history of serious GI events and other risk factors associated with peptic ulcer disease (e.g. alcoholism, smoking, and corticosteroid therapy) are at increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less than other individuals and account for most spontaneous reports for fatal GI events. For the use only of a registered Medical Practitioner or a Hospital or a Laboratory GELOXIB-200 (Celecoxib Capsules 200 mg) COMPOSITION: Each capsule contains: Celecoxib BP 200 mg DESCRIPTION: Geloxib-200 is Dark Green/Dark Green coloured hard gelatin capsule shell of size “2”, containing white granular powder. PHARMACODYNAMICS / PHARMACOKINETICS: _PHARMACODYNAMIC EFFECTS:_ 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 ductusarteriosus, 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. The dif Prečítajte si celý dokument