Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ETORICOXIB
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
ETORICOXIB
30tablet Tablets; 100tablet Tablets
CADILA PHARMACEUTICALS LIMITED
_Consumer Medication Information Leaflet (RiMUP)_ COXITOR 90MG & 120MG FILM-COATED TABLET Etoricoxib 90mg & 120mg 1 WHAT IS IN THIS LEAFLET: 1. What COXITOR is used for 2. How COXITOR works 3. Before you use COXITOR 4. How to use COXITOR 5. While you are using it 6. Side effects 7. Storage and Disposal of COXITOR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT COXITOR IS USED FOR Coxitor helps to reduce the pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. Coxitor is also used for the short-term treatment of moderate pain after dental surgery. HOW COXITOR WORKS Coxitor 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). BEFORE YOU USE COXITOR _When you must not use it _ DO NOT TAKE COXITOR: - if you are allergic to etoricoxib or any of the other ingredients of this medicine (see section on ingredients) - if you are allergic to non-steroidal anti- inflammatory drugs (NSAIDs), including acetylsalicylic acid and COX-2 inhibitors (see section on side effects) - if you have a current stomach ulcer or bleeding in your stomach or intestines - if you have serious liver disease - if you have serious kidney disease - if you are pregnant or breast-feeding - if you are under 16 years of age - if you have inflammatory bowel disease, such as Crohn’s Disease, Ulcerative Colitis, or Colitis - if your doctor has diagnosed heart problems including heart failure (moderate or severe types), angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries), or any kind of stroke (including mini-stroke, transient ischaemic attack or TIA). 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 proble সম্পূর্ণ নথি পড়ুন
PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Coxitor 90 mg film-coated tablets Coxitor 120 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 90 mg of etoricoxib. Each film-coated tablet contains 120 mg of etoricoxib. 3. PHARMACEUTICAL FORM Film-coated tablet. 90 mg tablets: White round, biconvex, film-coated tablets 120 mg tablets: Pale green, round, biconvex, film-coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated for: • Acute and chronic treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) • Treatment of ankylosing spondylitis (AS) • Treatment of acute gouty arthritis • Treatment of acute pain, including that related to primary dysmenorrhoea and minor dental procedures. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see Precautions). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1). _Osteoarthritis _ The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered. _Rheumatoid arthritis _ The recommended dose is 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may increase efficacy. Once the patient is clinically stabilised, down- titration to a 60 mg once daily dose may be appropriate. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered. _Ankylosing spondy সম্পূর্ণ নথি পড়ুন