Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Etoricoxib
Generic Health Sdn. Bhd.
Etoricoxib
10 Tablets
Rontis Hellas Medical and Pharmaceutical Products S.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ETORICAN 30MG, 60MG, 90MG, 120MG FILM-COATED TABLETS Etoricoxib (30mg, 60mg, 90mg, 120mg) 1 WHAT IS IN THIS LEAFLET 1. What ETORICAN is used for 2. How ETORICAN works 3. Before you use ETORICAN 4. How to use ETORICAN 5. While you are using it 6. Side effects 7. Storage and Disposal of ETORICAN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT ETORICAN IS USED FOR ETORICAN 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 ETORICAN WORKS ETORICAN 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 reduces pain and inflammation. BEFORE YOU USE ETORICAN _ _ _- When you must not use it _ You must not use ETORICAN if you: • are allergic to etoricoxib or any of the other ingredients of ETORICAN • have heart failure, a heart attack, bypass surgery, chest pain, narrow or blocked arte Izlasiet visu dokumentu
1. NAME OF THE MEDICINAL PRODUCT ETORICAN 30 mg film-coated tablets ETORICAN 60 mg film-coated tablets ETORICAN 90 mg film-coated tablets ETORICAN 120 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib. Excipients with known effect: 30 mg tablet: 1.3 mg lactose (as monohydrate) 60 mg tablet: 2.7 mg lactose (as monohydrate) 90 mg tablet: 4.0 mg lactose (as monohydrate) 120 mg tablet: 5.3 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. • 30 mg: Blue-green, apple-shaped, biconvex film coated tablet, debossed with "30" on one side and plain on the other side. • 60 mg: Dark green, apple-shaped, biconvex film coated tablet, debossed with "60" on one side and plain on the other side. • 90 mg: White, apple-shaped, biconvex film coated tablet, debossed with "90" on one side and plain on the other side. • 120 mg: Pale green, apple-shaped, biconvex film coated tablet, debossed with "120" on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Etoricoxib is indicated for: • Acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) and 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Etoricoxib is administered orally. Etoricoxib may be taken with or without food. Etoricoxib should be administered for the shortest duration possible and the lowest effective daily dose should be used. _Osteoarthritis _ The recommended dose is 30 mg or 60 mg once daily. _Rheumatoid arthritis _ The recommended dose is 60 mg once daily. In some patients with insufficient relie Izlasiet visu dokumentu