País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NAPROXEN SODIUM
IMEKS PHARMA SDN. BHD.
NAPROXEN SODIUM
100 Tablet Tablets; 50 Tablet Tablets; 500 Tablet Tablets
Sriprasit Pharma Co. Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ SONAP CAPLET / FORTE CAPLET Naproxen sodium (275mg, 550mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. What Sonap/Sonap Forte is used for 2. How Sonap/Sonap Forte works 3. Before you use Sonap/Sonap Forte 4. How to use Sonap/Sonap Forte 5. While you are using it 6. Side Effects 7. Storage and Disposal of Sonap/Sonap Forte 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT SONAP/SONAP FORTE IS USED FOR Sonap/Sonap Forte contains the active ingredient naproxen sodium. Sonap/Sonap Forte is used: • To treat signs and symptoms of acute gout, dysmenorrhoea (period pain), menorrhagia (heavy and prolonged menstrual period), headache, acute migraine attack. • To treat signs and symptoms of mild to moderately severe, acute or chronic musculoskeletal and soft tissue inflammation. • To relief mild and moderate pain including pain after giving birth, pain following IUD insertion (contraceptive coil fitted), pain after operation and pain due to orthopaedic surgery. HOW SONAP/SONAP FORTE WORKS Naproxen sodium belongs to the group of medicines called non-steroidal anti- inflammatory drug (NSAIDs). It works to reduce pain and inflammation (swelling and redness) by inhibiting the activity of certain hormones. BEFORE YOU USE SONAP/SONAP FORTE_ _ - _When you must not use it_ • Have ever had a reaction or been told that you are allergic to naproxen sodium or to any of the excipients. •If you have had asthma, rhinitis (inflammation of the nasal mucous membrane), urticaria (itching or hives) and the symptoms become worsen caused by Aspirin or NSAIDs. • If you have or have had stomach ulcer or intestinal inflammatory disease. - _Before you start to use it _ Tell your doctor if you: • Have allergies to any other medicines, food, preservatives or dyes. • Have heart problems, high blood pressure and previous stroke. • Have impaired kidney and liver functions. • Have blood cells disorder. • Sonap/Sonap Forte may cause severe skin react Leer el documento completo
SONAP 275 MG & SONAP FORTE 550 MG CAPLET Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with naproxen after careful consideration and the lowest effective dose should be used for the shortest possible duration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). Gastrointestinal ulceration, bleeding and perforation GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer (particularly if complicated with haemorrhage or perforation), in elderly, alcoholism and smoking patients. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk. Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could increase risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin. When GI bleeding or ulceration occurs in patients receiving naproxen, the treatment should be withdrawn. NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as t Leer el documento completo