Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NAPROXEN SODIUM
PHARMANIAGA MANUFACTURING BERHAD
NAPROXEN SODIUM
500 Tablets
PHARMANIAGA MANUFACTURING BERHAD
SAFROSYN S TABLET Naproxen Sodium (275mg, 550mg) 1 Consumer Medication Information Leaflet (RiMUP) What is in this leaflet 1. What Safrosyn S Tablet is used for 2. How Safrosyn S Tablet works 3. Before you use Safrosyn S Tablet 4. How to use Safrosyn S Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Safrosyn S Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision What Safrosyn S Tablet is used for It contains naproxen sodium which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in joints and muscles. Safrosyn S Tablet is used to treat: • Musculoskeletal and joints disorders such as ankylosing spondylitis (arthritis of the spine), osteoarthritis (arthritis in joints) and rheumatoid arthritis (autoimmune disease in which your body’s immune system, mistakenly attacks your joints and causes inflammation). Safrosyn S Tablet cannot cure arthritis but is used to give relief of some symptoms such as inflammation, swelling, stiffness and joint pain. • In mild to moderate pain such as dysmenorrhea (period pain) and migraine. • Signs and symptoms of acute gout. How Safrosyn S Tablet works Safrosyn S Tablet works by blocking the effect of chemicals called cyclo- oxygenase (COX) enzymes. These enzymes help to make other chemicals in the body, called prostaglandins. Some prostaglandins are produced at sites of injury or damage, and cause pain and inflammation. By blocking the effect of COX enzymes, fewer prostaglandins are produced, which means pain and inflammation, are eased. Before you use Safrosyn S Tablet -When you must not use it Do not take Safrosyn S Tablet if you:- are allergic (hypersensitive) to naproxen, aspirin and other non- steroid anti-inflammatory drugs have serious liver, kidney and heart failure In the last trimester of pregnancy have active or previous history of recurrent stomach ulcer or bleeding Have bleeding or perforat Baca dokumen lengkap
SAFROSY S TABLET Idealprins Industries Sdn Bhd Amendment 17 07-12-21 Safrosyn S Tablet Leaflet (F) Size: 300mm (W) x 150mm (L) HYPERTENSION NSAIDs may lead to the onset of new hypertension or worsening the pre-existing hypertension and patients taking antihypertensive with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter. GASTROINTESTINAL BLEEDING, ULCERATION 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. Debilitated patients seems to tolerate ulceration or bleeding less well than others. Most of the fatal gastrointestinal events associated with NSAIDs occurred in the elderly and/or debilitated patients. 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, and in the elderly. 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. Naproxen has been found to be well tolerated by patients exhibiting dyspepsia with other similar agents. Nonetheless, episodes of gastro-intestinal bleeding have been reported in patients with naproxen therapy. Patients with a history of GI toxicity, particularly when 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 the risk of ulceration, or bleeding, such as cortic Baca dokumen lengkap