Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
NAPROXEN
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
M01AE02
TABLETS
NAPROXEN 500 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
NAPROXEN
NAPROXEN
- Relief of the signs and symptoms of rheumatic diseases including osteoarthritis ankylosing spondylitis of Rheumatoid arthritis both in the treatment of acute flares and in the long-term management of the disease. - Juvenile Rheumatoid Arthritis. - Periarticular and musculoskeletal disorders - Relief of pain in bursitis tendinitis synovitis tenosynovitis and lumbago. - Relief of pain swelling tenderness and fever in acute gouty Arthritis. - Relief of symptoms of primary dysmenorrhea.
2012-02-28
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only NAXYN ® 500 MG TABLETS COMPOSITION Each tablet contains: Naproxen 500 mg For information on inactive ingredients and allergens: see section 2 “Important information about some of this medicine’s ingredients” and section 6 “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? For relief of signs and symptoms of rheumatic diseases, arthritis, joint disorders, tendon inflammation, musculoskeletal disorders and relief of back pain and menstrual pain. THERAPEUTIC GROUP: Nonsteroidal anti-inflammatory drugs (NSAIDs). 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to naproxen, naproxen sodium or to any of the other ingredients in this medicine, see section 2 “Important information about some of this medicine’s ingredients” and section 6 “Additional information”. You are sensitive (allergic) to aspirin, another medicine of the nonsteroidal anti-inflammatory drugs class (NSAIDs) or any other analgesic (such as ibuprofen or diclofenac). You have now or have ever had any problems with your stomach or gut (intestine), such as an ulcers or bleeding. You have previously experienced bleeding or perforation in your stomach while taking NSAIDs. You have SEVERE kidney, liver or heart problems. You are in the last three months of pregnancy. SPECIAL WARNINGS ABOUT USING THIS MEDICINE If you have heart problems, have had in the past a stroke or think that you might be at risk of such conditions (for example, if you have high blood pressure, diabete Soma hati kamili
NAXYN 500mg HS/MF 09/2019 Notification SUMMARY OF PRODUCT CHARACTERISTICS NAXYN 500 MG TABLETS 1. NAME OF THE MEDICINAL PRODUCT Naxyn 500 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each tablet contains 500mg naproxen For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Yellow, round biconvex coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of the signs and symptoms of rheumatic diseases including osteoarthritis ankylosing spondylitis of Rheumatoid arthritis both in the treatment of acute flares and in the long-term management of the disease. Juvenile Rheumatoid Arthritis. Periarticular and musculoskeletal disorders. Relief of pain in bursitis, tendinitis, synovitis, tenosynovitis and lumbago. Relief of pain, swelling, tenderness and fever in acute gouty Arthritis. Relief of symptoms of primary dysmenorrhea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ RHEUMATIC DISEASES The recommended daily dosage is 500 or 1000 mg taken as a single dose in the morning or in the evening. Alternatively, 250 or 500 mg may be taken twice daily at 12-hour intervals, morning and evening. In patients who tolerate lower doses well and have no history of gastrointestinal disease, the dose may be increased to 1500 mg/day for flare-ups or acute exacerbations of disease, for no longer than two weeks. Increased gastrointestinal side effects have been reported with these higher doses. NAXYN 500mg HS/MF 09/2019 Notification JUVENILE RHEUMATOID ARTHRITIS In children over 5 years of age: the recommended dosage is 10 mg/kg body weight per day, taken in 2 doses at 12-hour intervals. PERIARTICULAR AND MUSCULOSKELETAL DISORDERS 500 mg initially, followed thereafter by 250 mg at 8-12 hour intervals. ACUTE GOUTY ARTHRITIS 750 mg initially followed 8 hours later by 500 mg and thereafter by 250 mg 8-hourly, until the attack has passed. PRIMARY DYSMENORRHEA 500 mg at the onset of menstrual pain, followed by 250 mg every 6 hours until symptoms have subsided, up to a total of 1250 Soma hati kamili