Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Naproxen
Actavis UK Ltd
M01AE02
Naproxen
250mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5012617009838 5012617023582
8543 8543 PACKAGE LEAFLET: INFORMATION FOR THE USER NAPROXEN TABLETS 250MG AND 500MG [naproxen] READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Naproxen Tablets are and what they are used for 2. What you need to know before you take Naproxen Tablets 3. How to take Naproxen Tablets 4. Possible side effects 5. How to store Naproxen Tablets 6. Contents of the pack and other information 1. WHAT NAPROXEN TABLETS ARE AND WHAT THEY ARE USED FOR Naproxen is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Naproxen can relieve pain, stiffness and inflammation caused by: rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis (arthritis of the spine and pelvis) and juvenile rheumatoid arthritis. It is also used to treat acute gout and acute musculoskeletal disorders such as sprains, strains, trauma, lower back pain, neck pain and inflammation of tendons and muscles. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAPROXEN TABLETS DO NOT TAKE NAPROXEN TABLETS IF YOU: • Are allergic to naproxen or any other ingredients of this medicine (listed in section 6) • Have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation • Have a history of stomach bleeding or perforation which may be related to the use of NSAIDs (Mefenamic acid, ibuprofen, diclofenac) or aspirin • Have a history of allergy to aspirin, ibuprofen or NSAIDs, which includes atta Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Naproxen 250mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250mg Naproxen BP Also contains Lactose and Sunset yellow (E110) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Pale yellow, flat bevelled edge tablets with N breakline 250 on one side and BL on the other 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ _ADULTS _ Naproxen is indicated for the treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), ankylosing spondylitis, acute gout, acute musculoskeletal disorders and dysmenorrhoea. _CHILDREN _ _ _ Juvenile rheumatoid arthritis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. To be taken preferably with or after food. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). _ADULTS _ _ _ _RHEUMATOID ARTHRITIS, OSTEOARTHRITIS AND ANKYLOSING SPONDYLITIS _ _ _ The usual dose is 500mg to 1g per day taken in two doses at 12-hour intervals or alternatively, as a single administration. In the following cases a loading dose of 750mg or 1g per day for the acute phase is recommended: 1. In patients reporting severe night-time pain and / or morning stiffness. 2. In patients being switched to naproxen from a high dose of another antirheumatic compound. 3. In osteoarthrosis where pain is the predominant symptom. _ACUTE GOUT _ _ _ The recommended dosage is 750mg at once then 250mg every eight hours until the attack has passed. _ACUTE MUSCULOSKELETAL DISORDERS AND DYSMENORRHOEA _ _ _ The recommended dosage is 500mg initially followed by 250mg at 6 to 8 hour intervals as needed, with a maximum daily dose after the first day of l250mg. _ELDERLY_ Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. The implication of this finding for naproxen dosing is unknown. As with Preberite celoten dokument