Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Naproxen
Milpharm Ltd
M01AE02
Naproxen
250mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 8901175745111
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 or pharmacist. - 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 or pharmacist. This includes any 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 Tablets contain a medicine called naproxen. This is a 'Non Steroidal Anti Inflammatory Drug' or NSAID. Naproxen Tablets can lessen pain, swelling, redness and heat (inflammation) and is used to treat adults for: • Problems with your muscles, joints and tendons, like strains, gout, ankylosing spondylitis (pain and stiffness in the neck and back) or arthritis. • Women, while having period pain. It can also be used in children over 5 years with rheumatoid arthritis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAPROXEN TABLETS DO NOT TAKE NAPROXEN TABLETS • if you are ALLERGIC (hypersensitive) to naproxen or any of the other ingredients of Naproxen Tablets (listed in section 6) • if you are allergic to or have ever had a reaction to ASPIRIN or another NSAID (non- steroidal anti-inflammatory drug) such as ibuprofen, diclofenac or meloxicam • if you have a stomach ulcer or if you often get stomach ulcers • if you have a duodenal ulcer (in the first part of the small intestine) or if you often get duodenal ulcers • if you have serious liver or kidney disease • if you are suffering or have ever suffered from bleeding in the stomach or intestines whil Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Naproxen Tablets BP 250mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250mg Naproxen BP. Excipient with known effect: Lactose. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Naproxen Tablets BP 250mg are yellow coloured, round shaped, flat bevelled edge uncoated tablets with score lines between ‘NPY’ and ‘250’ embossed on one side and plain on the other side. 4.1 THERAPEUTIC INDICATIONS _Adults_:_ _ Naproxen is used in the treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), ankylosing spondylitis, acute musculoskeletal disorders, dysmenorrhoea and acute gout. _Children_:_ _ Juvenile rheumatoid arthritis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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 alkylosing spnodylitis 500mg to 1g taken in 2 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: a) In patients reporting severe night-time pain/or morning stiffness. b) In patients being switched to Naproxen from a high dose of another anti- rheumatic compound. c) In osteoarthrosis where pain is the predominant symptom. Acute gout In acute gout, an initial dose of 750 mg followed by 250 mg every 8 hours until the attack has passed. Acute musculoskeletal disorders and dysmenorrhoea 500 mg may be given initially, followed by 250 mg every 6 to 8 hour intervals as needed, with a maximum daily dose after the first day of 1250mg. Older people Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in older people. The implication of this finding for Naproxen dosing is unknown. The elderly are at increased risk of the serious conseque Preberite celoten dokument