Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Flurbiprofen
Abbott Laboratories Ltd
M01AE09
Flurbiprofen
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5016565111230
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FROBEN 50 MG TABLETS FROBEN 100 MG TABLETS Flurbiprofen IMPORTANT INFORMATION 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 possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Froben Tablets are and what they are used for 2. What you need to know before you take Froben Tablets 3. How to take Froben Tablets 4. Possible side effects 5. How to store Froben Tablets 6. Contents of the pack and other information 1. WHAT FROBEN TABLETS ARE AND WHAT THEY ARE USED FOR Froben Tablets belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). They can be used to relieve pain and inflammation (redness, heat and swelling) in conditions such as: osteoarthritis (a bone disorder, which is seen mostly in older persons, in which the joints become painful and stiff) rheumatoid disease (inflammation of the joints and sometimes surrounding tissues) ankylosing spondylitis (arthritis of the spine) swollen joints, frozen shoulder, bursitis (inflammation of the bursa), tendinitis (inflammation of tendons), tenosynovitis (inflammation of the covering layer of a tendon) low back pain, sprains and strains. Froben Tablets can also be used to treat other painful conditions such as toothache, pain after operations, period pain and migraine. The active substance in Froben Tablets is Flurbiprofen. Froben 50 mg Tablets contains 50 mg of Flurbiprofen and Froben 100mg Tablets contains 100 mg of Flurbiprofen. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FROBEN TABLETS DO NOT Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Froben Tablets 50 mg Flurbiprofen 50 mg coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Froben Tablets 50mg contain 50 mg flurbiprofen EP. Flurbiprofen 50 mg coated tablets contain 50 mg flurbiprofen EP. 3 PHARMACEUTICAL FORM The tablets are 7.6 mm in diameter, sugar-coated and white in colour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of rheumatoid disease, osteoarthritis, ankylosing spondylitis, musculoskeletal disorders and trauma such as periarthritis, frozen shoulder, bursitis, tendinitis, tenosynovitis, low back pain, sprains and strains. Flurbiprofen is also indicated for its analgesic effect in the relief of mild to moderate pain in conditions such as dental pain, post-operative pain, dysmenorrhoea and migraine. 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_: 150 to 200 mg daily in two, three or four divided doses. In patients with severe symptoms or disease of recent origin, or during acute exacerbations, the total daily dosage may be increased to 300 mg in divided doses. For dysmenorrhoea, a dosage of 100 mg may be administered at the start of symptoms followed by 50 or 100 mg given at four- to six-hour intervals. The maximum total daily dosage should not exceed 300 mg. _ _ _Paediatric population_: Not recommended for use in children under 12 years. _Older people_: The elderly are at increased risk of the serious consequences of adverse reactions. Although flurbiprofen is generally well tolerated in the elderly, some patients, especially those with impaired renal function, may eliminate NSAIDs more slowly than normal. In these cases, flurbiprofen should be used with caution and dosage should be assessed individually. If an NSAID is considered necessary, the lowest effective dose should Lue koko asiakirja