Country: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Piroxicam
Pfizer Ltd
M01AC01
Piroxicam
20mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5013457012521 5013457012545
PACKAGE LEAFLET: INFORMATION FOR THE USER FELDENE® 10MG AND 20MG CAPSULES PIROXICAM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Feldene is and what it is used for 2. Before you take Feldene 3. How to take Feldene 4. Possible side effects 5. How to store Feldene 6. Further information 1. WHAT FELDENE IS AND WHAT IT IS USED FOR Feldene is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This means it will help to relieve pain and reduce swelling affecting joints. Feldene is used to relieve some symptoms caused by osteoarthritis (joint disease), rheumatoid arthritis, and ankylosing spondylitis (rheumatism of the spine) such as swelling, stiffness and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it. Your doctor will only prescribe Feldene to you when you have had unsatisfactory relief of symptoms with other NSAIDs. 2. BEFORE YOU TAKE FELDENE DO NOT TAKE FELDENE • If you have previously had or currently have a stomach or intestinal ulcer, bleeding or perforation. • If you have, or have previously had disorders of the stomach or intestines such as ulcerative colitis, Crohn’s disease, gastrointestinal cancers or diverticulitis (inflamed or infected pouches/pockets in the colon). • If you are taking other NSAIDs such as ibuprofen, celecoxib or acetylsalicylic acid (aspirin), a substance present in many medicines used to relieve pain and lower fever. • If you are taking anticoagulants, such as warfarin, to prevent blood clots. Page 1 of 8 • If you previously ha Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT FELDENE 20mg CAPSULES 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: piroxicam 20 mg (anhydrous). Excipient with known effect: Lactose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules for oral administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Feldene is indicated for symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis. Due to its safety profile (see sections 4.2, 4.3 and 4.4), Feldene is not a first line option should an NSAID be indicated. The decision to prescribe Feldene should be based on an assessment of the individual patient’s overall risks (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The prescription of Feldene should be initiated by physicians with experience in the diagnostic evaluation and treatment of patients with inflammatory or degenerative rheumatic diseases. The maximum recommended daily dose is 20 mg. Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms. The benefit and tolerability of treatment should be reviewed within 14 days. If continued treatment is considered necessary, this should be accompanied by frequent review. Given that piroxicam has been shown to be associated with an increased risk of gastrointestinal complications, the need for possible combination therapy with gastro- protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients. USE IN THE ELDERLY Elderly, frail or debilitated patients may tolerate side-effects less well and such patients should be carefully supervised. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function. For oral administration. To be taken preferably with or after food. Undesirable effects may be minimised by using Прочитајте комплетан документ