Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Piroxicam
Viatris UK Healthcare Ltd
M01AC01
Piroxicam
20mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5016695680286
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER PIROXICAM CAPSULES BP 10MG & 20MG PIROXICAM 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Piroxicam is and what it is used for 2. What you need to know before you take Piroxicam 3. How to take Piroxicam 4. Possible side effects 5. How to store Piroxicam 6. Contents of the pack and other information 1. WHAT PIROXICAM IS AND WHAT IT IS USED FOR Piroxicam is one of a group of medicines called non-steroidal anti- inflammatory drugs (NSAIDs). It will help to relieve pain and reduce swelling affecting joints. Before prescribing Piroxicam, your doctor will assess the benefits this medicine may give you against your risk of developing side effects. Your doctor may need to give you check-ups and will tell you how often you need to be checked, due to your taking Piroxicam. Piroxicam is used to relieve some symptoms caused by osteoarthritis (arthrosis, degenerative joint disease), rheumatoid arthritis and ankylosing spondylitis (rheumatism of the spine), such as swelling, stiffness and joint pain. It does not cure arthritis and will help you only as long as you continue to take it. Your doctor will prescribe Piroxicam to you only when you have had unsatisfactory relief of symptoms with other Non-steroidal anti- inflammatory medicines (NSAIDs). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIROXICAM DO NOT TAKE PIROXICAM CAPSULES IF YOU: are allergic (hypersensitive) to Piroxicam or any of the other ingredients of these capsules (see section 6 Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Piroxicam Capsules 20mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Piroxicam 20 mg. Excipient with known effect: Lactose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard. Hard gelatin capsule with a scarlet opaque cap and a scarlet opaque body, printed in white ink with PRX 20 and Crescent moon logo containing a whitish to slightly yellowish, odourless, homogenous powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Piroxicam 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), piroxicam is not a first line option should an NSAID be indicated. The decision to prescribe piroxicam 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 Posology The prescription of piroxicam 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 possible need for combination therapy with gastro- protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients. Adults Initially 20mg given as a single daily dose. The majority of patients may be maintained on 20mg a day, a relatively small group of patients may be maintained on 10mg daily. Elderly There are no specific modifications required Perskaitykite visą dokumentą