Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Piroxicam
Pfizer Ltd
M01AC01
Piroxicam
10mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5013457012507 5013457012514
Mock up from 8814717 • Yellowing of the skin and the whites of your eyes (jaundice) • Inflammation of the liver (hepatitis) • Increased risk of heart attack (myocardial infarction) • Increased risk of stroke • Fixed drug eruption (may look like round or oval patches of redness and swelling of the skin), blistering (hives), itching Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE FELDENE Keep all medicines out of the reach and sight of children. Store below 30˚C. Do not use Feldene after the expiry date which is stamped on the carton and the bottle label. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Feldene contains The active substance in Feldene capsules is piroxicam. Feldene comes in two strengths; 10mg or 20mg. The other ingredients are: lactose, corn starch, vegetable magnesium stearate and sodium lauryl sulphate (see section 2 “Important information about some of the ingredients of Feldene”). The 10mg capsule shells contain gelatin, red iron oxide (E172), indigotin (E132) and titanium dioxide (E171). The 20mg capsule shells contain gelatin and titanium dioxide (E171). What Feldene looks like and contents of the pack Feldene 10mg capsules are blue and red. Feldene 20mg capsules are white. The 10mg capsules come in containers of 30 and 20mg capsules come in containers of 30. Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Manufacturer FarevПрочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT FELDENE 10mg CAPSULES 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: piroxicam 10 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 Прочетете целия документ