Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Piroxicam
A A H Pharmaceuticals Ltd
M01AC01
Piroxicam
10mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5025903004486
260x210 Leaflet Reel Fed Bi Fold Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Piroxicam, Capsules, 10 & 20mg 28s & 56s - UK 260x210 (Reel Fed) 50985207 Leaflet for Bottle 7872 RH 05-12-19 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. GTIN 13 (Belgium & Slovenia): EU-Artwork-Support@accord-healthcare.com PIROXICAM ALL STRENGTHS CAPSULES PIL - UK Black BBBA7192 R.Paul 02.01.2020 03.01.2020 R.Paul 210x260 reel fed 7.5pt Accord Barnstaple n/a 3 Version 6 12.12.2019 Profile page 1 page 4 German GTIN 14 (incorporating PZN): 50985207 BBBA7192 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. • The full name of this medicine is Piroxicam 10mg and 20mg Capsules but within this leaflet it will be referred to as Piroxicam capsules. WHAT IS IN THIS LEAFLET: 1 WHAT PIROXICAM CAPSULES ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIROXICAM CAPSULES 3 HOW TO TAKE PIROXICAM CAPSULES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE PIROXICAM CAPSULES 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT PIROXICAM CAPSULES ARE AND WHAT THEY ARE USED FOR Piroxicam belongs to a grou Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Piroxicam Capsules 10mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10mg Piroxicam PhEur. Excipient with known effect: 210.60mg lactose monohydrate per tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pink and turquoise hard gelatin capsules printed “C” and the identifying letters “YA” in black. 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 20mg. 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 gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients. _ _ _ _ _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. _ _ Lue koko asiakirja