Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CELECOXIB
Pfizer Healthcare Ireland
CELECOXIB
200 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
Version dKCB 5_0 Page 1 of 11 2013-0003707; 2014-0005428 Package leaflet: Information for the user _ _ KUDEQ® 100 MG HARD CAPSULES KUDEQ® 200 MG HARD CAPSULES celecoxib _ _ 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 KUDEQ IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KUDEQ 3. HOW TO TAKE KUDEQ 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE KUDEQ 6. CONTENTS OF THE PACK AND OTHER INFORMATION _ _ 1. WHAT KUDEQ IS AND WHAT IT IS USED FOR_ _ _ _ Kudeq is used for the relief of signs and symptoms of RHEUMATOID ARTHRITIS, OSTEOARTHRITIS and ANKYLOSING SPONDYLITIS. Kudeq belongs to a group of medicinal products called nonsteroidal anti-inflammatory drugs (NSAID), and specifically a sub-group known as (COX-2) inhibitors. Your body makes prostaglandins that may cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis your body makes more of these. Kudeq acts by reducing the production of prostaglandins, thereby reducing the pain and inflammation. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KUDEQ _ _ Version dKCB 5_0 Page 2 of 11 2013-0003707; 2014-0005428 You have bee Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kudeq 200 mg capsules, hard. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200 mg celecoxib. Excipient(s) with known effect: lactose (each capsule contains 49.8 mg lactose monohydrate; see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Opaque, white with two gold bands marked 7767 and 200. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kudeq is indicated for the symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The decision to prescribe a selective COX-2 inhibitor 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 As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1). _Osteoarthritis_ The usual recommended daily dose is 200 mg taken once daily or in two divided doses. In some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered. _Rheumatoid arthritis_ The initial recommended daily dose is 200 mg taken in two divided doses. The dose may, if needed, later be increased to 200 mg twice daily. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered. _Ank Read the complete document