Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Celecoxib
Actavis Group PTC ehf
M01AH; M01AH01
Celecoxib
100 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
Coxibs; celecoxib
Marketed
2014-02-14
PACKAGE LEAFLET: INFORMATION FOR THE USER CELECOXIB 100 MG HARD CAPSULES CELECOXIB 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 Celecoxib is and what it is used for 2. What you need to know before you take Celecoxib 3. How to take Celecoxib 4. Possible side effects 5. How to store Celecoxib 6. Contents of the pack and other information 1. WHAT CELECOXIB IS AND WHAT IT IS USED FOR Celecoxib is used for the relief of signs and symptoms of RHEUMATOID ARTHRITIS , OSTEOARTHRITIS and ANKYLOSING SPONDYLITIS IN ADULTS . Celecoxib 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. Celecoxib acts by reducing the production of prostaglandins, thereby reducing the pain and inflammation. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELECOXIB You have been prescribed this medicine by your doctor. The following information will help you get the best results with this medicine. If you have any further questions please ask your doctor or pharmacist. DO NOT TAKE CELECOXIB TELL YOUR DOCTOR IF ANY OF THE FOLLOWING ARE TRUE FOR YOU AS PATIENTS WITH THESE CONDITIONS SHOULD NOT TAKE CELECOXIB._ _ if you are ALLERGIC (HYPERSENSITIVE) TO CELECOXIB OR ANY OF THE OTHER INGREDIENTS of this medicine (listed in section 6) Read the complete document
Health Products Regulatory Authority 13 September 2019 CRN0097KN Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celecoxib 100mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg celecoxib. Excipients(s) with known effect: each capsule contains 23.56 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Opaque, white, hard gelatin capsule. The body contains a blue band and white text C90X-100 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. 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, 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 (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. Ankylosing Spondylitis The recommended daily dose is 200 mg taken once daily or in two divided doses. In a few patients, with insufficient relief from symptoms, an increased dose of 400 mg o Read the complete document