Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Celecoxib
Pfizer Healthcare Ireland
M01AH; M01AH01
Celecoxib
100 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
Coxibs; celecoxib
Marketed
2000-05-12
Page 1 of 10 2018-0040882 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ CELEBREX® 100 MG HARD CAPSULES CELEBREX® 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 CELEBREX IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELEBREX 3. HOW TO TAKE CELEBREX 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CELEBREX 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CELEBREX IS AND WHAT IT IS USED FOR Celebrex is used in adults for the relief of signs and symptoms of RHEUMATOID ARTHRITIS, OSTEOARTHRITIS and ANKYLOSING SPONDYLITIS. Celebrex belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAID), and specifically a sub-group known as cyclooxygenase-2 (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. Celebrex acts by reducing the production of prostaglandins, thereby reducing the pain and inflammation. You should expect your medicine to start working within hours of taking the first dose, but you may not experience a full effect for several days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELEBREX _ _ You have been prescribed Celebrex by your doctor. The following information will help you get the best results with Celebrex. If you have any further questions please ask your doctor or pharmacist. DO NOT TAKE CELEBREX Page 2 of 10 2018-0040882 TELL YOUR DOCTOR IF ANY OF THE FOLLOWING ARE TRUE F Baca dokumen lengkapnya
Health Products Regulatory Authority 11 December 2019 CRN008RLM Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celebrex 100 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg celecoxib. Excipient with known effect Lactose (each capsule contains 149.7 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 blue bands marked 7767 and 100. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Celebrex is indicated in adults for the symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The decision to prescribe a selective cyclooxygenase-2 (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 (CV) 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. _Ankylosing spondylitis_ The recommended daily dose is 200 mg taken once daily or in two divided doses. In a few patients, with insuffi Baca dokumen lengkapnya