البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Celecoxib
KRKA, d.d., Novo mesto
M01AH; M01AH01
Celecoxib
100 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
Coxibs; celecoxib
Marketed
2013-11-29
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER CELECOXIB KRKA 100 MG CAPSULES, HARD CELECOXIB KRKA 200 MG CAPSULES, HARD 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 Krka is and what it is used for 2. What you need to know before you take Celecoxib Krka 3. How to take Celecoxib Krka 4. Possible side effects 5. How to store Celecoxib Krka 6. Contents of the pack and other information 1. WHAT CELECOXIB KRKA IS AND WHAT IT IS USED FOR Celecoxib Krka is used in adults for the relief of signs and symptoms of RHEUMATOID ARTHRITIS , OSTEOARTHRITIS and ANKYLOSING SPONDYLITIS . Celecoxib Krka 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. Celecoxib Krka 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 CELECOXIB KRKA You have been prescribed Celecoxib Krka by your doctor. The following information will help you get the best results with Celecoxib Krka. If you have any further questions please ask your doctor or pharmacist. DO NOT TAKE CELECOXIB KRKA TELL YOUR DOCTOR IF اقرأ الوثيقة كاملة
Health Products Regulatory Authority 21 October 2021 CRN00CKHJ Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celecoxib Krka 100mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg celecoxib. Excipient with known effect: Lactose: 24 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (capsule) Each capsule has a white body and the cap, of length 15.4 mm – 16.2 mm; the capsules contain white or almost white granulate. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Celecoxib Krka 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 اقرأ الوثيقة كاملة