Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
celecoxib
Apotex Pty Ltd
Celecoxib
Registered
APO-CELECOXIB CAPSULES _Celecoxib_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about celecoxib. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Celecoxib. It contains the active ingredient celecoxib. Celecoxib is used to treat: • osteoarthritis • rheumatoid arthritis • ankylosing spondylitis, a chronic inflammatory rheumatic disorder that primarily affects, but is not limited to, the spine. Celecoxib also provides short term pain relief in conditions such as: • menstrual cramps or period pain • after surgery • muscle and joint injuries. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS_ Celecoxib belongs to a group of medicines called NSAIDs which are used to relieve pain and inflammation in a number of conditions. There is no evidence that this medication is addictive. _USE IN CHILDREN_ This medicine should not Přečtěte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION APO-CELECOXIB (CELECOXIB) CAPSULES 1 NAME OF THE MEDICINE Celecoxib 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100mg and 200mg celecoxib as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate, gelatin, sulfites (as residue). For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM APO-CELECOXIB 100 MG CAPSULES Opaque, white capsules with 2 blue bands and marked "100" on the body. APO-CELECOXIB 200 MG CAPSULES Opaque, white capsules with 2 gold bands and marked "200" on the body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis • Treatment of primary dysmenorrhoea in adults • Short-term treatment of acute pain in adults following surgery or musculoskeletal and/or soft tissue injury. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Celecoxib capsules are intended for oral administration. DOSAGE 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 (see section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS). Patients on long-term treatment should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment. ADULTS OSTEOARTHRITIS The usual recommended daily dose is 200 mg taken once daily (OD) or in two divided doses. 2 RHEUMATOID ARTHRITIS The recommended daily dose is 200 mg taken in two divided doses. Up to 400 mg daily may be used for short-term management of disease flares or exacerbations. ANKYLOSING SPONDYLITIS The maximum daily dose is 200 mg taken OD or in two divided doses. PRIMARY DYSMENORRHOEA 400 mg as a single dose or divided on the first day, followed by 200 mg OD on subsequent days. Patients may be instructed to take an additional dose of 200 mg on any given day, if needed. The maximum recommended treatment duration is 5 days. ACUTE PAIN FOLLOWING SURG Přečtěte si celý dokument