Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
celecoxib, Quantity: 100 mg
Viatris Pty Ltd
Capsule, hard
Excipient Ingredients: lactose monohydrate; Gelatin; sodium lauryl sulfate; magnesium stearate; croscarmellose sodium; povidone; titanium dioxide; propylene glycol; indigo carmine; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution
Oral
60 capsules, 20 capsules, 10 capsules, 50 capsules
(S4) Prescription Only Medicine
For the symptomatic treatment of osteoarthritis and rheumatoid arthritis and ankylosing spondylitis. For the treatment of primary dysmenorrhoea in adults. For the short term treatment of acute pain in adults following surgery or musculoskeletal and/or soft tissue injury.
Visual Identification: Opaque, white capsules with 2 blue bands marked "7767" and "100".; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
1999-08-25
CELEBREX ® _celecoxib_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Celebrex. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Celebrex against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CELEBREX IS USED FOR Celebrex is used to relieve the symptoms of joint pain, tenderness, swelling and stiffness in: • osteoarthritis • rheumatoid arthritis • ankylosing spondylitis, a chronic inflammatory rheumatic disorder that primarily affects, but is not limited to, the spine. Celebrex also provides short-term pain relief in conditions such as: • menstrual cramps or period pain • after surgery • muscle and joint injuries. Celebrex contains celecoxib and belongs to a group of medicines called coxibs which are used to relieve pain and inflammation in a number of conditions. Although Celebrex can relieve the symptoms of pain and inflammation, it will not cure your condition. Your doctor, however, may have prescribed Celebrex for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CELEBREX HAS BEEN PRESCRIBED FOR YOU. Celebrex is not recommended for use in children or adolescents under 18 years of age. This medicine is only available with a doctor's prescription. BEFORE YOU TAKE CELEBREX _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE CELEBREX IF YOU • SUFFER FROM CHEST PAINS OR ANGINA AND THEY OCCUR EVEN WHEN YOU ARE RESTING AND ARE BECOMING MORE FREQUENT, SEVERE, OR LASTING LONGER THAN USUAL • HAVE OR HAVE HAD PROBLEMS WITH YOUR BLOOD CIRCULATION • HAVE OR IF YOUR DOCTOR HAS TOLD YOU THAT SEVERE HEART OR BLOOD VESSEL DISEASE AFFECTING THE CIRCULATION IN YOUR BRAIN OR LIMBS. • HAVE SEVERE LIVER PROBLEMS Your doctor will decide if Lesen Sie das vollständige Dokument
Version: ujpcelec20821 Supersedes: pfpcelec10821 Page 1 of 40 AUSTRALIAN PRODUCT INFORMATION – CELEBREX ® (CELECOXIB) CAPSULES 1. NAME OF THE MEDICINE Celecoxib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each CELEBREX 100 mg capsule contains 100 mg celecoxib. Each CELEBREX 200 mg capsule contains 200 mg celecoxib. EXCIPIENT(S) WITH KNOWN EFFECT CELEBREX 100 mg and 200 mg capsules contain 149.7 mg and 49.8 mg of lactose monohydrate, respectively. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Capsule, hard. CELEBREX 100 mg capsule is opaque, white capsules with 2 blue bands marked 7767 and 100. CELEBREX 200 mg capsule is opaque, white capsules with 2 gold bands marked 7767 and 200. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. For the treatment of primary dysmenorrhoea in adults. For the short-term treatment of acute pain in adults following surgery or musculoskeletal and/or soft tissue injury. Version: ujpcelec20821 Supersedes: pfpcelec10821 Page 2 of 40 4.2 DOSE AND METHOD OF 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 _ 200 mg taken once daily (OD) or in two divided doses. _Rheumatoid arthritis _ 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 Lesen Sie das vollständige Dokument