Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
celecoxib, Quantity: 200 mg
Lupin Australia Pty Limited
Celecoxib
Capsule, hard
Excipient Ingredients: magnesium stearate; povidone; lactose monohydrate; sodium lauryl sulfate; croscarmellose sodium; titanium dioxide; purified water; iron oxide yellow; Gelatin; acetic acid; silicon dioxide; citric acid; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; ethanol absolute
Oral
120, 10, 30, 60, 50, 20
(S4) Prescription Only Medicine
- 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.
Visual Identification: Size '0' elongated hard gelatin capsule having Gold opaque cap imprinted with 'CX' in black ink and white opaque body with '200' in black ink. Containing white to off-white powder.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-06-13
CONSUMER MEDICINE INFORMATION CELECOXIB GH (CELECOXIB) CAPSULES WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Celecoxib GH. 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 Celecoxib GH 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 CELECOXIB GH IS USED FOR Celecoxib GH 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. Celecoxib GH also provides short term pain relief in conditions such as: • Menstrual cramps or period pain. • After surgery. • Muscle and joint injuries. Celecoxib GH 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 celecoxib can relieve the symptoms of pain and inflammation, it will not cure your condition. Your doctor, however, may have prescribed Celecoxib GH for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CELECOXIB GH HAS BEEN PRESCRIBED FOR YOU. Celecoxib GH 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 CELECOXIB GH _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE CELECOXIB GH 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 LI Olvassa el a teljes dokumentumot
AUSTRALIAN PRODUCT INFORMATION – CELECOXIB GH (CELECOXIB) CAPSULES 1 NAME OF THE MEDICINE Celecoxib. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Celecoxib GH capsules containing 100 mg or 200 mg celecoxib. List of excipients with known effects: lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Celecoxib GH capsules containing celecoxib 100 mg: Size ‘3’ hard gelatin capsule having blue opaque cap imprinted with ‘CX’ in black ink and white opaque body with ‘100’ in black ink. Containing white to off-white powder. Celecoxib GH capsules containing celecoxib 200 mg: Size ‘0’ elongated hard gelatin capsule having gold opaque cap, imprinted with ‘CX’ in black ink and white opaque body imprinted with ‘200’ in black ink containing white to off-white powder. 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. 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. Celecoxib GH v4 Page 2 of 36 (celecoxib) capsules 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 b Olvassa el a teljes dokumentumot