País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
celecoxib, Quantity: 200 mg
Sandoz Pty Ltd
Celecoxib
Capsule, hard
Excipient Ingredients: carrageenan; titanium dioxide; sodium lauryl sulfate; Gelatin; colloidal anhydrous silica; lactose monohydrate; magnesium stearate; iron oxide red; microcrystalline cellulose; iron oxide yellow; purified talc
Oral
30
(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: 200 mg Capsules: Opaque, white capsules with orange cap; Container Type: Blister Pack; Container Material: PVC/TE/PVDC/AI; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2014-05-12
CELECOXIB SANDOZ ® 1 CELECOXIB SANDOZ ® _celecoxib _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CELECOXIB SANDOZ. 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 SANDOZ against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE YOU START CELECOXIB SANDOZ AND KEEP IT WITH THE MEDICINE. You may need to read it again. WHAT CELECOXIB SANDOZ IS USED FOR CELECOXIB SANDOZ is used to relieve the symptoms of joint pain, tenderness, swelling and stiffness in: • osteoarthritis, • rheumatoid arthritis and • ankylosing spondylitis, a chronic inflammatory rheumatic disorder that primarily affects, but is not limited to, the spine. CELECOXIB SANDOZ also provides short-term pain relief in conditions such as: • menstrual cramps or period pain • after surgery • muscle and joint injuries. CELECOXIB SANDOZ belongs to a group of medicines called coxibs which are used to relieve pain and inflammation in a number of conditions. Although CELECOXIB SANDOZ can relieve the symptoms of pain and inflammation, it will not cure your condition. Your doctor, however, may have prescribed CELECOXIB SANDOZ for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CELECOXIB SANDOZ HAS BEEN PRESCRIBED FOR YOU. CELECOXIB SANDOZ 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 SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE CELECOXIB SANDOZ IF: • YOU SUFFER FROM CHEST PAINS OR ANGINA AND THEY OCCUR EVEN WHEN YOU ARE RESTING AND ARE BECOMING MORE FREQUENT, SEVERE, OR LASTING FOR LONGER THAN USUAL • YOU HAVE OR HAVE HAD PROBLEMS WITH YOUR BLOOD CIRCULATION • YOUR DOCTOR H Leer el documento completo
210806-celecoxib-sandoz-pi Page 1 of 35 AUSTRALIAN PRODUCT INFORMATION CELECOXIB SANDOZ ® (CELECOXIB) 1 NAME OF THE MEDICINE Celecoxib 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Celecoxib Sandoz ® 100 mg capsule contains 100 mg celecoxib. Each Celecoxib Sandoz ® 200 mg capsule contains 200 mg celecoxib. _Not all strengths may be marketed in Australia. _ _Excipient with known effect:_ Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Celecoxib Sandoz 100 mg capsules are opaque, white capsules with blue cap containing white to slightly yellowish pellets. Celecoxib Sandoz 200 mg capsules are opaque, white capsules with orange cap containing white to slightly yellowish pellets. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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 D OSE 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, such as every three months, with regards to efficacy, risk factors and ongoing need for treatment. _ADULTS_ _Osteoarthritis _ The usual recommended daily dose is 200 mg taken once daily or in two divided doses. _Rheumatoid Arthritis _ The recommended daily dose is 200 mg taken in two divided doses. 210806-celecoxib-sandoz-pi Page 2 of 35 A dose of up to 400 mg daily may be used for short-term management of disease flares or exacerbations. _Ankylosing Spondylitis _ The maximum recommended daily dose is 200 mg taken once daily or in two divided doses. _Primary Dysmenorrhoea _ The recommended dose is 400 mg as a single Leer el documento completo