Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
celecoxib, Quantity: 200 mg
Arrotex Pharmaceuticals Pty Ltd
Celecoxib
Capsule, hard
Excipient Ingredients: lactose monohydrate; sodium lauryl sulfate; Gelatin; titanium dioxide; croscarmellose sodium; magnesium stearate; povidone; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; iron oxide yellow; Shellac; strong ammonia solution
Oral
30 capsules
(S4) Prescription Only Medicine
Celecoxib is indicated for the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.,Celecoxib is indicated for the treatment of primary dysmenorrhoea in adults.,Celecoxib is indicated 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 gold bands and marked "200" on the body.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 42 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-01-10
Page 1 of 6 CELEXI CELECOXIB _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Celexi. 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 Celexi 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 CELEXI AND KEEP IT WITH THE MEDICINE. You may need to read it again. WHAT CELEXI IS USED FOR Celexi 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. Celexi also provides short-term pain relief in conditions such as: • menstrual cramps or period pain • after surgery • muscle and joint injuries. Celexi 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 Celexi can relieve the symptoms of pain and inflammation, it will not cure your condition. Your doctor, however, may have prescribed Celexi for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CELEXI HAS BEEN PRESCRIBED FOR YOU. Celexi 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 IT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE CELEXI 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 YOU HAVE SEVERE HEART OR BLOOD VESSEL DISEASE AFFECTING THE CIRCULATION IN YOUR BRAIN OR LIMBS • HAVE SEVERE L Прочитать полный документ
1 AUSTRALIAN PRODUCT INFORMATION – CELEXI (CELECOXIB) CAPSULES 1 NAME OF THE MEDICINE Celecoxib. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CELEXI 100 mg and 200 mg capsules contain 100 mg or 200 mg of celecoxib. EXCIPIENTS WITH KNOWN EFFECT The capsules also contain lactose monohydrate. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Capsule, hard. 100 mg capsules: Opaque, white capsules with 2 blue bands and marked “100” on the body. 200 mg capsules: Opaque, white capsules with 2 gold bands and marked “200” on the body. 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 2 DOSAGE As the cardiovascular 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. 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 dose or divided on the first day, followed by 200 mg once daily 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 duratio Прочитать полный документ