国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Celecoxib
Macleods Pharma UK Ltd
M01AH01
Celecoxib
100mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 8901463119365
Ÿ Dextromethorphan (used to treat coughs) The dose is usually: Celecoxib capsules contain LACTOSE (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. IF YOU TAKE MORE CELECOXIB CAPSULES THAN YOU SHOULD FOR RHEUMATOID ARTHRITIS: The initial recommended daily dose is 200 mg taken in two divided doses. The dose may, if needed, later be increased to 200 mg twice daily. n one 100 mg capsule twice a day. CELECOXIB CAPSULES CONTAIN LACTOSE You should not take more capsules than your doctor tells you to. If you take too many capsules contact your doctor, pharmacist or hospital and take your medicine with you. n one 100 mg capsule twice a day. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines: _ _ OTHER MEDICINES AND CELECOXIB CAPSULES You should be aware of how you react to Celecoxib capsules before you drive or operate machinery. If you feel dizzy or drowsy after taking Celecoxib capsules, do not drive or operate machinery until these effects wear off. IF YOU FORGET TO TAKE CELECOXIB CAPSULES_ _ The dose is usually: You should not take more than 400 mg per day. pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems to become pregnant (see section on Pregnancy and breast-feeding). DRIVING AND USING MACHINES n one 200 mg capsule once a day; or FOR ANKYLOSING SPONDYLITIS: the usual dose is 200 mg each day, increased by your doctor to a maximum of 400 mg, if needed. If you forget to take a capsule, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose. FOR OSTEOARTHRITIS: the usual dose is 200 mg each day, increased by your doctor to a maximum of 400 mg, if needed. KIDNEY OR LIVER PROBLEMS: make sure your doctor knows if you have liver or kidney problems as you may need a lower dose. NSAIDs, including Celecoxib capsules, may make it more difficult to become pregnant. You should tel 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celecoxib 100 mg capsules, hard. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg celecoxib. Excipient(s) with known effect: lactose (each capsule, contains 16.90 mg lactose, anhydrous; see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Size ‘4’capsules, containing white to off white powder, having white opaque cap, white opaque body with ‘C5’ imprinted on a blue band on the cap and ‘100mg’ imprinted on a blue band on the body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Celecoxib Capsules is indicated in adults for the symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. The patient's need for symptomatic relief and response to therapy should be re evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1). _Osteoarthritis _ The usual recommended daily dose is 200 mg taken once daily or in two divided doses. In some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered. _Rheumatoid arthritis _ The initial recommended daily dose is 200 mg taken in two divided doses. The dose may, if needed, later be increased to 200 mg twice daily. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered. _Ankylosing spondylitis _ The recommended daily dose is 200 mg taken once daily o 完全なドキュメントを読む