Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CELECOXIB
Pharmacia Healthcare Ireland
CELECOXIB
100 Milligram
Capsule
Withdrawn
2006-08-07
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solexa 100 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg celecoxib. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Opaque, white with two blue bands marked ‘7767’ and ‘100’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis. 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 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. The maximum recommended daily dose is 400 mg for both indications. Solexa may be taken with or without food. _Elderly_: (>65 years): As in younger adults, 200 mg per day sh Read the complete document