Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BUDESONIDE
AstraZeneca UK Limited
3 Milligram
Capsules Gastro-Resistant
2001-09-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Entocort CR 3 mg Gastro-Resistant Prolonged-Release Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains budesonide 3 mg Excipients: not more than 295 mg sucrose For full list of excipients, _see section 6.1_ 3 PHARMACEUTICAL FORM Gastro-resistant, prolonged release capsules, hard. Hard gelatin capsules with an opaque, light grey body and opaque, pink cap marked CIR 3MG in black radial print 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Entocort CR Capsules are indicated for the induction of remission in patients with mild to moderate Crohn's disease affecting the ileum and/or the ascending colon_. _The full effect is usually achieved within 2-4 weeks. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Active Crohn's disease: The recommended daily dose for induction of remission is 9 mg once daily in the morning, for up to eight weeks. The full effect is usually achieved within 2-4 weeks. When treatment is to be discontinued, the dose should normally be reduced for the last 2 to 4 weeks of therapy. For long-term use, to prolong remission, the recommended dose is 6 mg, administered once daily in the morning. To replace prednisolone in steroid dependent patients, the recommended dose is 6 mg, administered once daily in the morning. When treatment with Entocort CR capsules is initiated the prednisolone dose should be tapered. To prevent recurrence after surgery in patients with high disease activity, the recommended dose is 6mg, administered once daily in the morning. No benefit of Entocort has been shown in post surgical patients with obstructive fibrostenotic Crohn’s disease. Children: There is presently no experience with Entocort CR Capsules in children. Entocort is not Read the complete document