Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK
5 Milligram
Film Coated Tablet
2003-01-24
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Emvasc 5 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains bisoprolol fumarate 5 mg. Each tablet contains 0.015mg of E110. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets. Pink, round biconvex film coated tablets, embossed with BPL 5 on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Chronic stable angina pectoris 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Bisoprolol 5mg Tablets are for oral administration. The dosage should be individually adjusted. It is recommended to start with the lowest possible dose. In some patients, 5 mg per day may be adequate. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg per day. Patients with kidney impairment In patients with severe renal impairment (creatinine clearance < 20ml/min), the dose should not exceed 10 mg bisoprolol once daily. This dosage may eventually be halved to 5mg per day. Patients with severe liver impairment No dosage adjustment is required, however careful monitoring is advised. Elderly: No dosage adjustment is normally required. It is recommended to start with the lowest possible dose Children under 12 years and adolescents: There is no paediatric experience with this medicine, therefore its use cannot be recommended Discontinuation of treatment Treatment should not be stopped abruptly _(see section 4.4 Special warnings and precautions for use). _The dosage should be diminished slowly by a weekly halving of the dose. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 17/09/2009_ _CRN 2071407_ _page number: 1_ 4.3 CONTRAINDICATIONS o acute heart failure or during epi Lesen Sie das vollständige Dokument