Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
Ranbaxy Ireland Limited
10 Milligram
Tablets
2001-06-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bellimcor 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of bisoprolol fumarate. Excipients: also includes lactose monohydrate 130.9 mg per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. The tablets are mottled beige, round and convex with the following identification markings: “BI” centrally above a break-line with “10” below. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Chronic stable angina pectoris 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Bellimcor 10mg 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 once daily. This dosage may eventually be divided into halves. 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 _________________ Read the complete document