Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
Pfizer Healthcare Ireland
BISOPROLOL FUMARATE
5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2012-04-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisoprolol Pfizer 5mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of bisoprolol fumarate equivalent to 4.24 mg bisoprolol. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow coloured, circular, biconvex, film-coated tablets debossed with ‘I and score line’ on one side and ‘11’ on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Management of hypertension Management of chronic stable angina pectoris 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults The dosage should be individually adjusted. It is recommended to start with 5 mg per day. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg per day. Patients with renal impairment In patients with severe renal impairment (creatinine clearance < 20 ml/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 Bisoprolol is not recommended for use in children below age 12 and adolescents owing to a lack of data on safety and efficacy. Duration of therapy for all indications Treatment with bisoprolol is generally a long-term therapy. The treatment with bisoprolol must not be stopped abruptly since this might lead to a transitory worsening of condition. Especially in patients with ischaemic heart disease, treatment must not be discontinued suddenly. Gradual reduction of the dail Lue koko asiakirja