Bisoprolol-BP

Bisoprololum

Each film-coated tablet contains bisoprolol fumarate 2.5 mg, 5 mg or 10 mg. Excipient with known effect: lactose monohydrate (all strengths) and, for the 5 mg and 10 mg strengths, Sunset Yellow (E110) colourant.

Indication: Treatment of hypertension; treatment of coronary heart disease (angina pectoris); treatment of stable chronic heart failure with reduced ventricular systolic function, in combination with ACE inhibitors, diuretics and, optionally, cardiac glycosides.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications Bisoprolol is contraindicated in patients with: − hypersensitivity to bisoprolol or to any of the excipients listed in section 6.1, − acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy, − cardiogenic shock, − second- or third-degree atrioventricular (AV) block (without a pacemaker), − sick sinus syndrome, − sino-atrial block, − symptomatic bradycardia, − symptomatic hypotension, − severe bronchial asthma, − severe forms of peripheral arterial occlusive disease or severe forms of Raynaud's syndrome, − untreated phaeochromocytoma (see section 4.4), − metabolic acidosis.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Unless strictly necessary, treatment with bisoprolol should not be discontinued abruptly, particularly in patients with ischaemic heart disease, as this may cause transient worsening of the condition (see section 4.2). Bisoprolol should be used with caution in patients with hypertension or angina pectoris and associated heart failure. Bisoprolol-BP should be used with caution in the following situations: − bronchospasm (bronchial asthma, obstructive airway disease). Although selective (beta1) beta-blockers may have less effect on pulmonary function than non-selective beta-blockers, as with all beta-blockers they should be avoided in patients with obstructive airway disease unless there are compelling clinical reasons for […]