Nebivolol-BP

Nebivololum

Each Nebivolol-BP tablet contains nebivolol (as nebivolol hydrochloride) 5 mg. Excipient with known effect: lactose monohydrate.

Indication: Treatment of essential hypertension; treatment of mild to moderate chronic heart failure, as add-on therapy to standard treatment, in patients aged 70 years and over.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Hepatic impairment or hepatic dysfunction - Acute heart failure, cardiogenic shock, or episodes of heart failure decompensation requiring i.v. inotropic therapy. In addition, as with other beta-blocking agents, Nebivolol-BP is contraindicated in: • sick sinus syndrome, including sino-atrial block • second- and third-degree atrioventricular block (without a pacemaker) • history of bronchospasm and bronchial asthma • untreated phaeochromocytoma • metabolic acidosis • bradycardia (heart rate < 60 bpm before starting therapy) • hypotension (systolic blood pressure < 90 mmHg) • severe peripheral circulatory disturbances

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use The following special warnings and precautions apply to beta-adrenergic antagonists in general. Anaesthesia Continued beta-blockade reduces the risk of arrhythmias during anaesthetic induction and intubation. If beta-blocker treatment needs to be discontinued before surgery, this should be done at least 24 hours in advance. Caution is required when certain anaesthetic agents causing myocardial depression are used, such as cyclopropane, ether or trichloroethylene. The patient may be protected against vagal reactions by intravenous administration of atropine. Cardiovascular disorders In general, beta-adrenergic antagonists should not be used in patients with untreated congestive heart failure (CHF) unless their condition has been stabilised. In patients with ischaemic heart disease, […]