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  Part 1  Part 2  Part3

DOSAGE AND DIRECTIONS FOR USE:

5 mg should be taken once a day in the morning, either on an empty stomach or with breakfast. If necessary, the dosage can be increased to 10 mg in the morning. An increase in the dosage to 20 mg daily may sometimes be necessary.

The dose should always be selected individually, particularly according to the heart rate and the therapeutic result. It is not necessary to adjust the dose in patients suffering from mild to moderate disturbance of the liver or renal function. In patients with severe renal impairment (creatinine clearance < 20 mL/min) and in patients with severe liver function disturbance, the daily dose of 10 mg bisoprolol must not be exceeded. In some of these patients, halving the dose may be necessary. The normal dose of beta-blockers should be reduced in elderly patients.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

Side-effects:

These include lassitude, dizziness, mild headache, perspiration, bradycardia, sleep disorders, restlessness, cold extremities, nausea, vomiting, diarrhoea and skin rash. Constipation, hypotension, paradoxical hypertension, depression, mass gain, paraesthesia, transient hearing loss, heart block, hallucinations, disturbances of vision, blood disorders, fluid retention, muscle cramps, allergic reactions, metabolic disturbances, alopecia, myopathies and stomatitis may occur. Overt psychosis has been reported with other beta-blockers.

Exacerbation of peripheral vascular disease, or the development of Raynaud’s phenomenon (due to the unopposed arteriolar alpha-sympathetic activation), hypoglycaemia, skeletal muscle weakness and gastro-intestinal disturbances may occur during treatment with beta-blockers. Severe peripheral vascular disease and even peripheral gangrene may be precipitated.

Special precautions:

Abrupt discontinuation of therapy may cause exacerbation of angina pectoris in patients suffering from ischaemic heart disease. Discontinuation of therapy should be gradual, and patients should be advised to limit the extent of their physical activity during the period in which the medicine is being discontinued.

Bronchoconstriction may occur in patients suffering from asthma, bronchitis and other chronic pulmonary diseases. Since bisoprolol is a highly selective beta1-adrenoceptor blocking agent, it may be used with caution in patients with chronic obstructive airway disease. However, in some asthmatic patients, an increase in airway resistance may occur. This bronchospasm can usually be reversed by commonly-used bronchodilators. Congestive cardiac failure and marked bradycardia may occur.

Bisoprolol may mask the symptoms of hyperthyroidism.

It should be used with caution in patients with hypoglycaemia.

Special note:

Digitalisation of patients receiving long-term beta-blocker therapy may be necessary if congestive cardiac failure is likely to develop. This combination can be considered despite the potentiation of negative chronotropic effect of the two medicines. Careful control of dosages and of the individual patient’s response (and notably pulse rate) is essential in this situation.

Patients with phaeochromocytoma usually require treatment with an alpha-adrenergic blocker.

Adverse reactions are more common in patients with renal decompensation.

Alterations in the following serum biochemical values have been observed in patients receiving bisoprolol: Liver enzymes, lipoproteins, uric acid.

  Part 1  Part 2  Part3

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