BISOPROLOL

Route of Administration Oral Posology Adults:

The usual dose is 10mg once daily with a maximum recommended dose of 20mg per day. In some patients 5mg per day may be adequate. Experience of the use of bisoprolol fumarate in renal dialysis patients is limited; however, there is no evidence that the dosage regimen needs to be altered.

Elderly:

No dosage adjustment is normally required but 5mg per day may be adequate in some patients; as for other adults, dosage may have to be reduced in cases of severe renal or hepatic dysfunction.

Children:

There is no paediatric experience with bisoprolol, therefore its use cannot be recommended for children.

Renal impairment:

In patients with final stage impairment of renal (creatinine clearance <20ml/min), use a maximum 10mg daily in severe renal impairment Severe liver impairment: Maximum 10mg daily in severe liver impairment

Adverse reactions are ranked under headings of frequency, using the following convention: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very Rare (<1/10,000), including isolated reports.

g. vivid dreams), depression Airways: Bronchospasm in patients with bronchial asthma or a history of obstructive airways disease.

Common:

Circulatory: Feeling of coldness or numbness in the extremities, oedema CNS: Tiredness*, exhaustion*, dizziness*, headache* GI: Nausea, vomiting, diarrhoea, constipation Other effects: Perspiration *These symptoms especially occur at the beginning of the therapy.

They are generally mild and often disappear within 1-2 weeks.

5) • Diabetes Mellitus with large fluctuations in blood glucose values; symptoms of hypoglycaemia can be masked. • Strict fasting. • Ongoing desensitisation therapy. • AV block of first degree. • Prinzmetal’s angina • Peripheral arterial occlusive disease (intensification of complaints may occur particularly during the start of therapy).

In bronchial asthma or other chronic obstructive lung diseases, which may cause symptoms, bronchodilating therapy should be given concomitantly. Occasionally an increase of the airway resistance may occur in patients with asthma, therefore the dose of β2 stimulants may have to be increased.

As with other β-blockers, bisoprolol may increase both the sensitivity towards allergens and the severity of anaphylactic reactions. Adrenaline treatment does not always give the expected therapeutic effect. g. bisoprolol) after carefully balancing the benefits against the risks.

In patients with phaeochromocytoma bisoprolol must not be administered until after alpha-receptor blockade. Under treatment with bisoprolol the symptoms of a thyrotoxicosis may be masked. In patients with ischaemic heart disease, treatment should not be withdrawn abruptly.

Combination with calcium antagonists, clonidine or monoamine oxidase inhibitors (except MAO B inhibitors) is not recommended. 5.

As with other beta-adrenoceptor antagonists bisoprolol fumarate should not be used in cases of: • Hypersensitivity to bisoprolol fumarate or any other ingredients in the tablet. • Acute heart failure or during episodes of heart failure decompensation requiring iv inotropic therapy.

• Cardiogenic shock. • Marked bradycardia (heart rate less than 60 beats per minute prior to start of therapy). • Sinoatrial block • Second or third degree AV block (without a pacemaker) • Sick sinus syndrome. 4) Metabolic acidosis