BISOL

Treatment of stable chronic heart failure with reduced left ventricular systolic function, in addition to angiotensin-converting enzyme (ACE) inhibitors, diuretics and, if necessary, cardiotonic digitalis (for further information, see section 5.1).

Pregnancy

Bisoprolol possesses pharmacological properties likely to cause harmful effects on pregnancy and/or the foetus/newborn. In general, beta-blockers decrease placental perfusion; this effect has been associated with growth retardation, intrauterine deaths, abortions or preterm labour. Adverse effects (for example hypoglycemia and bradycardia) may occur in the foetus and the newborn. If beta-blocker treatment is necessary, ß1-selective agents should be preferred.

Bisoprolol is not recommended during pregnancy except in cases of absolute necessity. If bisoprolol treatment proves necessary, monitoring of uteroplacental blood flow and foetal growth is recommended. In case of harmful effects on pregnancy or on the foetus, starting another treatment should be considered. The newborn must be subject to close monitoring. Symptoms of hypoglycemia and bradycardia generally appear within the first 3 days of life.

Breastfeeding

It is unknown if this medicine is excreted in breast milk. Consequently, breastfeeding is not recommended during administration of bisoprolol.

In a study conducted in patients with coronary artery disease, bisoprolol did not impair driving abilities. Depending on the individual patient's response, the ability to drive vehicles and use machines may be impaired. This effect should be taken into account, particularly at the start of treatment, in case of treatment modification, or in case of association with alcohol.

The frequency terms used below correspond to the following definitions:

· Very frequent (≥ 1/10),

· Frequent (≥ 1/100, < 1/10),

· Uncommon (≥ 1/1 000, < 1/100),

· Rare (≥ 1/10 000, < 1/1 000),

· Very rare (< 1/10 000),

· Frequency unknown (cannot be estimated based on available data).

Psychiatric disorders:

Uncommon: sleep disorders, depression.

Rare: nightmares, hallucinations.

Nervous system disorders:

Frequent: dizziness, headache.

Rare: syncope.

Eye disorders:

Rare: dry eyes (to be taken into account if the patient wears contact lenses).

Very rare: conjunctivitis.

Ear and labyrinth disorders:

Rare: hearing disorders.

Cardiac disorders:

Very frequent: bradycardia in patients suffering from chronic heart failure.

Frequent: worsening of pre-existing heart failure in patients suffering from chronic heart failure.

Uncommon: atrioventricular conduction disorders.

Vascular disorders:

Frequent: sensation of cold or numbness in the extremities, hypotension (especially in patients suffering from heart failure).

Uncommon: orthostatic hypotension

Respiratory, thoracic and mediastinal disorders:

Uncommon: bronchospasm in patients suffering from asthma or having a history of obstructive airway disorders.

Rare: allergic rhinitis.

Gastrointestinal disorders:

Frequent: gastrointestinal disorders of the type nausea, vomiting, diarrhea, constipation.

Hepatobiliary disorders:

Rare: hepatitis.

Skin and subcutaneous tissue disorders:

Rare: hypersensitivity reactions (pruritus, flush, rash and angioedema).

Very rare: beta-blockers can cause or worsen psoriasis or induce a psoriasiform rash, alopecia.

Musculoskeletal and systemic disorders:

Uncommon: muscular weakness and muscle cramps.

Reproductive system and breast disorders:

Rare: erectile dysfunction.

General disorders and administration site conditions:

Frequent: fatigue, asthenia.

Investigations:

Rare: hypertriglyceridemia, elevation of liver enzymes (ALAT, ASAT).

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorization of the medicine is important. It allows continuous monitoring of the benefit/risk ratio of the medicine. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr .