BISOPROLOL FUMARATE

Posology Adults Treatment of stable chronic heart failure Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a beta-blocking agent, diuretics, and when appropriate cardiac glycosides.

Patients should be stable (without acute failure) when bisoprolol treatment is initiated. It is recommended that the treating physician should be experienced in the management of chronic heart failure. Titration phase The treatment of stable chronic heart failure with bisoprolol requires a titration phase.

5 mg once daily for the 4 following weeks, if well tolerated increase to - 10 mg once daily for the maintenance therapy. The maximum recommended dose is 10 mg once daily. Transient worsening of heart failure, hypotension, or bradycardia may occur during the titration period and thereafter.

Close monitoring of vital signs (heart rate, blood pressure) and symptoms of worsening heart failure is recommended during the titration phase. Symptoms may occur within the first day after initiating the therapy. Treatment modification If the maximum recommended dose is not well tolerated, gradual dose reduction may be considered.

In case of transient worsening of heart failure, hypotension, or bradycardia reconsideration of the dosage of the concomitant medication is recommended. It may also be necessary to temporarily lower the dose of bisoprolol or to consider discontinuation.

The reintroduction and/or uptitration of bisoprolol should always be considered when the patient becomes stable again. If discontinuation is considered, gradual dose decrease is recommended, since abrupt withdrawal may lead to acute deterioration of the patient’s condition.

Treatment of stable chronic heart failure with bisoprolol is generally a long-term treatment.

Special populations Hepatic or renal impairment:

There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and with impaired hepatic or renal function. Titration of the dose in these populations should therefore be made with particular caution.

Elderly No dosage adjustment is normally required. Paediatric population No data are available. Method of administration For oral use. Bisoprolol fumarate tablets should be taken in the morning and can be taken with food. They should be swallowed with liquid and should not be chewed.

The following definitions apply to the frequency terminology used hereafter:

Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data).

Psychiatric disorders:

Uncommon: sleep disorders, depression. Rare: nightmares, hallucinations.

Nervous system disorders:

Common: dizziness, headache. Rare: syncope.

Eye disorders:

Rare: reduced tear flow (to be considered if the patient uses lenses). Very rare: conjunctivitis.

Ear and labyrinth disorders:

Rare: hearing disorders.

Cardiac disorders:

Very common: bradycardia. Common: worsening of pre-existing heart failure.

Uncommon:

AV-conduction disturbances.

Vascular disorders:

Common: feeling of coldness or numbness in the extremities, hypotension especially in patients with heart failure. Uncommon: orthostatic hypotension.

Respiratory, thoracic and mediastinal disorders:

Uncommon: bronchospasm in patients with bronchial asthma or a history of obstructive airways disease. Rare: allergic rhinitis.

Gastrointestinal disorders:

Common: gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation.

Hepatobiliary disorders:

Rare: hepatitis.

Skin and subcutaneous tissue disorders:

Rare: hypersensitivity reactions such as pruritus, flush, rash and angioedema. Very rare: alopecia, beta-blockers may provoke or worsen psoriasis or induce psoriasis-like rash.

Musculoskeletal and connective tissue disorders:

Uncommon: muscular weakness, muscle cramps.

Reproductive system and breast disorders:

Rare: erectile dysfunction.

General disorders and administration site conditions:

Common: asthenia, fatigue. Investigations Rare: increased triglycerides, increased liver enzymes (ALAT, ASAT). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

5 mg and 10 mg tablets only: Contains sunset yellow (E110) that may cause allergic reactions. Precautions The initiation and cessation of treatment with bisoprolol necessitates regular monitoring. 2). g. tachycardia, palpitations, sweating) can be masked • strict fasting • ongoing desensitisation therapy.

As with other beta-blockers, bisoprolol may increase both the sensitivity towards allergens and the severity of anaphylactic reactions. Epinephrine treatment may not always yield the expected therapeutic effect. • first degree AV block • Prinzmetal's angina: Cases of coronary vasospasm have been observed.

Despite its high beta1-selectivity, angina attacks cannot be completely excluded when bisoprolol is administered to patients with Prinzmetal's angina • peripheral arterial occlusive disease. Aggravation of symptoms may occur especially when starting therapy • general anaesthesia.

g. bisoprolol) after a careful balancing of benefits against risks. The symptoms of thyrotoxicosis may be masked under treatment with bisoprolol. In patients with phaeochromocytoma bisoprolol must not be administered until after alpha- receptor blockade.

In patients undergoing general anaesthesia beta-blockade reduces the incidence of arrhythmias and myocardial ischemia during induction and intubation, and the post-operative period. It is currently recommended that maintenance of beta-blockade be continued peri- operatively.

The anaesthetist must be aware of beta-blockade because of the potential for interactions with other drugs, resulting in bradyarrhythmias, attenuation of reflex tachycardia, and decreased reflex ability to compensate for blood loss.

If it is thought necessary to withdraw beta-blocker therapy before surgery, this should be done gradually and completed about 48 hours before anaesthesia. Combination of bisoprolol with calcium antagonists of the verapamil or diltiazem type, with Class I antiarrhythmic drugs and with centrally acting antihypertensive drugs is generally not recommended, for details please refer to section

v. 4) • metabolic acidosis