Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

The treatment of stable chronic heart failure with bisoprolol has to be initiated with a special titration phase.

Especially in patients with ischaemic heart disease the cessation of therapy with bisoprolol must not be done abruptly unless clearly indicated, because this may lead to transitional worsening of heart condition.

The initiation and cessation of treatment with bisoprolol necessitates regular monitoring.

There is no therapeutic experience of bisoprolol treatment of heart failure in patients with the following diseases and conditions:

•     insulin dependent diabetes mellitus (type I)
•     severely impaired renal function
•     severely impaired hepatic function
•     restrictive cardiomyopathy
•     congenital heart disease
•     haemodynamically significant organic valvular disease
•     myocardial infarction within 3 months 
Bisoprolol must be used with caution in:

•     bronchospasm (bronchial asthma, obstructive airways diseases)
•     diabetes mellitus with large fluctuations in blood glucose values; Symptoms of hypoglycaemia 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 does 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
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 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 the reflex tachycardia and the 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 4.5.

Although cardioselective (beta1) beta-blockers may have less effect on lung function than non- selective beta-blockers, as with all beta-blockers, these should be avoided in patients with obstructive airways diseases, unless there are compelling clinical reasons for their use. Where such reasons exist, Concor may be used with caution. In patients with obstructive airways diseases, the treatment with bisoprolol should be started at the lowest possible dose and patients should be carefully monitored for new symptoms (e.g. dyspnea, exercise intolerance, cough). 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 beta2-stimulants may have to be increased.

Patients with psoriasis or with a history of psoriasis should only be given beta-blockers (e.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 thyreotoxicosis may be masked.

Effects on Driving

4.7   Effects on ability to drive and use machines

This should be considered particularly at start of treatment and upon change of medication as well as in conjunction with alcohol.