Bisodac-HF Special Precautions

The following section describes when BISODAC-HF must be used with special caution: diabetes mellitus with extremely fluctuating blood glucose levels: symptoms of markedly reduced blood glucose (hypoglycaemia) such as tachycardia, palpitations or sweating can be masked, strict fasting, ongoing desensitization therapy, mild disturbances of atrioventricular conduction (first degree AV block), disturbed blood flow in the coronary vessels due to vasospasms (Prinzmetal's angina), peripheral arterial occlusive disease (aggravation of symptoms may occur especially when starting therapy), Patients with psoriasis or with a personal history of psoriasis.
Respiratory system: In bronchial asthma or other symptomatic chronic obstructive pulmonary diseases concomitant bronchodilator therapy is indicated. An increase in airway resistance may occasionally occur in patients with asthma, requiring a higher dose of beta2-sympathomimetics.
Allergic reactions: Beta-blockers, including BISODAC-HF, may increase the sensitivity to allergens and the severity of anaphylactic reactions because the adrenergic counter regulation under beta-blockade may be alleviated. Treatment with adrenaline may not always yield the expected therapeutic effect.
General anaesthesia: In patients undergoing general anaesthesia the anesthetist must be aware of beta-blockade. If it is thought necessary to withdraw BISODAC-HF before surgery, this should be done gradually and completed about 48 hours prior to anaesthesia.
Phaeachramocytoma: In patients with a tumour of the adrenal gland (phaeochromocytoma) BISODAC-HF may only be administered after previous alpha-receptor blockade.
Thyrotoxicosis: Under treatment with BISODAC-HF the symptoms of a thyroid hyperfunction (thyrotoxicosis) may be masked.
Special populations: So far no sufficient therapeutic experience is available for BISODAC-HF in patients with heart failure and concomitant insulin dependent type I diabetes mellitus, severely impaired kidney function, severely impaired hepatic function, restrictive cardiomyopathy, congenital heart diseases or hemodynamically relevant organic valvular heart disease.
No sufficient therapeutic experience is available either in patients with heart failure and myocardial infarction within the last 3 months.
There is insufficient experience with bisoprolol in children, therefore the use of BISODAC-HF cannot be recommended for children.
Effects on the ability to drive and use machines: In a study with patients suffering from coronary heart disease bisoprolol did not affect the driving performance of the patients. However, depending on the individual patients response to treatment an effect on the ability to drive a vehicle or to use machines may be impaired. This needs to be considered particularly at the start of treatment, upon change of medication, or in conjunction with alcohol.