Concor Special Precautions

The following section describes when Concor 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 desensitisation therapy; mild disturbances of atrioventricular conduction (first degree AV block); disturbed blood flow in the coronary vessels due to vasospasms (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); patients with psoriasis or with a personal history of psoriasis.
Respiratory system: 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 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 Concor, 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 anaesthetist must be aware of beta-blockade. If it is thought necessary to withdraw Concor before surgery, this should be done gradually and completed about 48 hours prior to anaesthesia.
Phaeochromocytoma: In patients with a tumour of the adrenal gland (phaeochromocytoma) Concor may only be administered after previous alpha-receptor blockade.
Thyrotoxicosis: Under treatment with Concor the symptoms of a thyroid hyperfunction (thyrotoxicosis) may be masked.
Special populations: So far, no sufficient therapeutic experience is available for Concor 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 haemodynamically 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.
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 patient response to treatment, 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.
Use in pregnancy & lactation: During pregnancy Concor is only recommended following careful assessment of benefit-to-risk ratio by the doctor.
In general, beta-blockers reduce placental blood flow and may affect the development of the unborn child. Placental and uterine blood flow as well as the growth of the unborn child must be monitored and, in case of harmful effects on pregnancy or the foetus, alternative therapeutic measures considered.
The newborn infant must be monitored closely after delivery. Symptoms of reduced blood glucose and slowed pulse rate generally may occur within the first 3 days of life.
There are no data on the excretion of bisoprolol in human breast milk or the safety of bisoprolol exposure in infants. Therefore, administration of Concor is not recommended during breastfeeding.
Use in children: There is insufficient experience with bisoprolol in children, therefore the use of Concor cannot be recommended for children.