Concor AM Special Precautions

In connection with amlodipine: The safety and efficacy of amlodipine in hypertensive crisis has not been established.
Patients with cardiac failure: Patients with heart failure should be treated with caution. In a long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group (see Pharmacology: Pharmacodynamics under Actions).
Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
Use in patients with impaired hepatic function: The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established. Amlodipine should therefore be administered with caution in these patients. Careful monitoring may be required in patients with severe hepatic impairment.
Use in renal failure: Amlodipine may be used in such patients at normal doses. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialyzable.
In connection with bisoprolol: Especially in case of patients suffering from ischaemic heart disease the cessation of therapy with bisoprolol must not be done abruptly unless clearly indicated, as it may lead to temporary deterioration of heart disease (see Dosage & Administration).
Bisoprolol should be administered with special caution in patients with hypertension or angina associated with heart failure.
Bisoprolol must be used with caution in: Diabetes mellitus with large fluctuations in blood glucose values; symptoms of hypoglycaemia (e.g. tachycardia, palpitations or sweating) can be masked.
Strict fasting/diet.
Concomitant desensitisation therapy. As with other beta-blockers, bisoprolol may increase both the sensitivity towards allergens and the severity of anaphylactic reactions. Adrenaline treatment may not always give 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 (intensification of complaints might happen especially during the start of therapy).
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.
Under treatment with bisoprolol the symptoms of hyperthyreosis may be masked.
In patients with phaeochromocytoma bisoprolol must not be administered until after alphareceptor blockade.
In patients undergoing general anaesthesia beta-blockade reduces the incidence of arrhythmias and myocardial ischemia during induction of anaesthesia and intubation, and the post-operative period. It is currently recommended that maintenance beta blockade be continued perioperatively. 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.
Although cardioselective (beta1) beta-blockers may have less effect on lung function than nonselective beta-blockers, as with all beta-blockers, these should be avoided in patients with obstructive airway diseases, unless there are compelling clinical reasons for their use. Where such reasons exists, Concor AM may be used with caution. 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 β2-stimulants may have to be increased.
Effects on the ability to drive and use machines: Amlodipine can have minor or moderate influence on the ability to drive and use machines. If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired. In a study with coronary heart disease patients, bisoprolol did not impair driving performance. However, depending on the individual patients response to treatment an effect on the ability to drive a vehicle or to use machines cannot be excluded. This may occur mostly at the beginning of therapy, during changing therapy and during concomitant alcohol intake.
Use in the Elderly: In the elderly increase of the dosage should take place with care (see Pharmacology: Pharmacokinetics under Actions).