Product Description: Concor AMLO is indicated for treatment of hypertension as substitution therapy in patients adequately controlled with the individual products given concurrently at the same doses level as in the combination, but as separate tablets How to use: Recommended daily dose is one tablet of the given strength the morning with or without food. Caution & Warnings: 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, but this was not associated with worsening of the heart failure. Use in patients with impaired hepatic function: The half-life of amlodipine is prolonged in patients with impaired liver function; dosage recommendations have not been established. Amlodipine should therefore be administered with caution in these patients. Use in elderly patients: In the elderly increase of the dosage should take place with care (see Pharmacology: Pharmacokinetics under Actions). 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 ischemic 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. Utmost caution must be exercised. 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 alpha-receptor blockage. In patients undergoing general anesthesia beta-blockage reduces the incidence of arrhythmias and myocardial ischemia during induction of anesthesia and intubation, and the post-operative period. It is currently recommended that maintenance of beta-blockage be continued perioperatively. The anesthetist must be aware of beta-blockage because of the potential for interactions with other drugs, resulting in bradyarrhythmia, 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 anesthesia. Although cardioselectivity (beta 1) 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 AMLO may be used with caution. In bronchial asthma or other chronic obstructive lung diseases, which may cause symptoms, bronchodilation 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. Ingredients: 0 mg bisoprolol fumarate, 5.0 mg amlodipine (as 6.95 mg amlodipine besilate) per tablet.

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