Index of drugs

The preparation is indicated for the treatment of hypertension, replacing the individual active substances administered at the same doses as in Concoram, but in separate tablets, in patients who have been adequately controlled for their blood pressure.

1 tabl contains a combination of Bisoprolol fumarate and Amlodipine (as the besilate): 5 mg + 5 mg, 5 mg + 10 mg, 10 mg + 5 mg or 10 mg + 10 mg respectively.

The preparation is a combination of bisoprolol and amlodipine. Bisoprolol is a selective drug blocking β receptors₁-renergic, lacking internal agonist activity and important properties stabilizing cell membranes. It has low affinity for β receptors₂ smooth muscle of the bronchi and vessels as well as receptors related to the regulation of metabolism. Amlodipine is a Calcium antagonist belonging to the dihydropyridine group. It inhibits the transmembrane influx of calcium ions to the cells of the myocardium and vascular smooth muscle. The mechanism of antihypertensive effect of amlodipine results from direct vasodilatory action of vascular smooth muscle. There are two mechanisms of action in angina: extension of the peripheral arterioles, thus reducing the total peripheral resistance (afterload) - because the frequency of heart contractions remains unchanged, this action reduces the energy consumption of the myocardium and its oxygen demand; the expansion of large arteries and coronary arterioles in both well-supplied and excreted areas due to ischaemia - this action increases the supply of oxygen. The bioavailability of bisoprolol after oral administration is approximately 90%. It binds to plasma proteins in about 30%. In 50% it is metabolized in the liver and excreted in the urine. The remaining 50% is excreted unchanged by the kidneys. T_0,5 is 10-12 h. After oral administration, amlodipine reaches C_max in the blood between 6 and 12 h (bioavailability is 64-80%, food does not affect bioavailability). It is metabolized in the liver. It is excreted in the urine in the form of inactive metabolites (60%) and unchanged (10%) and faeces (20-25%). It is not removed from the body by dialysis. T_0,5 is 35-50 h.

Hypersensitivity to Amlodipine, dihydropyridine derivatives, bisoprolol or other components of the preparation. Amlodipine: severe hypotension, shock (including cardiogenic shock), narrowing of the outflow pathway from the left ventricle (eg aortic valve stenosis), haemodynamically unstable heart failure after myocardial infarction. Bisoprolol: acute heart failure or periods of heart failure that require intravenous use of positive inotropic drugs, cardiogenic shock, second degree or third degree atrioventricular block (without an implanted cardiac pacemaker), sick sinus syndrome, sinoatrial block, bradycardia (heart rate <60 spasms / min) before starting therapy, hypotension (systolic blood pressure <100 mmHg), severe bronchial asthma, severe peripheral arterial occlusive disease or Raynaud's syndrome, untreated phaeochromocytoma, metabolic acidosis.

amlodipine. The safety and efficacy of use in the hypertensive crisis has not been established. Amlodipine can be used in patients with renal failure at the usual recommended dose (amlodipine is not removed from the body during dialysis). Particular care should be taken in patients with impaired hepatic function. Use with caution in patients with heart failure (risk of pulmonary edema) and in elderly patients when increasing the dose.bisoprolol. Treatment with bisoprolol should not be interrupted suddenly, particularly in patients with ischemic heart disease, unless there are clear indications, because it may cause a transient worsening of cardiac function. Particularly cautiously used in patients with hypertension or angina pectoris with concomitant heart failure.Carefully used in patients with diabetes mellitus, with high fluctuations in blood Glucose (symptoms of hypoglycaemia may be masked); during a strict fasting and / or on a diet; during desensitization therapy (bisoprolol may increase the sensitivity to allergens and the severity of anaphylactic reactions, adrenaline treatment may not always bring the expected effect); with first degree atrioventricular block; with Prinzmetal's gland; with obliterative disease of peripheral arteries (intensification of symptoms is possible especially at the beginning of treatment); with a history of psoriasis or with a history of psoriasis (bisoprolol can only be administered after careful assessment of the benefit / risk ratio); with hyperthyroidism (there is a risk of masking the symptoms of thyrotoxicosis); with a pheochromocytoma that must not be administered with bisoprolol if alpha-blockers are not given; anesthetized in general, the use of β-blockers reduces the incidence of arrhythmias and myocardial ischaemia during the introduction of anesthesia and intubation, as well as in the post-operative period. Currently, it is recommended to administer β-blockers in the perioperative period. The anesthetist must be informed about the administration of β-blockers due to the risk of interaction with other drugs, which may lead to bradyarrhythmias, weak reflex tachycardia, and reduced ability to reflex cardiovascular compensation in the event of blood loss. If it is necessary to stop the use of β-blockers prior to anesthesia, their dose should be gradually reduced and the treatment should be completed 48 hours before the planned anesthesia. Despite the fact that β₁- cardiac arrest-inhibitors may have a lower impact on lung function than non-elliptory beta-adrenolytics, should be avoided in patients with obstructive airways disease unless there are significant clinical reasons. The preparation should then be used with caution. In bronchial asthma or other chronic obstructive pulmonary disease that may produce symptoms, bronchodilators should be used concomitantly. Occasionally, patients with asthma may experience an increase in resistance in the airways, so it may be necessary to increase the dose of β₂-sympatykomimetyku.

The preparation should not be used during pregnancy unless clearly necessary. If the treatment is considered necessary, the utero-placental blood flow and fetal development should be carefully monitored. If the product is found to be unfavorable to pregnancy or to the fetus, other treatments should be considered. The newborn baby must remain under close observation. Symptoms of hypoglycaemia and bradycardia usually occur in the first three days of life. Bisoprolol may have a detrimental effect on pregnancy and / or the fetus / newborn. Β-blockers reduce the flow of blood through the placenta, which was associated with fetal growth retardation, intrauterine death, spontaneous abortion and preterm delivery. In the fetus or newborn, side effects may occur (e.g., hypoglycaemia and bradycardia). If beta blockers therapy is necessary, it is recommended to use drugs that act selectively on β receptors₁-Adrenergic. The safety of amlodipine in pregnant women has not been established. It is not known whether bisoprolol or amlodipine is excreted in human milk. Therefore, the use of the preparation during breastfeeding is not recommended.

amlodipine. Common: pain and dizziness, drowsiness (especially at the beginning of treatment), palpitations, flushing, nausea, abdominal pain, swelling of the ankles, swelling, fatigue. Uncommon: insomnia, mood changes (including anxiety), depression, fainting, hypoesthesia, paresthesia, taste disorders, tremors, blurred vision (including double vision), tinnitus, hypotension, dyspnea, rhinitis, vomiting, indigestion , change of bowel movements (including diarrhea and constipation), dry mouth, baldness, purpura, skin discoloration, increased sweating, pruritus, rash, exanthema, joint pain, muscle pain, muscle cramps, back pain, frequent urination, urination disorders, nocturia, impotence, gynecomastia, chest pain, weakness, pain, malaise, weight gain or loss. Rare: confusion.Very rare: leukopenia, thrombocytopenia, allergic reactions, hyperglycemia, hypertonia, peripheral neuropathy, myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), inflammation of the blood vessels, cough, gastritis, gingival hyperplasia, pancreatitis, hepatitis or jaundice (in most cases with cholestasis), vasomotor edema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke's edema, photosensitivity, increased liver enzymes (in most cases cholestasis). Occasional cases of extrapyramidal syndrome have been reported.bisoprolol. Common: pain and dizziness, feeling of cold and limb numbness, nausea, vomiting, diarrhea, constipation, fatigue. Uncommon: depression, sleep disorders, atrioventricular conduction disorders, exacerbation of existing heart failure, bradycardia, hypotension, bronchospasm in patients with bronchial asthma or obstructive pulmonary disease, muscle weakness and spasms, weakness. Rare: triglycerides increased, nightmares, hallucinations, decreased tear secretion, impaired hearing, allergic rhinitis, hepatitis, hypersensitivity reactions (pruritus, sudden redness of the face, rash), impotence, increased ALT and AST. Very rare: conjunctivitis, alopecia, psoriasis or its severity, psoriasis-like rash.

Orally. Adults: the recommended daily dose is 1 tablet. with the power corresponding to the dose so far taken. Treatment must not be interrupted suddenly, as it may lead to a temporary exacerbation of the disease. Treatment must not be interrupted suddenly, especially in patients with ischemic heart disease; it is recommended to gradually reduce the dose.Special groups of patients. In the case of liver dysfunction, the elimination of amlodipine may be prolonged. No precise dose recommendations for amlodipine have been established, therefore these preparations should be used with extreme caution. In case of severe liver dysfunction, the daily dose of bisoprolol can not exceed 10 mg. No dosage adjustment is necessary in patients with mild or moderate renal impairment. Amlodipine can not be removed by dialysis, therefore it should be administered with special care to patients undergoing dialysis. In the case of severe renal impairment (creatinine clearance <20 ml / min), the daily dose of bisoprolol can not exceed 10 mg. Elderly patients may be given the usual recommended dose, caution should be advised when increasing the dose. The safety and efficacy of the preparation in children and adolescents under 18 years have not been established.Way of giving. The tablets should be taken in the morning, regardless of the meal. Do not chew tablets.