Bisoprolol PMCS 2.5 mg, Bisoprolol PMCS 5 mg, Bisoprolol PMCS 10 mg

Basic information

Composition

Bisoprololi fumaras 2.5 mg or 5 mg or 10 mg in 1 tablet

Pharmacotherapeutic group

Beta-blocker, selective (ATC code: C07AB07)

Therapeutic indications

Hypertension; ischemic heart disease (angina pectoris); stabilised chronic cardiac failure with decreased systolic function of the left heart ventricle together with ACE inhibitors, diuretics or cardiac glycosides.

Pharmacological properties

Bisoprolol is a highly cardioselective beta-blocker of adrenergic receptors without intrinsic sympathomimetic activity (ISA). It has antihypertensive, negative inotropic and negative chronotropic effects. Bisoprolol is well absorbed after oral administration, about 50 % is metabolised in the liver, the rest is excreted through the kidneys in unchanged form. Biological half-life is 10—12 hours.

Pharmaceutical form

Tablets

More information

Posology and method of administration

Hypertension and angina pectoris: Treatment is initiated with 5 mg daily; the usual dose is 10 mg. If effects are insufficient, the dose may be increased up to 20 mg daily. In patients with severe hepatic and renal impairment (creatinine clearance under 20 ml/min) the daily dose of 10 mg should not be exceeded. Stable chronic heart failure: Bisoprolol treatment should be initiated by titrating the dose as follows: 1.25 mg daily for 1 week; if well tolerated increase to 2.5 mg daily for a further week; if well tolerated increase to 3.75 mg daily for a further week; if well tolerated increase to 5 mg daily for the 4 following weeks; if well tolerated increase to 7.5 mg daily for the following 4 weeks; if well tolerated increase to 10 mg daily for the maintenance therapy. The maximum recommended dose is 10 mg daily. Bisoprolol is taken in the morning on empty stomach or with a meal and is washed down with a sufficient amount of liquid.

Contraindications

Hypersensitivity to bisoprolol or any excipient, acute cardiac failure or decompensated heart failure requiring i.v. inotropic therapy, cardiogenic shock, 2nd or 3rd degree AV block (without pacemaker), sick sinus syndrome, sinoatrial block, bradycardia, hypotension, severe bronchial asthma or chronic obstruction pulmonary diseases (COPD), severe form of lower limb ischemia or severe Rynaud’s syndrome, pheochromocytoma (apart from the previous therapy by alpha receptor blockers), metabolic acidosis. The medicinal product should not be administered during pregnancy and lactation.

Interactions

Bisoprolol exacerbates hypotension in concomitant use with other antihypertensive agents. Combination with calcium antagonists of the verapamil type or some antiarrhythmics may induce bradycardia and decreased contractility. Concomitant use with centrally acting antihypertensive drugs (clonidine, methyldopa, moxonidine, rilmenidine) may result in decreased heart rate and cardiac output. Combination with calcium antagonists of the dihydropyridin type (e.g., nifedipine, amlodipine) may result in hypotension. Digitalis glycosides may lead to a delayed transmission of cardiac excitation resulting in slower heart rate.

Undesirable effects

Vertigo, headaches, feelings of cold or insensitive limbs, bradycardia, deteriorated existing cardiac failure, hypotension, constipation, diarrhoea, nausea, depression, sleeping disorders, asthenia. 

Special warnings and precautions for use

Bisoprolol may cover symptoms of hypoglycemia (tachycardia, palpitation, sweating) and thyrotoxicosis. Caution is required in patients with psoriasis, Prinzmetal’s angina, restrictive cardiomyopathy, congenital heart disease, in ongoing desensibilisation therapy. Prior to surgical intervention in genral anesthesia it is necessary to inform anesthesiologist of bisoprolol treatment. Bisoprolol treatment must be terminated by downtitrating the dose. 

For more detailed product information, see the Summary of Product Characteristics.

Availability

The product can only be obtained with a prescription. 30, 100 tablets of 2.5 or 5 mg are partly covered by health insurance. 30, 100 tablets of 10 mg are fully covered by health insurance.

Contents of container

30, 60, 100 or 500 tablets of 2.5 mg, 5 mg or 10 mg each

Package available in the Czech Republic

30, 100 tablets of 2.5 mg, 5 mg or 10 mg each

SPC and PIL

Manufacturer and marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Date of revision of the text

27 May 2016

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