1 tabl contains 5 mg or 10 mg Bisoprolol hemifumarate.
Action:
Cardioselective drug β1-adrenolytic, deprived of intrinsic sympathomimetic activity and stabilizing properties of cell membranes. The mechanism of hypotensive action is not explained, it is known that bisoprolol significantly reduces renin activity in plasma. In patients with ischemic heart disease blocking β receptors1-adrenergic relieves heart rate, reduces ejection volume and myocardial oxygen demand. Bioavailability is 90%. Plasma proteins are approximately 30% bound. It is metabolized in the liver and excreted in the urine, including 50% in the form of metabolites. T0,5 is 10-12 h, the effect is maintained for 24 h after a single administration.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. acute heart failure or conditions of decompensated heart failure requiring intravenous inotropic medication. Cardiogenic shock. Atrio-ventricular block IIst. or IIIst. (without a pacemaker). Sick node syndrome. Sinus-vestibular block. Symptomatic bradycardia (less than 45-50 beats per minute during treatment or below 50 beats per minute before starting treatment). Symptomatic hypotension (blood systolic blood pressure below 100 mm Hg). Severe bronchial asthma or severe chronic obstructive pulmonary disease. Severe peripheral arterial occlusive disease and a severe form of Raynaud's syndrome. Untreated phaeochromocytoma. Metabolic acidosis. Co-administration of floctafenine and sultopride.
Precautions:
The drug should not be used in the treatment of chronic heart failure (due to the inability to gradually increase the dose with this preparation). Due to the lack of data on safety and efficacy, it is not recommended for use in children and adolescents under 12 years of age. Caution for patients with bronchoconstriction (bronchial asthma, obstructive airways disease), diabetes mellitus with large fluctuations in blood Glucose (the risk of masking the symptoms of hypoglycaemia), with hyperthyroidism (the ability to mask the symptoms of hyperthyroidism), in people using a strict diet; during desensitization treatment (the possibility of increasing the sensitivity to allergens and the severity of anaphylactic reactions, the use of adrenaline may not always bring the expected therapeutic effects); in first degree atrioventricular block; in Prinzmetal's stuffing box; in peripheral arterial disease of the peripheral arteries (symptoms may increase, especially at the beginning of treatment); in patients with pheochromocytoma (the drug should be used only after administration of alpha-blocker drugs); in patients with a history of psoriasis or psoriasis only after careful consideration of benefits and risks; in patients using contact lenses (reduction of tear secretion and dryness of the conjunctiva); if inhaled anesthetics are used. Do not interrupt treatment with bisoprolol unless clearly indicated, especially in patients with ischemic heart disease, due to the possibility of temporary worsening of cardiac function (risk of myocardial infarction and sudden death). The preparation contains an active substance that causes positive anti-doping tests.
Pregnancy and lactation:
Bisoprolol may have a detrimental effect on pregnancy and / or the development of the fetus or newborn baby. Β-blockers reduce placental flow, which may cause fetal growth retardation, fetal death, miscarriage or premature birth. In the fetus and newborn, bisoprolol may cause, among others, hypoglycaemia and bradycardia. If beta blocker therapy is necessary, selective β-medication should be used1-adrenolitycznym. The drug should not be used during pregnancy unless it is necessary. If treatment with bisoprolol was considered necessary, the uterine-placental flow and fetal development should be monitored. The newborn should be under strict control.Symptoms of hypoglycaemia and bradycardia usually occur within 3 days after birth. Breastfeeding during administration of bisoprolol is not recommended.
Side effects:
Common: fatigue, exhaustion, dizziness, headaches (especially at the beginning of treatment, they are generally mild and often disappear within 1-2 weeks), feelings of cold or numbness in the limbs, Raynaud's syndrome, exacerbation of existing claudication, disorder gastrointestinal (nausea, vomiting, diarrhea, abdominal pain and constipation). Uncommon: sleep disturbances, depression, bradycardia, atrioventricular conduction disorders (releasing atrioventricular conduction or exacerbation of the existing atrio-ventricular block), worsening of concomitant heart failure, orthostatic hypotension, bronchospasm in patients with bronchial asthma or obstructive pulmonary disease interview, weakness and muscle spasms, joint pain, asthenia. Rare: allergic rhinitis, emergence of antinuclear antibodies with atypical clinical symptoms, such as lupus syndrome, which disappears after discontinuation of treatment, increased triglycerides, hypoglycaemia, nightmares, hallucinations, syncope, decreased tear secretion, impaired hearing, hepatitis , hypersensitivity reactions (pruritus, redness, rash), potency disorders, increased liver enzymes (ALAT, AST). Very rare: conjunctivitis, alopecia, induction or worsening of psoriasis or psoriasis-like rash.
Dosage:
Oral: it is recommended to start treatment with the lowest possible dose; initially 5 mg a day; the usual therapeutic dose is 10 mg once a day; the maximum daily dose is 20 mg. For the treatment of mild hypertension, a dose of 2.5 mg bisoprolol may be sufficient. The maximum dose of 20 mg should only be used in special cases. In patients with severe renal impairment (creatinine clearance <20 ml / min) and in patients with severe hepatic impairment, the daily dose should not exceed 10 mg. It is not necessary to change the dose in elderly patients, but it is recommended to start with the lowest possible dose. The tablets should be taken in the morning, you can during the meal with liquid.
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