Bisoprolol-Teva tablets coated.pl.ob. 5 mg 30 pcs. (bisoprolol)

Release form

film-coated tablets.

Packing

30 pcs.

Pharmacological action

Bisoprolol-Teva has an antianginal, antiarrhythmic, hypotensive effect.

Contraindications

Hypersensitivity, sinus bradycardia (less than 45-50 beats / min), sinus node weakness syndrome, sinoatrial and AV block II – III degree, cardiogenic shock, acute and refractory to treatment severe heart failure, acute myocardial infarction, arterial hypotension (SBP below 90 mm Hg), severe obstructive respiratory failure, pregnancy, breastfeeding.

Use during pregnancy and lactation

It is possible if the expected effect of the therapy on the mother outweighs the potential risk to the fetus and the baby (there were no adequate and strictly controlled studies on the safety of pregnant and lactating women). Since there is a risk of developing bradycardia, hypotension, hypoglycemia, and respiratory distress (neonatal asphyxia) in newborns, treatment with bisoprolol fumarate should be discontinued 48–72 hours before delivery. If this is not possible, the newborn should be under close medical supervision for 48–72 hours after birth. The secretion of bisoprolol fumarate with breast milk has not been studied, but since it is secreted into breast milk in rats (less than 2%), infants should be under medical supervision.

Special instructions

Test results may be changed during laboratory testing.

Composition

1 tablet contains bisoprolol fumarate 5 mg excipients: croscarmellose sodium (primellose), povidone (polyvinylpyrrolidone medium molecular weight), pregelatinized starch (starch 1500), silicon dioxide colloidal sucrose, cellulose microcrystalline sucrose (cellulose microcrystalline sucrose) , magnesium stearate film coating composition: Opadry II (polyvinyl alcohol, partially hydrolyzed, titanium dioxide, talc, macrogol (polyethylene glycol 3350), iron dye oxide (II)).

Dosage and administration of

Bisoprolol-Teva is taken orally, without chewing, with a small amount of liquid, in the morning on an empty stomach or during breakfast 1.25-10 mg 1 time per day. The dosing regimen is individual, the dose is increased under the control of blood pressure and pulse. Arterial hypertension and angina pectoris: 5–10 mg mild arterial hypertension (dAD less than 105 mm Hg): 2.5 mg chronic heart failure: 1.25 mg / day (for 1 week), then with good tolerance the dose increase to 2.5 mg / day (1 week), 3.75 mg / day (1 week), 5 mg / day (4 weeks), 7.5 mg / day (4 weeks), then 10 mg / day (target dose). The maximum daily dose for adults is 20 mg.

Side effects

The frequency of side effects is indicated with doses not exceeding 40 mg.

From the side of the nervous system and sensory organs: dizziness (3.5%), insomnia (2.5%), asthenia (1.5%), hypesthesia (1.5%), depression (0.2%), drowsiness , anxiety, paresthesia (feeling cold in the extremities), hallucinations, impaired thinking, concentration, orientation in time and space, balance, emotional lability, tinnitus, conjunctivitis, visual disturbances, decreased secretion of lacrimal fluid, convulsions.

From the cardiovascular system and blood (hematopoiesis, hemostasis): bradycardia (0.5%), arrhythmia, palpitations, AV block, hypotension, heart failure, impaired microcirculation in the myocardium and limbs, intermittent claudication, vasculitis, agranulocytosis, thrombocytopenia thrombocytopenic purpura.

From the digestive tract: diarrhea (3.5%), nausea (2.2%), vomiting (1.5%), dry mouth (1.3%), dyspeptic symptoms, constipation, ischemic colitis, mesenteric thrombosis arteries.

Respiratory system: cough (2.5%), shortness of breath (1.5%), bronchus and laryngospasm, pharyngitis (2.2%), rhinitis (4%), sinusitis (2.2%), infections respiratory tract (5%), respiratory distress syndrome.

From the genitourinary system: peripheral edema (3%), decreased libido, impotence, Peyronie's disease, cystitis, renal colic.

From the skin: rash, acne, eczema-like reactions, prurigo, redness of the skin, hyperhidrosis, dermatitis, alopecia.

From the side of metabolism: increased concentration of liver enzymes (AST, ALT), hyperglycemia or increased glucose tolerance, hyperuricemia, a change in the concentration of potassium in the blood.

Other: pain (headache - 10.9%, arthralgia - 2.7%, myalgia, pain in the abdomen, chest - 1.5%, eyes, ears), weight gain.

Drug interaction

The probability of impaired automatism, conduction and contractility of the heart increases (mutually) against amiodarone, diltiazem, verapamil, quinidine preparations, cardiac glycosides, reserpine, alpha-methyldopa. Concomitant administration of dihydropyridine calcium antagonists, especially in patients with latent heart failure, increases the risk of hypotension and decompensation of cardiac activity. Xanthines and sympathomimetics decrease effectiveness, rifampicin reduces T1 / 2, ergotamine derivatives potentiate peripheral circulation disturbance. Incompatible with MAO inhibitors.

overdose

Symptoms: bradycardia, arrhythmia, hypotension, heart failure (shortness of breath, acrocyanosis, edema), hypoglycemia, in severe cases - collapse.

Treatment: gastric lavage and the appointment of adsorbing agents, symptomatic therapy: atropine, beta-adrenomimetics (isoprenaline), sedatives (diazepam, lorazepam) and cardiotonic (dobutamine, dopamine, epinephrine, norepinephrine, etc.) With blockade of the heart - transvenous stimulation, the connection of an artificial rhythm driver.

Storage Conditions

The product should be stored in a dry, dark place inaccessible to children at a temperature not exceeding 25 ° C.

Shelf life

3 years.

Deystvuyushtee substance

Bisoprolol

Terms and conditions

prescription

dosage form

tablets

Appointment

Prescribing

For adults as prescribed by a doctor

Teva Ltd., Israel



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