Bisoprolol Teva tablets 10 mg 30 pcs.

• active ingredient: bisoprolol;
• 1 tablet contains bisoprolol hemifumarate 10 mg;
• excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, magnesium stearate;
• for 10 mg tablets, beige dye RV 27215 (which contains: lactose monohydrate, iron oxide yellow (E 172), iron oxide red (E 172)).

• hypersensitivity to bisoprolol, other β-blockers or any components of the drug;
• − acute heart failure or heart failure in a state of decompensation requiring intravenous inotropic therapy;
• cardiogenic shock;
• atrioventricular block of the 2nd and 3rd degree (except in patients with an artificial pacemaker);
• sick sinus syndrome;
• sinoatrial block;
• symptomatic bradycardia;
• symptomatic arterial hypotension;
• severe bronchial asthma or severe chronic obstructive pulmonary disease;
• severe forms of peripheral arterial occlusive disease or severe forms of Raynaud’s syndrome;
• metabolic acidosis;
• untreated pheochromocytoma;
• simultaneous use with floctafenine and sultopride.

Immune system disorders: Rare: appearance of antinuclear antibodies with specific clinical symptoms such as lupus-like syndrome, which resolves after discontinuation of treatment.

Metabolism and nutrition disorders: Rare: hypoglycemia.

Psychiatric disorders: Uncommon: sleep disorders, depression. Rare: nightmares, hallucinations.

Nervous system disorders: Common: fatigue, exhaustion, dizziness*, headache*. Rare: loss of consciousness.

On the part of the organs of vision. Rare: decreased lacrimation (should be taken into account when wearing contact lenses). Very rare: conjunctivitis.

Cardiac disorders: Very common: bradycardia (in patients with chronic heart failure). Common: signs of worsening of pre-existing heart failure (in patients with chronic heart failure). Uncommon: bradycardia (in patients with hypertension or coronary heart disease), atrioventricular conduction disorders, signs of worsening of pre-existing heart failure (in patients with hypertension or coronary heart disease).

Vascular disorders: Common: feeling of coldness or numbness of the extremities, worsening of pre-existing intermittent claudication, hypotension (especially in patients with heart failure). Uncommon: orthostatic hypotension.

Gastrointestinal disorders: Common: gastrointestinal complaints such as nausea, vomiting, diarrhea, abdominal pain, constipation.

The tablets are intended for oral administration. Bisoprolol-Teva tablets should be taken in the morning on an empty stomach, during or after breakfast, swallowed without chewing, with a small amount of liquid. The tablet can be divided into equal doses.

Arterial hypertension; coronary heart disease (angina pectoris)

Treatment should be started gradually with low doses and then increased. The recommended dose is 5 mg per day. In case of moderate hypertension (diastolic blood pressure up to 105 mm Hg), a dose of 2.5 mg is suitable.

If necessary, the daily dose can be increased to 10 mg per day. Further dose increases are justified only in exceptional cases. The maximum recommended dose is 20 mg per day.

Dose adjustments are determined by the physician individually depending on pulse rate and therapeutic benefit.

Chronic heart failure with left ventricular systolic dysfunction in combination with ACE inhibitors, diuretics, and if necessary, cardiac glycosides

Standard therapy for chronic heart failure: ACE inhibitors (or angiotensin receptor blockers in case of intolerance to ACE inhibitors), β-adrenergic blockers, diuretics and, if necessary, cardiac glycosides.

Bisoprolol is prescribed for the treatment of patients with chronic heart failure without signs of exacerbation.

Therapy should be carried out by a doctor with experience in the treatment of chronic heart failure.

Bisoprolol at a dose of 2.5 mg is recommended for use at the beginning of therapy for chronic heart failure.

The maximum recommended dose is 10 mg once a day.

Use during pregnancy or breastfeeding

During pregnancy, the drug should be used only if the expected benefit to the mother outweighs the potential risk to the fetus. It is necessary to monitor uteroplacental blood flow and fetal growth. In case of harmful effects on the course of pregnancy or the fetus, alternative treatment should be considered.

Breastfeeding. There is no data on the excretion of bisoprolol into breast milk. Therefore, taking the drug is not recommended during breastfeeding.

Children

There is no clinical data on the efficacy and safety of the drug for the treatment of children, therefore the drug should not be used in this category of patients.

Ability to influence reaction speed when driving vehicles or other mechanisms

It has been reported that in patients with coronary heart disease, the drug did not affect the ability to drive. However, in individual cases, the drug may affect the ability to drive or operate complex mechanisms. Special caution is required at the beginning of treatment, when changing the dose of the drug or when interacting with alcohol.

Symptoms

In case of overdose (for example, using a daily dose of 15 mg instead of 7.5 mg), cases of third-degree atrioventricular block, bradycardia and dizziness have been recorded. The most common signs of overdose with β-blockers are bradycardia, arterial hypotension, acute heart failure, bronchospasm, hypoglycemia. There is a wide variability in individual sensitivity to a single high dose of bisoprolol, patients with heart failure may be more sensitive to the drug. Therefore, treatment should be started with a gradual increase in dosage.

Treatment

In case of overdose, treatment with the drug is discontinued and supportive and symptomatic therapy is carried out. There is limited evidence that bisoprolol is difficult to dialyze. In case of suspected overdose, in accordance with the expected pharmacological action and based on recommendations for other β-blockers, the following general measures should be considered.

For bradycardia: intravenous atropine. If there is no response, isoprenaline or another drug with a positive chronotropic effect is administered with caution. In exceptional cases, transvenous administration of an artificial pacemaker may be necessary.

For hypotension: intravenous fluids and vasoconstrictors. Intravenous glucagon may be useful.

In case of second and third degree atrioventricular block: careful observation and infusion of isoprenaline or transvenous pacemaker.

In case of exacerbation of chronic heart failure: intravenous administration of diuretics, inotropic drugs, vasodilators.

For bronchospasm: bronchodilators (e.g. isoprenaline), β2-adrenomimetics and/or aminophylline.

For hypoglycemia: intravenous glucose administration.

Store at a temperature not exceeding 25 ° C in the original packaging in order to protect from moisture. Keep out of the reach of children.