Avecor 5 mg Film-Coated Tablets

Composition:

Each film-coated tablet contains:
Active substance: Bisoprolol fumarate – 5 mg.

Excipients: Microcrystalline cellulose, lactose, sodium starch glycolate, purified talc, magnesium stearate, colloidal silicon dioxide, sodium croscarmellose (in Avecor 2.5), coating mix "White Coating Premix" (hypromellose, propylene glycol, purified talc, titanium dioxide (E171) – in Avecor 2.5), and coating mix "Instacoat – Pink 1011" (hypromellose, polyethylene glycol, purified talc, ponceau 4R (E124), titanium dioxide (E171) – in Avecor 5 and 10).

Indications:

• Arterial hypertension

• Coronary heart disease (angina pectoris)

• Chronic heart failure

Dosage and Administration:

For arterial hypertension and ischemic heart disease, the recommended dose is 5 mg once daily.
Treatment can begin with 2.5 mg bisoprolol fumarate, and if necessary, the daily dose may be increased to 10 mg. Further increase is only allowed in exceptional cases. The dose should be individualized based on treatment response and heart rate.
Patients with mild to moderate liver or kidney dysfunction or elderly patients usually do not require dose adjustment. For patients with severe hepatic or renal impairment (creatinine clearance <20 ml/min), the daily dose should not exceed 10 mg.

For chronic heart failure, Avecor 5 mg is prescribed for patients with moderately to severely expressed failure (ejection fraction ≤35%) with no exacerbation in the past 6 weeks. Treatment should be in combination with other therapies (e.g. ACE inhibitors or other vasodilators, diuretics, and, if necessary, cardiac glycosides).
Titration schedule:

• Week I: 1.25 mg once daily

• Week II: 2.5 mg once daily

• Week III: 3.75 mg once daily

• Weeks IV–VIII: 5 mg once daily

• Weeks IX–XII: 7.5 mg once daily

• From Week XIII: Maximum dose of 10 mg once daily

Dose adjustments may be needed based on the patient's tolerance. Monitoring during the first 4 hours of therapy initiation should include blood pressure, heart rate, ECG, and symptoms of heart failure.

If adverse effects occur at maximum dosage, dose reduction or discontinuation may be required, with potential resumption per the same titration scheme. Discontinue immediately in case of severe hypotension, worsening heart failure, pulmonary edema, cardiogenic shock, bradycardia, or AV block.

Tablets should be taken in the morning, on an empty stomach or with breakfast, with a small amount of water, without chewing. Treatment is usually long-term, and withdrawal must be gradual.
In coronary artery disease or chronic heart failure, reduce the dose weekly by half. The treatment duration and discontinuation must be determined by a physician.

Pregnancy and Lactation:

Use of the medication during pregnancy and breastfeeding is contraindicated, as there are no clinical data confirming its safety.
If necessary, bisoprolol may be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.
Use during the third trimester may cause bradycardia, hypotension, respiratory depression, and hypoglycemia in the fetus/newborn. Discontinue 72 hours before expected delivery. If not possible, monitor the newborn closely. Symptoms of hypoglycemia may appear within the first 3 days of life.

Storage Conditions:

Store at a temperature not exceeding 25°C, in a dry place, out of the reach of children.
Do not use the medication if any visible defects are detected.