Procoralan 7.5 mg 28 tablets

Procoralan 7.5 mg 28 tablets

Composition:

Each tablet contains ivabradine — 7.5 mg.
Excipients: cellulose, stabilizers, coloring agents (per manufacturer’s specification)

Product Description:

Procoralan is a cardiovascular medicine containing the active substance ivabradine.
It is used in the treatment of chronic heart failure with reduced ejection fraction, sinus tachycardia, and stable angina pectoris.

Indications for Use:

• Symptomatic treatment of chronic stable angina in patients with ischemic heart disease and normal sinus rhythm.
• Treatment of patients intolerant to or contraindicated for beta‑blockers, or in combination with beta‑blockers when optimal doses do not adequately control symptoms.
• Treatment of chronic heart failure (NYHA class II–IV) with systolic dysfunction, sinus rhythm, and heart rate ≥ 75 bpm, in combination with standard therapy including beta‑blockers, or when beta‑blockers are contraindicated or not tolerated.
• May be prescribed for hypertension by physician’s decision.

Method of Administration and Dosage:

• Initial dose: 5 mg twice daily.
• Dose may be increased to 7.5 mg twice daily or reduced to 2.5 mg twice daily depending on patient’s heart rate.
• In patients over 75 years, a lower starting dose of 2.5 mg twice daily is recommended.
• Treatment should be discontinued if heart rate persistently falls below 50 bpm or if bradycardia symptoms occur.
• In angina, discontinue therapy if no improvement after 3 months.

Contraindications:

• Resting heart rate < 70 bpm.
• Severe hypotension.
• Cardiogenic shock, acute rhythm disorders, acute or unstable heart failure, unstable angina.
• Severe liver impairment.
• Pregnancy and breastfeeding.
• Women of childbearing potential without effective contraception.

Precautions:

Use only under medical supervision.
Monitor heart rate and symptoms during therapy.
Adjust dose or discontinue if bradycardia or adverse effects occur.

Adverse Effects:

Most common: visual disturbances (“phosphenes” — transient brightness in the visual field).
Possible: cough, diarrhea or constipation, dizziness, erectile dysfunction, nervousness, fatigue, weakness, drowsiness, headache, nausea, vomiting.
Rare: allergic reactions.

Pregnancy and Lactation:

Contraindicated.
Use only if prescribed by a physician when no alternatives are available.

Storage Conditions:

Store at room temperature (20–25 °C), out of reach of children and pets.
Do not use damaged tablets.

Packaging:

Cardboard box containing 4 blisters of 7 tablets each (28 tablets total), with patient information leaflet.