Procoralan is a medicine that contains the active substance ivabradine. It is available as tablets (5 and 7.5 mg. The 5 mg tablets have a score line that enables them to be divided into two halves each containing 2.5 mg ivabradine).
The recommended starting dose is 5 mg twice a day, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg twice a day depending on the patient’s heart rate. If the heart rate decreases during treatment to between 50 and 60 beats per minute, the dose of 5 mg twice daily should be maintained. The adjustment is made after three to four weeks in long-term stable angina and after two weeks in long-term heart failure. In patients over 75 years old, a lower starting dose of 2.5 mg twice a day can be used. For angina, the starting dose should never exceed 5 mg twice daily in patients under 75 years of age. Treatment must be stopped if the heart rate decreases persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue. When used for angina, treatment should be stopped if there is no improvement in symptoms after 3 months and the doctor should consider stopping treatment if the improvement in symptoms or the reduction in the heart rate is only limited.
The most common side effect with Procoralan (seen in more than 1 patient in 10) is luminous phenomena or ‘phosphenes’ (a temporary brightness in the field of vision). For the full list of all side effects reported with Procoralan, see the package leaflet.
Procoralan must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems. It must not be used in women who are pregnant, breast-feeding or by women who could become pregnant and who are not using appropriate contraceptives. For the full list of restrictions, see the package leaflet.
Caution is needed if Procoralan is taken with some other medicines. See the package leaflet for full details.
A risk management plan has been developed to ensure that Procoralan is used as safely and effectively as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Procoralan, including the appropriate precautions to be followed by healthcare professionals and patients.
The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.
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