Procoralan is a medicine that contains the active substance ivabradine. It is available as salmon-coloured tablets (oblong: 5 mg; triangular: 7.5 mg). The 5-mg tablets have a score line that enables them to be divided into two equal halves, each containing 2.5 mg ivabradine.
|Table of Contents|
|What is it used for?|
|How is it used?|
|How does it work?|
|How has it been studied?|
|What benefits has it shown during the studies?|
|What is the risk associated?|
|Why has it been approved?|
Procoralan is used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort and due to problems with the blood flow to the heart). It is used in adults (aged 18 years or over) with coronary artery disease (obstruction of the blood vessels that supply the heart) who have a normal sinus rhythm (heartbeat). It can be used in the following groups:
- patients who cannot take or tolerate beta-blockers (another type of medicine to treat angina);
- patients whose disease is not controlled with beta-blockers and whose heart rate is above 60 beats per minute. Procoralan is used in combination with beta-blockers in these patients.
The medicine can only be obtained with a prescription.
Procoralan is taken twice a day with meals, once in the morning and once in the evening.
The recommended starting dose is 5 mg twice a day, although 2.5 mg twice a day can be used in patients over the age of 75 years, before the dose is increased to 5 mg twice a day. After three to four weeks of treatment, the dose may be increased to 7.5 mg twice a day depending on the patient?s response.
The symptoms of angina are caused by the heart not receiving enough oxygenated blood. In stable angina, these symptoms appear during physical effort. The active substance in Procoralan, ivabradine, works by blocking the ?I f currents? in the sinus node, the ?pacemaker? for the heart that controls the heart?s contractions and regulates the heart rate. When these currents are blocked, the heart rate is lowered, so that the heart has less work to do and needs less oxygenated blood. Procoralan therefore reduces or prevents the symptoms of angina.
Procoralan has been studied in five main studies involving over 4,000 adults with long-term stable angina. The medicine was compared with placebo (a dummy treatment) in 360 patients, atenolol (a beta-blocker) in 939 patients and amlodipine (another medicine used to treat angina) in 1,195 patients. It was also compared with placebo as an add-on to atenolol in 889 patients and as an add-on to amlodipine in 728 patients. Each study lasted three to four months. The main measure of effectiveness was how long the patients could exercise on a bicycle or a treadmill, measured at the start and the end of each study.
Procoralan was more effective than placebo at improving exercise capacity and was as effective as atenolol and amlodipine. Procoralan was also more effective than placebo when added to atenolol. However, adding Procoralan to amlodipine did not provide an additional benefit.
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 should not be used in people who may be hypersensitive (allergic) to ivabradine or any of the other ingredients. It must not be used in patients who have a resting heart rate below 60 beats per minute, very low blood pressure, various types of heart disorder (cardiogenic shock, rhythm disorders, heart attack or heart failure) or severe liver problems. It must not be used in women who are pregnant or breast-feeding. 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.
The CHMP concluded that Procoralan has sufficient effectiveness against angina and an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta-blockers or whose disease is not controlled with them. The Committee decided that Procoralan?s benefits are greater than its risks and recommended that it be given marketing authorisation.