Procoralan - ivabradine

What is Procoralan?

Procoralan is a salmon-colored tablet (5 mg oblong, 7.5 mg triangular shaped) to be taken by mouth. The active substance is ivabradine in the strengths of 5 and 7.5 mg.

What is Procoralan used for?

Procoralan is used in the symptomatic treatment of chronic stable angina pectoris (pain in the chest, jaw and back following physical exertion, due to problems with the blood supply to the heart). Procoralan is used in patients with normal sinus rhythm (heartbeat) who cannot be treated or who cannot tolerate therapy with beta blockers (another medicine to treat angina).
The medicine can only be given with a prescription.

How is Procoralan used?

Procoralan is taken by mouth with meals twice a day, in the morning and in the evening.
The recommended starting dose is 5 mg twice a day. In patients over 75 years of age it is possible to start with a dose of 2.5 mg up to a dose of 5 mg. After 3-4 weeks of treatment the dose can be increased to 7.5 mg twice daily, depending on the individual response.

How does Procoralan work?

Symptoms of angina (pain in the chest, arm or jaw) are due to an insufficient supply of oxygenated blood to the heart. In chronic stable angina, these symptoms occur during physical exertion. Procoralan is a medicine that selectively reduces heart rate. The active substance in the medicine, ivabradine, works by inhibiting the lf channels, the specialized cells located in the sinus node, the natural pacemaker that controls the heart's contractions and regulates the heart rate. cardiac decreases, the heart works less and therefore requires less oxygenated blood. Procoralan therefore works by reducing or preventing the symptoms of angina.

How has Procoralan been studied?

Procoralan has been the subject of four clinical trials lasting 3 or 4 months involving a total of 3 222 patients, of whom 2 168 were treated with Procoralan. The medicine was compared with placebo (a dummy treatment), atenolol or amlodipine (other anti
angina). The medicine was also studied as an add-on treatment in patients taking amlodipine concomitantly. Effectiveness was primarily assessed by physical tests, such as measuring the amount of movement the patient could do before angina set in.

What benefit has Procoralan shown during the studies?

Procoralan was significantly better than placebo in increasing exercise endurance and as effective as atenolol and amlodipine. Adding Procoralan to amlodipine therapy showed no additional benefit.

What are the risks associated with Procoralan?

The most common side effect, which occurs in more than one in 10 patients, is constituted by light phenomena or "phosphenes" (temporary light sensation in the visual field). Other side effects are blurred vision, bradycardia (very low heart rate), heartbeat irregular headache (usually during the first month of treatment) and dizziness For the full list of side effects reported with Procoralan, see the package insert.
Procoralan should not be used in patients who may be hypersensitive (allergic) to ivabradine or any of the other ingredients, in patients with a resting heart rate below 60 beats per minute, in patients with very low blood pressure, in patients with from various heart diseases (cardiogenic shock, heart rhythm disturbances, heart attack, heart failure), in patients with severe liver problems and in patients who are pregnant or breastfeeding. For the complete list of limitations, see the package insert.

Why has Procoralan been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Procoralan has shown sufficient anti-angina efficacy and an acceptable safety profile as an alternative treatment for patients suffering from chronic stable angina pectoris with normal sinus rhythm who cannot be treated with beta blockers. The CHMP considered that the benefits outweigh the risks and therefore recommended the granting of the "Marketing Authorization".

Learn more about Procoralan:

On 25 October 2005, the European Commission granted to Les Laboratoires Servier the marketing authorization for Procoralan valid throughout the European Union.
For the full EPAR version of Procoralan, click here.

Last update of this summary: March 2006


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