What is Ivabradine Zentiva used for and what is it used for?
Ivabradine Zentiva is a heart medicine used to treat long-term stable angina symptoms (chest, jaw and back pain caused by physical exertion) in adults with coronary artery disease (heart disease caused by heart block blood vessels supplying the heart muscle). The medicine is used in patients with normal heart rhythms whose heart rate is at least 70 beats per minute. It is indicated in patients who cannot take beta-blockers (another type of medicine used to treat angina) or in combination with a beta-blocker in patients whose disease is not completely controlled with a beta-blocker.
Ivabradine Zentiva is also used in patients with long-term heart failure (a condition in which the heart cannot pump enough blood to other parts of the body) and normal heart rate, whose heart rate is at least 75 beats per minute . It is used in combination with a standard therapy including beta-blockers or in patients who cannot be treated with beta-blockers.
Ivabradine Zentiva contains the active substance ivabradine. It is a "generic medicine". This means that Ivabradine Zentiva is similar to a 'reference medicine' already authorized in the European Union (EU) called Procoralan. For more information on generic medicines, see the questions and answers by clicking here.
How is Ivabradine Zentiva used?
Ivabradine Zentiva is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription. The recommended starting dose is 5 mg twice a day, with meals; your doctor may increase this dose to 7.5 mg twice a day or decrease it to 2.5 mg (half a 5 mg tablet) twice a day, depending on your heart rate and your patient's symptoms. In subjects over 75 years of age, a lower starting dose of 2.5 mg can be used twice a day. Treatment should be stopped if the heart rate decreases persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) persist. In the treatment of angina, if there is no improvement in symptoms within 3 months of starting treatment, treatment should be stopped. Furthermore, if the medicine has only a limited effect on reducing symptoms or reducing heart rate, your doctor should consider stopping treatment.
How does Ivabradine Zentiva work?
The symptoms of angina are due to an insufficient supply of oxygenated blood to the heart. In stable angina these symptoms occur during physical exertion. The active ingredient in the medicine Ivabradine Zentiva, ivabradine, blocks the "current If" in the sinus node, the natural "pacemaker" that regulates the heart rate. When this current freezes, the heart rate decreases, causing the heart to work less and therefore need less oxygenated blood. Ivabradine Zentiva therefore reduces or prevents the symptoms of angina.
The symptoms of heart failure are due to the fact that the amount of blood pumped from the heart into the body is not enough. By reducing the heart rate, Ivabradine Zentiva reduces heart stress, slowing the progression of heart failure and improving symptoms.
What benefit has Ivabradine Zentiva shown during the studies?
Because Ivabradine Zentiva is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Procoralan. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
Because Ivabradine Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
What are the risks associated with Ivabradine Zentiva?
Because Ivabradine Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Ivabradine Zentiva been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ivabradine Zentiva has been shown to have comparable quality and to be bioequivalent to Procoralan. Therefore, the CHMP considered that, as in the case of Procoralan, the benefits outweigh the identified risks and recommended to approve the use of Ivabradine Zentiva in the EU.
What measures are being taken to ensure the safe and effective use of Ivabradine Zentiva?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivabradine Zentiva have been included in the summary of product characteristics and the package leaflet.
More information on Ivabradine Zentiva
The full EPAR for Ivabradine Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Ivabradine Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website.
