Ivabradine Zentiva

What is Ivabradine Zentiva and what is it used for?

Ivabradine Zentiva is a heart medicine used to treat the symptoms of long-term stable angina (pain in the chest, jaw and back caused by physical exertion) in adults with coronary artery disease (heart disease caused by blockage of the blood vessels that supply the heart muscle) The medicine is used in patients with normal heart rhythm, whose heart rate is at least 70 beats per minute. It is used in patients who cannot take beta-blockers (another type of medicine used). in the treatment of angina) or in combination with a beta-blocker in patients whose disease is not fully 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 rhythm, whose heart rate is at least 75 beats per minute. . It is used in combination with 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, please 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 the patient's heart rate and symptoms. In people over 75 years of age, a lower starting dose of 2.5 mg twice daily can be used. Treatment should be stopped if heart rate decreases persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) persist. In the treatment of angina, if symptoms do not improve within 3 months of starting therapy, treatment should be stopped. Also, 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 substance in the medicine Ivabradine Zentiva, ivabradine, blocks the "If current" in the sinus node, the natural "pacemaker" that regulates heart rate. When this current is blocked, the heart rate decreases, causing the the heart works less and therefore requires 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 to the body is not enough. By reducing the heart rate, Ivabradine Zentiva reduces stress on the heart, slowing the progression of heart failure and improving symptoms.

What benefit has Ivabradine Zentiva shown during the studies?

Since 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 the active substance in the body.

Because Ivabradine Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

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 taken as being the same as the reference medicine's.

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 that Ivabradine Zentiva be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Ivabradine Zentiva?

The recommendations and precautions that healthcare professionals and patients need to observe in order for Ivabradine Zentiva to be used safely and effectively have been set out in the summary of product characteristics and package leaflet.

Other information about Ivabradine Zentiva

For the complete version of Ivabradine Zentiva's EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Ivabradine Zentiva therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. The full EPAR version of the reference medicine can also be found on the Agency's website.

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