drugs

Ivabradina JensonR

What is Ivabradina JensonR and what is it used for?

Ivabradine JensonR is a heart medicine used for the symptomatic treatment of chronic stable angina pectoris (pain in the chest, jaw and back following physical exertion) in adult patients with coronary artery disease (heart disease caused by obstruction of the vessels blood vessels that supply the heart muscle). The medicine is used in patients with a normal heart rhythm whose frequency is at least 70 beats per minute. It is used both in patients who cannot take beta-blockers (another type of medicine to treat angina) or in combination with a beta-blocker in patients whose disease is not controlled by a beta-blocker alone.

Ivabradine JensonR is also used in patients with chronic heart failure (when the heart cannot pump enough blood to the rest of the body) and with a normal heart rate, whose frequency is at least 75 beats per minute. It is used in combination with standard therapy, which may include a beta-blocker.

Ivabradine JensonR contains the active substance ivabradine. It is a "generic medicine". This means that Ivabradine JensonR 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 Ivabradina JensonR used?

Ivabradine JensonR 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, which your doctor can increase to 7.5 mg twice a day or reduce to 2.5 mg (half a 5 mg tablet) twice a day depending on of the patient's heart rate and symptoms. In patients over 75 years of age, a lower starting dose of 2.5 mg can be used twice a day. Treatment should be discontinued if the heart rate decreases persistently below 50 beats per minute or if the symptoms of bradycardia (slow heart rate) continue. When used for angina, treatment should be stopped if symptoms do not improve after 3 months. In addition, the doctor should consider discontinuing treatment if the medicine has only a limited effect on reducing symptoms or heart rate.

How does Ivabradina JensonR work?

Angina symptoms are caused by the fact that the heart does not receive enough oxygenated blood. In stable angina, these symptoms occur during physical exertion. The active ingredient in Ivabradine JensonR, ivabradine, blocks the "current If" in the sinus node, the natural "pacemaker" that regulates heart rate. When this current is blocked, the heart rate is lowered so that the heart has less work to do and needs less oxygenated blood. Therefore, Ivabradine JensonR reduces or prevents the symptoms of angina.

The symptoms of heart failure are caused by the fact that the heart does not pump enough blood into the body. By lowering the heart rate, Ivabradine JensonR reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.

What benefit has Ivabradina JensonR shown during the studies?

Because Ivabradine JensonR 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 JensonR 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 Ivabradina JensonR?

Because Ivabradine JensonR 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 Ivabradina JensonR been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ivabradine JensonR 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 JensonR in the EU.

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

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivabradine Jenson have been included in the summary of product characteristics and the package leaflet.

More information on Ivabradina JensonR

The full EPAR for Ivabradine JensonR 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 JensonR, 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.