hypertension drugs

Amlodipine / Valsartan Mylan

What is Amlodipina / Valsartan Mylan used for and what is it used for?

Amlodipine / Valsartan Mylan is a medicine used in patients with essential hypertension (high blood pressure) that is not adequately controlled with amlodipine or valsartan alone. The term "essential" indicates that hypertension has no obvious cause.

Amlodipine / Valsartan Mylan contains two active substances, amlodipine and valsartan. It is a "generic medicine". This means that Amlodipine / Valsartan Mylan is similar to a 'reference medicine' already authorized in the European Union (EU) called Exforge. For more information on generic medicines, see the questions and answers by clicking here.

How is Amlodipine / Valsartan Mylan used?

Amlodipine / Valsartan Mylan is available as tablets (5 mg of amlodipine and 80 mg of valsartan; 5 mg of amlodipine and 160 mg of valsartan; 10 mg of amlodipine and 160 mg of valsartan). The usual dose is one tablet a day by mouth with water. It is recommended that the patient takes amlodipine and valsartan as separate tablets or capsules before switching to the combined tablet. The dosage of the tablet to be used depends on the doses of amlodipine or valsartan that the patient previously took.

The medicine can only be obtained with a prescription.

How does Amlodipine / Valsartan Mylan work?

Amlodipine / Valsartan Mylan contains two active substances, amlodipine and valsartan. Both are two antihypertensive drugs available separately in the European Union (EU) since the mid-1990s. They act in a similar way to reduce blood pressure by allowing the blood vessels to relax. With the reduction in blood pressure, the risks associated with high blood pressure, such as stroke, decrease.

Amlopidine is a calcium channel blocker. It blocks particular channels on the cell surface through which calcium normally enters cells. When calcium penetrates the cells of the muscles of the blood vessel walls, it causes a contraction. By reducing the flow of calcium in the cells, amlodipine inhibits the contraction of cells, thus promoting the relaxation of blood vessels.

Valsartan is an "angiotensin II receptor antagonist", meaning that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, valsartan blocks the effect of the hormone, allowing the blood vessels to dilate.

What benefit has Amlodipine / Valsartan Mylan shown during the studies?

Because Amlodipine / Valsartan Mylan is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Exforge. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.

What is the risk associated with Amlodipine / Valsartan Mylan?

Because Amlodipine / Valsartan Mylan 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 Amlodipine / Valsartan Mylan been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Amlodipine / Valsartan Mylan has been shown to have comparable quality and to be bioequivalent / comparable to Exforge. Therefore, the CHMP considered that, as in the case of Exforge, the benefits outweigh the identified risks. and recommended to approve the use of Amlodipine / Valsartan Mylan in the EU.

What measures are being taken to ensure the safe and effective use of Amlodipine / Valsartan Mylan?

A risk management plan has been developed to ensure that Amlodipine / Valsartan Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Amlodipine / Valsartan Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.

More information on Amlodipina / Valsartan Mylan

For the full EPAR version of Amlopidine / Valsartan Mylan, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Amlopidine / Valsartan Mylan, 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.