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Amlodipine / Valsartan Mylan

Active Substance: amlodipine besilate / valsartan
Common Name: amlodipine / valsartan
ATC Code: C09DB01
Marketing Authorisation Holder: Mylan S.A.S
Active Substance: amlodipine besilate / valsartan
Status: Authorised
Authorisation Date: 2016-03-22
Therapeutic Area: Hypertension
Pharmacotherapeutic Group: Agents acting on the renin-angiotensin system

Therapeutic Indication

Treatment of essential hypertension.

Amlodipine/Valsartan Mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

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

Amlodipine/Valsartan Mylan is a medicine used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone. ‘Essential’ means that the 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 authorised in the European Union (EU) called Exforge.

How is Amlodipine/Valsartan Mylan used?

Amlodipine/Valsartan Mylan is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan). One tablet is taken daily by mouth with water. It is recommended that the patient takes amlodipine and valsartan as separate tablets or capsules before switching to the combination tablet. The strength of the tablet to be used depends on the doses of amlodipine or valsartan that the patient was taking before.

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 anti–hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s. They work in similar ways to reduce blood pressure by allowing the blood vessels to relax. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

Amlodipine is a calcium channel blocker. It blocks special channels on the surface of cells through which calcium normally enters the cells. When calcium enters the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.

Valsartan is an ‘angiotensin II receptor antagonist’, which means 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 stops the hormone having an effect, allowing the blood vessels to widen.

How has Amlodipine/Valsartan Mylan been studied?

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

What are the benefits and risks of Amlodipine/Valsartan Mylan?

Because Amlodipine/Valsartan Mylan 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 is Amlodipine/Valsartan Mylan 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/be comparable to Exforge. Therefore, the CHMP’s view was that, as for Exforge, the benefit outweighs the identified risk. The Committee recommended that Amlodipine/Valsartan Mylan be approved for use 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.

Other information about Amlodipine/Valsartan Mylan

The European Commission granted a marketing authorisation valid throughout the European Union for Amlodipine/Valsartan Mylan on 22 March 2016.

For more information about treatment with Amlodipine/Valsartan Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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