What is Amlodipine / Valsartan Mylan and what is it used for?
Amlodipine / Valsartan Mylan is a medicine used in patients with essential hypertension (high blood pressure) which 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, please 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 orally with water. It is recommended that the patient take amlodipine and valsartan as separate tablets or capsules before switching to the combination tablet. The strength of the tablet to use depends on the doses of amlodipine or valsartan that the patient was taking previously.
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 medicines that have been available separately in the European Union (EU) since the mid-1990s. They work in a similar way to reduce blood pressure by allowing blood vessels to relax. By lowering blood pressure, the risks associated with high blood pressure decrease. blood pressure, such as that of stroke.
Amlopidine is a calcium channel blocker. It blocks particular channels on the cell surface through which calcium normally enters cells. When calcium enters the muscle cells of the blood vessel walls, it causes a contraction. by reducing the flow of calcium into the cells, amlodipine inhibits the contraction of cells, thus promoting relaxation of the blood vessels.
Valsartan is an 'angiotensin II receptor antagonist', meaning it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a potent vasoconstrictor (a substance that constricts blood vessels). By blocking the receptors that angiotensin II normally attaches to, valsartan blocks the hormone's effect, allowing the blood vessels to widen.
What benefit has Amlodipine / Valsartan Mylan shown during the studies?
Since 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 the active substance 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 taken as being the same as the reference medicine's.
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 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 added to the summary of product characteristics and package leaflet for Amlodipine / Valsartan Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
More information about Amlodipine / Valsartan Mylan
For the complete version of the Amlopidine / Valsartan Mylan EPAR, please consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Amlopidine / Valsartan Mylan 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.
The information on Amlodipine / Valsartan Mylan published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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