What is it?

irbesartan and hydrochlorothiazide

EPAR summary for the public

This document is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

is a medicine that contains two active substances, irbesartan and hydrochlorothiazide. It is available as pink, capsule-shaped tablets (150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; and 300 mg irbesartan and 25 mg hydrochlorothiazide). is a ?generic medicine?. This means that
is similar to a ?reference medicine? already authorised in the European Union (EU) called CoAprovel. For more information on generic medicines, see the question-and-answer document here.

How is it used?

What is used for?

is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone. ?Essential? means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.

How is used?

is taken by mouth, with or without food. The dose of Irbesartan/Hydrochlorothiazide Teva to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before. Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended. may be added to other treatments for hypertension.

How does it work?

How does work?

contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan 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, irbesartan stops the hormone having an effect, allowing the blood vessels to widen. Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension. It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.

The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

How has it been studied?

How has been studied?

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

What benefits has it shown during the studies?

Because is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.

What is the risk associated?

Because is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.

Why has it been approved?

Why has been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, has been shown to have comparable quality and to be bioequivalent to CoAprovel. Therefore, the CHMP?s view was that, as for CoAprovel, the benefit outweighs the identified risk. The Committee recommended that
be given marketing authorisation.

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