Irbesartan Teva

What is Irbesartan Teva?

Irbesartan Teva is a medicine that contains the active substance irbesartan. available as white, oval-shaped tablets (75, 150 and 300 mg).
Irbesartan Teva is a 'generic medicine', which implies that it is similar to a 'reference medicine' already authorized in the European Union (EU) called Aprovel. For more information on generic medicines, please see the questions and answers by clicking here.

What is Irbesartan Teva used for?

Irbesartan Teva is used in patients with essential hypertension (high blood pressure). The term "essential" means that hypertension has no obvious cause. Irbesartan Teva is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes). The use of Irbesartan Teva is not recommended for patients under 18 years of age because there is no information on safety and efficacy for this age group.
The medicine can only be obtained with a prescription.

How is Irbesartan Teva used?

Irbesartan Teva is taken by mouth, with or without meals. The usually recommended dose is 150 mg once a day. If blood pressure is not sufficiently controlled, the dose can be increased to 300 mg per day or other medicines for hypertension, such as hydrochlorothiazide, can be added. A starting dose of 75 mg can be used in patients undergoing hemodialysis (a blood purification technique) or in patients over 75 years of age.
In patients with hypertension and type 2 diabetes, Irbesartan Teva is added to other treatments for hypertension. Treatment starts with a dose of 150 mg once daily, which is usually increased to 300 mg once daily. day.

How does Irbesartan Teva work?

The active substance in Irbesartan Teva, irbesartan, is an 'angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II, which is a potent vasoconstrictor (a substance that constricts blood vessels By blocking the receptors that angiotensin II normally attaches to, irbesartan blocks the hormone's effect, allowing the blood vessels to widen. This results in a drop in blood pressure and reduces the risks associated with high blood pressure, such as stroke.

How has Irbesartan Teva been studied?

Since Irbesartan Teva is a generic medicine, the studies were limited to evidence designed to show that the medicine is bioequivalent to the reference medicine Aprovel. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Irbesartan Teva?

Because Irbesartan Teva is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks are assumed to be the same as the reference medicine.

Why has Irbesartan Teva been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Irbesartan Teva has been shown to have comparable quality and to be bioequivalent to Aprovel. It is therefore the view of the CHMP that, as in the case of Aprovel, the benefits outweigh the identified risks. The Committee recommended that Irbesartan Teva be given a Marketing Authorization.

More information about Irbesartan Teva

On 30 October 2009, the European Commission released Teva Pharma B.V. a "Marketing Authorization" for Irbesartan Teva, valid throughout the European Union.
The full version of the EPAR for Irbesartan Teva can be found here.
The full EPAR version of the reference medicine can also be found on the Agency's website.

Last update of this summary: 08-2009.

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