What is Irbesartan Teva?
Irbesartan Teva is a medicine that contains the active substance irbesartan. available in white, oval tablets (75, 150 and 300 mg).
Irbesartan Teva is a "generic medicine", which means that it is similar to a "reference medicine" already authorized in the European Union (EU) called Aprovel. For more information on generic medicines, 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" indicates 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 in patients below 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 should be taken by mouth, with or without food. The usual recommended dose is 150 mg once a day. If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines can be added for hypertension, such as hydrochlorothiazide. 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 begins with a dose of 150 mg once a day, which is usually increased up to 300 mg once a day.
How does Irbesartan Teva work?
The active substance in Irbesartan Teva, irbesartan, is an "angiotensin II receptor antagonist", which means it blocks the action of a hormone in the body called angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels ). By blocking the receptors to which angiotensin II normally attaches, irbesartan blocks the effect of the hormone, allowing the blood vessels to dilate. This causes a drop in blood pressure and reduces the risks associated with high blood pressure, such as stroke.
How has Irbesartan Teva been studied?
Because Irbesartan Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Aprovel. Two medicines are bioequivalent when they produce the same levels of active ingredient 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, its benefits and risks are assumed to be the same as the latter.
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 opinion of the CHMP that, as in the case of Aprovel, the benefits outweigh the risks identified. The Committee recommended the granting of a marketing authorization for Irbesartan Teva.
More information on Irbesartan Teva
On 30 October 2009, the European Commission granted a marketing authorization valid throughout the European Union for Irbesartan Teva to Teva Pharma BV.
The full EPAR for Irbesartan Teva can be found here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 08-2009.
