What is Irbesartan / Hydrochlorothiazide Teva?
Irbesartan / Hydrochlorothiazide Teva is a medicine containing two active substances, irbesartan and hydrochlorothiazide. It is available as pink, capsule-shaped tablets (150 mg or 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide; 300 mg of irbesartan and 25 mg of hydrochlorothiazide).
Irbesartan / Hydrochlorothiazide Teva is a "generic medicine", ie similar to a "reference medicine" already authorized in the European Union (EU) called CoAprovel. For more information on generic medicines, see the questions and answers by clicking here.
What is Irbesartan / Hydrochlorothiazide Teva used for?
Irbesartan / Hydrochlorothiazide Teva is used to treat essential hypertension (high blood pressure) in adults where it cannot be adequately controlled with irbesartan or hydrochlorothiazide alone. The term "essential" indicates that hypertension has no obvious cause.
The medicine can only be obtained with a prescription.
How is Irbesartan / Hydrochlorothiazide Teva used?
Irbesartan / Hydrochlorothiazide Teva should be taken by mouth, with or without food. The dose of Irbesartan / Hydrochlorothiazide Teva to use depends on the dose of irbesartan or hydrochlorothiazide that the patient previously took. Doses above 300 mg of irbesartan and 25 mg of hydrochlorothiazide once daily are not recommended. Irbesartan / Hydrochlorothiazide Teva can be taken as an adjunct to other treatments for hypertension.
How does Irbesartan / Hydrochlorothiazide Teva work?
Irbesartan / Hydrochlorothiazide Teva contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan is an "angiotensin II receptor antagonist", which means it blocks the action of a hormone called angiotensin II in the body, which is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone effect and allows the blood vessels to dilate.
Hydrochlorothiazide is a diuretic, another type of treatment for hypertension. It works by increasing urine excretion, reducing the amount of fluid in the blood and lowering blood pressure. The combination of the two active ingredients has an additive effect, reducing blood pressure to a greater extent than the two medicines taken individually. With the reduction in blood pressure, the risks associated with high blood pressure, such as stroke, decrease.
What studies have been performed on Irbesartan / Hydrochlorothiazide Teva?
Because Irbesartan / Hydrochlorothiazide Teva 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 active ingredient in the body.
What are the benefits and risks of Irbesartan / Hydrochlorothiazide Teva?
Because Irbesartan / Hydrochlorothiazide 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 / Hydrochlorothiazide Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Irbesartan / Hydrochlorothiazide Teva has been shown to have comparable quality and to be bioequivalent to CoAprovel. It is therefore the opinion of the CHMP that, as in the case of CoAprovel, the benefits outweigh the identified risks. The Committee recommended the granting of a marketing authorization for Irbesartan / Hydrochlorothiazide Teva.
Other information on Irbesartan / Hydrochlorothiazide Teva:
On 26 November 2009, the European Commission granted Teva Pharma BV a marketing authorization for Irbesartan / Hydrochlorothiazide Teva, valid throughout the European Union. The marketing authorization is valid for five years and can be renewed after this period.
For the full EPAR of Irbesartan / Hydrochlorothiazide Teva, click here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 10-2009
