What is Irbesartan / Hydrochlorothiazide Teva?
Irbesartan / Hydrochlorothiazide Teva is a medicine that contains 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, please 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 by either irbesartan or hydrochlorothiazide taken alone. The term "essential" means that hypertension does not have an obvious cause.
The medicine can only be obtained with a prescription.
How is Irbesartan / Hydrochlorothiazide Teva used?
Irbesartan / Hydrochlorothiazide Teva is taken by mouth, with or without meals. The dose of Irbesartan / Hydrochlorothiazide Teva to be used depends on the dose of irbesartan or hydrochlorothiazide the patient was previously taking. Doses greater than 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 that it blocks the action in the body of a hormone called angiotensin II, which is a potent vasoconstrictor (a substance that constricts blood vessels). II normally binds, irbesartan stops the hormone from working and allows blood vessels to dilate.
Hydrochlorothiazide is a diuretic, another type of treatment for hypertension. It works by increasing urine output, 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. By lowering blood pressure, the risks associated with high blood pressure, such as that of stroke.
How has Irbesartan / Hydrochlorothiazide Teva been studied?
As Irbesartan / Hydrochlorothiazide Teva is a generic medicine, studies have been limited to evidence to show 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 are the benefits and risks associated with Irbesartan / Hydrochlorothiazide Teva?
Because Irbesartan / Hydrochlorothiazide 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 / Hydrochlorothiazide Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with Community requirements, Irbesartan / Hydrochlorothiazide Teva has been shown to have comparable quality and to be bioequivalent to CoAprovel. It is therefore the CHMP's view that, as in the case of CoAprovel, the benefits outweigh the identified risks. The Committee recommended that Irbesartan / Hydrochlorothiazide Teva be given marketing authorization.
Other information about Irbesartan / Hydrochlorothiazide Teva:
On November 26, 2009, the European Commission issued Teva Pharma B.V. 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 that period.
For the full version of Irbesartan / Hydrochlorothiazide Teva EPAR, click here.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 10-2009
The information on Irbesartan / Hydrochlorothiazide Teva 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.
