What is Telmisartan Teva?
Telmisartan Teva is a medicine that contains the active substance telmisartan available as white, oval-shaped tablets (20, 40 and 80 mg).
Telmisartan Teva is a 'generic medicine', which means that it is similar to a 'reference medicine' already authorized in the European Union (EU) called Micardis.
What is Telmisartan Teva used for?
Telmisartan Teva is used in adults with essential hypertension (high blood pressure). The term "essential" means that hypertension has no obvious cause.
The medicine can only be obtained with a prescription.
How is Telmisartan Teva used?
Telmisartan Teva is taken by mouth, with or without meals. The recommended dose is 40 mg once daily, but some patients may find benefit using a 20 mg dose. If the desired blood pressure has not been achieved, the dose can be increased up to 80 mg or another medicine for hypertension, such as hydrochlorothiazide, can be added.
How does Telmisartan Teva work?
The active substance in Telmisartan Teva, 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 potent vasoconstrictor (a substance that restricts blood vessels).By blocking the receptors to which angiotensin II normally attaches, telmisartan prevents the hormone from working by letting the blood vessels dilate. This leads to a drop in blood pressure and reduces the risks associated with high blood pressure, such as the stroke.
How has Telmisartan Teva been studied?
Since Telmisartan Teva is a generic medicine, the studies were limited to evidence designed to show that the medicine is bioequivalent to the reference medicine Micardis. Two medicines are bioequivalent when they produce the same levels of the active substance in the body
What are the benefits and risks of Telmisartan Teva?
Since Telmisartan 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 Telmisartan Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Telmisartan Teva has been shown to have comparable quality and to be bioequivalent to Micardis. Therefore, it is the CHMP's view that, as in case of Micardis, the benefits outweigh the identified risks. The Committee recommended that Telmisartan Teva be given a Marketing Authorization.
More information about Telmisartan Teva
On January 26, 2010, the European Commission released Teva Pharma B.V. a "Marketing Authorization" for Telmisartan Teva, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
The full version of the EPAR for Telmisartan 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: 12-2009.
The information on Telmisartan 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.
