What is Telmisartan Teva?
Telmisartan Teva is a medicine that contains the active substance telmisartan available as white, oval 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 should be taken by mouth, with or without food. The recommended dose is 40 mg once a day, but some patients may benefit from using a 20 mg dose. If the desired blood pressure has not been obtained, 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 powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, telmisartan prevents the hormone effect, leaving the blood vessels to dilate. This causes a drop in blood pressure and reduces the risks associated with high blood pressure, such as stroke.
What studies have been performed on Telmisartan Teva?
Because Telmisartan Teva is a generic medicine, studies have been limited to tests to show that it is bioequivalent to the reference medicine, Micardis. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body
What are the benefits and risks of Telmisartan Teva?
Because Telmisartan Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are supposed to be the same as the latter.
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 opinion of the CHMP that, as in the case of Micardis, the benefits outweigh the risks identified. The Committee recommended the granting of a marketing authorization for Telmisartan Teva.
More information on Telmisartan Teva
On 26 January 2010, the European Commission granted Teva Pharma BV 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 of the reference medicine is also found on the Agency's website.
Last update of this summary: 12-2009.
