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Author: Teva Pharma B.V.


Long information

What is it?

Telmisartan Teva is a medicine that contains the active substance telmisartan. It is available as white oval tablets (20, 40 and 80 mg).
Telmisartan Teva is a ?generic medicine?. This means that Telmisartan Teva is similar to a ?reference medicine? already authorised in the European Union (EU) called Micardis. For more information on generic medicines, see the question-and-answer document here.

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Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Telmisartan Teva is used in adults who have essential hypertension (high blood pressure). ?Essential? means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.

How is it used?

Telmisartan Teva is 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 target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.

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How does it work?

The active substance in Telmisartan Teva, telmisartan, 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 stops the hormone having an effect, allowing the blood vessels to widen. This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.

How has it been studied?

Because Telmisartan Teva is a generic medicine, studies have been limited to tests to determine that it 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 benefits has it shown during the studies?

Because Telmisartan Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.

What is the risk associated?

Because Telmisartan Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Telmisartan Teva has been shown to have comparable quality and to be bioequivalent to Micardis. Therefore, the CHMP?s view was that, as for Micardis, the benefit outweighs the identified risk. The Committee recommended that Telmisartan Teva be given marketing authorisation.

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