What is Telmisartan Teva Pharma?
Telmisartan Teva Pharma is a medicine that contains the active substance telmisartan. It is available as tablets (20 mg, 40 mg and 80 mg).
Telmisartan Teva Pharma is a 'generic medicine'. This means that Telmisartan Teva Pharma is similar to a 'reference medicine' already authorized in the European Union (EU) called Micardis.
What is Telmisartan Teva Pharma used for?
Telmisartan Teva Pharma is indicated for the treatment of essential hypertension (high blood pressure) in adults. The term "essential" means that hypertension has no obvious cause.
The medicine can only be obtained with a prescription.
How is Telmisartan Teva Pharma used?
The recommended dose of Telmisartan Teva Pharma 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 achieved, the dose can be increased to 80 mg or another medicine for hypertension can be added.
How does Telmisartan Teva Pharma work?
The active substance in Telmisartan Teva Pharma, 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 potent vasoconstrictor (a substance which narrows 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 results in a drop in blood pressure and reduces the risks associated with high blood pressure.
How has Telmisartan Teva Pharma been studied?
Since Telmisartan Teva Pharma is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence 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?
Because Telmisartan Teva Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Telmisartan Teva Pharma been approved?
The CHMP concluded that, in accordance with EU requirements, Telmisartan Teva Pharma has been shown to have comparable quality and to be bioequivalent to Micardis. Therefore, the CHMP considered that, as in the case of Micardis, the benefits outweigh the identified risks. and recommended the granting of a marketing authorization for Telmisartan Teva Pharma.
More information about Telmisartan Teva Pharma
On 3 October 2011, the European Commission issued a "Marketing Authorization" for Telmisartan Teva Pharma, valid throughout the European Union.
For more information about Telmisartan Teva Pharma therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 08-2011.
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