Author: Actavis Group PTC ehf


Long information

What is it?

Telmisartan Actavis is a medicine that contains the active substance telmisartan. It is available as white tablets (round: 20mg; oval: 40 and 80mg).

Telmisartan Actavisis a ?generic medicine?. This means that Telmisartan Actavisis 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.

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 Actavisis used to treat essential hypertension (high blood pressure) in adults. ?Essential? means that the hypertension has no obvious cause.

Telmisartan Actavisis also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes. It is used in patients who have had problems due to blood clots in the past (such as heart disease, a stroke or artery disease) or who have type2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).

The medicine can only be obtained with a prescription.

How is it used?

For the treatment of essential hypertension, the recommended dose of Telmisartan Actavisis 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.

For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day. The doctor should monitor the patient?s blood pressure closely when starting Telmisartan Actavis, and may decide to adjust the patient?s blood pressure-lowering medication.

How does it work?

The active substance in Telmisartan Actavis, 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 heart attack or stroke. It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.

How has it been studied?

Because Telmisartan Actavisis a generic medicine, studies in patients 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 Actavisis a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine?s.

Why has Telmisartan Actavisbeen approved?

The CHMP concluded that, in accordance with EU requirements, Telmisartan Actavishas been shown to have comparable quality and to be bioequivalentto Micardis. Therefore, the CHMP?s view was that, as for Micardis, the benefit outweighs the identified risk. The Committee recommended that Telmisartan Actavisbegiven marketing authorisation.

Other information about Telmisartan Actavis:

The European Commission granted a marketing authorisation valid throughout the European Union for Telmisartan Actavisto Actavis Group PTC ehf.on 30September2010. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatmentwith Telmisartan Actavis, read the package leaflet (also part of the EPAR)or contact your doctor or pharmacist.

This summary was last updated in 07-2010.

What is the risk associated?

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

Why has it been approved?

The CHMP concluded that, in accordance with EU requirements, Telmisartan Actavishas been shown to have comparable quality and to be bioequivalentto Micardis. Therefore, the CHMP?s view was that, as for Micardis, the benefit outweighs the identified risk. The Committee recommended that Telmisartan Actavisbegiven marketing authorisation.

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