What is Telmisartan Actavis?
Telmisartan Actavis is a medicine that contains the active substance telmisartan and is available as white tablets (round shape: 20 mg; oval shape: 40 and 80 mg). Telmisartan Actavis is a 'generic medicine', which means it is similar to a 'reference medicine' already authorized in the European Union (EU) called Micardis.
What is Telmisartan Actavis used for?
Telmisartan Actavis is used to treat essential hypertension (high blood pressure) in adults; 'essential' means that it has no apparent cause. Telmisartan Actavis is also used as a preventative against vascular problems (that is, affecting the heart and blood vessels ) such as heart attack and stroke in patients who have already had problems caused by the formation of blood clots (heart disease, stroke or vascular disease) or with type 2 diabetes that has already caused damage to an organ (eyes, heart or kidneys).
The medicine can only be obtained with a prescription.
How is Telmisartan Actavis used?
For the treatment of essential hypertension the recommended dose of Telmisartan Actavis is 40 mg once a day, although some patients already benefit from a 20 mg dose. dose at 80 mg or combine with another anti-hypertension drug, such as hydrochlorothiazide. For the prevention of cardiovascular problems the recommended dose is 80 mg once a day.
At the start of treatment with Telmisartan Actavis, the physician should closely monitor the patient's blood pressure and may decide to change the antihypertensive therapy.
How does Telmisartan Actavis work?
The active substance in Telmisartan Actavis, telmisartan, is an "angiotensin II receptor antagonist", that is, it inhibits the action of a hormone present in the body called "angiotensin II", a powerful vasoconstrictor (narrows blood vessels ). By blocking the receptors to which angiotensin II normally binds, telmisartan stops the hormone's effect and allows the blood vessels to widen. In doing so, blood pressure drops and decreases the risks associated with high blood pressure, such as heart attack. It also facilitates pumping of the heart, which can help reduce the risk of subsequent cardiovascular problems.
How has Telmisartan Actavis been studied?
As Telmisartan Actavis is a generic medicine, the studies in patients were limited to verifying its bioequivalence with the reference medicine Micardis. Two drugs are bioequivalent if, once in the body, they deliver the same levels of active ingredient.
What benefits and risks has Telmisartan Actavis shown during the studies?
Since Telmisartan Actavis is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks associated with it are believed to be the same as the reference medicine.
Why has Telmisartan Actavis been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in line with EU requirements, Telmisartan Actavis has been shown to be qualitatively comparable and bioequivalent to Micardis and therefore considered that, as in the case of Micardis, the benefits outweigh the risks identified. The committee recommended the granting of a marketing authorization for Telmisartan Actavis.
Other information about Telmisartan Actavis
On 30 September 2010 the European Commission released PTC ehf to Actavis Group. a "Marketing Authorization" for Telmisartan Actavis, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed. For more information on Telmisartan Actavis therapy, read the package leaflet (enclosed with the EPAR) or contact your doctor or pharmacist. Last update of this summary: 7-2010.
The information on Telmisartan Actavis 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.
