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 that 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 preventive measure against vascular problems (ie concerning the heart and blood vessels) such as heart attack and stroke in patients who have already had problems caused by blood clots (heart disease, stroke or vasculopathy) or with diabetes type 2 which 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 are already helped with a 20 mg dose. If you are unable to get the desired blood pressure you can take the dose to 80 mg or combine another drug against hypertension, like 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 doctor should carefully 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", ie it inhibits the action of a hormone in the body called "angiotensin II", a powerful vasoconstrictor (constricts blood vessels ). By inhibiting the receptors to which angiotensin II normally attaches, telmisartan stops the hormone effect and allows blood vessels to widen. By doing this the pressure drops and the risks associated with high blood pressure, such as heart attack and stroke, decrease. This mechanism also facilitates pumping of the heart, which can help reduce the risk of subsequent onset of cardiovascular problems.
How has Telmisartan Actavis been studied?
Because Telmisartan Actavis is a generic medicine, studies in patients have been limited to checking that it is bioequivalent 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, it is believed that the benefits and risks associated with it are 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, it was shown that Telmisartan Actavis is qualitatively comparable and bioequivalent to Micardis and therefore considered that, as in the case of Micardis, the advantages are greater than the risks identified. The committee recommended the granting of a marketing authorization for Telmisartan Actavis.
More information on Telmisartan Actavis
On 30 September 2010, the European Commission issued to Actavis Group PTC ehf. 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 about treatment with Telmisartan Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 7-2010.
