What is Tolura?
Tolura is a medicine that contains the active substance telmisartan. It is available as white tablets (round: 20 mg; oval: 40 mg; capsule-shaped: 80 mg).
Tolura is a 'generic medicine'. This means that it is similar to a 'reference medicine' already authorized in the European Union (EU) called Micardis.
What is Tolura used for?
Tolura 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 Tolura used?
The recommended dose of Tolura is 40 mg once daily, but some patients may find benefit using a 20 mg dose. If the desired blood pressure has not been achieved, the dose can be increased up to 80 mg or another medicine for hypertension, such as hydrochlorothiazide, can be added.
How does Tolura work?
The active substance in Tolura, telmisartan, is an 'angiotensin II receptor antagonist', which means that it blocks the action of a hormone produced by the body called angiotensin II.Angiotensin II is a potent vasoconstrictor (a substance that constricts blood vessels). By blocking the receptors that angiotensin II normally attaches to, telmisartan prevents the hormone from working, allowing the blood vessels to dilate. This results in a drop in blood pressure and reduces the risks associated with high blood pressure, such as heart attack or stroke.
How has Tolura been studied?
Since Tolura is a generic medicine, the studies have been limited to evidence designed to show that the medicine 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 are the benefits and risks of Tolura?
Because Tolura is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks of the medicine are assumed to be the same as the reference medicine.
Why has Tolura been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Tolura has been shown to have comparable quality and to be bioequivalent to Micardis. Therefore, it is the view of the CHMP that, as in the case of Micardis, the benefits outweigh the identified risks. The Committee therefore recommended the granting of a marketing authorization for Tolura.
More information about Tolura
On June 4, 2010, the European Commission issued a "marketing authorization" for Tolura, valid throughout the European Union, to Krka dd, Novo Mesto. The "marketing authorization" is valid for five years, after of which it can be renewed.
For the full version of Tolura's EPAR, click here. For more information about Tolura therapy, read the package leaflet (also 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: 04-2010.
The information on Tolura 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.
