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 a day, but some patients may find it beneficial to use a dose of 20 mg. If the desired blood pressure has not been obtained, 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 powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, telmisartan prevents the hormone effect, leaving the blood vessels to dilate. This causes 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?
Because Tolura is a generic medicine, studies have been limited to tests to show that it is bioequivalent to the reference medicine, Micardis. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Tolura?
Because Tolura 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 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 opinion of the CHMP that, as in the case of Micardis, the benefits outweigh the risks identified. The Committee therefore recommended that Tolura be given marketing authorization.
More information on Tolura
On 4 June 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 which it can be renewed.
For the full EPAR of Tolura, click here. For more information about treatment with Tolura, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 04-2010.
