Tolura 80 mg tablets

ATC Code
C09CA07
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Krka, D.D., Novo Mesto

Substance Narcotic Psychotropic
Telmisartan No No
Pharmacological group Angiotensin ii receptor blockers (arbs), plain

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All to know

Author

Krka, D.D., Novo Mesto

What is it?

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 Tolura is 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.

What is it used for?

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

The medicine can only be obtained with a prescription.

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How is it used?

The recommended dose of Tolura is 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.

How does it work?

The active substance in Tolura, 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.

How has it been studied?

Because Tolura is 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 Tolura is 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.

What is the risk associated?

Because Tolura is 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, Tolura has been shown to have comparable quality and to be bioequivalent to Micardis. Therefore, the CHMP?s view was that, as for Micardis, the benefit outweighs the identified risk. The Committee recommended that Tolura be given marketing authorisation.

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