Author: Krka, d.d., Novo mesto


Long information

What is it?

Ifirmasta is a medicine that contains the active substance irbesartan. It is available as white, oval tablets (75, 150 and 300 mg).

Ifirmasta is a ?generic medicine?. This means that Ifirmasta is similar to a ?reference medicine? already authorised in the European Union (EU) called Aprovel. For more information on generic medicines, see the question-and-answer document here.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Ifirmasta is used in patients who have essential hypertension (high blood pressure). ?Essential? means that the hypertension has no obvious cause. Ifirmasta is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes). Ifirmasta is not recommended for use in patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group.

The medicine can only be obtained with a prescription.

How is it used?

Ifirmasta is taken by mouth, with or without food. The usual recommended dose is 150 mg once a day. If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other

1 Previously known as Irbesartan Krka. medicines for hypertension can be added, such as hydrochlorothiazide. A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.

In patients with hypertension and type 2 diabetes, Ifirmasta is added to other treatments for hypertension. Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.

How does it work?

The active substance in Ifirmasta, irbesartan, 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, irbesartan stops the hormone having an effect, allowing the blood vessels to widen. This allows the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.

How has it been studied?

Because Ifirmasta is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine. 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 Ifirmasta is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

What is the risk associated?

Because Ifirmasta is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has it been approved?

The CHMP concluded that, in accordance with EU requirements, Ifirmasta has been shown to have comparable quality and to be bioequivalent to Aprovel. Therefore, the CHMP?s view was that, as for Aprovel, the benefit outweighs the identified risk. The Committee recommended that Ifirmasta be given marketing authorisation.

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