Author: Krka, d.d., Novo mesto


Long information

What is it?

Ifirmacombi is a medicine that contains two active substances, irbesartan and hydrochlorothiazide. It is available as oval tablets (pink: 150 mg irbesartan and 12.5 mg hydrochlorothiazide; pink: 300 mg irbesartan and 25 mg hydrochlorothiazide; white: 300 mg irbesartan and 12.5 mg
hydrochlorothiazide).

Ifirmacombi is a ?generic medicine?. This means that Ifirmacombi is similar to a ?reference medicine? already authorised in the European Union (EU) called CoAprovel. 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?

Ifirmacombi is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone. ?Essential? means that the hypertension has no obvious cause.

The medicine can only be obtained with a prescription.

How is it used?

Ifirmacombi is taken by mouth, with or without food. The dose of Ifirmacombi to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before. Doses higher than

300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended. Ifirmacombi may be added to other treatments for hypertension.

How does it work?

Ifirmacombi contains two active substances, irbesartan and hydrochlorothiazide.

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.

Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension. It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.

The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

How has it been studied?

Because Ifirmacombi is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, CoAprovel. 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 Ifirmacombi 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.

What is the risk associated?

Because Ifirmacombi 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 it been approved?

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

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