Ifirmasta (Formerly known as Irbesartan Krka)

What is Ifirmasta?

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 authorized in the European Union (EU) called Aprovel. For more information on generic medicines, see the questions and answers by clicking here.

What is Ifirmasta used for?

Ifirmasta is used in patients with essential hypertension (high blood pressure). Hypertension is said to be "essential" when it is not caused by other disorders. Ifirmasta is also used to treat kidney disease in hypertensive patients and patients with type 2 (non-insulin-dependent) diabetes mellitus. Ifirmasta is not recommended for older patients. under the age of 18.
The medicine can only be obtained with a prescription.

How is Ifirmasta used?

Ifirmasta is taken orally, with or without food. The usually recommended dose is 150 mg once a day. If blood pressure is not adequately controlled, the dosage can be increased to 300 mg per day, or other medications for hypertension, such as hydrochlorothiazide, can be given. A starting dose of 75 mg can be used in patients undergoing hemodialysis (blood clearance technique) or in patients over 75 years of age.
In hypertensive patients with type 2 diabetes, Ifirmasta is added to other treatments for hypertension. Therapy starts with a dose of 150 mg once daily, which is usually increased up to 300 mg once daily.

How does Ifirmasta 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 potent vasoconstrictor (a substance that restricts blood vessels). By blocking the receptors that angiotensin II normally binds to, irbesartan blocks the hormone's effect, allowing blood vessels to dilate. This allows blood pressure to drop, reducing the risk of high blood pressure such as developing blood pressure. a stroke.

How has Ifirmasta been studied?

Since Ifirmasta is a generic medicine, studies have been limited to tests to determine that the medicine is bioequivalent to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the risks and benefits associated with Ifirmasta?

Since Ifirmasta is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks are assumed to be the same as the reference medicine.

Why has Ifirmasta been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Ifirmasta has been shown to have comparable quality and to be bioequivalent to Aprovel. It is therefore the view of the CHMP that, as in the case of Aprovel, the benefits outweigh the identified risks. The Committee recommended the granting of the "Marketing Authorization" for Ifirmasta

More information about Ifirmasta

On 1 December 2008, the European Commission granted Krka, dd, Novo Mesto, a "marketing authorization" valid throughout the European Union for Irbetesan Krka. The name of the medicine was changed to Ifirmasta on 24 September 2009 The marketing authorization is valid for five years, after which it can be renewed
For the full version of the EPAR for Ifirmasta, click here.

Last update of this summary: 10-2009.

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