What is Ifirmacombi - Irbesartan / hydrochlorothiazide?
Ifirmacombi is a medicine containing two active substances, namely irbesartan and hydrochlorothiazide, available as oval tablets (pink: 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide; pink: 300 mg of irbesartan and 25 mg of hydrochlorothiazide ; white: 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide).
Ifirmacombi is a "generic medicine". This implies that it is similar to a "reference drug" already authorized in the European Union (EU), called CoAprovel.
What is Ifirmacombi - Irbesartan / hydrochlorothiazide used for?
Ifirmacombi is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is not adequately controlled by irbesartan or hydrochlorothiazide taken alone. The term "essential" means that there is no identified direct cause of hypertension.
The medicine can only be obtained with a prescription.
How is Ifirmacombi - Irbesartan / hydrochlorothiazide used?
Ifirmacombi should be taken orally, regardless of food intake. The dosage depends on the dose of irbesartan or hydrochlorothiazide that the patient has previously taken. Dosages higher than 300 mg of irbesartan / 25 mg of hydrochlorothiazide once daily are not recommended. Ifirmacombi can be given with other antihypertensive medicines.
How does Ifirmacombi - Irbesartan / hydrochlorothiazide work?
Ifirmacombi contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan is an "angiotensin II receptor antagonist" which works by blocking the action of a hormone in the body called angiotensin II. The latter is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, irbesartan blocks its effectiveness, allowing the blood vessels to dilate.
Hydrochlorothiazide is a diuretic, which is another type of treatment against hypertension. Its mechanism of action involves an increase in urine excretion which reduces the amount of fluid in the blood and lowers blood pressure.
The combination of the two active ingredients determines an additive reduction of blood pressure higher than that obtained by administering the two medicines individually. With the reduction of blood pressure the risks associated with it are reduced, including stroke.
What studies have been performed on Ifirmacombi - Irbesartan / hydrochlorothiazide?
Being a generic medicine, studies conducted on patients were limited to demonstrating the bioequivalence of Ifirmacombi compared to the reference drug, CoAprovel. Two medicines are considered bioequivalent when they produce the same levels of active ingredient in the body.
What are the risks and benefits of Ifirmacombi - Irbesartan / hydrochlorothiazide?
Since Ifirmacombi is a generic bioequivalent medicine to the reference medicine, the benefits and risks are considered the same for both drugs.
Why has Ifirmacombi - Irbesartan / hydrochlorothiazide been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Ifirmacombi has been shown to have comparable quality and to be bioequivalent to the reference medicine. The Committee therefore considered that, like the latter, the benefits outweigh the risks identified and recommended the issuing of the marketing authorization for Ifirmacombi.
Other information on Ifirmacombi - Irbesartan / hydrochlorothiazide
On March 4, 2011, the European Commission issued a marketing authorization for Ifirmacombi, valid throughout the European Union, to KRKA, dd, Novo mesto. The marketing authorization is valid for five years, after which it can be renewed.
Last update of this summary: 01-2011.
