What is Ifirmacombi - Irbesartan / hydrochlorothiazide?
Ifirmacombi is a medicine containing two active substances, 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 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 used - Irbesartan / hydrochlorothiazide?
Ifirmacombi should be taken orally, regardless of food intake. The dosage depends on the dose of irbesartan or hydrochlorothiazide the patient has previously taken. The use of dosages higher than 300 mg irbesartan / 25 mg is not recommended. hydrochlorothiazide once daily. 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' that works by blocking the action of a hormone in the body called angiotensin II. The latter is a potent vasoconstrictor (a substance that constricts blood vessels). By blocking the receptors to which angiotensin II normally attaches, irbesartan blocks its effectiveness by allowing the blood vessels to widen.
Hydrochlorothiazide is a diuretic, which is another type of treatment for 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 results in an additive reduction in blood pressure greater than that obtained by administering the two medicines individually. With the reduction in blood pressure, the associated risks, including stroke, decrease.
How has Ifirmacombi - Irbesartan / hydrochlorothiazide been studied?
As a generic medicine, the studies in patients were limited to demonstrating the bioequivalence of Ifirmacombi to the reference medicine, CoAprovel. Two medicines are considered bioequivalent when they produce the same levels of the active substance in the body.
What are the risks and benefits associated with Ifirmacombi - Irbesartan / hydrochlorothiazide?
Since Ifirmacombi is a generic medicine that is bioequivalent to the reference medicine, the benefits and risks are considered to be the same for both medicines.
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 this " lastly, the benefits outweigh the identified risks and recommended the granting of a marketing authorization for Ifirmacombi.
More information about Ifirmacombi - Irbesartan / hydrochlorothiazide
On March 4, 2011, the European Commission granted KRKA, dd, Novo mesto a "marketing authorization" for Ifirmacombi, valid throughout the European Union. The "marketing authorization" is valid for five years, after of which it can be renewed.
Last update of this summary: 01-2011.
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