What is Sabervel - Irbesartan?
Sabervel is a medicine that contains the active substance irbesartan, available as tablets (75, 150 and 300 mg).
Sabervel is a "generic medicine". This means that Sabervel is similar to a "reference medicine" already authorized in the European Union (EU) called Aprovel.
What is Sabervel - Irbesartan used for?
Sabervel is used in adults with essential hypertension (high blood pressure). The term "essential" means that the cause of hypertension is unclear. Sabervel is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
The medicine can only be obtained with a prescription.
How is Sabervel - Irbesartan used?
The usual recommended dose of Sabervel is 150 mg once a day. If blood pressure is not adequately controlled, the dose can be increased to 300 mg a day or other medicines can be added for hypertension, such as hydrochlorothiazide. A starting dose of 75 mg can be used in patients undergoing hemodialysis (a blood purification technique) or in patients over 75 years of age.
In patients with hypertension and type 2 diabetes, Sabervel is associated with other treatments for hypertension. Treatment begins with a dose of 150 mg once a day, which is usually increased up to 300 mg once a day.
How does Sabervel - Irbesartan work?
The active substance in Sabervel, irbesartan, is an "angiotensin II receptor antagonist", which means it blocks 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 the effectiveness of the hormone, allowing the blood vessels to dilate. This causes a drop in blood pressure and reduces the risks associated with high blood pressure, such as stroke.
What studies have been carried out on Sabervel - Irbesartan?
Because Sabervel is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference drug, Aprovel. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Sabervel - Irbesartan?
Because Sabervel is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Sabervel - Irbesartan been approved?
The CHMP concluded that, in accordance with EU requirements, Sabervel has been shown to have comparable quality and to be bioequivalent to Aprovel. Therefore, the CHMP considered that, as in the case of Aprovel, the benefits outweigh the identified risks and recommended that Sabervel be given marketing authorization.
More information on Sabervel - Irbesartan
On 13 April 2012, the European Commission issued a marketing authorization for Sabervel, valid throughout the European Union.
For more information on Sabervel therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 03-2012.
