What is Sabervel - Irbesartan?
Sabervel is a medicine containing 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 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 used - Irbesartan?
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 per day or other medicines for hypertension, such as hydrochlorothiazide, can be added. 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 combined with other treatments for hypertension. Treatment starts with a dose of 150 mg once daily, which is usually increased up to 300 mg once daily. .
How does Sabervel - Irbesartan work?
The active substance in Sabervel, irbesartan, is an 'angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. blood vessels). By blocking the receptors to which angiotensin II normally attaches, irbesartan blocks the hormone's effectiveness, allowing blood vessels to widen. This results in a drop in blood pressure and reduces the risks associated with high blood pressure, such as blood pressure. "stroke.
How has Sabervel - Irbesartan been studied?
As Sabervel is a generic medicine, patient studies have been limited to trials to determine its bioequivalence to the reference medicine, Aprovel. Two medicines are bioequivalent when they produce the same levels of the active substance 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 taken as being the same as the reference medicine's.
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 the granting of the marketing authorization for Sabervel.
More information about Sabervel - Irbesartan
On 13 April 2012, the European Commission issued a "Marketing Authorization" for Sabervel, valid throughout the European Union.
For more information about Sabervel therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 03-2012.
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