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Sabervel

Active Substance: irbesartan
Common Name: irbesartan
ATC Code: C09CA04
Marketing Authorisation Holder: Pharmathen S.A.
Active Substance: irbesartan
Status: Authorised
Authorisation Date: 2012-04-13
Therapeutic Area: Hypertension
Pharmacotherapeutic Group: Agents acting on the renin-angiotensin system

Therapeutic Indication

Sabervel is indicated in adults for the treatment of essential hypertension.

It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1).

What is Sabervel?

Sabervel is a medicine that contains the active substance irbesartan. It is available as tablets (75, 150 and 300 mg).

Sabervel is a ‘generic medicine’. This means that Sabervel is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aprovel.

What is Sabervel used for?

Sabervel is used in adults who have essential hypertension (high blood pressure). ‘Essential’ means that the hypertension has no obvious cause. 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?

The usual recommended dose of Sabervel is 150 mg once a day. If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide. A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.

In patients with hypertension and type 2 diabetes, Sabervel is added to other treatments for hypertension. Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.

How does Sabervel 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. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen. This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.

How has Sabervel been studied?

Because Sabervel is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent 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?

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 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’s view was that, as for Aprovel, the benefit outweighs the identified risk. The Committee recommended that Sabervel be given marketing authorisation.

Other information about Sabervel

The European Commission granted a marketing authorisation valid throughout the European Union for Sabervel on 13 April 2012.

For more information about treatment with Sabervel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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