About
This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
- What is Irbesartan/Hydrochlorothiazide Teva?
Irbesartan/Hydrochlorothiazide Teva is a medicine that contains two active substances, irbesartan and hydrochlorothiazide. It is available as pink, capsule-shaped tablets (150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; and 300 mg irbesartan and 25 mg hydrochlorothiazide).
Irbesartan/Hydrochlorothiazide Teva is a ‘generic medicine’. This means that Irbesartan/Hydrochlorothiazide Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called CoAprovel.
- What is Irbesartan/Hydrochlorothiazide Teva used for?
Irbesartan/Hydrochlorothiazide Teva is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone. ‘Essential’ means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.
- How is Irbesartan/Hydrochlorothiazide Teva used?
Irbesartan/Hydrochlorothiazide Teva is taken by mouth, with or without food. The dose of Irbesartan/Hydrochlorothiazide Teva to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before. Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended. Irbesartan/Hydrochlorothiazide Teva may be added to other treatments for hypertension.
- How does Irbesartan/Hydrochlorothiazide Teva work?
Irbesartan/Hydrochlorothiazide Teva contains two active substances, irbesartan and hydrochlorothiazide.
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.
Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension. It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.- How has Irbesartan/Hydrochlorothiazide Teva been studied?
Because Irbesartan/Hydrochlorothiazide Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, CoAprovel. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
- What are the benefit and risk of Irbesartan/Hydrochlorothiazide Teva?
Because Irbesartan/Hydrochlorothiazide Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
- Why has Irbesartan/Hydrochlorothiazide Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Irbesartan/Hydrochlorothiazide Teva has been shown to have comparable quality and to be bioequivalent to CoAprovel. Therefore, the CHMP’s view was that, as for CoAprovel, the benefit outweighs the identified risk. The Committee recommended that Irbesartan/Hydrochlorothiazide Teva be given marketing authorisation.
- Other information about Irbesartan/Hydrochlorothiazide Teva:
The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan/Hydrochlorothiazide Teva to Teva Pharma B.V. on 26 November 2009. The marketing authorisation is valid for five years, after which it can be renewed.
This EPAR was last updated on 07/02/2012 .
More detail is available in the summary of product characteristics
Authorisation details
Product information
Product information
19/09/2011 Irbesartan / Hydrochlorothiazide Teva -EMEA/H/C/001112 -IA/0008/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Agents acting on the renin-angiotensin system
Therapeutic indication
Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone
Assessment History
Changes since initial authorisation of medicine
| Name | Language | First published | Last updated |
|---|---|---|---|
| Irbesartan / Hydrochlorothiazide Teva : EPAR - Procedural steps taken and scientific information after authorisation | (English only) | 30/03/2010 | 07/02/2012 |
Initial marketing-authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Irbesartan / Hydrochlorothiazide Teva : EPAR - Public assessment report | (English only) | 16/12/2009 |
Authorised
This medicine is approved for use in the European Union
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