Irbesartan/Hydrochlorothiazide Teva

Authorised

This medicine is authorised for use in the European Union

irbesartan / hydrochlorothiazide

Overview

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 its 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 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. 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 in people 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 benefits and risks are taken as being the same as the reference medicine’s.

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 on 26 November 2009.

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

Irbesartan / Hydrochlorothiazide Teva : EPAR - Summary for the public

Product information

Irbesartan / Hydrochlorothiazide Teva : EPAR - Product Information

Latest procedure affecting product information: IB/0064/G

04/06/2024

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Irbesartan / Hydrochlorothiazide Teva : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Irbesartan/Hydrochlorothiazide Teva
• Active substance:
  • irbesartan
  • hydrochlorothiazide
• International non-proprietary name (INN) or common name:
  • irbesartan
  • hydrochlorothiazide
• Therapeutic area (MeSH):
  Hypertension
• Anatomical therapeutic chemical (ATC) code:
  C09DA04

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.

Authorisation details

• EMA product number:
  EMEA/H/C/001112
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Teva B.V.

  Teva B.V.; Swensweg 5; 2031 GA Haarlem; The Netherlands

• Opinion adopted:
  24/09/2009
• Marketing authorisation issued:
  26/11/2009
• Revision:
  23

Assessment history

Changes since initial authorisation of medicine

Irbesartan / Hydrochlorothiazide Teva : EPAR - Procedural steps taken and scientific information after authorisation

Angiotensin-II-receptor antagonists (sartans) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines

Adopted

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines

AdoptedReference Number: EMA/47245/2021

Irbesartan / Hydrochlorothiazide Teva : EPAR - Scientific conclusions - Annex IV

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report

AdoptedReference Number: EMA/217823/2019

Irbesartan/Hydrochlorothiazide Teva-H-C-1112-A31-0019 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differe...

Irbesartan/Hydrochlorothiazide Teva-H-C-1112-A31-0019 : EPAR - Assessment Report - Article 31

AdoptedReference Number: EMA/PRAC/294920/2014

Initial marketing authorisation documents

Irbesartan / Hydrochlorothiazide Teva : EPAR - Public assessment report

Committee for medicinal products for human use, summary of positive opinion for Irbesartan/Hydrochlorothiazide Teva

Reference Number: EMEA/592212/2009