Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)

irbesartan / hydrochlorothiazide

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Irbesartan Hydrochlorothiazide Zentiva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Irbesartan Hydrochlorothiazide Zentiva.

: Irbesartan Hydrochlorothiazide Zentiva 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; 300 mg irbesartan and 25 mg hydrochlorothiazide).
This medicine is the same as CoAprovel, which is already authorised in the European Union (EU). The company that makes CoAprovel has agreed that its scientific data can be used for Irbesartan Hydrochlorothiazide Zentiva.

: Irbesartan Hydrochlorothiazide Zentiva 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.

: The dose of Irbesartan Hydrochlorothiazide Zentiva 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 Zentiva may be added to some other treatments for hypertension.

: Irbesartan Hydrochlorothiazide Zentiva 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.

: Irbesartan on its own has been approved in the EU since 1997 under the names Karvea and Aprovel. It can be used with hydrochlorothiazide to treat hypertension. The studies of Karvea / Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide Zentiva. Further studies were also carried out with doses of 300 mg irbesartan in combination with 25 mg hydrochlorothiazide. The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).

: Irbesartan Hydrochlorothiazide Zentiva was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure. Increasing the dose to 300 mg irbesartan and 25 mg hydrochlorothiazide may give a further decrease in blood pressure.

: The most common side effects with Irbesartan Hydrochlorothiazide Zentiva (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscles). For the full list of all side effects reported with Irbesartan Hydrochlorothiazide Zentiva, see the package leaflet.
Irbesartan Hydrochlorothiazide Zentiva must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients. It must not be used in women who are more than three months pregnant. Its use during the first three months of pregnancy is not recommended. Irbesartan Hydrochlorothiazide Zentiva must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Irbesartan Hydrochlorothiazide Zentiva in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment. Care must be taken when using Irbesartan Hydrochlorothiazide Zentiva with other medicines that have an effect on blood potassium levels. The full list of these medicines is given in the package leaflet.

: The CHMP decided that Irbesartan Hydrochlorothiazide Zentiva’s benefits are greater than its risks and recommended that it be given marketing authorisation.

: The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Hydrochlorothiazide Winthrop on 19 January 2007. The name of the medicine was changed to Irbesartan Hydrochlorothiazide Zentiva on 6 February 2012.
For more information about treatment with Irbesartan Hydrochlorothiazide Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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Irbesartan Hydrochlorothiazide Zentiva : EPAR - Summary for the public (PDF/108.1 KB)

First published: 05/05/2009
Last updated: 20/09/2013
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  (PDF/140.98 KB)
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  (PDF/127.28 KB)
- Italian
  (PDF/107.56 KB)
- Latvian
  (PDF/131.02 KB)
- Lithuanian
  (PDF/134.58 KB)
- Maltese
  (PDF/136.49 KB)
- Polish
  (PDF/137.8 KB)
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  (PDF/108.33 KB)
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  (PDF/131.32 KB)
- Slovak
  (PDF/135.78 KB)
- Slovenian
  (PDF/126.87 KB)
- Spanish
  (PDF/108.19 KB)
- Swedish
  (PDF/109.68 KB)

This EPAR was last updated on 28/09/2022

Authorisation details

Product details
Name	Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
Agency product number	EMEA/H/C/000783
Active substance	irbesartan hydrochlorothiazide
International non-proprietary name (INN) or common name	irbesartan hydrochlorothiazide
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09DA04

Publication details
Marketing-authorisation holder	sanofi-aventis groupe
Revision	33
Date of issue of marketing authorisation valid throughout the European Union	18/01/2007
Contact address	sanofi-aventis groupe 54 rue La Boétie, 75008 Paris France

Product information

27/09/2022 Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) - EMEA/H/C/000783 - IAIN/0125

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Irbesartan Hydrochlorothiazide Zentiva : EPAR - Product information (PDF/1.32 MB)

First published: 19/10/2009
Last updated: 28/09/2022
- Bulgarian
  (PDF/1.2 MB)
- Croatian
  (PDF/1.45 MB)
- Czech
  (PDF/1.33 MB)
- Danish
  (PDF/1.14 MB)
- Dutch
  (PDF/1.43 MB)
- Estonian
  (PDF/1.13 MB)
- Finnish
  (PDF/1.18 MB)
- French
  (PDF/1.46 MB)
- German
  (PDF/1.37 MB)
- Greek
  (PDF/1.63 MB)
- Hungarian
  (PDF/1.49 MB)
- Icelandic
  (PDF/1.14 MB)
- Italian
  (PDF/1.36 MB)
- Latvian
  (PDF/1.44 MB)
- Lithuanian
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- Maltese
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- Norwegian
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- Polish
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- Portuguese
  (PDF/1.28 MB)
- Romanian
  (PDF/1.17 MB)
- Slovak
  (PDF/1.41 MB)
- Slovenian
  (PDF/1.23 MB)
- Spanish
  (PDF/1.19 MB)
- Swedish
  (PDF/1.13 MB)

Other EU languages available icon 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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Irbesartan Hydrochlorothiazide Zentiva : EPAR - All Authorised presentations (PDF/31.92 KB)

First published: 05/02/2007
Last updated: 01/08/2012
- Bulgarian
  (PDF/66.28 KB)
- Czech
  (PDF/44.32 KB)
- Danish
  (PDF/31.24 KB)
- Dutch
  (PDF/31.43 KB)
- Estonian
  (PDF/32.18 KB)
- Finnish
  (PDF/31.56 KB)
- French
  (PDF/31.46 KB)
- German
  (PDF/31.45 KB)
- Greek
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- Hungarian
  (PDF/43.88 KB)
- Icelandic
  (PDF/31.65 KB)
- Italian
  (PDF/32.17 KB)
- Latvian
  (PDF/60.51 KB)
- Lithuanian
  (PDF/60.04 KB)
- Maltese
  (PDF/58.13 KB)
- Norwegian
  (PDF/30.96 KB)
- Polish
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- Portuguese
  (PDF/31.84 KB)
- Romanian
  (PDF/61.15 KB)
- Slovak
  (PDF/61.09 KB)
- Slovenian
  (PDF/31.71 KB)
- Spanish
  (PDF/31.39 KB)
- Swedish
  (PDF/31.79 KB)

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

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Irbesartan Hydrochlorothiazide Zentiva: EPAR - Procedural steps taken and scientific information after authorisation (PDF/329.51 KB)

First published: 26/10/2009
Last updated: 28/09/2022
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Angiotensin-II-receptor antagonists (sartans) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/119.28 KB)

Adopted

First published: 05/07/2021
- Bulgarian
  (PDF/145.18 KB)
- Croatian
  (PDF/142.87 KB)
- Czech
  (PDF/139.02 KB)
- Danish
  (PDF/126.81 KB)
- Dutch
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- Estonian
  (PDF/123.85 KB)
- Finnish
  (PDF/125.84 KB)
- French
  (PDF/127.12 KB)
- German
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- Greek
  (PDF/139.5 KB)
- Hungarian
  (PDF/137.17 KB)
- Italian
  (PDF/126.56 KB)
- Latvian
  (PDF/147.7 KB)
- Lithuanian
  (PDF/148.34 KB)
- Maltese
  (PDF/151.21 KB)
- Polish
  (PDF/137.7 KB)
- Portuguese
  (PDF/128.87 KB)
- Romanian
  (PDF/143.59 KB)
- Slovak
  (PDF/135.07 KB)
- Slovenian
  (PDF/149.74 KB)
- Spanish
  (PDF/125.85 KB)
- Swedish
  (PDF/126.99 KB)
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Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/362.31 KB)

Adopted

First published: 02/03/2021
EMA/47245/2021
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Irbesartan Hydrochlorothiazide Zentiva : EPAR - Scientific conclusions (PDF/99.42 KB)

First published: 23/05/2019
- Bulgarian
  (PDF/136.15 KB)
- Croatian
  (PDF/125.02 KB)
- Czech
  (PDF/131.08 KB)
- Danish
  (PDF/96.12 KB)
- Dutch
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- Estonian
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- Finnish
  (PDF/97.12 KB)
- French
  (PDF/97.56 KB)
- German
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- Greek
  (PDF/142.79 KB)
- Hungarian
  (PDF/119.82 KB)
- Italian
  (PDF/95.54 KB)
- Latvian
  (PDF/130.68 KB)
- Lithuanian
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- Maltese
  (PDF/133.78 KB)
- Polish
  (PDF/130.65 KB)
- Portuguese
  (PDF/96.47 KB)
- Romanian
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- Slovak
  (PDF/119.14 KB)
- Slovenian
  (PDF/124.14 KB)
- Spanish
  (PDF/98.31 KB)
- Swedish
  (PDF/96.85 KB)
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Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report (PDF/531.32 KB)

Adopted

First published: 02/05/2019
EMA/217823/2019
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Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)-H-C-PSUSA-00001653-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisat... (PDF/75.5 KB)

First published: 07/11/2017
Last updated: 07/11/2017
EMA/715525/2017
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Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)-H-C-783-A31-75: EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed e... (PDF/48.81 KB)

First published: 30/09/2014
Last updated: 30/09/2014
- Bulgarian
  (PDF/87.49 KB)
- Croatian
  (PDF/80.12 KB)
- Czech
  (PDF/82.81 KB)
- Danish
  (PDF/49.01 KB)
- Dutch
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- Estonian
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- Finnish
  (PDF/49.15 KB)
- French
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- German
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- Greek
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- Hungarian
  (PDF/68.7 KB)
- Italian
  (PDF/51.13 KB)
- Latvian
  (PDF/81.63 KB)
- Lithuanian
  (PDF/82.54 KB)
- Maltese
  (PDF/84.23 KB)
- Polish
  (PDF/83.62 KB)
- Portuguese
  (PDF/49.74 KB)
- Romanian
  (PDF/88.19 KB)
- Slovak
  (PDF/81.5 KB)
- Slovenian
  (PDF/79.79 KB)
- Spanish
  (PDF/50.51 KB)
- Swedish
  (PDF/50.18 KB)
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Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)-H-C-A31-75 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 30/09/2014
Last updated: 30/09/2014
EMA/PRAC/294920/2014
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Irbesartan Hydrochlorothiazide Zentiva-H-C-783-II-69 : EPAR - Assessment Report - Variation (PDF/123.98 KB)

Adopted

First published: 20/09/2013
Last updated: 20/09/2013
EMA/CHMP/377924/2013
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CHMP post-authorisation summary of positive opinion for Irbesartan Hydrochlorothiazide Zentiva (PDF/66.48 KB)

Adopted

First published: 28/06/2013
Last updated: 28/06/2013
EMA/CHMP/388295/2013

Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)

Table of contents

Overview

Irbesartan Hydrochlorothiazide Zentiva : EPAR - Summary for the public (PDF/108.1 KB)

Authorisation details

Product information

Irbesartan Hydrochlorothiazide Zentiva : EPAR - Product information (PDF/1.32 MB)

Irbesartan Hydrochlorothiazide Zentiva : EPAR - All Authorised presentations (PDF/31.92 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Irbesartan Hydrochlorothiazide Zentiva: EPAR - Procedural steps taken and scientific information after authorisation (PDF/329.51 KB)

Angiotensin-II-receptor antagonists (sartans) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/119.28 KB)

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/362.31 KB)

Irbesartan Hydrochlorothiazide Zentiva : EPAR - Scientific conclusions (PDF/99.42 KB)

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report (PDF/531.32 KB)

Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)-H-C-PSUSA-00001653-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisat... (PDF/75.5 KB)

Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)-H-C-783-A31-75: EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed e... (PDF/48.81 KB)

Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)-H-C-A31-75 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Irbesartan Hydrochlorothiazide Zentiva-H-C-783-II-69 : EPAR - Assessment Report - Variation (PDF/123.98 KB)

CHMP post-authorisation summary of positive opinion for Irbesartan Hydrochlorothiazide Zentiva (PDF/66.48 KB)

Initial marketing-authorisation documents

Irbesartan Hydrochlorothiazide Winthrop : EPAR - Procedural steps taken before authorisation (PDF/21.07 KB)

Irbesartan Hydrochlorothiazide Winthrop : EPAR - Scientific Discussion (PDF/23.76 KB)

News

More information on Irbesartan Hydrochlorothiazide Zentiva

Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer (PDF/511.41 KB)

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