Karvezide

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 Karvezide. 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 Karvezide.

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 of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

: Karvezide 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).

: Karvezide 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 Karvezide 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. Karvezide may be added to some other treatments for hypertension.

: Karvezide 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 European Union (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 Karvezide. 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).

: Karvezide 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 Karvezide (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 Karvezide, see the package leaflet.
Karvezide 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. Karvezide 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. Karvezide 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 Karvezide 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 Karvezide’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 EU for Karvezide on 16 October 1998.

List item

Karvezide : EPAR - Summary for the public (PDF/81.53 KB)

First published: 05/05/2009
Last updated: 24/09/2013
- Bulgarian
  (PDF/112.55 KB)
- Croatian
  (PDF/94.46 KB)
- Czech
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- Danish
  (PDF/103.57 KB)
- Dutch
  (PDF/83.13 KB)
- Estonian
  (PDF/82.6 KB)
- Finnish
  (PDF/103.56 KB)
- French
  (PDF/84.58 KB)
- German
  (PDF/106.36 KB)
- Greek
  (PDF/133.66 KB)
- Hungarian
  (PDF/102.11 KB)
- Italian
  (PDF/103.56 KB)
- Latvian
  (PDF/126.62 KB)
- Lithuanian
  (PDF/127.62 KB)
- Maltese
  (PDF/109.02 KB)
- Polish
  (PDF/132.65 KB)
- Portuguese
  (PDF/103.94 KB)
- Romanian
  (PDF/103.98 KB)
- Slovak
  (PDF/128.43 KB)
- Slovenian
  (PDF/99.52 KB)
- Spanish
  (PDF/103.78 KB)
- Swedish
  (PDF/105.48 KB)

More detail is available in the summary of product characteristics

This EPAR was last updated on 26/04/2021

Authorisation details

Product details
Name	Karvezide
Agency product number	EMEA/H/C/000221
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	41
Date of issue of marketing authorisation valid throughout the European Union	16/10/1998
Contact address	54 rue La Boétie 75008 Paris France

Product information

25/03/2021 Karvezide - EMEA/H/C/000221 - WS/1969

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Karvezide : EPAR - Product Information (PDF/1.3 MB)

First published: 19/10/2009
Last updated: 26/04/2021
- Bulgarian
  (PDF/1.64 MB)
- Croatian
  (PDF/1.48 MB)
- Czech
  (PDF/1.37 MB)
- Danish
  (PDF/1.2 MB)
- Dutch
  (PDF/1.22 MB)
- Estonian
  (PDF/1.75 MB)
- Finnish
  (PDF/1.2 MB)
- French
  (PDF/715.2 KB)
- German
  (PDF/1.63 MB)
- Greek
  (PDF/1.73 MB)
- Hungarian
  (PDF/1.63 MB)
- Icelandic
  (PDF/1.09 MB)
- Italian
  (PDF/492.4 KB)
- Latvian
  (PDF/1.34 MB)
- Lithuanian
  (PDF/1.42 MB)
- Maltese
  (PDF/1.56 MB)
- Norwegian
  (PDF/1.09 MB)
- Polish
  (PDF/1.51 MB)
- Portuguese
  (PDF/955.47 KB)
- Romanian
  (PDF/1.23 MB)
- Slovak
  (PDF/1.35 MB)
- Slovenian
  (PDF/1.26 MB)
- Spanish
  (PDF/517.55 KB)
- Swedish
  (PDF/1.08 MB)

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.

List item

Karvezide : EPAR - All Authorised presentations (PDF/17.77 KB)

First published: 17/04/2007
Last updated: 17/04/2007
- Bulgarian
  (PDF/103.69 KB)
- Czech
  (PDF/56.44 KB)
- Danish
  (PDF/18.66 KB)
- Dutch
  (PDF/17.88 KB)
- Estonian
  (PDF/19.44 KB)
- Finnish
  (PDF/18.78 KB)
- French
  (PDF/18.81 KB)
- German
  (PDF/17.94 KB)
- Greek
  (PDF/103.08 KB)
- Hungarian
  (PDF/57.1 KB)
- Italian
  (PDF/18.12 KB)
- Latvian
  (PDF/105.72 KB)
- Lithuanian
  (PDF/102.33 KB)
- Polish
  (PDF/58.53 KB)
- Portuguese
  (PDF/18.61 KB)
- Romanian
  (PDF/101.75 KB)
- Slovak
  (PDF/103.3 KB)
- Slovenian
  (PDF/55.36 KB)
- Spanish
  (PDF/19.29 KB)
- Swedish
  (PDF/18.23 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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Karvezide : EPAR - Procedural steps taken and scientific information after authorisation (PDF/423.64 KB)

First published: 16/10/2006
Last updated: 26/04/2021
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Karvezide : EPAR - Scientific conclusions (PDF/99.42 KB)

First published: 03/06/2019
- Bulgarian
  (PDF/136.15 KB)
- Croatian
  (PDF/125.02 KB)
- Czech
  (PDF/131.08 KB)
- Danish
  (PDF/96.12 KB)
- Dutch
  (PDF/99.3 KB)
- Estonian
  (PDF/94.4 KB)
- Finnish
  (PDF/97.12 KB)
- French
  (PDF/97.56 KB)
- German
  (PDF/100.2 KB)
- Greek
  (PDF/142.79 KB)
- Hungarian
  (PDF/119.82 KB)
- Italian
  (PDF/95.54 KB)
- Latvian
  (PDF/130.68 KB)
- Lithuanian
  (PDF/130.84 KB)
- Maltese
  (PDF/133.78 KB)
- Polish
  (PDF/130.65 KB)
- Portuguese
  (PDF/96.47 KB)
- Romanian
  (PDF/128.25 KB)
- 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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Karvezide-H-C-PSUSA-00001653-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/75.5 KB)

First published: 04/01/2018
Last updated: 04/01/2018
EMA/715525/2017
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Karvezide-H-C-221-A31-165 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 02/10/2014
Last updated: 02/10/2014
EMA/PRAC/294920/2014
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Karvezide-H-C-221-A31-165 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommend... (PDF/48.81 KB)

First published: 02/10/2014
Last updated: 02/10/2014
- Bulgarian
  (PDF/87.49 KB)
- Croatian
  (PDF/80.12 KB)
- Czech
  (PDF/82.81 KB)
- Danish
  (PDF/49.01 KB)
- Dutch
  (PDF/49.82 KB)
- Estonian
  (PDF/50.6 KB)
- Finnish
  (PDF/49.15 KB)
- French
  (PDF/51.91 KB)
- German
  (PDF/53.54 KB)
- Greek
  (PDF/89.54 KB)
- 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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Karvezide-H-C-221-II-158 : EPAR - Assessment Report - Variation (PDF/123.49 KB)

Adopted

First published: 24/09/2013
Last updated: 24/09/2013
EMA/CHMP/378050/2013
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CHMP post-authorisation summary of positive opinion for Karvezide (PDF/66.14 KB)

Adopted

First published: 28/06/2013
Last updated: 28/06/2013
EMA/CHMP/388323/2013
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Karvezide : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/41.89 KB)

First published: 16/10/2006
Last updated: 16/10/2006

Karvezide

Table of contents

Overview

Karvezide : EPAR - Summary for the public (PDF/81.53 KB)

Authorisation details

Product information

Karvezide : EPAR - Product Information (PDF/1.3 MB)

Contents

Karvezide : EPAR - All Authorised presentations (PDF/17.77 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Karvezide : EPAR - Procedural steps taken and scientific information after authorisation (PDF/423.64 KB)

Karvezide : EPAR - Scientific conclusions (PDF/99.42 KB)

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

Karvezide-H-C-PSUSA-00001653-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/75.5 KB)

Karvezide-H-C-221-A31-165 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Karvezide-H-C-221-A31-165 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommend... (PDF/48.81 KB)

Karvezide-H-C-221-II-158 : EPAR - Assessment Report - Variation (PDF/123.49 KB)

CHMP post-authorisation summary of positive opinion for Karvezide (PDF/66.14 KB)

Karvezide : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/41.89 KB)

Initial marketing-authorisation documents

Karvezide : EPAR - Scientific Discussion (PDF/569.46 KB)

Karvezide : EPAR - Procedural steps taken before authorisation (PDF/85.81 KB)

News

More information on Karvezide

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

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