MicardisPlus

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 MicardisPlus. 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 MicardisPlus.

: MicardisPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide. It is available as oval tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).

: MicardisPlus is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. ‘Essential’ means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.

: MicardisPlus is taken by mouth once a day with liquid. The dose of MicardisPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets. The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to MicardisPlus.

: MicardisPlus contains two active substances, telmisartan and hydrochlorothiazide.
Telmisartan 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, telmisartan 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 reducing 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.

: MicardisPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension. In four of these studies, MicardisPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients. The fifth study compared the effects of remaining on the 80/12.5 mg tablet with switching to the 80/25 mg tablet in 713 patients who had not responded to the 80/12.5 mg tablet. In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).

: MicardisPlus was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo.
In patients who were not controlled on the 80/12.5 mg tablet, switching to the 80/25 mg tablet was more effective in reducing diastolic blood pressure than remaining on the lower dose.

: The most common side effect with MicardisPlus (seen in between 1 and 10 patients in 100) is dizziness. For the full list of all side effects reported with MicardisPlus, see the package leaflet.
MicardisPlus 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. MicardisPlus must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high. In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, MicardisPlus must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension). For the full list of restrictions, see the package leaflet.
Care must be taken when using MicardisPlus with other medicines that have an effect on blood potassium levels. The full list of these medicines is given in the package leaflet.

: The Committee for Medicinal Products for Human Use (CHMP) decided that MicardisPlus’s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone. The Committee recommended that MicardisPlus be given marketing authorisation.

: A risk management plan has been developed to ensure that MicardisPlus is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for MicardisPlus including the appropriate precautions to be followed by healthcare professionals and patients.

: The European Commission granted a marketing authorisation valid throughout the European Union for MicardisPlus on 19 April 2002
For more information about treatment with MicardisPlus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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MicardisPlus : EPAR - Summary for the public (PDF/75.62 KB)

First published: 06/05/2009
Last updated: 10/11/2015
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- Estonian
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- Finnish
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- Greek
  (PDF/108.56 KB)
- Hungarian
  (PDF/99.24 KB)
- Italian
  (PDF/82.25 KB)
- Latvian
  (PDF/100.48 KB)
- Lithuanian
  (PDF/101.08 KB)
- Maltese
  (PDF/105.4 KB)
- Polish
  (PDF/103.48 KB)
- Portuguese
  (PDF/82.88 KB)
- Romanian
  (PDF/99.62 KB)
- Slovak
  (PDF/102.43 KB)
- Slovenian
  (PDF/97.99 KB)
- Spanish
  (PDF/82.63 KB)
- Swedish
  (PDF/82.49 KB)

This EPAR was last updated on 21/03/2023

Authorisation details

Product details
Name	MicardisPlus
Agency product number	EMEA/H/C/000413
Active substance	Telmisartan hydrochlorothiazide
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09DA07

Publication details
Marketing-authorisation holder	Boehringer Ingelheim International GmbH
Revision	33
Date of issue of marketing authorisation valid throughout the European Union	19/04/2002
Contact address	Bingerstr. 173 55216 Ingelheim am Rheim Germany

Product information

31/10/2022 MicardisPlus - EMEA/H/C/000413 - IG1564/G

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MicardisPlus : EPAR - Product Information (PDF/387.92 KB)

First published: 15/10/2009
Last updated: 03/11/2022
- Bulgarian
  (PDF/442.42 KB)
- Croatian
  (PDF/421.54 KB)
- Czech
  (PDF/409.36 KB)
- Danish
  (PDF/419.12 KB)
- Dutch
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- Estonian
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- Finnish
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- French
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- German
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- Greek
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- Hungarian
  (PDF/426.58 KB)
- Icelandic
  (PDF/394.98 KB)
- Italian
  (PDF/417.23 KB)
- Latvian
  (PDF/398.94 KB)
- Lithuanian
  (PDF/390.17 KB)
- Maltese
  (PDF/488.98 KB)
- Norwegian
  (PDF/387.96 KB)
- Polish
  (PDF/432.93 KB)
- Portuguese
  (PDF/395.76 KB)
- Romanian
  (PDF/454.99 KB)
- Slovak
  (PDF/398.18 KB)
- Slovenian
  (PDF/382.69 KB)
- Spanish
  (PDF/406.62 KB)
- Swedish
  (PDF/387.21 KB)

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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MicardisPlus : EPAR - All Authorised presentations (PDF/36.73 KB)

First published: 06/05/2008
Last updated: 26/05/2010
- Bulgarian
  (PDF/109.17 KB)
- Croatian
  (PDF/29.61 KB)
- Czech
  (PDF/66.36 KB)
- Danish
  (PDF/37.34 KB)
- Dutch
  (PDF/36.62 KB)
- Estonian
  (PDF/38.57 KB)
- Finnish
  (PDF/38.66 KB)
- French
  (PDF/39.07 KB)
- German
  (PDF/38.04 KB)
- Greek
  (PDF/104.97 KB)
- Hungarian
  (PDF/105.47 KB)
- Icelandic
  (PDF/29.8 KB)
- Italian
  (PDF/37.5 KB)
- Latvian
  (PDF/105.11 KB)
- Lithuanian
  (PDF/105.84 KB)
- Maltese
  (PDF/101.42 KB)
- Norwegian
  (PDF/28.52 KB)
- Polish
  (PDF/69.09 KB)
- Portuguese
  (PDF/38.08 KB)
- Romanian
  (PDF/100.55 KB)
- Slovak
  (PDF/66.53 KB)
- Slovenian
  (PDF/38.4 KB)
- Spanish
  (PDF/37.02 KB)
- Swedish
  (PDF/38.34 KB)

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension.

MicardisPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.

MicardisPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on MicardisPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.

Assessment history

Changes since initial authorisation of medicine

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MicardisPlus : EPAR - Procedural steps taken and scientific information after authorisation (PDF/307.31 KB)

First published: 15/10/2009
Last updated: 03/11/2022
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MicardisPlus-H-C-413-A31-0085 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 24/09/2014
Last updated: 24/09/2014
EMA/PRAC/294920/2014
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MicardisPlus-H-C-413-A31-0085 : 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 recom... (PDF/48.81 KB)

First published: 24/09/2014
Last updated: 24/09/2014
- 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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CHMP post-authorisation summary of positive opinion for MicardisPlus (PDF/66.74 KB)

Adopted

First published: 26/04/2013
Last updated: 26/04/2013
EMA/CHMP/261191/2013
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MicardisPlus-H-C-413-X-0040 : EPAR - Scientific Discussion - Extension (PDF/368.97 KB)

Adopted

First published: 04/06/2008
Last updated: 04/06/2008
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MicardisPlus : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/84.42 KB)

First published: 20/07/2006
Last updated: 20/07/2006

MicardisPlus

Table of contents

Overview

MicardisPlus : EPAR - Summary for the public (PDF/75.62 KB)

Authorisation details

Product information

MicardisPlus : EPAR - Product Information (PDF/387.92 KB)

MicardisPlus : EPAR - All Authorised presentations (PDF/36.73 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

MicardisPlus : EPAR - Procedural steps taken and scientific information after authorisation (PDF/307.31 KB)

MicardisPlus-H-C-413-A31-0085 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

MicardisPlus-H-C-413-A31-0085 : 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 recom... (PDF/48.81 KB)

CHMP post-authorisation summary of positive opinion for MicardisPlus (PDF/66.74 KB)

MicardisPlus-H-C-413-X-0040 : EPAR - Scientific Discussion - Extension (PDF/368.97 KB)

MicardisPlus : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/84.42 KB)

Initial marketing-authorisation documents

MicardisPlus : EPAR - Scientific Discussion (PDF/284.88 KB)

MicardisPlus : EPAR - Procedural steps taken before authorisation (PDF/85.44 KB)

News

More information on MicardisPlus

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

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