Micardis

telmisartan

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

: Micardis is a medicine that contains the active substance telmisartan. It is available as tablets (20, 40 and 80 mg).

: Micardis is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the hypertension has no obvious cause.
Micardis is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes. It is used in patients who have had problems due to blood clots in the past (such as heart disease, a stroke or artery disease) or who have type-2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).
The medicine can only be obtained with a prescription.

: For the treatment of essential hypertension, the usual recommended dose of Micardis is 40 mg once a day, but some patients may benefit from using 20 mg once a day. If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day. The doctor should monitor the patient’s blood pressure closely when starting Micardis, and may decide to adjust the patient’s blood-pressure-lowering medication. Patients with severely reduced kidney function should receive a lower starting dose of 20 mg once a day. Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day.

: The active substance in Micardis, 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. This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke. It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.

: For the treatment of essential hypertension, Micardis has been studied in 2,647 patients who took Micardis either alone or in combination with hydrochlorothiazide. Various doses of Micardis were compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine). The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
For the prevention of cardiovascular problems, 80 mg Micardis once a day has been studied in one main study involving almost 26,000 patients aged 55 years or over who had heart or artery disease, had had a stroke, or had diabetes and were at high risk of cardiovascular problems. Micardis was compared with ramipril (another medicine to prevent cardiovascular problems), and with the combination of both medicines. The main measure of effectiveness was the reduction in the number of patients who died or were admitted to hospital, or who had a heart attack or stroke. The patients were followed up for an average of four and a half years.

: In the treatment of essential hypertension, Micardis was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
In the prevention of cardiovascular problems, Micardis had a similar effect to ramipril, with around 17% of patients dying, being admitted to hospital because of cardiovascular problems, or having a heart attack or stroke. The combination of the two medicines was no more effective than either medicine taken alone and was linked to an increased risk of side effects.

: Side effects with Micardis are not common. However, the following side effects are seen in between 1 and 10 patients in 1,000: upper-respiratory-tract infection (colds) including inflammation of the throat and sinuses, urinary-tract infection (infection of the structures that carry urine) including bladder infection, anaemia (low red-blood-cell counts), hyperkalaemia (high blood potassium levels), depression, insomnia (difficulty sleeping), syncope (fainting), vertigo (a spinning sensation), bradycardia (slow heart rate), hypotension (low blood pressure), dyspnoea (difficulty breathing), cough, abdominal pain (stomach ache), diarrhoea, dyspepsia (heartburn), flatulence (gas), vomiting, hyperhidrosis (excessive sweating), pruritus (itching), rash, myalgia (muscle pain), back pain, muscle spasms, renal impairment (reduced kidney function) including sudden kidney failure, chest pain, asthenia (weakness) and increased blood levels of creatinine (a marker of muscle breakdown). Hypotension may be more common in patients receiving Micardis to prevent cardiovascular problems. For the full list of all side effects reported with Micardis, see the package leaflet.
Micardis 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. Micardis must not be used in people who have severe liver problems or bile problems. In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Micardis 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.

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

: A risk management plan has been developed to ensure that Micardis 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 Micardis, 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 Micardis on 16 December 1998.
For more information about treatment with Micardis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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Micardis : EPAR - Summary for the public (PDF/77.12 KB)

First published: 06/05/2009
Last updated: 06/11/2015
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More detail is available in the summary of product characteristics

This EPAR was last updated on 06/09/2018

Authorisation details

Product details
Name	Micardis
Agency product number	EMEA/H/C/000209
Active substance	telmisartan
International non-proprietary name (INN) or common name	telmisartan
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09CA07

Publication details
Marketing-authorisation holder	Boehringer Ingelheim International GmbH
Revision	23
Date of issue of marketing authorisation valid throughout the European Union	16/12/1998
Contact address	Bingerstr. 173 55216 Ingelheim am Rheim Germany

Product information

22/05/2018 Micardis - EMEA/H/C/000209 - IB/0114/G

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Micardis : EPAR - Product Information (PDF/304.62 KB)

First published: 25/06/2009
Last updated: 06/09/2018
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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.

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Micardis : EPAR - All Authorised presentations (PDF/30.75 KB)

First published: 23/01/2007
Last updated: 07/09/2018
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Pharmacotherapeutic group

Angiotensin II antagonists
plain

Therapeutic indication

Hypertension

Treatment of essential hypertension in adults.

Cardiovascular prevention

Reduction of cardiovascular morbidity in patients with:

manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;
type-2 diabetes mellitus with documented target-organ damage.

Assessment history

Changes since initial authorisation of medicine

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Micardis : EPAR - Procedural steps taken and scientific information after authorisation (PDF/223.76 KB)

First published: 25/06/2009
Last updated: 06/09/2018
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Micardis-H-C-209-A31-0099 : 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: 25/09/2014
Last updated: 25/09/2014
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  (PDF/87.49 KB)
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  (PDF/49.01 KB)
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- Estonian
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- Finnish
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- German
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- Hungarian
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- Italian
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- Spanish
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- Swedish
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Micardis-H-C-209-A31-0099 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 25/09/2014
Last updated: 25/09/2014
EMA/PRAC/294920/2014
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CHMP post-authorisation summary of positive opinion for Micardis (PDF/67.42 KB)

Adopted

First published: 26/04/2013
Last updated: 26/04/2013
EMA/CHMP/261191/2013
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Micardis-H-C-209-WS-0254 : EPAR - Assessment Report - Variation (PDF/547.43 KB)

Adopted

First published: 27/03/2013
Last updated: 27/03/2013
EMA/CHMP/549534/2012
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Micardis-H-C-209-II-0073 : EPAR - Assessment Report - Variation (PDF/1.1 MB)

Adopted

First published: 08/02/2010
Last updated: 08/02/2010
EMA/CHMP/768468/2009
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CHMP post-authorisation summary of positive opinion for Micardis on 22 October 2009 (PDF/30.26 KB)

Adopted

First published: 22/10/2009
Last updated: 22/10/2009
EMEA/CHMP/676934/2009
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Micardis : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/104.66 KB)

First published: 10/07/2006
Last updated: 10/07/2006

Micardis

Table of contents

Overview

Micardis : EPAR - Summary for the public (PDF/77.12 KB)

Authorisation details

Product information

Micardis : EPAR - Product Information (PDF/304.62 KB)

Contents

Micardis : EPAR - All Authorised presentations (PDF/30.75 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Micardis : EPAR - Procedural steps taken and scientific information after authorisation (PDF/223.76 KB)

Micardis-H-C-209-A31-0099 : 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)

Micardis-H-C-209-A31-0099 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

CHMP post-authorisation summary of positive opinion for Micardis (PDF/67.42 KB)

Micardis-H-C-209-WS-0254 : EPAR - Assessment Report - Variation (PDF/547.43 KB)

Micardis-H-C-209-II-0073 : EPAR - Assessment Report - Variation (PDF/1.1 MB)

CHMP post-authorisation summary of positive opinion for Micardis on 22 October 2009 (PDF/30.26 KB)

Micardis : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/104.66 KB)

Initial marketing-authorisation documents

Micardis : EPAR - Procedural steps taken before authorisation (PDF/84.5 KB)

Micardis : EPAR - Scientific Discussion (PDF/239.29 KB)

News

More information on Micardis

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

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