What is Micardis?
Micardis is a medicine that contains the active substance telmisartan. It is available as white tablets (round: 20 mg; oblong: 40 and 80 mg).
What is Micardis used for?
Micardis is used in adults with essential hypertension (high blood pressure). The term "essential" indicates that hypertension has no obvious cause.
The medicine can only be obtained with a prescription.
How is Micardis used?
Micardis is taken by mouth, with meals or between meals. The recommended dose is 40 mg once daily, but some patients may find benefit using a 20 mg dose. If the desired blood pressure has not been achieved, the dose can be increased up to 80 mg or another medicine for hypertension, such as hydrochlorothiazide, can be added.
How does Micardis work?
The active substance in Micardis, telmisartan, is an 'angiotensin II receptor antagonist', which means that it blocks the action of a hormone produced by the body called angiotensin II. Angiotensin II is a potent vasoconstrictor (a substance that constricts blood vessels). By blocking the receptors to which angiotensin II normally attaches, telmisartan prevents the hormone from working by letting the blood vessels dilate. This results in a drop in blood pressure and reduces the risks associated with high blood pressure, such as stroke.
How has Micardis been studied?
Micardis has been studied in 1,647 patients who have been treated with telmisartan alone or in combination with hydrochlorothiazide. Micardis was compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine). interval between two heartbeats).
What benefit has Micardis shown during the studies?
Micardis was more effective than placebo in lowering diastolic blood pressure, showing similar effects to other medicines for hypertension.
What is the risk associated with Micardis?
Side effects related to myocardis are not common. However, the following side effects have occurred in 1 to 10 out of 1,000 patients: hyperkalaemia (high blood potassium levels), syncope (fainting), insomnia, dizziness (a feeling of dizziness), hypotension (low blood pressure) , dyspnoea (breathing problems), abdominal pain, diarrhea, dry mouth, dyspepsia (heartburn), flatulence (gas), hyperhidrosis (excessive sweating), itching, myalgia (muscle pain), kidney impairment (kidney problems), including including kidney failure, and chest pain. For the full list of side effects reported with Micardis, see the Package Leaflet.
Micardis must not be used in people who may be hypersensitive (allergic) to telmisartan or any of the other ingredients of the medicine. It must not be used in women who are more than three months pregnant. It is not recommended for use during the first three months of pregnancy. Micardis should not be used in patients who have severe liver or bile problems.
Why has Micardis been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Micardis's benefits are greater than its risks for the treatment of essential hypertension in adults. The Committee recommended that Micardis be given marketing authorization.
Other information about Micardis:
On 16 December 1998, the European Commission granted Boehringer Ingelheim International GmbH a "marketing authorization" for Micardis, valid throughout the European Union. The "marketing authorization" was renewed on 16 December 2003 and on December 16, 2008.
For the full version of Micardis EPAR, click here.
Last update of this summary: 03-2009.
The information on Micardis - telmisartan published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
