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 should be taken by mouth, with or without food. The recommended dose is 40 mg once a day, but some patients may benefit from using a 20 mg dose. If the desired blood pressure has not been obtained, the dose can be increased up to 80 mg or another hypertension medicine, 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 powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, telmisartan prevents the hormone effect by letting the blood vessels dilate. This causes a drop in blood pressure and reduces the risks associated with high blood pressure, such as stroke.
What studies have been carried out on Micardis?
Micardis has been studied in 1 647 patients, who were treated with telmisartan alone or in combination with hydrochlorothiazide. Micardis has been compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine). The main efficacy index was based on the reduction of diastolic blood pressure (the blood pressure measured in the interval between two heartbeats).
What benefit has Micardis shown during the studies?
Micardis was more effective than placebo in reducing the diastolic blood pressure, showing effects similar to other medicines for hypertension.
What is the risk associated with Micardis?
Side effects related to Miocardis are not common. However, the following side effects occurred from 1 in 10 patients in 1 000: hyperkalemia (high levels of potassium in the blood), syncope (fainting), insomnia, dizziness (a feeling of dizziness), hypotension (low blood pressure), dyspnoea (respiratory problems), abdominal pain, diarrhea, dry mouth, dyspepsia (heartburn), flatulence (gas), hyperhidrosis (excessive sweating), itching, myalgia (muscle pain), renal impairment (kidney problems), which renal failure, and chest pain. For the full list of all side effects reported with Micardis, see the Package Leaflet.
Micardis should not be used in people who may be hypersensitive (allergic) to telmisartan or other ingredients in the medicine. It must not be used in women who have been pregnant for more than three months. Not recommended for use during the first three months of pregnancy. Micardis should not be used in patients who have severe problems with their liver or bile.
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.
More information on Micardis:
On 16 December 1998, the European Commission issued a marketing authorization valid throughout the European Union to Boehringer Ingelheim International GmbH for Micardis. The marketing authorization was renewed on 16 December 2003 and 16 December 2008.
For the full EPAR for Micardis, click here.
Last update of this summary: 03-2009.
