What is MicardisPlus?
Micardis Plus is a medicine that contains two active substances telmisartan and hydrochlorothiazide. It is found in the form of an oval tablet (red and white: 40 mg or 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide; yellow and white: 80 mg of telmisartan and 25 mg of hydrochlorothiazide).
What is MicardisPlus used for?
MicardisPlus is used to treat essential arterial hypertension (high blood pressure) that cannot be adequately controlled with telmisartan alone. The term "essential" indicates that hypertension has no obvious cause. The use of MicardisPlus is not recommended in patients under the age of 18 because there is no information on the safety and efficacy of the product for this age group.
The medicine can only be obtained with a prescription.
How is MicardisPlus used?
MicardisPlus should be taken by mouth once a day with a liquid drink, with or without food. The dose of MicardisPlus to be used depends on the dose of telmisartan the patient previously took: patients receiving 40 mg telmisartan should take 40 / 12.5 mg tablets and patients receiving 80 mg telmisartan should take the tablets from 80 / 12.5 mg. 80/25 mg tablets should be administered to patients whose blood pressure is not controlled using 80 / 12.5 mg tablets or patients who have been stabilized using the two active substances separately before switching to MicardisPlus.
How does MicardisPlus work?
MicardisPlus contains two active substances, telmisartan and hydrochlorothiazide.
Telmisartan is an "angiotensin II receptor antagonist", which means it inhibits the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (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.
Hydrochlorothiazide is a diuretic, another type of treatment against hypertension. It works by increasing urine excretion, reducing the amount of fluid in the blood and lowering blood pressure. The combination of the two active ingredients has an additional effect, reducing blood pressure to a greater extent than the two medicines taken individually. As blood pressure decreases, the risks associated with hypertension, such as having a stroke, decrease.
How has MicardisPlus been studied?
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 as a whole in 2 272 patients. In the fifth study, the effects of the continuation of the 80 / 12.5 mg tablet were compared with those of switching to the 80/25 mg tablet in 713 patients who had not responded to the 80 / 12.5 mg tablet. In all the studies the main measure of effectiveness was the reduction of diastolic blood pressure (blood pressure measured between two heartbeats).
What benefit has MicardisPlus shown during the studies?
MicardisPlus was more effective than placebo and telmisartan administered alone in reducing diastolic blood pressure. In patients who had not been controlled with the 80 / 12.5 mg tablet, switching to the 80/25 mg tablet was more effective than continuing with the lower dose in lowering the diastolic blood pressure.
What is the risk associated with MicardisPlus?
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 should not be used in patients who may be hypersensitive (allergic) to telmisartan, hydrochlorothiazide, sulphonamide or any of the other ingredients (including sorbitol). 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. MicardisPlus should also not be used in patients who have severe problems with their liver, kidneys or bile, who have too low levels of potassium in their blood or too high levels of calcium in their blood.
Particular attention should be paid if MicardisPlus is taken at the same time as other drugs that affect the level of potassium in the blood. For the full list of these drugs, see the package leaflet.
Why has MicardisPlus been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of MicardisPlus are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled with telmisartan alone. The committee recommended that MicardisPlus be given marketing authorization.
More information on MicardisPlus:
On 19 April 2002, the European Commission issued a marketing authorization valid throughout the European Union to Boehringer Ingelheim International GmbH for MicardisPlus. The marketing authorization was renewed on 19 April 2007.
For the full EPAR for MicardisPlus, click here.
Last update of this summary: 03-2009.
