What is MicardisPlus?
Micardis Plus is a medicine that contains two active substances telmisartan and hydrochlorothiazide. It comes 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 hypertension (high blood pressure) which cannot be adequately controlled with telmisartan alone. The term "essential" means that hypertension has no obvious cause. MicardisPlus is not recommended for use in patients below 18 years of age, as 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 is taken by mouth once a day with a liquid drink, during meals or between meals. The dose of MicardisPlus to use depends on the dose of telmisartan the patient was previously taking: patients receiving 40 mg telmisartan should take 40 / 12.5 mg tablets and patients receiving 80 mg telmisartan should take tablets. from 80 / 12.5 mg. The 80/25 mg tablets are given to patients whose blood pressure is not controlled using the 80 / 12.5 mg tablets or to 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 that it inhibits the action of a hormone in the body called angiotensin II. Angiotensin II is a potent vasoconstrictor (a substance that constricts blood vessels). angiotensin II binds, telmisartan prevents the effect of the hormone by letting the blood vessels dilate.
Hydrochlorothiazide is a diuretic, another type of treatment for 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 alone in a total of 2 272 patients. The fifth study compared the effects of continuing the 80 / 12.5 mg tablet with those of switching to the 80/25 mg tablet in 713 patients who failed to respond to the 80 / 12.5 mg tablet. In all of the studies, the main measure of effectiveness was the reduction in diastolic blood pressure (blood pressure measured between two heart beats).
What benefit has MicardisPlus shown during the studies?
MicardisPlus was more effective than placebo and telmisartan alone in lowering the diastolic blood pressure. In patients who were not controlled on 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 1 to 10 patients in 100) is dizziness. For the full list of side effects reported with MicardisPlus, see the Package Leaflet.
MicardisPlus should not be used in patients who may be hypersensitive (allergic) to telmisartan, hydrochlorothiazide, sulphonamides or any of the other ingredients (including sorbitol). It should not be used in women who are more than three months pregnant. Its use is not recommended during the first three months of pregnancy. MicardisPlus should also not be used in patients who have severe liver, kidney or bile problems, who have too low blood potassium levels or too high blood calcium levels.
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 complete list of these drugs, see the Package Leaflet.
Why has MicardisPlus been approved?
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 it should be used. release of the marketing authorization for MicardisPlus.
Other information about MicardisPlus:
On 19 April 2002, the European Commission granted Boehringer Ingelheim International GmbH a "Marketing Authorization" for MicardisPlus, valid throughout the European Union. The "Marketing Authorization" was renewed on 19 April 2007.
For the full version of MicardisPlus EPAR, click here.
Last update of this summary: 03-2009.
The information on Micardis Plus 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.
