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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/568173/2015

EMEA/H/C/000413

EPAR summary for the public

MicardisPlus

telmisartan / hydrochlorothiazide

This is a summary of the European public assessment report (EPAR) for MicardisPlus. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for MicardisPlus.

What is MicardisPlus?

MicardisPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide. It is available as oval tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).

What is MicardisPlus used for?

MicardisPlus is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. 'Essential' means that the hypertension has no obvious cause

The medicine can only be obtained with a prescription.

How is MicardisPlus used?

MicardisPlus is taken by mouth once a day with liquid. The dose of MicardisPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets. The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to MicardisPlus.

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How does MicardisPlus work?

MicardisPlus contains two active substances, telmisartan and hydrochlorothiazide.

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.

Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension. It works by increasing urine output, reducing the amount of fluid in the blood and reducing the blood pressure.

The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

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 remaining on the 80/12.5 mg tablet with switching to the 80/25 mg tablet in 713 patients who had not responded to the 80/12.5 mg tablet. In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).

What benefit has MicardisPlus shown during the studies?

MicardisPlus was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo. In patients who were not controlled on the 80/12.5 mg tablet, switching to the 80/25 mg tablet was more effective in reducing diastolic blood pressure than remaining on the lower dose.

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 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. MicardisPlus must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high. In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, MicardisPlus 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.

Care must be taken when using MicardisPlus with other medicines that have an effect on blood potassium levels. The full list of these medicines is given in 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 MicardisPlus be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of MicardisPlus?

A risk management plan has been developed to ensure that MicardisPlus 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 MicardisPlus including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about MicardisPlus

The European Commission granted a marketing authorisation valid throughout the European Union for MicardisPlus on 19 April 2002

The full EPAR for MicardisPlus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with MicardisPlus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2015.