Kinzalkomb

What is Kinzalkomb?

Kinzalkomb 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 Kinzalkomb used for?

Kinzalkomb is used in patients with essential hypertension (high blood pressure) which is not adequately controlled on telmisartan alone. The term "essential" indicates that hypertension has no obvious cause.
The medicine can only be obtained with a prescription.

How is Kinzalkomb used?

Kinzalkomb is taken by mouth once a day with a liquid drink, with or without meals. The dose of Kinzalkomb to use depends on the dose of telmisartan the patient was previously taking: patients receiving 40 mg telmisartan should take the 40 / 12.5 mg tablets and patients receiving 80 mg telmisartan should take the tablets. from 80 / 12.5 mg. The 80/25 mg tablets are for use in patients whose blood pressure is not controlled using the 80 / 12.5 mg tablets or in patients who have been stabilized using the two active substances separately before switching to Kinzalkomb.

How does Kinzalkomb work?

Kinzalkomb 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). Normally angiotensin II binds, telmisartan prevents the hormone from acting by letting the blood vessels dilate.
Hydrochlorothiazide is a diuretic, another type of treatment for hypertension. It works by increasing urine output, 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. By lowering blood pressure, the risks associated with hypertension, such as having a stroke, decrease. .

How has Kinzalkomb been studied?

Kinzalkomb has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension. In four of these studies, Kinzalkomb 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 Kinzalkomb shown during the studies?

Kinzalkomb 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 Kinzalkomb?

The most common side effect with Kinzalkomb (seen in 1 to 10 patients in 100) is dizziness. For the full list of side effects reported with Kinzalkomb, see the package leaflet.
Kinzalkomb 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. Kinzalkomb should also not be used in people 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 Kinzalkomb is taken with other medicines that affect the level of potassium in the blood. For the complete list of these drugs, see the Package Leaflet.

Why has Kinzalkomb been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Kinzalkomb'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 Kinzalkomb.

Other information about Kinzalkomb:

On April 19, 2002, the European Commission issued a "Marketing Authorization" for Kinzalkomb, valid throughout the European Union. The "Marketing Authorization" was renewed on April 19, 2007. The Marketing Authorization Holder "placing on the market is Bayer Schering Pharma AG.
For the full version of the Kinzalkomb EPAR, click here.

Last update of this summary: 05-2009.

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