Kinzalmono - telmisartan

What is Kinzalmono?

Kinzalmono 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 Kinzalmono used for?

Kinzalmono 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 Kinzalmono used?

Kinzalmono should be taken by mouth, with or without food. The usual 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 Kinzalmono work?

The active substance in Kinzalmono, 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.

How has Kinzalmono been studied?

Kinzalmono has been studied in 1 647 patients, who were treated with telmisartan alone or in combination with hydrochlorothiazide. Kinzalmono 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 Kinzalmono shown during the studies?

Kinzalmono 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 Kinzalmono?

Side effects related to Kinzalmono are not common. However, the following side effects occurred in 1 to 10 patients in 1 000: hyperkalemia (high levels of potassium in the blood), syncope (fainting), insomnia, 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), including kidney failure, and pain chest. For the full list of all side effects reported with Kinzalmono, see the Package Leaflet.

Kinzalmono 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. Kinzalmono should not be used in people with severe liver or bile problems.

Why has Kinzalmono been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Kinzalmono's benefits are greater than its risks for the treatment of essential hypertension in adults. The Committee recommended that Kinzalmono be given marketing authorization.

More information on Kinzalmono:

On 16 December 1998, the European Commission issued a marketing authorization for Kinzalmono, valid throughout the European Union. The marketing authorization was renewed on 16 December 2003 and 16 December 2008. The marketing authorization holder is Bayer Schering Pharma AG.

For the full EPAR for Kinzalmono, click here. Last update of this summary: 05-2009