Pritor - telmisartan

What is Pritor?

Pritor 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 Pritor used for?

Pritor 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 Pritor used?

Pritor is to be taken by mouth, with or between meals. The recommended dose is 40 mg once daily, but some patients may find benefit using a 20 mg dose. If the desired blood pressure has not been achieved, the dose can be increased up to 80 mg or another medicine for hypertension, such as hydrochlorothiazide, can be added.

How does Pritor work?

The active substance in Pritor, telmisartan, is an 'angiotensin II receptor antagonist', meaning it blocks the action of a hormone produced by the body called angiotensin II. Angiotensin II is a potent vasoconstrictor (a substance that constricts blood vessels). By blocking the receptors that angiotensin II normally attaches to, telmisartan stops the hormone from working. This results in a drop in blood pressure and reduces the risks associated with high blood pressure, such as stroke.

How has Pritor been studied?

Pritor has been studied in 1,647 patients who have been treated with telmisartan alone or in combination with hydrochlorothiazide. Pritor was compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine). The main measure of effectiveness was based on the reduction in diastolic blood pressure (blood pressure measured in the interval between two heartbeats).

What benefit has Pritor shown during the studies?

Pritor was more effective than placebo in lowering diastolic blood pressure, showing similar effects to other medicines for hypertension.

What is the risk associated with Pritor?

Side effects related to Pritor are not common. However, the following side effects have occurred in 1 to 10 out of 1,000 patients: hyperkalaemia (high blood potassium levels), syncope (fainting), insomnia, dizziness (a feeling of dizziness), hypotension (low blood pressure) , dyspnoea (breathing problems), abdominal pain, diarrhea, dry mouth, dyspepsia (heartburn), flatulence (gas), hyperhidrosis (excessive sweating), itching, myalgia (muscle pain), kidney impairment (kidney problems), including including kidney failure, and chest pain. For the full list of side effects reported with Pritor, see the package leaflet.
Pritor must not be used in people who may be hypersensitive (allergic) to telmisartan or any of the other ingredients of the medicine. It must not be used in women who are more than three months pregnant. It is not recommended for use during the first three months of pregnancy. Pritor should not be used in people with severe liver or bile problems.

Why has Pritor been approved?

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

Other information about Pritor:

On 11 December 1998, the European Commission issued a "Marketing Authorization" for Pritor, valid throughout the European Union. The marketing authorization was renewed on 11 December 2003 and 11 December 2008. The holder of the marketing authorization is Bayer Schering Pharma AG.
For the full version of Pritor's EPAR, click here.

Last update of this summary: 05-2009.

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