This is a summary of the European public assessment report (EPAR) for PritorPlus. 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 PritorPlus.
- What is PritorPlus?
PritorPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide. It is available as oval tablets (red and white: 40 or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; yellow and white: 80 mg telmisartan and 25 mg hydrochlorothiazide).
- What is PritorPlus used for?
PritorPlus is used in 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 PritorPlus used?
PritorPlus is taken by mouth once a day with liquid, with or without food. The dose of PritorPlus 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 PritorPlus.
- How does PritorPlus work?
PritorPlus 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 blood pressure.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone. By lowering blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
- How has PritorPlus been studied?
PritorPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension. In four of these studies, PritorPlus 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 PritorPlus shown during the studies?
PritorPlus 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 PritorPlus?
The most common side effect with PritorPlus (seen in between 1 and 10 patients in 100) is dizziness. For the full list of all side effects reported with PritorPlus, see the package leaflet.
PritorPlus should not be used in people who may be hypersensitive (allergic) to telmisartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients (including sorbitol). It 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. PritorPlus 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.
Care must be taken when using PritorPlus 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 PritorPlus been approved?
The CHMP decided that PritorPlus’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 PritorPlus be given marketing authorisation.
- Other information about PritorPlus
The European Commission granted a marketing authorisation valid throughout the European Union for PritorPlus on 22 April 2002.
For more information about treatment with PritorPlus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 07/11/2013 .
29/05/2013 PritorPlus -EMEA/H/C/000414 -WS/0362
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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Agents acting on the renin-angiotensin system
Treatment of essential hypertension.
PritorPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.
PritorPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on PritorPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|PritorPlus : EPAR - Procedural steps taken and scientific information after authorisation||SV = svenska||26/11/2009||07/11/2013|
|CHMP post-authorisation summary of positive opinion for PritorPlus||SV = svenska||26/04/2013|
|PritorPlus-H-C-414-X-42 : EPAR - Scientific Discussion - Extension||SV = svenska||04/06/2008|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|PritorPlus : EPAR - Scientific Discussion||SV = svenska||04/06/2008|
|PritorPlus : EPAR - Procedural steps taken before authorisation||SV = svenska||21/10/2005|
This medicine is approved for use in the European Union