Karvezide

irbesartan / hydrochlorothiazide

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Karvezide?

Karvezide is a medicine that contains two active substances, irbesartan and hydrochlorothiazide. It is available as oval tablets (peach: 150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; pink: 300 mg irbesartan and 25 mg hydrochlorothiazide).

What is Karvezide used for?

Karvezide is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone. ‘Essential’ means that the hypertension has no obvious cause.

The medicine can only be obtained with a prescription.

How is Karvezide used?

Karvezide is taken by mouth, with or without food. The dose of Karvezide to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before. Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended. Karvezide may be added to other treatments for hypertension.

How does Karvezide work?

Karvezide contains two active substances, irbesartan and hydrochlorothiazide.

Irbesartan 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, irbesartan 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 lowering 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 Karvezide been studied?

Irbesartan on its own has been approved in the European Union (EU) since 1997 under the names Karvea and Aprovel. It can be used with hydrochlorothiazide to treat hypertension. The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Karvezide. Further studies were also carried out with doses of 300 mg irbesartan in combination with 25 mg hydrochlorothiazide. The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).

What benefit has Karvezide shown during the studies?

Karvezide was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure. Increasing the dose to 300 mg irbesartan and 25 mg hydrochlorothiazide may give a further decrease in blood pressure.

What is the risk associated with Karvezide?

The most common side effects with Karvezide (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscles). For the full list of all side effects reported with Karvezide, see the package leaflet.

Karvezide should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients. 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. Karvezide must also not be used in patients 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 Karvezide 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 Karvezide been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Karvezide’s benefits are greater than its risks for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. The Committee recommended that Karvezide be given marketing authorisation.

Other information about Karvezide

The European Commission granted a marketing authorisation valid throughout the EU for Karvezide to Bristol-Myers Squibb Pharma EEIG on 16 October 1998. The marketing authorisation was renewed on 16 October 2003 and on 16 October 2008.

This EPAR was last updated on 07/02/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

20/10/2011  Karvezide -EMEA/H/C/000221 -WS/0171

Contents

• 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.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents