Rasilez HCT

aliskiren / 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 its 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 Rasilez HCT?

Rasilez HCT is a medicine that contains the active substances aliskiren and hydrochlorothiazide. It is available as oval tablets (white: 150 mg aliskiren and 12.5 mg hydrochlorothiazide; pale yellow: 150 mg aliskiren and 25 mg hydrochlorothiazide; pale violet: 300 mg aliskiren and 12.5 mg hydrochlorothiazide; light yellow: 300 mg aliskiren and 25 mg hydrochlorothiazide).

What is Rasilez HCT used for?

Rasilez HCT is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that no specific cause for the hypertension can be found.

Rasilez HCT is used in patients whose blood pressure is not adequately controlled by aliskiren or hydrochlorothiazide taken alone. It can also be used in patients whose blood pressure is adequately controlled with aliskiren and hydrochlorothiazide taken as separate tablets, to replace the same doses of the two active substances.

The medicine can only be obtained with a prescription.

How is Rasilez HCT used?

The recommended dose of Rasilez HCT is one tablet per day. It should be taken with a light meal preferably at the same time each day, but grapefruit juice should not be taken together with Rasilez HCT. The dose depends on the doses of aliskiren and/or hydrochlorothiazide that the patient was taking before.

Patients previously taking only aliskiren or hydrochlorothiazide may need to take the two substances as separate tablets and adjust the doses before switching to Rasilez HCT. After two to four weeks of taking Rasilez HCT, the dose can be increased in patients whose blood pressure remains uncontrolled.

In patients already adequately controlled with the two active substances, the dose of Rasilez HCT must contain the same doses of aliskiren and hydrochlorothiazide that the patient was taking before.

Rasilez HCT should be used with caution in patients who have problems.

How does Rasilez HCT work?

Rasilez HCT contains two active substances, aliskiren and hydrochlorothiazide.

Aliskiren is a renin inhibitor. It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body. Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall. This causes vasodilation (widening of the blood vessels), so that the blood pressure drops.

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 risk caused by high blood pressure, such as having a stroke, is reduced.

How has Rasilez HCT been studied?

Aliskiren on its own has been authorised in the European Union (EU) since August 2007 as Rasilez, Enviage, Sprimeo, Tekturna and Riprazo. The company presented information used in the assessment of aliskiren and from the published literature to support its application for Rasilez HCT, as well as information from additional studies.

Overall, the company presented the results of nine main studies involving a total of almost 9,000 patients with essential hypertension. Most studies involved patients with mild to moderate hypertension and one involved patients with severe hypertension. The studies compared the combination of aliskiren and hydrochlorothiazide with placebo (a dummy treatment), with aliskiren or hydrochlorothiazide taken alone, or with other medicines for hypertension (valsartan, irbesartan, lisinopril or amlodipine). The studies lasted for between eight weeks and a year, and the main measure of effectiveness was the change in blood pressure either during the resting phase of the heartbeat (diastolic) or when the chambers of the heart were contracting (systolic).

Three additional studies were carried out to show that the active substances were absorbed in the body in the same way when they taken as separate tablets and as Rasilez HCT.

What benefit has Rasilez HCT shown during the studies?

Rasilez HCT was more effective than placebo in reducing blood pressure. In patients whose blood pressure was not adequately controlled on either aliskiren or hydrochlorothiazide alone, switching to the combination resulted in greater falls in blood pressure than remaining on one active substance alone.

What is the risk associated with Rasilez HCT?

The most common side effect with Rasilez HCT (seen in between 1 and 10 patients in 100) is diarrhoea. For the full list of all side effects reported with Rasilez HCT, see the package leaflet.

Rasilez HCT should not be used in people who may be hypersensitive (allergic) to aliskiren, hydrochlorothiazide, any of the other ingredients or sulfonamides. It must not be used in patients who have had angioedema (swelling under the skin) with aliskiren, who have severe kidney or liver problems, or whose blood potassium levels are too low or blood calcium levels are too high. It must not be taken with ciclosporin (a medicine that reduces the activity of the immune system), itraconazole (used to treat fungal infections) or quinidine (used to correct irregular heartbeat). It must not be used in women who are more than three months pregnant or breast-feeding. Its use during the first three months of pregnancy is not recommended.

Why has Rasilez HCT been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Rasilez HCT’s benefits are greater than its risks for the treatment of essential hypertension in adults whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone, or adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination. The Committee recommended that Rasilez HCT be given marketing authorisation.

Other information about Rasilez HCT

The European Commission granted a marketing authorisation valid throughout the EU for Rasilez HCT to Novartis Europharm Limited on 16 January 2009. The marketing authorisation is valid for five years, after which it can be renewed.

This EPAR was last updated on 16/03/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

22/11/2011  Rasilez HCT -EMEA/H/C/000964 -WS/146

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 in adults.

Rasilez HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.

Rasilez HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents