drugs

Sprimeo HCT - aliskiren / hydrochlorothiazide

PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED

What is Sprimeo HCT - aliskiren / hydrochlorothiazide?

Sprimeo HCT is a medicine containing the active substances aliskiren and hydrochlorothiazide. It is available as oval tablets (white: 150 mg of aliskiren and 12.5 mg of hydrochlorothiazide; pale yellow: 150 mg of aliskiren and 25 mg of hydrochlorothiazide; purple: 300 mg of aliskiren and 12.5 mg of hydrochlorothiazide ; light yellow: 300 mg of aliskiren and 25 mg of hydrochlorothiazide).

This medicine is the same as Rasilez HTC, already authorized in the European Union (EU). The company that makes Rasilez HTC has agreed that its scientific data will be used for Sprimeo HTC ("informed consent").

What is Sprimeo HCT used for - aliskiren / hydrochlorothiazide?

Sprimeo HCT is indicated for the treatment of essential hypertension (high blood pressure) in adults. The term "essential" means that the specific cause of hypertension is unknown.

Sprimeo 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 ingredients.

The medicine can only be obtained with a prescription.

How is Sprimeo HCT - aliskiren / hydrochlorothiazide used?

The recommended dose of Sprimeo HCT is one tablet a day. The medicine should be taken with a light meal, preferably at the same time each day, avoiding taking it with grapefruit juice. The dosage depends on the doses of aliskiren and / or hydrochlorothiazide previously taken by the patient.

In patients who previously took only aliskiren or hydrochlorothiazide it may be necessary to take the two substances in separate tablets and adjust the doses before switching to Sprimeo HCT. After two to four weeks of Sprimeo HCT therapy, the dose may be increased in patients whose blood pressure remains uncontrolled.

In patients already adequately controlled with the two active substances, the dose of Sprimeo HCT must contain the same doses of aliskiren and hydrochlorothiazide that the patient took previously.

How does Sprimeo HCT - aliskiren / hydrochlorothiazide work?

Sprimeo HCT contains two active substances, aliskiren and hydrochlorothiazide.

Aliskiren is a renin inhibitor. It blocks the activity of a human enzyme called renin, which participates in the production in the body of a substance called angiotensin I. Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that causes shrinkage of the blood vessels). When angiotensin I production is blocked, angiotensin I and angiotensin II levels decrease. This causes vasodilation (dilation of blood vessels) and therefore a decrease in blood pressure.

Hydrochlorothiazide is a diuretic, which is another type of treatment against hypertension. It works by increasing urine excretion, reducing the amount of fluid in the blood and lowering blood pressure.

The combination of the two active ingredients has an additive effect and allows to achieve a reduction in arterial pressure higher than that obtained by administering the two medicines individually. With the lowering of blood pressure, the risk of episodes related to hypertension, such as stroke, decreases.

What studies have been performed on Sprimeo HCT - aliskiren / hydrochlorothiazide?

Aliskiren alone is authorized in the European Union (EU) since August 2007 as Rasilez, Enviage, Sprimeo, Tekturna and Riprazo. The company presented the information used in the evaluation of aliskiren and taken from the published literature supporting the application for Sprimeo HCT as well as information from additional studies.

Overall, the company presented the results of nine main studies involving almost 9, 000 patients with essential hypertension. Most of the studies involved patients with mild to moderate hypertension; one study involved patients with severe hypertension. The studies compared the combination of aliskiren and hydrochlorothiazide with a placebo (a dummy treatment), with aliskiren or hydrochlorothiazide taken alone, or with other antihypertensive drugs (valsartan, irbesartan, lisinopril or amlodipine). The duration of the studies ranged from eight weeks to one year; the main measure of effectiveness was the change in arterial pressure during the resting phase of the heartbeat (diastolic pressure) or during the contraction of the cardiac cavities (systolic pressure). Three further studies were carried out to show that the active ingredients were absorbed by the body in the same way they were absorbed when taken in separate tablets and in the form of Sprimeo HCT.

What benefit has Sprimeo HCT - aliskiren / hydrochlorothiazide shown during the studies?

Sprimeo HCT was more effective than placebo in reducing blood pressure. In patients whose blood pressure was not adequately controlled with aliskiren or hydrochlorothiazide taken on their own, switching to their combination led to declines in blood pressure higher than those obtained with the intake of only one active ingredient.

What are the risks associated with Sprimeo HCT - aliskiren / hydrochlorothiazide?

The most common side effect with Sprimeo HCT (seen in between 1 and 10 patients out of 100) is diarrhea. For the full list of all side effects reported with Sprimeo HCT, see the Package Leaflet.

Sprimeo 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 developed angioedema (subcutaneous swelling) after taking aliskiren, who are suffering from severe kidney or liver problems or who have too low levels of potassium in the blood or calcium levels in the blood 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 an irregular heartbeat) or verapamil (used to treat heart problems). It must not be used in women who have been pregnant for more than three months or who are breast-feeding. Not recommended for use during the first three months of pregnancy.

Why has Sprimeo HCT - aliskiren / hydrochlorothiazide been approved?

The CHMP decided that Sprimeo HCT's benefits are greater than its risks and recommended that it be given marketing authorization.

Other information on Sprimeo HCT - aliskiren / hydrochlorothiazide

The European Commission granted a marketing authorization valid throughout the European Union for Sprimeo HCT to Novartis Europharm Limited on 23 June 2011. The marketing authorization is valid for five years, after which it can be renewed.

For more information on Sprimeo HCT therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Last update of this summary: 03-2011.