PLEASE NOTE: MEDICINAL PRODUCT 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, which is already authorized in the European Union (EU). The company that makes Rasilez HTC has agreed that its scientific data are 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 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 Sprimeo HCT used - aliskiren / hydrochlorothiazide?
The recommended dose of Sprimeo HCT is one tablet per 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.
Patients who previously took only aliskiren or hydrochlorothiazide may need to take the two as 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 should contain the same doses of aliskiren and hydrochlorothiazide that the patient was taking 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 body's production of a substance called angiotensin I. Angiotensin I is converted into the hormone angiotensin II, which is a potent 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 drop in blood pressure.
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 blood pressure.
The combination of the two active ingredients has an additive effect and allows to achieve a reduction in blood pressure higher than that obtained by administering the two medicines individually. With the lowering of blood pressure, the risk of episodes related to hypertension decreases. such as stroke.
How has Sprimeo HCT - aliskiren / hydrochlorothiazide been studied?
Aliskiren alone has been authorized 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 the application for Sprimeo HCT as well as information from additional studies.
Overall, the company presented the results of nine main studies involving nearly 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 placebo (a dummy treatment), with aliskiren or hydrochlorothiazide taken alone, or with other antihypertensive medicines (valsartan, irbesartan, lisinopril or amlodipine). The duration of the studies ranged from eight weeks to a year; the main measure of effectiveness was the change in blood pressure during the resting phase of the heartbeat (diastolic pressure) or during the contraction of the heart 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 as 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 lowering blood pressure. In patients whose blood pressure was not adequately controlled with aliskiren or hydrochlorothiazide taken alone, switching to the combination resulted in higher blood pressure drops than those achieved with a single active ingredient alone.
What are the risks associated with Sprimeo HCT - aliskiren / hydrochlorothiazide?
The most common side effect reported with Sprimeo HCT (seen in 1 to 10 patients out of a total of 100) is diarrhea. For the full list of side effects reported with Sprimeo HCT, see the Package Leaflet. .
Sprimeo HCT must not be used in people who may be hypersensitive (allergic) to aliskiren, hydrochlorothiazide, any of the other ingredients or sulphonamides. It must not be used in patients who have developed angioedema (swelling under the skin) after taking aliskiren, who have severe kidney or liver problems or who have too low blood potassium or blood calcium levels too high. It should not be taken with cyclosporine (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 are more than three months pregnant or breastfeeding. Its use is not recommended 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 a Marketing Authorization for the medicine.
More information about Sprimeo HCT - aliskiren / hydrochlorothiazide
On 23 June 2011 the European Commission granted Novartis Europharm Limited a "Marketing Authorization" for Sprimeo HCT, valid throughout the European Union. 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 (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 03-2011.
The information on Sprimeo HCT - aliskiren / hydrochlorothiazide published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
