PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Riprazo HCT?
Riprazo 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; light purple: 300 mg aliskiren and 12.5 mg hydrochlorothiazide; yellow clear: 300 mg of aliskiren and 25 mg of hydrochlorothiazide).
This medicine is similar to Rasilez HCT, which is already authorized in the European Union (EU). The company that made Rasilez HCT considered that the related scientific data could also be used for Riprazo HCT ("informed consent").
What is Riprazo HCT used for - aliskiren / hydrochlorothiazide?
Riprazo HCT is indicated for the treatment of essential hypertension (high blood pressure) in adults. The term "essential" means that hypertension has no obvious cause.
Riprazo 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 Riprazo HCT used - aliskiren / hydrochlorothiazide?
The recommended dose of Riprazo HCT is one tablet once a day. The medicine should be taken with a light meal, preferably at the same time each day. Riprazo HCT should not be taken 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 Riprazo HCT. After taking Riprazo HCT for two to four weeks, the dose may be increased in patients whose blood pressure remains uncontrolled.
In patients adequately controlled with the two active substances, the dose of Riprazo HCT should contain the same doses of aliskiren and hydrochlorothiazide that the patient was taking previously.
How does Riprazo HCT - aliskiren / hydrochlorothiazide work?
Riprazo HCT contains two active substances, aliskiren and hydrochlorothiazide.
Aliskiren is a renin inhibitor. It inhibits 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 narrowing of the blood vessels). When angiotensin I production is blocked, angiotensin I and angiotensin II levels decrease. As a result, the vessels dilate (vasodilation) and blood pressure drops.
Hydrochlorothiazide is a diuretic, another drug used to treat hypertension. It causes an increase in urine production and, consequently, a reduction in the amount of fluid in the blood and blood pressure.
The combination of the two active ingredients produces an additional effect which is to reduce blood pressure to a greater extent than the two medicines taken separately. By lowering blood pressure, the risk of hypertension, such as stroke, decreases.
How has Riprazo HCT 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 Riprazo HCT as well as information from additional studies.
Overall, the company presented the results of nine main studies involving around 9,000 patients with essential hypertension. Most of the studies involved the participation of patients with mild to moderate hypertension and one study with patients with severe hypertension. The studies compared the combination of aliskiren and hydrochlorothiazide with placebo (a dummy treatment), with aliskiren or hydrochlorothiazide taken separately or with other antihypertensive medicines (valsartan, irbesartan, lisinopril or amlodipine). The duration of the studies ranged from eight weeks to one year and the main measure of effectiveness was the change in blood pressure during the resting phase of the heartbeat (diastolic pressure) or during the contraction phase of the heart cavities (systolic pressure). Three further studies were carried out to show that the active substances were absorbed by the body in the same way they were absorbed when taken as separate tablets and in the form of Riprazo HCT.
What benefit has Riprazo HCT shown during the studies?
Riprazo 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 their combination resulted in greater drops in blood pressure than taking an active substance alone.
What is the risk associated with Riprazo HCT - aliskiren / hydrochlorothiazide?
The most common side effect reported with Riprazo HCT (seen in 1 to 10 patients in 100) is diarrhea. For the full list of side effects reported with Riprazo HCT, see the package leaflet.
Riprazo HCT should not be used in people who may be hypersensitive (allergic) to aliskiren, hydrochlorothiazide or any of the other ingredients or sulfonamides. It must not be used in patients who have had angioedema (swelling under the skin) with aliskiren, have severe kidney or liver problems, or whose potassium levels are too low or calcium levels too high. Riprazo HCT must not be taken together with cyclosporine (a drug that reduces the activity of the immune system), itraconazole (used to treat fungal infections), quinidine (used to treat irregular heartbeat) or verapamil (used to treat heart problems). It should not be used in women who are pregnant for more than three months or are breastfeeding. Use of the medicine during the first three months of pregnancy is not recommended.
Why has Riprazo HCT - aliskiren / hydrochlorothiazide been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Yondelis's benefits are greater than its risks for the treatment of patients with advanced soft tissue sarcoma after failure of anthracyclines and ifosfamide therapy or who are unsuitable for receive such agents. The committee noted that the evidence for the effects of Yondelis is mainly based on the treatment of liposarcoma and leiomyosarcoma. The committee recommended that Yondelis be given a marketing authorization.
Yondelis was authorized under "exceptional circumstances". This means that, as the disease is rare, it has not been possible to obtain complete information on Yondelis. The European Medicines Agency will review the new information available annually and, if necessary, this summary will be updated.
What information is still awaited for Riprazo HCT - aliskiren / hydrochlorothiazide?
The CHMP decided that Riprazo HCT's benefits are greater than its risks and therefore recommended that it be given a Marketing Authorization.
More information about Riprazo HCT - aliskiren / hydrochlorothiazide
On 13 April 2011, the European Commission granted Novartis Europharm Limited a "Marketing Authorization" for Riprazo HCT, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
For more information about Riprazo HCT therapy, read the package leaflet (also included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 02-2011.
The information on Riprazo 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.
