What is Rasilez HCT?
Rasilez HCT is a medicine containing the active substances aliskiren and hydrochlorothiazide. It is available as oval tablets (white: 150 mg aliskiren and 12.5 mg hydrochlorothiazide; yellowish: 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).
What is Rasilez HCT used for?
Rasilez HCT is indicated for the treatment of essential hypertension (high blood pressure) in adults. The term "essential" means that the cause of the hypertension is unknown.
Rasilez 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 Rasilez HCT used?
The recommended dose of Rasilez 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 Rasilez HCT. After taking Rasilez 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 Rasilez HCT should contain the same doses of aliskiren and hydrochlorothiazide that the patient was taking previously.
Rasilez HCT should be used with caution in patients suffering from liver problems and must not be used in patients with severe liver or kidney problems.
How does Rasilez HCT work?
Rasilez 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 (substance that causes the
narrowing of 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, another type of antihypertensive treatment. It works by increasing urinary output, reducing the amount of fluid in the blood and thereby reducing 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 Rasilez HCT been studied?
Aliskiren alone has been licensed 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 Rasilez 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 ingredients were absorbed by the body in the same way they were absorbed when taken as separate tablets and in the form of Rasilez HCT.
What benefit has Rasilez HCT shown during the studies?
Rasilez 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 Rasilez HCT?
The most common side effect reported with Rasilez HCT (seen in 1 to 10 patients out of a total of 100) is diarrhea. For the full list of 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 or any of the other ingredients or sulphonamides. It must not be used in patients who have angioedema (swelling under the skin) after taking aliskiren, have severe kidney or liver problems, or whose potassium levels are too low or calcium levels are too high. It must not be taken. together with ciclosporin (medicine that reduces the activity of the immune system) or other medicines that slow down the metabolism of aliskiren in the body, such as quinidine (used to correct an irregular heartbeat) or verapamil (used to treat heart problems). It should be used in women who are more than three months pregnant or breastfeeding It is not recommended in the first three months of pregnancy.
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 sufficiently controlled on aliskiren or hydrochlorothiazide taken alone, or adequately controlled with aliskiren and hydrochlorothiazide taken together, in the same doses as in the combination. The Committee therefore recommended the granting of a marketing authorization for Rasilez HCT.
More information about Rasilez HCT
On January 16, 2009, the European Commission granted Novartis Europharm Limited a "Marketing Authorization" for Rasilez HCT, valid throughout the European Union.
For the full version of the Rasilez HCT EPAR, click here.
Last update of this summary: 12-2008
Information on Rasilez HCT 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.
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