What is Rasilamlo - aliskiren / amlodipine?
Rasilamlo is a medicine that contains the active substances aliskiren and amlodipine, available as tablets (light yellow: 150 mg of aliskiren and 5 mg of amlodipine; yellow: 150 mg of aliskiren and 10 mg of amlodipine; dark yellow: 300 mg of aliskiren and 5 mg of amlodipine; yellow-brown: 300 mg of aliskiren and 10 mg of amlodipine).
What is Rasilamlo used for - aliskiren / amlodipine?
Rasilamlo is indicated for the treatment of essential hypertension (high blood pressure) in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone. The term "essential" means that the cause of the hypertension is not. manifests.
The medicine can only be obtained with a prescription.
How is Rasilamlo used - aliskiren / amlodipine?
The patient should take one tablet a day, with a light meal, preferably at the same time each day. The tablet should be swallowed whole with water. Grapefruit juice should not be taken together with the medicine.
The strength of the tablet depends on the doses of aliskiren or amlodipine previously taken by the patient. The dose may be adjusted based on patient-reported side effects with previous aliskiren or amlodipine therapy as well as a function of the patient's clinical response to Rasilamlo.
Rasilamlo can be administered with other antihypertensive medicinal products.
How does Rasilamlo - aliskiren / amlodipine work?
Rasilamlo contains two active substances, aliskiren and amlodipine.
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.
Amlodipine is a calcium channel blocker, meaning it blocks particular channels on the cell surface, called calcium channels, which normally allow calcium ions to enter cells. When calcium ions penetrate the muscle cells of the vascular walls, they cause a contraction. By reducing the flow of calcium into the cells, amlodipine inhibits the contraction of cells, thus promoting relaxation of the vessels.
The combination of the two active ingredients reduces blood pressure to a greater extent than the two medicines taken separately.
How has Rasilamlo - aliskiren / amlodipine been studied?
The effects of Rasilamlo were first tested in experimental models before being studied in humans.
In three main studies involving 2 212 patients Rasilamlo was compared to aliskiren or amlodipine monotherapy for eight or six weeks. The main measure of effectiveness was the mean diastolic pressure (blood pressure measured in the interval between two heartbeats) measured with the patient in a sitting position.
What benefit has Rasilamlo - aliskiren / amlodipine shown during the studies?
Rasilamlo was more effective in reducing essential hypertension than placebo and aliskiren or amlodipine monotherapy.
In the first study, patients treated with Rasilamlo 300/10 mg and 300/5 mg recorded a decrease in diastolic blood pressure while sitting equal, respectively, to 13.07 mmHg and 10.54 mmHg, compared to a reduction of 5, 84 mmHg in patients taking aliskiren 300 mg.
In the second study, the reduction in blood pressure was, respectively, 10.99 mmHg and 8.95 mmHg with Rasilamlo 300/10 mg and 150 / 10mg, compared with a reduction of 7.23mmHg with amlodipine 10 mg.
The third study showed a decrease in blood pressure of 8.46 mmHg with Rasilamlo 150/5 mg compared with a reduction of 8.04 mmHg and 4.84 mmHg with amlodipine 10 mg and 5 mg, respectively.
What are the risks associated with Rasilamlo - aliskiren / amlodipine?
Side effects reported with Rasilamlo are hypotension (low blood pressure) and peripheral edema (swelling, especially of the ankles and feet). For the full list of side effects reported with Rasilamlo, see the package leaflet.
Rasilamlo should not be used in people who may be hypersensitive (allergic) to aliskiren, amlodipine or any of the other ingredients of the medicine or other substances derived from dihydropyridine (a group including amlodipine). It must not be used in patients with a history of angioedema (swelling of the skin) with aliskiren, hereditary angioedema or angioedema of no known cause, severe hypotension, shock, aortic valve stenosis or in patients with heart failure after acute myocardial infarction. It must also not be given to women in the second and third trimester of pregnancy or to patients taking medicines containing cyclosporine and itraconazole, as well as other medicines known as 'potent P-glycoprotein inhibitors'.
Why has Rasilamlo - aliskiren / amlodipine been approved?
The CHMP decided that Rasilamlo's benefits are greater than its risks and recommended that it be given a Marketing Authorization for this medicine.
More information about Rasilamlo - aliskiren / amlodipine
On April 14, 2011, the European Commission granted Novartis Europharm Limited a "Marketing Authorization" for Rasilamlo, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
For more information about Rasilamlo therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 03-2011.
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