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 - aliskiren / amlodipine used for?
Rasilamlo is indicated for the treatment of essential hypertension (high blood pressure) in adult patients in whom blood pressure is not adequately controlled with aliskiren or amlodipine used on its own. The term "essential" means that the cause of hypertension is not manifest.
The medicine can only be obtained with a prescription.
How is Rasilamlo - aliskiren / amlodipine used?
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 dosage of the tablet depends on the doses of aliskiren or amlodipine previously taken by the patient. The dose can be adjusted based on the side effects reported by the patient with the previous aliskiren or amlodipine therapy as well as on the patient's clinical response to Rasilamlo.
Rasilamlo can be given with other antihypertensive medicines.
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 production of a substance in the body called angiotensin I. Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (substance that causes shrinkage 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, which means that it blocks particular channels on the cell surface, called calcium channels, which normally allow calcium ions to enter cells. When calcium ions penetrate the cells of the musculature of the vascular walls, they cause a contraction. By reducing the flow of calcium in the cells, amlodipine inhibits the contraction of the cells, thus favoring the relaxation of the vessels.
The combination of the two active ingredients reduces blood pressure to a greater extent than the two medicines taken separately.
What studies have been performed on Rasilamlo - aliskiren / amlodipine?
The effects of Rasilamlo were first tested in experimental models before being studied in humans.
In three main studies involving 212 patients, Rasilamlo was compared to aliskiren or amlodipine monotherapy for eight or six weeks. The main measure of effectiveness was the average 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 monotherapy with aliskiren or amlodipine.
In the first study, patients treated with Rasilamlo 300/10 mg and 300/5 mg showed a drop in sitting diastolic pressure equal, respectively, to 13.07 mmHg and 10.54 mmHg, compared with a reduction of 5, 84 mmHg in patients treated with 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 drop in blood pressure of 8.46 mmHg with Rasilamlo 150/5 mg compared to the reduction, respectively, of 8.04 mmHg and 4.84 mmHg with amlodipine 10 mg and 5 mg.
What are the risks associated with Rasilamlo - aliskiren / amlodipine?
The side effects reported with Rasilamlo are hypotension (low blood pressure) and peripheral edema (swelling, especially of ankles and feet). For the full list of all 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 to other substances derived from dihydropyridine (a group that includes amlodipine). It must not be used in patients with a history of angioedema (skin swelling) with aliskiren, hereditary angioedema or angioedema without known cause, severe hypotension, shock, aortic valve stenosis or in patients with heart failure after acute myocardial infarction. It must also not be administered to women in the second and third trimesters of pregnancy or to patients taking medicines containing ciclosporin 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 marketing authorization.
Other information on Rasilamlo - aliskiren / amlodipine
On 14 April 2011, the European Commission granted Rasilamlo a marketing authorization valid throughout the European Union to Novartis Europharm Limited. The marketing authorization is valid for five years, after which it can be renewed.
For more information on Rasilamlo therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 03-2011.
