Author: Novartis Europharm Ltd.


Long information

What is it?

Rasilamlo is a medicine that contains the active substances aliskiren and amlodipine. It is available as tablets (light yellow: 150 mg aliskiren and 5 mg amlodipine; yellow: 150 mg aliskiren and 10 mg amlodipine; dark-yellow: 300 mg aliskiren and 5 mg amlodipine; brown-yellow: 300 mg aliskiren and 10 mg amlodipine).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Rasilamlo is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone. 'Essential' means that the hypertension has no obvious cause.

The medicine can only be obtained with a prescription.

How is it used?

The patient should take one tablet once a day with a light meal, preferably at the same time each day. The tablet should be swallowed whole with water. It should not be taken together with grapefruit juice.

The strength of the tablet the patient takes depends on the doses of aliskiren or amlodipine that they received previously. The dose may be adjusted based on the side effects the patient experienced with their previous treatment with aliskiren or amlodipine and also on how the patient responds to treatment with Rasilamlo.

Rasilamlo can be used with other antihypertensive medicines.

How does it work?

Rasilamlo contains two active substances, aliskiren and amlodipine.

Aliskiren is a renin inhibitor. It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body. Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall. This causes vasodilation (widening of the blood vessels), so that the blood pressure drops.

Amlodipine is a calcium channel blocker. It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter. When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the blood vessel walls from contracting, thus lowering the blood pressure.

The combination of the two active substances reduces blood pressure more than either medicine acting alone.

How has it 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 with aliskiren or amlodipine taken alone for eight or six weeks. The main measure of effectiveness was the change in the average diastolic blood pressure (blood pressure measured between two heartbeats) measured when the patients were seated.

What benefits has it shown during the studies?

Rasilamlo was more effective at controlling essential hypertension than placebo, aliskiren or amlodipine used alone.

In the first study, patients taking Rasilamlo 300/10 mg and 300/5 mg had a fall in their sitting diastolic blood pressure of 13.07 mmHg and 10.54 mmHg, respectively, compared with a fall of 5.84 mmHg in patients taking aliskiren 300 mg.

In the second study the falls in blood pressure were 10.99 mmHg and 8.95 mmHg with Rasilamlo 300/10 mg and 150/10mg, respectively, compared with 7.23mmHg with amlodipine 10 mg.

The third study showed a fall in blood pressure of 8.46 mmHg with Rasilamlo 150/5 mg compared with 8.04 mmHg and 4.84 mmHg with amlodipine 10 mg and 5 mg, respectively.

What is the risk associated?

The most common side effects with Rasilamlo are hypotension (low blood pressure) and peripheral oedema (swelling, especially of the 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, to any of the other ingredients of the medicine or other substances derived from dihydropyridine (a group that includes amlodipine). It must not be used in patients with a history of angioedema (swelling beneath the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, severe hypotension, shock, narrowing of the aortic heart valve or in patients with heart failure after a heart

Page attack. It must also not be used in women who are more than three months pregnant or in patients taking medicines containing ciclosporin and itraconazole and other medicines known as ?potent P-glycoprotein inhibitors?.

Why has it been approved?

The CHMP decided that Rasilamlo?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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