Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Noden Pharma DAC, DOlier Chambers, 16A DOlier Street, Dublin 2, Ireland
Treatment of essential hypertension in adults.
The recommended dose of Rasilez is 150 mg once daily. In patients whose blood pressure is not adequately controlled, the dose may be increased to 300 mg once daily.
The antihypertensive effect is substantially present within two weeks (85-90%) after initiating therapy with 150 mg once daily.
Rasilez may be used alone or in combination with other antihypertensive agents with the exception of use in combination with angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m²) (see sections 4.3, 4.4 and 5.1).
No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.4 and 5.2). Aliskiren is not recommended in patients with severe renal impairment (GFR <30 ml/min/1.73 m²).
No adjustment of the initial dose is required for patients with mild to severe hepatic impairment (see section 5.2).
The recommended starting dose of aliskiren in elderly patients is 150 mg. No clinically meaningful additional blood pressure reduction is observed by increasing the dose to 300 mg in the majority of elderly patients.
Rasilez is contraindicated in children from birth to less than 2 years. Rasilez should not be used in children aged 2 to less than 6 years because of safety concerns due to potential aliskiren overexposure (see sections 4.3, 4.4, 5.2, and 5.3). The safety and efficacy of Rasilez in children aged 6 to 17 years have not yet been established. Currently available data are described in sections 4.8, 5.1, and 5.2. Use of Rasilez is not recommended in this population.
Oral use. The tablets should be swallowed whole with some water. Rasilez should be taken once a day, always with or always without food, preferably at the same time each day. Patients should establish a convenient daily schedule of medicinal product intake and maintain a steady temporal relationship with food intake. Concomitant intake with fruit juice and/or drinks containing plant extracts (including herbal teas) should be avoided (see section 4.5).
Limited data are available related to overdose in humans. The most likely manifestations of overdosage would be hypotension, related to the antihypertensive effect of aliskiren.
If symptomatic hypotension should occur, supportive treatment should be initiated.
In a study conducted in patients with end stage renal disease (ESRD) receiving haemodialysis, dialysis clearance of aliskiren was low (<2% of oral clearance). Therefore dialysis is not adequate to treat aliskiren over-exposure.
3 years.
Do not store above 25°C. Store in the original package in order to protect from moisture.
Rasilez 150 mg film-coated tablets:
PVC/polychlorotrifluoroethylene (PCTFE) – Alu blisters:
Unit packs containing 14, 28, 30, 50, 56, 90 or 98 tablets.
Unit packs containing 56x1 tablets in perforated unit dose blisters.
Multipacks containing 280 (20x14) tablets.
Multipacks containing 98 (2x49x1) tablets in perforated unit dose blisters.
Rasilez 300 mg film-coated tablets:
PVC/polychlorotrifluoroethylene (PCTFE) – Alu blisters:
Unit packs containing 14, 28, 30, 50, 56, 90 or 98 tablets.
Unit packs containing 56x1 tablets in perforated unit dose blisters.
Multipacks containing 280 (20x14) tablets.
Multipacks containing 98 (2x49x1) tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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