RASILEZ HCT Film-coated tablet Ref.[109366] Active ingredients: Aliskiren Aliskiren and Hydrochlorothiazide Hydrochlorothiazide

Posology

The recommended dose of Rasilez HCT is one tablet per day.

The antihypertensive effect is largely manifested within 1 week and the maximum effect is generally seen within 4 weeks.

Posology in patients not adequately controlled with aliskiren or hydrochlorothiazide monotherapy

Individual dose titration with each of the two components may be recommended before changing to the fixed combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.

Rasilez HCT 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or hydrochlorothiazide 12.5 mg alone.

Rasilez HCT 150 mg/25 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or hydrochlorothiazide 25 mg alone or by Rasilez HCT 150 mg/12.5 mg.

Rasilez HCT 300 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or hydrochlorothiazide 12.5 mg alone or by Rasilez HCT 150 mg/12.5 mg.

Rasilez HCT 300 mg/25 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or hydrochlorothiazide 25 mg alone or by Rasilez HCT 300 mg/12.5 mg or Rasilez HCT 150 mg/25 mg.

If blood pressure remains uncontrolled after 2-4 weeks of therapy, the dose may be titrated up to a maximum of Rasilez HCT 300 mg/25 mg daily. Dosing should be individualised and adjusted according to the patient’s clinical response.

Posology as substitution therapy

For convenience, patients receiving aliskiren and hydrochlorothiazide from separate tablets may be switched to a fixed combination tablet of Rasilez HCT containing the same component doses.

Special populations

Renal impairment

Due to the hydrochlorothiazide component, Rasilez HCT is contraindicated for use in patients with anuria and in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m²). No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.4 and 5.2).

Hepatic impairment

Rasilez HCT is contraindicated in patients with severe hepatic impairment and should be used with caution in patients with mild to moderate hepatic impairment or progressive liver disease. No adjustment of the initial dose is required for patients with mild to moderate hepatic impairment (see sections 4.3, 4.4 and 5.2).

Elderly people (over 65 years)

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.

Paediatric population

The safety and efficacy of Rasilez HCT in children below 18 years have not yet been established. No data are available.

Rasilez HCT is contraindicated in children from birth to less than 2 years. Rasilez HCT 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 HCT 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 HCT is not recommended in this population.

Method of administration

Oral use. The tablets should be swallowed whole with some water. Rasilez HCT 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).

Symptoms

The most likely manifestation of overdose would be hypotension, related to the antihypertensive effect of aliskiren.

Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis. The most common signs and symptoms of overdose are nausea and somnolence. Hypokalaemia may result in muscle spasms and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain antiarrhythmic medicinal products.

Treatment

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.

PA/Alu/PVC – Alu blisters:

Single-packs containing 7, 14, 28, 30, 50 or 56 tablets.

Multi-packs containing 90 (3 packs of 30), 98 (2 packs of 49) or 280 (20 packs of 14) tablets.

PVC/polychlorotrifluoroethylene (PCTFE) – Alu blisters:

Single-packs containing 7, 14, 28, 30, 50, 56, 90 or 98 tablets.

Single-packs (perforated unit dose blister) containing 56 × 1 tablets.

Multi-packs containing 280 (20 packs of 14) tablets.

Multi-packs (perforated unit dose blister) containing 98 (2 packs of 49 × 1) tablets.

Not all pack sizes or strengths may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.