Rasilez HCT 150 mg/12.5 mg film-coated tablets

Rasilez HCT 150 mg/25 mg film-coated tablets

Rasilez HCT 300 mg/12.5 mg film-coated tablets

Rasilez HCT 300 mg/25 mg film-coated tablets

Rasilez HCT 150 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.

Rasilez HCT 150 mg/25 mg film-coated tablets: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.

Rasilez HCT 300 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.

Rasilez HCT 300 mg/25 mg film-coated tablets: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.

Excipients:

Rasilez HCT 150 mg/12.5 mg film-coated tablets: Each tablet contains 25 mg lactose monohydrate and 24.5 mg wheat starch.

Rasilez HCT 150 mg/25 mg film-coated tablets: Each tablet contains 50 mg lactose monohydrate and 49 mg wheat starch.

Rasilez HCT 300 mg/12.5 mg film-coated tablets: Each tablet contains 25 mg lactose monohydrate and 24.5 mg wheat starch

Rasilez HCT 300 mg/25 mg film-coated tablets: Each tablet contains 50 mg lactose monohydrate and 49 mg wheat starch.

For a full list of excipients, see section 6.1.

Film-coated tablet

Rasilez HCT 150 mg/12.5 mg film-coated tablets: White, biconvex, ovaloid film-coated tablet imprinted with “LCI” on one side and “NVR” on the other.

Rasilez HCT 150 mg/25 mg film-coated tablets: Pale yellow, biconvex, ovaloid film-coated tablet imprinted with “CLL” on one side and “NVR” on the other.

Rasilez HCT 300 mg/12.5 mg film-coated tablets: Violet white, biconvex, ovaloid film-coated tablet imprinted with “CVI” on one side and “NVR” on the other.

Rasilez HCT 300 mg/25 mg film-coated tablets: Light yellow, biconvex, ovaloid film-coated tablet imprinted with “CVV” on one side and “NVR” on the other.

Treatment of essential hypertension in adults.

Rasilez HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.

Rasilez HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.

The recommended dose of Rasilez HCT is one tablet per day. Rasilez HCT should be taken with a light meal once a day, preferably at the same time each day. Grapefruit juice should not be taken together with Rasilez HCT.

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 film-coated tablets: 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 film-coated tablets: 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 film-coated tablets: 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 film-coated tablets: 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.

Renal impairment

No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.4 and 5.2). Due to the hydrochlorothiazide component, Rasilez HCT is contraindicated for use in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min/1.73 m²) (see sections 4.3 and 5.2).

Hepatic impairment

Thiazides should be used with caution in patients with impaired hepatic function. No adjustment of the initial dose is required for patients with mild to moderate hepatic impairment (see section 5.2). Due to the hydrochlorothiazide component, Rasilez HCT is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).

Elderly patients (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 patients

Rasilez HCT is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).

− Hypersensitivity to the active substances or to any of the excipients (see section 6.1), or to other sulphonamide-derived substances.

− History of angioedema with aliskiren.

− Hereditary or idiopathic angioedema.

− Second and third trimesters of pregnancy, lactation (see section 4.6).

− Severe renal impairment (GFR < 30 ml/min/1.73 m²).

− Refractory hypokalaemia, hypercalcaemia.

− Severe hepatic impairment.

− The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-glycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated (see section 4.5).

Heart failure

Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association (NYHA) functional class III-IV). Rasilez HCT should be used with caution in patients with heart failure due to limited clinical efficacy and safety data.

Angioedema

As with other agents acting on the renin-angiotensin system, angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have been reported in patients treated with aliskiren.

A number of these patients had a history of angioedema or symptoms suggestive of angioedema, which in some cases followed use of other medicines that can cause angioedema, including RAS blockers (angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)) (see section 4.8).

Patients with a history of angioedema may be at increased risk of experiencing angioedema during treatment with aliskiren (see sections 4.3 and 4.8). Caution should therefore be exercised when prescribing aliskiren to patients with a history of angioedema, and such patients should be closely monitored during treatment (see section 4.8) especially at the beginning of the treatment.

If angioedema occurs, Rasilez HCT should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred. Where there is involvement of the tongue, glott