Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Noden Pharma DAC, DOlier Chambers, 16A DOlier Street, Dublin 2, Ireland
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.
| Pharmaceutical Form |
|---|
|
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. |
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Excipients with known effect: Each tablet contains 25 mg lactose (as monohydrate) and 24.5 mg wheat starch.
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Excipients with known effect: Each tablet contains 50 mg lactose (as monohydrate) and 49 mg wheat starch.
Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Excipients with known effect: Each tablet contains 25 mg lactose (as monohydrate) and 24.5 mg wheat starch.
Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Excipients with known effect: Each tablet contains 50 mg lactose (as monohydrate) and 49 mg wheat starch.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Aliskiren |
Aliskiren is an orally active, non-peptide, potent and selective direct inhibitor of human renin. By inhibiting the enzyme renin, aliskiren inhibits the RAAS at the point of activation, blocking the conversion of angiotensinogen to angiotensin I and decreasing levels of angiotensin I and angiotensin II. |
|
| Aliskiren and Hydrochlorothiazide |
Combination of two antihypertensive active substances to control blood pressure in patients with essential hypertension. Aliskiren belongs to the class of direct renin inhibitors and hydrochlorothiazide to the class of thiazide diuretics. The combination of these substances with complementary mechanisms of action provides an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone. |
|
| Hydrochlorothiazide |
Hydrochlorothiazide is a diuretic with antihypertensive properties. It acts by inhibiting the renal tubular re-absorption of sodium and chloride ions, which are excreted with an accompanying volume of water. Potassium excretion is also promoted. |
| List of Excipients |
|---|
Rasilez HCT 150 mg/12.5 mg film-coated tabletsTablet core: Microcrystalline cellulose Coating: Talc Rasilez HCT 150 mg/25 mg film-coated tabletsTablet core: Microcrystalline cellulose Coating: Talc Coating: Rasilez HCT 300 mg/25 mg film-coated tabletsTablet core: Microcrystalline cellulose Coating: Talc |
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.
Noden Pharma DAC, D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland
Rasilez HCT 150 mg/12.5 mg film-coated tablets: EU/1/08/491/001-020
Rasilez HCT 150 mg/25 mg film-coated tablets: EU/1/08/491/021-040
Rasilez HCT 300 mg/12.5 mg film-coated tablets: EU/1/08/491/041-060
Rasilez HCT 300 mg/25 mg film-coated tablets: EU/1/08/491/061-080
Date of first authorisation: 16 January 2009
Date of latest renewal: 27 August 2018
| Drug | Countries | |
|---|---|---|
| RASILEZ HCT | Austria, Cyprus, Estonia, Spain, Hong Kong, Lithuania, Netherlands, Poland, Romania |
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