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. |
|
| 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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