Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
CoAprovel 150 mg/12.5 mg tablets.
Pharmaceutical Form |
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Tablet. Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side. |
Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Excipient with known effect: Each tablet contains 26.65 mg of lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
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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. |
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Irbesartan |
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II. The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration. |
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Irbesartan and Hydrochlorothiazide |
The combination of irbesartan and hydrochlorothiazide has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone. Irbesartan is a potent, orally active, selective angiotensin-II receptor (AT1 subtype) antagonist. Hydrochlorothiazide is a thiazide diuretic. The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges. |
List of Excipients |
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Microcrystalline cellulose |
Cartons of 14 tablets in PVC/PVDC/Aluminium blisters.
Cartons of 28 tablets in PVC/PVDC/Aluminium blisters.
Cartons of 56 tablets in PVC/PVDC/Aluminium blisters.
Cartons of 98 tablets in PVC/PVDC/Aluminium blisters.
Cartons of 56 × 1 tablets in PVC/PVDC/Aluminium perforated unit dose blisters.
Not all pack sizes may be marketed.
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
EU/1/98/086/001-003
EU/1/98/086/007
EU/1/98/086/009
Date of first authorisation: 15 October 1998
Date of latest renewal: 15 October 2008
Drug | Countries | |
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COAPROVEL | Austria, Cyprus, Germany, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Italy, Lithuania, Mexico, Nigeria, Netherlands, Poland, Romania, Singapore, Tunisia, United Kingdom |
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