COAPROVEL Tablet Ref.[50773] Active ingredients: Hydrochlorothiazide Irbesartan Irbesartan and Hydrochlorothiazide

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France

Product name and form

CoAprovel 150 mg/12.5 mg tablets.

Pharmaceutical Form

Tablet.

Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.

Qualitative and quantitative composition

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
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.

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.

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

Microcrystalline cellulose
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate
Colloidal hydrated silica
Pregelatinised maize starch
Red and yellow ferric oxides (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France

Marketing authorization dates and numbers

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

Drugs

Drug Countries
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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