COVERSYL ARGININE Film-coated tablet Ref.[7037] Active ingredients: Perindopril

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

Product name and form

Coversyl Arginine 2.5 mg film-coated tablets.

Coversyl Arginine 5 mg film-coated tablets.

Coversyl Arginine 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

2.5mg: White, round, convex, film-coated tablet.

5mg: Light-green, rod-shaped film-coated tablet engraved with on one face and scored on both edges. The tablet can be divided into equal doses.

10mg: Green, round, biconvex, film-coated tablet engraved with a ♡ on one face and on the other face.

Qualitative and quantitative composition

Perindopril arginine.

2.5mg: One film-coated tablet contains 1.6975 mg perindopril corresponding to 2.5 mg perindopril arginine.

Excipient with known effect: 36.29 mg lactose monohydrate.

5mg: One film-coated tablet contains 3.395 mg perindopril corresponding to 5 mg perindopril arginine.

Excipient with known effect: 72.58 mg lactose monohydrate.

10mg: One film-coated tablet contains 6.790 mg perindopril corresponding to 10 mg perindopril arginine.

Excipient with known effect: 145.16 mg lactose monohydrate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Perindopril

Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin Converting Enzyme ACE). The converting enzyme, or kinase, is an exopeptidase that allows conversion of angiotensin I into the vasoconstrictor angiotensin II as well as causing the degradation of the vasodilator bradykinin into an inactive heptapeptide. Inhibition of ACE results in a reduction of angiotensin II in the plasma, which leads to increased plasma renin activity (by inhibition of the negative feedback of renin release) and reduced secretion of aldosterone. Since ACE inactivates bradykinin, inhibition of ACE also results in an increased activity of circulating and local kallikrein-kinin systems (and thus also activation of the prostaglandin system).

List of Excipients

Core:

Lactose monohydrate
Magnesium stearate
Maltodextrin
Hydrophobic colloidal silica
Sodium starch glycolate (type A)

Film-coating:

Glycerol
Hypromellose
Copper chlorophyllin (not 2.5 mg)
Macrogol 6000
Magnesium stearate
Titanium dioxide

Pack sizes and marketing

White polypropylene tablet container equipped with a polyethylene flow reducer and a white opaque stopper containing a desiccant gel.

Box of 5, 10, 14, 20, 28, 30, 50, 60 (60 or 2 containers of 30), 84 (84 or 3 containers of 28), 90 (90 or 3 containers of 30), 100 (100 or 2 containers of 50), 120 (120 or 4 containers of 30) or 500 tablets (500 or 10 containers of 50).

Not all pack sizes may be marketed.

Marketing authorization holder

Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

Marketing authorization dates and numbers

2.5mg: PL 05815/0035
5mg: PL 05815/0036
10mg: PL 05815/0037

28/02/2007 – 10/12/2009

Drugs

Drug Countries
COVERSYL Australia, Brazil, Cyprus, Ecuador, Spain, Finland, France, Ireland, Italy, Japan, Malta, Mexico, Netherlands, New Zealand, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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