COVERSYL PLUS Tablet Ref.[50551] Active ingredients: Indapamide Perindopril

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2020  Publisher: Servier Laboratories South Africa (Pty) Ltd, Building Number 4, Country Club Estate, 21 Woodlands Drive, Woodmead, 2191

Product name and form

Coversyl Plus, tablet.

Pharmaceutical Form

White, 8-mm x 4-mm rod-shaped tablets.

Qualitative and quantitative composition

Each tablet contains 4 mg of perindopril tert-butylamine salt and 1,25 mg of indapamide.

Excipient with known effect: 61,55 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Indapamide

Indapamide is a sulfonamide derivative with an indole ring, pharmacologically related to thiazide diuretics, which acts by inhibiting the reabsorption of sodium in the cortical dilution segment. It increases the urinary excretion of sodium and chlorides and, to a lesser extent, the excretion of potassium and magnesium, thereby increasing urine output and having an antihypertensive action.

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

Lactose monohydrate
Magnesium stearate (E470B)
Colloidal hydrophobic silica
Microcrystalline cellulose

Pack sizes and marketing

Blister packs of clear PVC and Aluminium with 30 tablets in a carton.

Marketing authorization holder

Servier Laboratories South Africa (Pty) Ltd, Building Number 4, Country Club Estate, 21 Woodlands Drive, Woodmead, 2191

Marketing authorization dates and numbers

33/7.1.3/0363

10 October 2000

Drugs

Drug Countries
COVERSYL PLUS Australia, Brazil, Canada, Ireland, Malta, Nigeria, Netherlands, Singapore, Turkey, South Africa

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