NATRILIX Prolonged-release tablet Ref.[27711] Active ingredients: Indapamide

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

Natrilix SR 1.5 mg Tablets.

Pharmaceutical Form

Prolonged-release tablet.

White, round, film-coated tablet.

Qualitative and quantitative composition

One prolonged-release film-coated tablet contains 1.5 mg indapamide.

Excipient with known effect: 124.5 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.

List of Excipients

Tablet:

Silica, colloidal anhydrous
Hypromellose
Lactose monohydrate
Magnesium stearate
Povidone

Film-coating:

Glycerol
Hypromellose
Macrogol 6000
Magnesium stearate
Titanium dioxide

Pack sizes and marketing

10, 14, 15, 20, 30, 50, 60, 90, 100 tablets in blisters (PVC/aluminium).

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

PL 05815/0010

9th January 1996/25th February 2007 (MRP)

Drugs

Drug Countries
NATRILIX Australia, Brazil, Germany, Ecuador, Finland, Hong Kong, Ireland, Italy, Malta, Mexico, Nigeria, Singapore, United Kingdom, South Africa

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