NATRIXAM Modified-release tablet Ref.[51086] Active ingredients: Amlodipine Indapamide

Source: Web Search  Revision Year: 2022  Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex – France

Product name and form

Natrixam 1.5 mg / 5 mg modified-release tablets.

Natrixam 1.5 mg / 10 mg modified-release tablets.

Pharmaceutical Form

Modified-release tablet.

White, round, film-coated, bilayered, modified-release tablet of 9 mm diameter engraved with on one face.

Pink, round, film-coated, bilayered, modified-release tablet of 9 mm diameter engraved with on one face.

Qualitative and quantitative composition

One tablet contains 1.5 mg indapamide and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine.

One tablet contains 1.5 mg indapamide and 13.87 mg amlodipine besilate equivalent to 10 mg amlodipine.

Excipient with known effect: 104.5 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Amlodipine

Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.

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 core:

Hypromellose (E464)
Lactose monohydrate
Magnesium stearate (E572)
Povidone (E1201)
Silica colloidal anhydrous
Calcium hydrogen phosphate dihydrate
Cellulose, microcrystalline (E460)
Croscarmellose sodium (E468)
Pregelatinized maize starch

Tablet film-coating:

Glycerol (E422)
Hypromellose (E464)
Macrogol 6000
Magnesium stearate (E572)
Titanium dioxide (E171)

Tablet core:

Hypromellose (E464)
Lactose monohydrate
Magnesium stearate (E572)
Povidone (E1201)
Silica colloidal anhydrous
Calcium hydrogen phosphate dihydrate
Cellulose, microcrystalline (E460)
Croscarmellose sodium (E468)
Pregelatinized maize starch

Tablet film-coating:

Glycerol (E422)
Hypromellose (E464)
Iron oxide red (E172)
Macrogol 6000
Magnesium stearate (E572)
Titanium dioxide (E171)

Pack sizes and marketing

PVC/Aluminium blisters: 1x15 (15) tablets, 2x15 (30) tablets, 4x15 (60) tablets, 6x15 (90) tablets

High density polyethylene bottles equipped with a screw tamper evident polypropylene cap: 1x100 (100) tablets, 5x100 (500) tablets.

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

MA066/02101
MA066/02102

Date of first authorisation: 23rd September 2013
Date of renewal: 25th June 2020

Drugs

Drug Countries
NATRIXAM Estonia, France, Hong Kong, Croatia, Lithuania, Malta, Nigeria, Netherlands, Romania, Singapore, Tunisia, Turkey

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