FERROUS GLUCONATE Coated tablet Ref.[6827] Active ingredients: Ferrous gluconate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland

Product name and form

Ferrous Gluconate 300mg Tablets.

Pharmaceutical Form

Coated tablet.

Appearance: Red, circular, biconvex, sugar-coated tablet.

Qualitative and quantitative composition

Each tablet contains 300mg ferrous gluconate.

Excipients with known effect: contains sucrose and ponceau 4R red (E124).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Ferrous gluconate

Iron is an essential constituent of the body, being necessary for haemoglobin formation and for the oxidative processes of living tissues. More than 80% of the iron present in the body is involved in the support of red blood cell production. Ferrous gluconate is indicated for the prevention and treatment of iron deficiency states.

List of Excipients

Sodium starch glycollate
Stearic acid
Colloidal anhydrous silica

Sugar-coat excipients:

Sucrose
Polyvinylacetate phthalate
Stearic acid
Talc
Calcium carbonate
Acacia
Titanium dioxide(E171)
Ponceau 4R Red (E124)
Carnauba wax
White beeswax shellac

Pack sizes and marketing

Polypropylene tubes with high-density/low-density polyethylene caps and a silica gel desiccant. A low-density polyethylene bag contains the leaflet in the pot.

Pack sizes: 28, 100, 250,500, 1000 and 5000 tablets.

White opaque PVC 250μm and 9μm soft aluminium/35 gm 2 glassine paper child resistant foil.

Pack size: 28.

Marketing authorization holder

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland

Marketing authorization dates and numbers

PL 30464/0026

Date of first authorisation: 07/08/1979
Date of last renewal: 21/09/2006

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