FERROUS FUMARATE Film-coated tablet Ref.[7682] Active ingredients: Ferrous fumarate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mercury Pharma Group Ltd, Capital House, 85 King William Street, London, EC4N 7BL, UK

Product name and form

Fersamal 322mg tablets.

Ferrous Fumarate 322mg Film-Coated Tablets.

Pharmaceutical Form

Film-coated Tablets.

Each film coated tablet is brown ochre in colour and engraved ‘FE’ on one face and ‘322’ on the other.

Qualitative and quantitative composition

Each tablet contains 322.0mg Ferrous Fumarate BP (equivalent to approximately 100 mg ferrous iron).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ferrous fumarate

Ferrous fumarate is an easily absorbed source of iron for replacement therapy. It is a salt of ferrous iron with an organic acid and is less irritant to the gastro-intestinal tract than salts with inorganic acids. Iron and iron salts should be given for the treatment or prophylaxis of iron deficiency anaemias.

List of Excipients

Tablet core:

Maize Starch BP
Sodium Lauryl Sulphate BP
Gelatin BP
Paraffin Liquid BP

Film coating:

Acetylated Monoglyceride
Opadry20A270006

Opadry20A270006 contains:

Hypromellose
Iron Oxide Yellow
Titanium dioxide
Talc
Hydroxypropyl cellulose
Iron Oxide Red

Pack sizes and marketing

Cartons containing two blister packs of 14 tablets, prepared from White 250/60 micron PVC/PVDC film and printed 30 micron hard-tempered aluminium foil. 28 tablets in each carton or dispensing pack of 1000 tablets in Polypropylene container with tamper evident low density polyethylene cap.

Marketing authorization holder

Mercury Pharma Group Ltd, Capital House, 85 King William Street, London, EC4N 7BL, UK

Marketing authorization dates and numbers

PL 10972/0041

07/01/2009

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