NIFEREX Gastro-resistant capsule, hard Ref.[8263] Active ingredients: Ferrous glycine sulfate

Source: European Medicines Agency (EU)  Revision Year: 2017 

Product name and form

Niferex 100 mg gastro-resistant capsules, hard.

Pharmaceutical Form

Gastro-resistant capsule, hard.

Capsule cap: chocolate brown.

Capsule body: orange.

Capsule content: grey-brownish pellets.

Qualitative and quantitative composition

1 capsule contains: Ferrous (II) glycine-sulphate complex 567.7 mg (equivalent to 100 mg Fe2+).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Ferrous glycine sulfate

Ferrous glycine sulfate is a medicinal product for the treatment of iron deficiency. It contains iron (Fe2+) in a form that the body can easily absorb and utilize and is therefore suitable to eliminate symptoms caused by iron deficiency. Like all iron preparations, ferrous glycine sulfate has no effects on erythropoiesis or anaemia that is not due to iron deficiency.

List of Excipients

Ascorbic acid
Cellulose microcrystalline
Hhypromellose
Hydroxypropylcellulose
Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (Eudragit L30 D-55) (contains methacrylic acid-ethyl acrylate copolymer (1:1), sodium lauryl sulphate, polysorbate 80)
Acetyltriethyl citrate
Talc
Purified
Water

Capsule shell:

Body:

Gelatin
Titanium dioxide (E171)
Red iron oxide (E172)
Yellow iron oxide (E172)

Cap:

Gelatin
Titanium dioxide (E171)
Red iron oxide (E172)
Black iron oxide (E172)
Sodium lauryl
Sulphate

Pack sizes and marketing

Blister of paper/aluminium composite film with a polypropylene (PP) white opaque foil with 30, 50, 90 and 500x1 gastro-resistant capsules.

Not all pack sizes may be marketed.

Marketing authorization dates and numbers

1999-08-27/2009-08-27

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