FERROGRAD Prolonged release tablet Ref.[49982] Active ingredients: Ferrous sulfate

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Teofarma S.R.L, Valle Salimbene (PV), Via F. LLI Cervi, 8 CAP 27010, Italy

Product name and form

Ferrograd 325mg Prolonged release Tablets.

Pharmaceutical Form

Prolonged release tablet.

Circular, biconvex, red film-coated tablet.

Qualitative and quantitative composition

Each tablet contains Dried Ferrous Sulphate 325mg (elemental iron 105mg).

Excipients with known effect: Each tablet contains 19.4mg lactose monohydrate and sunset yellow FCF (E110).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ferrous sulfate

Iron sulphate is a co-factor of various enzymes necessary for the transfer of energy (eg. cytochrome oxidase, xanthine oxidase). Iron is also present in hemoglobin and myoglobin, which are essential for the transport and use of oxygen.

List of Excipients

Core:

Methylacrylate methylmethacrylate copolymer
Lactose monohydrate
Povidone
Magnesium stearate

Film coating:

Hypromellose
Ethylcellulose
Sodium saccharin
Triethyl citrate
Sorbitan oleate
Castor oil, virgin
Titanium dioxide (E171)
Erythrosine (E127)
Sunset Yellow FCF (E110)

Pack sizes and marketing

Carton containing 30 (3 × 10) tablets in an AL/PVC blister.

Marketing authorization holder

Teofarma S.R.L, Valle Salimbene (PV), Via F. LLI Cervi, 8 CAP 27010, Italy

Marketing authorization dates and numbers

PA1235/001/001

Date of first authorisation: 01 April 1980
Date of last renewal: 01 April 2010

Drugs

Drug Countries
FERROGRAD Ireland, Malta, New Zealand, United Kingdom

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