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FERROGRAD C

Information leaflet

                                                     Irish Medicines Board




                                  Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Ferrograd C 325mg/500mg Prolonged release Tablets

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each tablet contains:
 Dried Ferrous Sulphate        325.0mg (elemental iron 105mg)
 Ascorbic Acid                 500mg (as sodium ascorbate)
 Excipients: also contains Dye Red Ponceau 4R Lake (E124)

 For a full list of excipients, see section 6.1

 3 PHARMACEUTICAL FORM

 Prolonged release tablet.

 Product imported from the UK
 Ovoid, biconvex, red film-coated tablets.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 For the prevention and treatment of iron deficiency anaemia and for the simultaneous treatment of vitamin C
 deficiency.

 4.2 Posology and method of administration

 Adults: The recommended dosage is one tablet daily before food

 Children: Not recommended for children under 12 years. Above this age, as for adults.

 Elderly: As for adults. The sustained release tablet and its plastic inert matrix may cause a safety hazard in some
 elderly or other patients suffering from delayed intestinal transit.

 *       Medical advice should be sought if symptoms do not improve after four weeks of use of this product at these
         symptoms may reflect an underlying disease process.

 Tablets should be swallowed whole.

 4.3 Contraindications

 Use in patients with a known hypersensitivity to any of the active ingredients.

 Use in patients with intestinal diverticular disease or any intestinal obstruction.

 *       Individuals with haemochromatosis and iron overload syndromes.




______________________________________________________________________________________________________________________
Date Printed 20/12/2010                               CRN 2085704                                         page number: 1
                                                    Irish Medicines Board




 4.4 Special warnings and precautions for use

 The label will state “Important warning: Contains iron. Keep out of reach and sight of children, as overdose may be
 fatal”. This will appear on the front of the pack within a rectangle in which there is no other information.

 As with all iron preparations, it is advised that this product should be used with caution in individuals with a family
 history haemochromatosis, or iron overload syndromes. It should be noted that conditions may be underdiagnosed.
 Overdose may be fatal. The sustained release tablet and its inert plastic matrix may cause a safety hazard in patients
 suffering from delayed intestinal transit. There may also be a further delay in release of the iron. The administration of
 therapeutic doses of sodium ascorbate may interfere with the Clinistix test for glycosuria giving a false negative result.

 Ferrorgrad C contains the colour E124, which may cause allergic type reactions including asthma; allergy is more
 common in those people who are allergic to aspirin.

 This product should only be used for the prevention and treatment of iron deficiency anaemia diagnosed by laboratory
 testing under the supervision of a medical doctor.

 4.5 Interaction with other medicinal products and other forms of interaction

 The absorption of iron salts is decreased in the presence of antacids. Iron salts diminish the absorption of tetracyclines.

 A potential chemical interaction between ferric iron and captopril in the gastrointestinal tract has been reported, which
 results in a significant increase in the area and curve when captopril is ingested with ferrous sulphate.

 4.6 Fertility, pregnancy and lactation

 Iron containing products if required, should be used during pregnancy after the first 13 weeks.

 4.7 Effects on ability to drive and use machines

 None

 4.8 Undesirable effects

 Those associated with conventional oral iron preparations, such as nausea, vomiting, abdominal pain or discomfort,
 diarrhoea and/or constipation, are less likely to occur, because of the sustained release pattern of the formulation.
 Isolated cases of injury to mouth and pharynx, oesophageal ulcer, haemetemesis and ileus have been reported.

 4.9 Overdose

 Initial symptoms of iron overdosage include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal
 bleeding. However, following a massive overdosage, these initial symptoms may be absent due to the sustained release
 formulation. Therefore, if overdosage is suspected, treatment should not be delayed by the absence of symptoms. A
 latent phase, followed by a relapse 24-48 hours after ingestion manifested by hypotension, coma and hepatocellular
 necrosis may occur.

 Vitamin C overdosage may cause acidosis and haemolytic anaemia in predisposed individuals (glucose-6-phosphate
 dehydrogenase deficiency). Renal failure may occur in massive vitamin C overdosage.
 Treatment: The ingested Gradumet matrix cannot be readily aspirated through a stomach tube and there is no known
 chemical that will dissolve the gradumet without harming gastric mucosa.




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Date Printed 20/12/2010                               CRN 2085704                                         page number: 2
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