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
Iron provided by Ferrograd aids haemoglobin regeneration. Once haemoglobin returns to normal, continuing with iron supplementation for 3 months will help replenish the iron stores within the body.
The Gradumet device allows controlled release of ferrous sulphate over a number of hours, which increases iron utilisation and reduces gastro-intestinal intolerance. The device consists of an inert plastic matrix, honeycombed by thousands of narrow passages which contain ferrous sulphate together with a water soluble channelling agent. As the tablet passes down the gastro-intestinal tract the iron is leached out. The spent matrix is finally excreted in the stools.
Oral iron is absorbed better when administered between meals. However, conventional iron preparations often cause gastric irritation when taken on an empty stomach.
Studies with Gradumet iron have indicated that relatively little of the iron is released into the stomach, the major proportion being released in the upper intestinal tract. Thus the possibility of gastric irritation is minimised when iron is administered in the Gradumet form in comparison with conventional oral iron preparations. Controlled release iron, therefore, is beneficial to patients who have a demonstrated intolerance to oral iron preparations.
There are no pre-clinical data of relevance to the prescriber which are additional to information contained in other sections of the SPC.
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