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
For the prevention and treatment of iron deficiency anaemias.
The recommended dosage is one tablet daily before food.
Not recommended for children under 12 years. Above this age, as for adults.
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.
The tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water. Tablets should be taken before meals or during meals, depending on gastrointestinal tolerance
Initial symptoms of iron overdosage include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding. However, following a massive overdose, 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.
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. Accordingly when overdosage is discovered early, the following procedure is recommended.
1. Administer an emetic by stomach tube.
2. Withdraw the stomach tube and wait for the patient to vomit.
3. Keep the patient under constant surveillance to detect possible aspiration of vomitus; maintain suction apparatus and standby emergency oxygen in case of need.
4. Examine the vomitus for returned Gradumet tablets.
5. Administer a saline purgative. By the time toxic signs have appeared Gradumet tablets are in most cases past the pylorus so that emesis is of no value. Gastric lavage may be considered to remove amounts of the drug already released in the stomach. A saline purgative should then be given to speed the Gradumet tablets along the alimentary canal so as to minimise or prevent further absorption of the medication.
6. The use of an iron-chelating agent such as oral desferrioxamine should be considered. In severe cases parenteral desferrioxamine may be necessary.
5 years.
Do not store above 25°C. Store in the original package. Keep out of the reach and
sight of children.
Carton containing 30 (3 × 10) tablets in an AL/PVC blister.
No special requirements.
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