Acute iron overdosage can be divided into four stages. In the first phase, which occurs up to 6 hours after oral ingestion, gastrointestinal toxicity, notably vomiting and diarrhoea, predominates. Other effects may include cardiovascular disorders such as hypotension and tachycardia, metabolic changes including acidosis and hyperglycaemia, and CNS depression ranging from lethargy to coma. Patients with only mild to moderate poisoning do not generally pass this first phase. The second phase may occur at 6-24 hours after ingestion and is characterised by a temporary remission or clinical stabilisation. In the third phase gastrointestinal toxicity recurs together with shock, metabolic acidosis, convulsions, coma, hepatic necrosis and jaundice, hypoglycaemia, coagulation disorders, oliguria or renal failure, and pulmonary oedema. The fourth phase may occur several weeks after ingestion and is characterised by gastrointestinal obstruction and possibly late hepatic damage.
Overdosage of ferrous salts is particularly dangerous to young children.
Treatment consists of gastric lavage followed by the introduction of 5g desferrioxamine into the stomach. Serum iron levels should be monitored and in severe cases iv desferrioxamine should be given together with supportive and symptomatic measures as required. Gastric lavage with 5% sodium bicarbonate and saline cathartics (e.g. sodium sulfate 30g for adults); milk and eggs with 5g bismuth carbonate every hour as demulcents. Blood or plasma transfusion for shock, oxygen for respiratory embarrassment. Chelating agents (e.g. disodium calcium edetate) may be tried (500mg/500ml by continuous iv infusion). Dimercaprol should not be used since it forms a toxic complex with iron. Desferrioxamine is a specific iron chelating agent and severe acute poisoning in infants should always be treated with desferrioxamine at a dose of 90mg/kg im followed by 15mg/kg per hour iv until the serum iron is within the plasma binding capacity.
Screw cap plastic container: Two years
Blister packs: Two years
Hypersensitivity to the product and its ingredients; haemosiderosis and haemochromatosis; active peptic ulcer; repeated blood transfusion; haemolytic anaemia. Oral and parenteral iron preparations should not be used concomitantly.
Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine.
None relevant known.
Kaolin
Dextrose (glucose)
Povidone
Stearic acid
Magnesium stearate
Sodium lauryl sulfate
Starch
Opaglos
Titanium dioxide (E171)
Sucrose
Tablet
White, sugar coated tablets.
Gastro-intestinal disorders: abdominal pain, nausea and vomiting (these are usually dose related), constipation, diarrhoea and dark stools. Contact irritation can occur with ferrous sulfate tablets resulting in erosion or ulceration, particularly if they become lodged in the upper gastrointestinal tract.
Allergic reactions have been reported.
Post-marketing: The following ADRs have been reported during post-marketing surveillance. The frequency of these reactions is considered not known (cannot be estimated from the available data).
Gastrointestinal disorders:
mouth ulceration*
* in the context of incorrect administration, when the tablets are chewed, sucked or kept in mouth. Elderly patients and patients with deglutition disorders may also be at risk of oesophageal lesions or of bronchial necrosis, in case of false route.
Reporting of suspected adverse reactions
Reporting suspected adverse drug reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard
None available.
Ferrous Sulfate is used for iron-deficiency anaemia.
Ferrous Sulfate contains iron. Most of the iron in the body is present as haemoglobin. The remainder is present in the storage forms ferritin or haemosiderin, in the reticuloendothelial system or as myoglobin with smaller amounts occurring in haem-containing enzymes or in plasma bound to transferrin.
Iron is absorbed mainly in the small intestine, but can be absorbed along the entire length of the alimentary canal. It is absorbed most easily in the ferrous state, passing into and through the mucosal cells directly into the blood stream where it is immediately attached to transferrin.
27 September 2017
Wockhardt UK Ltd
Ash Road North
Wrexham.
LL13 9UF
UK
Do not store above 25°C
Screw cap container: Store in original container in order to protect from moisture.
Blister packs: Store in the original package in order to protect from moisture.
Packs of 50, 100, 250, 500 and 1000 contained in screw cap plastic containers.
Blister pack (white opaque PVC/PVDC film) containing14 tablets. Pack size of 28 tablets.
Not all pack sizes may be marketed.
PL 29831/0220
Patients post-gastrectomy have poor absorption of iron. Caution is advised when prescribing iron preparations to individuals with history of peptic ulcer, and inflammatory bowel disease, including regional enteritis and ulcerative colitis. Care should be taken in patients with intestinal strictures or diverticulae. Duration of treatment should generally not exceed 3 months after correction of anaemia. Co-existing deficiency of vitamin B12 or folic acid should be ruled out since combined deficiency produces microcytic blood film. Dental caries is a definite risk following long term treatment with this product. These tablets contain sugar and should be administered with care to patients with diabetes. Patients suffering from iron overload are particularly susceptible to infection. Treatment of iron overload should be with caution.
Due to the risk of mouth ulcerations and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water.
The label will state:
“Important warning: Contains iron. Keep out of the sight and reach of children, as overdose may be fatal.â€
This will appear on the front of the pack within a rectangle in which there is no other information.
None known.
For iron-deficiency anaemia:-
| Adults:- | Prophylaxis - One tablet daily |
| Therapeutic - One tablet 2-3 times daily | |
| Elderly:- | As for adults |
| Children:- | This presentation is not recommended. |
Method of administration:
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.
Not applicable.
01/07/2008
