Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland
Hypersensitivity to the active ingredient ferrous gluconate or to any of the excipients listed in section 6.1.
Iron preparations are contra-indicated in patients with haemochromatosis, iron storage or absorption diseases such as and haemosiderosis or haemoglobinuria.
Iron is contraindicated in patients receiving repeated blood transfusions, or in patients receiving parenteral iron therapy or to patients with anaemias not produced by iron deficiency (some conditions, such as thalassemia may cause excess storage of iron).
Alcoholism and hepatitis.
Iron preparations are contraindicated in active peptic ulcer, regional enteritis and ulcerative colitis.
Ferrous Gluconate Tablets should not be used in patients with anaemia not produced by iron deficiency unless iron deficiency is also present.
Large doses may have irritant/corrosive effect on gastro-intestinal mucosa which can lead to necrosis and perforation.
Ferrous Gluconate should be used with caution in patients with haemolytic anaemia. Caution is required in the elderly, who may be at increased risk of serious adverse reactions.
Before starting treatment it is important to exclude any underlying causes of anaemia, e.g. gastric erosions or coloniccarcinoma.
Care should be exercised in patients with iron-absorption diseases. 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 and care should be exercised in patients with intestinal strictures and 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.
Patients suffering from iron overload are particularly susceptible to infection. Treatment of iron overload should be with caution.
Iron preparations colour the faeces black, which may interfere with tests used for detection of occultblood in the stools.
These tablets contain sugar and should be administered with care to patients with diabetes.
This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
The label will state: “Important warning: Contains iron. Keep out of the sight and reach of children, as overdose may befatal”.
This will appear on the front of the pack within a rectangle in which there is no other information.
Iron and possibly other heavy metals are chelated with concurrent oral administration of acetohydroxamic acid resulting in reduced intestinal absorption of both drugs.
Antacids and mineral supplements: Concurrent administration of antacids may reduce absorption of iron. Compounds containing calcium, magnesium, bicarbonates, carbonates, oxalates or phosphates may impair the absorption of iron because of the formation of less soluble or insoluble complexes and should be administered at least 2 hours apart.
Penicillamine: Iron reduces the absorption of penicillamine, and may decrease the effect of penicillamine. Also the absorption of iron is impaired by penicillamine. A period of 2 hours should elapse between administration of penicillamine and iron.
Antibacterials: Absorption of both iron and antibiotic may be reduced if Ferrous Gluconate is given with tetracycline antibiotics. Administration of iron preparations and tetracyclines should be separated by 2 to 3 hours. Iron compounds impair the bioavailability of fluoroquinolones (ciprofloxacin, norfloxacin, ofloxacin). Administration should be separated by at least 2 hours. Oral chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis. Neomycin may alter the absorption of iron.
Vitamin E: Concurrent use of Vitamin E may impair the hematologic response in patients with iron deficiency anaemia. Large doses of iron may increase daily requirements of Vitamin E.
Bisphosphonates: The absorption of bisphosphonates is reduced when taken concurrently with iron preparations. Administration should be separated by at least 2 hours.
Dopaminergics: Oral iron preparations may reduce the absorption of dopaminergics such as levodopa, entacapone and co-careldopa.
Methyldopa: Administration of oral iron may reduce the hypotensive effect of methyldopa.
Mycophenolat emofetil: Iron reduces absorption of mycophenolate mofetil.
Zinc and Aluminium: *Iron salts may reduce the absorption of aluminium and zinc salts and absorption of both iron and zinc are reduced if taken concomitantly.
Cholestyramine: Absorption of iron is impaired by cholestyramine.
Trientine: Absorption of oral iron preparations is reduced by trientine. Administration should be separated by at least 2 hours
Food products: Absorption of iron is impaired by tea (contains tannic acid), eggs, milk and milk products and whole grain breads and cereals (contain phytic acid). Coffee may be a factor in reducing iron bioavailability.
Thyroid hormone: Iron reduces the absorption of thyroxine and so should be taken at least 2 hours apart.
Dimercaprol: Avoid concomitant administration of oral iron with dimercaprol or use of dimercaprol for treatment of iron poisoning due to the formation of toxic compounds.
Proton pump inhibitors may reduce absorption of oral iron.
Carbidopa: Iron compounds impair the bioavailability of carbidopa.
In addition iron possibly reduces the absorption of eltrombopag (a period of 4 hours should elapse between administration of eltrombopag and iron) and nalidixic acid.
Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of iron during the first trimester requires definite evidence of iron deficiency. There is no evidence of any harmful effects due to normal doses of Ferrous gluconate in pregnant women and nursing mothers, but as with all drugs care should be exercised in administering this preparation during pregnancy and lactation.
Prophylaxis of iron deficiency during the remainder of pregnancy is justified.
Iron is excreted in breast milk but not in significant amounts (about 0.5 mg/day).
None known.
Gastro-intestinal disorders have been reported with large doses of Iron including gastro-intestinal discomfort, epigastric pain, anorexia, nausea, heartburn, vomiting, constipation, and diarrhoea. These side effects have been reported to occur in up to 20% or more of patients treated and are related to the amount of elemental iron taken rather than the type of preparation. Continued administration of Ferrous gluconate may result in constipation and faecal impaction. Darkening of the stools mayoccur.
Symptoms which may not appear for several hours include epigastric pain, diarrhoea, vomiting and haematemesis. Circulatory failure may follow if diarrhoea and haemorrhage are severe.
Rarely allergicreactions may occur.
Contact irritation can occur with high doses of ferrous gluconate tablets resulting in erosion or ulceration on the gastro-intestinal mucosa and necrosis, and perforation may occur; stricture formation may subsequently follow particularly if theybecome lodged in theupper gastrointestinal tract.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
None known.
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