Ferrous Gluconate 300mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferrous Gluconate 300mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg ferrous gluconate.
Excipients with known effect: contains sucrose and ponceau 4R red (E124).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Coated tablet.
Appearance: Red, circular, biconvex, sugar-coated tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ferrous Gluconate 300mg Tablets are indicated for the prevention and treatment of iron deficiency states.
4.2 Posology and method of administration
Adults and the elderly
Prophylactic: 2 tablets daily.
Therapeutic: 4-6 tablets daily in divided doses.
Children (aged 6-12 years)
Prophylactic: 1 or 2 tablets daily.
Therapeutic: 3 tablets daily in divided doses.
Ferrous Gluconate 300mg Tablets are best taken about one hour before meals.
Method of administration
The route of administration for Ferrous Gluconate 300mg tablets is oral.
4.3 Contraindications
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.
Iron preparations are contraindicated in active peptic ulcer.
Ferrous Gluconate Tablets should not be used in patients with anaemia not produced by iron deficiency unless iron deficiency is also present.
4.4 Special warnings and precautions for use
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 colonic carcinoma.
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 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 occult blood 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 be fatal”.
This will appear on the front of the pack within a rectangle in which there is no other information.
4.5 Interaction with other medicinal products and other forms of interaction
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 and should be administered at least 2 hours apart.
Penicillamine: Iron reduces the absorption of penicillamine. Also the absorption of iron is impaired by penicillamine.
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.
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
Mycophenolate mofetil: Iron reduces absorption of mycophenolate mofetil
Zinc: 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, eggs or milk. 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.
4.6 Fertility, pregnancy and lactation
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.
Prophylaxis of iron deficiency during the remainder of pregnancy is justified.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Gastro-intestinal disorders have been reported including gastro-intestinal discomfort, epigastric pain, anorexia, nausea, vomiting, constipation, and diarrhoea. Darkening of the stools may occur.
Rarely allergic reactions may occur.
Contact irritation can occur with ferrous gluconate tablets resulting in erosion or ulceration, particularly if they become lodged in the upper gastrointestinal tract.
Reporting of suspected adverse reactions
Reporting suspected adverse 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
4.9 Overdose
Symptoms
Iron poisoning is commonest in childhood and is usually accidental. In the first phase of acute iron overdosage, 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 progress past this phase. The second phase may occur at 6 to 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.
Management
Local guidelines should be used or the National Poisons Information Centre should be contacted about individual patient management.
In less severe cases gastric lavage may be employed to remove unabsorbed iron from the stomach if the patient presents within one hour of ingestion. The serum-iron concentration should be measured as an emergency. In severe toxicity
desferrioxamine should be given by continuous intravenous infusion without waiting for the results of the serum iron measurement. Desferrioxamine is a specific iron chelating agent which may be administered by intravenous injection.using desferrioxamine mesylate solution 2g in 1 litre of water. The dose should be adjusted according to the severity of the poisoning. A solution of 10g of desferrioxamine mesylate in 50ml water should be left in the stomach. Absorbed iron can be chelated by an intramuscular injection of 2g of desferrioxamine mesylate in 10ml of water. Dimercaprol should not be used in the treatment of iron poisoning.
PHARMACOLOGICAL PROPERTIES
5
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antianemic preparations, ATC code: B03AA03
Iron is an essential constituent of the body, being necessary for haemoglobin formation and for the oxidative processes of living tissues. More than 80% of the iron present in the body is involved in the support of red blood cell production. Iron is also an essential component of myoglobin, hema enzymes such as cytochromes, catalase, peroxidase, and the metalloflavoprotein enzymes, including xanthine oxidase and the mitochondrial enzyme alpha glycerophosphate oxidase.
5.2 Pharmacokinetic properties
After acidification and partial digestion of food in the stomach its content of iron is presented to the intestinal mucosa as either inorganic or heme iron. These fractions are taken up by the absorptive cells of the duodenum and upper small intestine and the iron is either transported directly into the plasma or is stored as mucosal ferritin. Normal absorption is about1mg per day in the adult male and about 1.4mg per day in the adult female. Increased uptake and delivery of iron into the circulation occurs when there is an iron deficiency, when iron stores are depleted or when erythropoiesis is increased. Only 10% of total iron is lost per year from normal men and that accounts for 1mg per day. Two thirds of this iron is excreted from the gastrointestinal tract as extravasated red cells, iron in bile and iron in exfoliated mucosal cells. The other third is accounted for by small amounts of iron in desquamated skin and in the urine. Physiological losses of iron in the male vary over a relatively narrow range decreasing to about 0.5mg in the iron deficient individual and increasing to as much as 1.5mg or possibly 2mg per day when excessive iron is consumed. Additional losses of iron occur in females due to menstruation. While this averages about 0.5mg per day, 10% of normal menstruating females lose over 2mg per day.
5.3 Preclinical safety data
Not available
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium starch glycollate Stearic acid
Colloidal anhydrous silica
Sugar-coat excipients Sucrose
Polyvinyl acetate phthalate
Stearic acid
Talc
Calcium carbonate Acacia
Titanium dioxide (E171) Ponceau 4R Red (E124) Camauba wax White beeswax Shellac
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C.
Keep the container tightly closed. Store in the original container.
6.5 Nature and contents of container
Polypropylene tubes with high-density/low-density polyethylene caps and a silica gel desiccant. A low-density polyethylene bag contains the leaflet in the pot.
Pack sizes: 28, 100, 250,500, 1000 and 5000 tablets.
White opaque PVC 250pm and 9pm soft aluminium /35 gm2 glassine paper child resistant foil.
Pack size: 28
6.6 Special precautions for disposal
Not applicable
7. MARKETING AUTHORISATION HOLDER
Athlone Pharmaceuticals Limited
Ballymurray
Co. Roscommon
Ireland
8 MARKETING AUTHORISATION NUMBER(S)
PL 30464/0026
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/09/2006
10 DATE OF REVISION OF THE TEXT
18/05/2016