Ferrous Gluconate 300mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferrous Gluconate 300mg Tablets BP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg Ferrous Gluconate For the full list of excipients, see Section 6.1
3. PHARMACEUTICAL FORM
Coated tablet.
Appearance: Red, circular, biconvex, sugar coated, printed with APS and 1701.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ferrous gluconate tablets 300 mg 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 tablets 300 mg are best taken about one hour before meals.
4.3. Contraindications
Use in patients with known hypersensitivity to ferrous gluconate or to any of the excipients listed in section 6.1
Iron preparations are contra-indicated in patients with haemochromatosis and haemosiderosis or haemoglobinuria
Iron is contraindicated in patients receiving receiving repeated blood transfusions, or in patients receiving parenteral iron therapy.
Iron preparations are contraindicated in active peptic ulcer, regional enteritis and ulcerative colitis.
Ferrous Gluconate Tablets should not be used in treatment of anaemia other than those due to iron deficiency
4.4. Special warnings and precautions for use
Ferrous gluconate should be used with caution in patients with haemolytic anaemia.
Care should be exercised in patients with intestinal strictures and diverticulae.
Caution is required in the elderly, who may be at increased risk of serious adverse reactions.
The label will state:
“Important warning: Contains Iron. Keep out of the reach and sight of children, as overdose may be fatal”.
(This will appear on the front of pack within a rectangle in which there is no other information).
Before starting treatment it is important to exclude any underlying causes of anaemia, e.g. gastric erosions or colonic carcinoma.
This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5. Interactions with other medicinal products and other forms of interaction
Iron reduces the absorption of penicillamine.
Iron compounds impair the bioavailability of fluoroquinolones, levodopa, carbidopa, thyroxine and bisphosphonates.
Administration of Oral iron may reduce the hypotensive effect of methyldopa.
Iron reduces absorption of mycophenolate.
Absorption of both iron and antibiotic may be reduced if Ferrous Gluconate is given with tetracycline.
Absorption of both iron and zinc are reduced if taken concomitantly.
Concurrent administration of antacids may reduce absorption of iron. Oral chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Some inhibition of iron absorption may occur if it is taken with cholestyramine, trientine, tea, eggs or milk.
Coffee may be a factor in reducing iron bioavailability.
Neomycin may alter the absorption of iron.
Entacapone and proton pump inhibitors may reduce absorption of oral iron.
Avoid concomitant administration of oral iron with dimercaprol (formation of toxic compounds).
4.6. Fertility, pregnancy and lactation
Ferrous salts may be administered in pregnancy or during lactation when there is a risk of iron deficiency.
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, anorexia, vomiting, nausea, constipation, diarrhoea.
Darkening of the stools may occur.
Rarely allergic reactions may occur.
4.9 Overdose
Iron poisoning is commonest in childhood and is usually accidental. The symptoms are nausea, vomiting, abdominal pain, diarrhoea, haematemesis, coma and hepatocellular necrosis occur later. Mortality is reduced with intensive and specific therapy. The effective antidote is desferrioxamine, which chelates iron. The stomach should be emptied at once, preferably by inducing vomiting as this is the quickest. Gastric lavage in hospital should follow as soon as possible, using desferrioxamine mesilate solution 2 g in 1 litre of water. A solution of 10 g of desferrioxamine mesilate in 50 ml water should be left in the stomach. Absorbed iron can also be chelated by an intramuscular injection of 2 g of desferrioxamine mesilate in 10 ml of water.
5 PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Iron trivalent, oral preparations ATC code: B03AB
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 about 1 mg per day in the adult male and about 1.4 mg per day in the adult female. Increased uptake and delivery of iron into the circulation occurs when there is 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 1 mg 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 0.5 mg in the iron deficient individual and increasing to as much as 1.5 mg or possibly 2 mg per day when excessive iron is consumed. Additional losses of iron occur in the female due to menstruation. While this averages about 0.5 mg per day, 10% of normal menstruating females lose over 2 mg per day.
5.3. Preclinical safety data
Not available
6.1. List of excipients
Core: Sodium starch glycollate Type A, stearic acid, colloidal anhydrous silica.
Sugar Coating Excipients: Sucrose, purified talc, calcium carbonate, acacia, titanium dioxide E171, Industrial Methylated Spirit Ponceau 4R, Opaglos 6000P
6.2 Incompatibilities
None known.
6.3 Shelf life
3 Years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container. Keep the container tightly closed.
6.5 Nature and contents of container
Polypropylene tubes with low density polyethylene cap.
Pack sizes: 100, 250, 500, 1000 and 5000 tablets.
6.6 Special precautions for disposal
Not applicable
7
MARKETING AUTHORISATION HOLDER
BRISTOL LABORATORIES, UNIT 3, CANALSIDE, NORTHBRIDGE ROAD, BERKHAMSTED HP4 1EG, UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 17907/0347
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22 April 2002
10 DATE OF REVISION OF THE TEXT
28/01/2013