Ferrous Gluconate 300mg Tablets Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferrous Gluconate 300mg Tablets BP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg Ferrous Gluconate.
Also 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 tablets.
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
Posology
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.
Method of Administration
Ferrous Gluconate tablets 300 mg are best taken about one hour before meals.
Contraindications
4.3
Use in patients with known hypersensitivity to the active ingredient.
Iron preparations are contra-indicated in patients with haemochromatosis 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, 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
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.
Care should be exercised in patients with iron-absorption diseases, existing gastro-intestinal disease, 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 the pack within a rectangle in which there is no other information.
This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Before starting treatment it is important to exclude any underlying causes of anaemia, e.g. gastric erosions or colonic carcinoma.
4.5 Interaction with other medicinal products and other forms of interaction
• Concurrent use with iron, of antacids containing calcium salts, carbonates or magnesium trisilicate, and other medications containing bicarbonates, carbonates, oxalates or phosphates will decrease iron absorption because of the formation of less soluble or insoluble complexes; iron supplements should not be used within 1 hour before or 2 hours after ingestion of any of these preparations.
• Antibacterials: tetracyclines reduce absorption of oral iron (and vice versa).
• Absorption of ciprofloxacin, levofloxacin, norfloxacin and ofloxacin reduced by oral iron.
• Antihypertensives: reduced hypotensive effect methyldopa.
• Bisphosphonates: reduced absorption.
• Dopaminergics: absorption of entacapone and levodopa may be reduced.
• Penicillamine: reduced absorption of Penicillamine, a period of 2 hours should elapse between administration of penicillamine and iron.
• Trientine, cholestyramine, tea, egg or milk: reduced absorption of oral iron.
• 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).
• Iron compounds impair the bioavailability of fluoroquinolones, carbidopa, thyroxine.
• Iron reduces absorption of mycophenolate
• Absorption of both iron and antibiotic may be reduced if Ferrous Gluconate is given with tetracycline. If treatment with both drugs is required, the iron salt should be administered 3 hours before or 2 hours after tetracycline.
• Oral chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
• Iron and possibly other heavy metals are chelated with concurrent oral administration of acetohydroxamic acid resulting in reduced intestinal absorption of both drugs
• 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.
• Iron salts may reduce the absorption of aluminium and zinc salts and the absorption of iron is also reduced with concurrent administration with zinc salts.
• Iron also reduces the absorption of levothyroxine, a period of 2 hours should elapse between administration of levothyroxine and iron.
• In addition iron possibly reduces the absorption of eltrombopag (a period of 4 hours should elapse between administration of eltrombopag and iron), nalidixic acid and levodopa.
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
Because iron salts are astringent gastro-intestinal disorders have been reported including gastro-intestinal discomfort, anorexia, heartburn, vomiting, constipation, and diarrhoea. Nausea and epigastric pain may occur and are dose related but the relationship between dose and altered bowel habit, giving rise to constipation or diarrhoea, is less clear. 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.
Darkening of the stools may occur.
Higher doses of Ferrous gluconate may have irritant and corrosive effects on the gastro-intestinal mucosa and necrosis and perforation may occur; stricture formation may subsequently follow.
Rarely allergic reactions may occur
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.
Website: www.mhra.gov.uk/yellowcard
4.9. Overdose
Iron poisoning is most common 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 way. Gastric lavage in hospital should follow as soon as possible, using desferrioxamine mesylate solution 2 g in 1 litre of water. A solution of 10 g of desferrioxamine mesylate 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 mesylate in 10 ml of water.
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 about l 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 l 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
No relevant information additional to that contained elsewhere in the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Sodium starch glycollate, stearic acid, colloidal anhydrous silica.
Sugar-coat excipients: Sucrose, polyvinylacetate phthalate, stearic acid, talc, calcium carbonate, acacia, titanium dioxide (E171), certolake ponceau 4R, yellow carnauba wax, white beeswax, shellac.
6.2. Incompatibilities
Not applicable.
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 low density polyethylene caps and a silica gel desiccant.
Pack sizes: 7, 14, 28, 56, 84, 100, 250, 500, 1000 and 5000 tablets.
Not all pack sizes may be marketed
6.6 Special precautions for disposal
Not applicable
7. MARKETING AUTHORISATION HOLDER
Pharmvit Ltd
Unit 13 Metropolitan Centre
Derby Road
Greenford
Middlesex UB6 8UJ United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 04556/0038
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20 March 2003
10 DATE OF REVISION OF THE TEXT
19/08/2016