Ferrous Gluconate Tablets Bp 300mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferrous Gluconate 300 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg of Ferrous Gluconate.
Excipients of known effect: Each tablet also contains 168.2 mg of Sucrose and
2.7 mg of Liquid glucose.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablet
A dark-red, smooth, polished tablet with a slight odour.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ferrous Gluconate 300 mg Tablets is 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 to 6 tablets daily in divided doses.
Children (aged 6-l2 years):
Prophylactic: 1 or 2 tablets daily Therapeutic: 3 tablets daily in divided doses
Method of administration:
The route of administration for Ferrous Gluconate 300 mg tablets is oral. These tablets are best taken about one hour before meals.
Contraindications
4.3
• Hypersensitivity to 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 treatment of anaemia 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 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 occult blood in the stools.
These tablets contain sugar and should be administered with care to patients with diabetes.
This product contains glucose and 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 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 bypenicillamine.
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, diarrhoea, constipation and 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 cardschemeatwww.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 2 g in 1 litre of water. The dose should be adjusted according to the severity of the poisoning. A solution of 10 g of desferrioxamine mesylate in 50 ml water should be left in the stomach. Absorbed iron can be chelated by an intramuscular injection of 2g of desferrioxamine mesylate in 10 ml of water. Dimercaprol should not be used in the treatment of iron poisoning.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antianemic preparations ATC code: B03AB
Iron is an essential constituent of the body, being necessary for the formation of haemoglobin and hence the oxidative process 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. Pre-clinical Safety Data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize Starch Magnesium Stearate Stearic Acid Orange Shellac French, Chalk for Tablets Sucrose Liquid glucose Opalux AS 4910 red Opaglos 6000
6.2. Incompatibilities
None stated
6.3. Shelf-Life
36 months
6.4
Special precautions for storage
Keep the container tightly closed.
6.5 Nature and contents of container
80 ml amber coloured glass bottle with a wadless polypropylene screw cap or a polypropylene clic-loc cap with a lectraseal liner.
660 ml amber coloured glass bottle with a tinplate screw cap with a waxed pulpboard liner.
Pack sizes: 1000 tablets.
6.6. Instruction for Use, Handling and Disposal
Not applicable.
7. MARKETING AUTHORISATION HOLDER
Bristol Laboratories Ltd Unit3 , Canalside,
Northbridge Road Berkhamsted Herts HP4 1EG United Kingdom
8. MARKETING AUTHORIZATION NUMBER(S)
PL 17907/0170
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07/06/2011
10 DATE OF REVISION OF THE TEXT
25/07/2016