Ferrous Gluconate Tablets Bp 300mg
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1.
Ferrous Gluconate 300mgTablets BP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient mg/tablet
Ferrous Gluconate 300
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
Indicated for the treatment and prevention of iron deficiency states.
4.2. Posology and Method of Administration
Adults and the elderly:
Therapeutic: 4 to 6 tablets daily in divided doses.
Prophylactic: 2 tablets daily.
Children (aged 6-l2 years):
Prophylactic: 1 or 2 tablets daily Therapeutic: 3 tablets daily in divided doses
These tablets are best taken about one hour before meals.
4.3. Contra-Indications
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 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 taken when given to 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 Medicaments and other forms of Interaction
Iron salts may reduce 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).
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
No adverse effects known.
4.8. Undesirable Effects
Gastro-intestinal disorders have been reported including gastro-intestinal discomfort, anorexia, nausea, vomiting, diarrhoea, constipation and black stools.
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 induced vomiting as this is the quickest. Gastric lavage in hospital should follow as soon as possible, using desferrioxamine mesylate solution 2g in 1 litre of water. 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.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Pharmacotherapeutic group: Iron trivalent, oral preparations ATC code: B03AB
Iron is 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.
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
Industrial Methylated Spirit
French Chalk for Tablets
SucroseGlucose liquidOpalux AS 4910 red
Purified Water
Opaglos 6000
6.2. Incompatibilities
None stated
6.3.
Shelf-Life
36 months
6.4. Special Precautions for Storage
Keep tightly closed.
6.5. Nature and Content of Container
80ml amber coloured glass bottle with a wadless polypropylene screw cap or a polypropylene clic-loc cap with a lectraseal liner.
660ml amber coloured glass bottle with a tinplate screw cap with a waxed pulpboard liner.
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
28/01/2013