Ferrous Gluconate Tablets Bp 300mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferrous Gluconate Tablets 300 mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg Ferrous Gluconate.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Red, sugar coated, deep convex tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Prophylaxis of iron deficiency anaemia in pregnancy, menorrhagia following subtotal or total gastrectomy.
Treatment of iron deficiency anaemia due to severe or chronic haemorrhage, nutritional deficiency, pregnancy, parasitic infestation and malabsorption of iron from the diet.
4.2
Posology and method of administration
Route of administration: Oral Dosage instructions:
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.
The above doses are best taken about 1 hour before meals.
4.3 Contraindications
Hypersensitivity to iron preparations or to any of the excipients.
Iron preparations are contraindicated in patients with haemochromatosis, haemosiderosis or haemoglobinuria.
Iron salts should not be given to patients receiving repeated blood transfusions or parenteral iron therapy or to patients with anaemias not produced by iron deficiency (some conditions, such as thalassemia may cause excess storage of iron).
Alcoholism and hepatitis.
Iron preparations are contraindicated in active peptic ulcer, regional enteritis and ulcerative colitis.
4.4 Special warnings and precautions for use
Ferrous gluconate should be used with caution in patients with haemolytic anaemia.
Care should also be taken when given to patients with iron-absorption diseases, existing gastro-intestinal disease, intestinal strictures and diverticulae.
Before starting treatment it is important to exclude any underlying causes of anaemia, e.g. gastric erosions or colonic carcinoma.
Caution is required in the elderly, who may be at increased risk of serious adverse reactions.
This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This product contains E124, E122 & E110 which may cause allergic reactions. 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
Iron and possibly other heavy metals are chelated with concurrent oral administration of acetohydroxamic acid resulting in reduced intestinal absorption of both drugs.
Concomitant use of iron and dimercaprol should be avoided (formation of toxic compounds).
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.
The absorption of iron is also slowed down by the concurrent intake of coffee, eggs, milk and milk products, tea (contains tannic acid) and whole grain breads and cereals (contain phytic acid).
The absorption of iron is also reduced by the concurrent administration of trientine.
Some inhibition of iron absorption may occur if it is taken with colestyramine.
Concomitant administration of penicillamine with iron medications reduces absorption and may decrease the effect of penicillamine, a period of 2 hours should elapse between administration of penicillamine and iron.
Concurrent use of tetracyclines with iron reduces absorption and resultant therapeutic effects of both medications. If treatment with both drugs is required, the iron salt should be administered 3 hours before or 2 hours after tetracycline.
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.
Oral iron antagonises the hypotensive effect of methyldopa.
Oral iron reduces the absorption of bisphosphonates, fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin) entacapone, mycophenolate.
Proton pump inhibitors may reduce absorption of oral iron.
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, levodopa and carbidopa.
Oral chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Neomycin may alter the absorption of iron.
4.6 Pregnancy and lactation
There is no evidence of any harmful effects due to normal doses of Ferrous gluconate in pregnant women and nursing mothers. Iron is excreted in breast milk but not in clinically significant amounts (about 0.5 mg /day).
4.7 Effects on ability to drive and use machines
None reported.
4.8 Undesirable effects
Large doses of iron may cause gastro-intestinal discomfort, anorexia, diarrhoea, nausea and vomiting. These side effects have been reported to occur in up 20% or more of patients treated and are related to the amount of elemental iron taken rather than the type of preparation. Continued administration may result in constipation. Darkening of 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.
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.
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 at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Iron poisoning is commonest in childhood and is usually accidental.
Symptoms: The symptoms of iron overdosage include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy, circulatory collapse, coma and hepatocellular necrosis occur later. Hyperglycaemia and metabolic acidosis may also occur.
Therefore if overdosage is suspected, treatment should be implemented immediately.
Treatment; The following steps are recommended to minimise or prevent further absorption of the medication:
Children: Administer an emetic such as syrup of ipecacuanha. Emesis should be followed by gastric lavage with desferrioxamine solution (2g/L). This should then be followed by the installation of desferrioxamine 5g in 50-100 ml water, to be retained in the stomach. Inducing diarrhoea in children may be dangerous and should not be undertaken in young children. Keep the patient under constant surveillance to detect possible aspiration of vomitus; maintain suction apparatus and standby emergency oxygen in case of need.
Severe poisoning: In the presence of shock and/or coma with high serum iron levels (serum iron >90pMOL/L) immediate supportive measures plus IV infusion of desferrioxamine should be instituted. Desferrioxamine 15 mg/kg body weight should be administered every hour by slow IV infusion to a maximum 80 mg/kg/24 hours.
Warning: Hypotension may occur if the infusion rate is too rapid.
Less severe poisoning: IM desferrioxamine 1g 4-6 hourly is recommended. Serum iron levels should be monitored throughout.
Adults: Administer an emetic. Gastric lavage may be necessary to remove drug already released into stomach. This should be undertaken using a desferrioxamine solution (2g/L). Desferrioxamine 5g in 50-100 ml water should be introduced into the stomach following gastric emptying. Keep the patient under constant surveillance to detect possible aspiration of vomitus; maintain suction apparatus and standby emergency oxygen in case of need.
A drink of mannitol or sorbitol should be given to induce small bowel emptying.
Severe poisoning: In the presence of shock and/or coma with high serum iron levels (>142 p.MOL/1) immediate supportive measures plus IV infusion of desferrioxamine should be instituted. The recommended dose of desferrioxamine is 5 mg/kg/h slow IV infusion up to a maximum of 80 mg/kg/24 hours.
Warning: Hypotension may occur if the infusion rate is too rapid.
Less severe poisoning: IM desferrioxamine 50 mg/kg up to a maximum dose of 4 g should be given.
Serum iron levels should be monitored throughout.
5 PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic classification: Antianemic preparations, iron preparations ATC code: B03A A03
5.1 Pharmacodynamic properties
Iron is an essential component in the physiological formation of haemoglobin, adequate amounts of which are necessary for effective erythropoiesis and the resultant oxygen transport capacity of the blood. A similar function is provided by iron in myoglobin production. It also serves as a co-factor of several essential enzymes.
Pharmacokinetic properties
5.2
Absorption of iron mainly takes place in the duodenum and proximal jejunum. Absorption being aided by the acid secretion of the stomach and being more readily effected when the iron is in the Ferrous state. The absorption of iron varies, in noniron deficient individuals it is 3-10% of the ingested iron. In those individuals suffering from deficiency state, it is 20-30%, the amount being approximately proportional to the degree of deficiency.
The absorption is more efficient when iron is ingested in its ferrous rather than ferric form on an empty stomach. When administered with food, the amount of iron absorbed may be reduced by 1/2-1/3 as when taken on an empty stomach. It is highly bound to plasma proteins.
There is no existence of physiological system of excretion of iron; however small amounts are lost daily in the shedding of skin, hair and nails, and in faeces, perspiration, breast milk (0.5-1.0 mg/day), menstrual blood and urine. Average daily loss of iron for healthy adult males and postmenopausal females is 1mg/day; in premenopausal females it is 1.5mg/day.
Absorption is increased in the presence of ascorbic acid or succinic acid. Some dietary products such as eggs, which have a high iron content also contain phosphates and phytates which inhibit absorption by the formation of unabsorbable complexes. Absorption is also decreased by antacids, tetracyclines and tea.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Colloidal anhydrous silica Alginic acid Magnesium stearate Maize starch Purified water
Tablet coating materials:
Purified talc
Syrup
Coating varnish comprising of:
Shellac
IMS
Standard coating cream comprising of
Sucrose
Heavy kaolin
Purified talc
Titanium dioxide (E171)
Opalux Red AS-F-2864 comprising of: Sucrose
Ponceau 4R aluminium lake (E124) Carmoisine dioxide lake (E122)
Titanium dioxide (E171)
Povidone
Sunset yellow FCF aluminium lake (E110) Sodium benzoate (E211)
Purified water
Polish ingredients:
Carnauba Wax Beeswax
6.2 Incompatibilities
None
6.3 Shelf life
Opaque plastic containers: 36 months, as packaged for sale Blister packs: 36 months, as packaged for sale
6.4 Special precautions for storage
Opaque plastic containers: Store in container provided. Do not store above 25°C.
Keep out of the reach and sight of children.
Blisters: Do not store above 25°C. Store in the original package. Keep the blister in the outer carton.
Keep out of the reach and sight of children.
6.5 Nature and contents of container
1) Opaque plastic containers composed of either high density polypropylene or high density polyethylene with a tamper evident or child resistant tamper evident closure composed of high density polyethylene in pack sizes of 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 and 1,000 tablets.
2) Aluminium/PVC/paper blister packs (child resistant) in pack sizes of 28 tablets. Not all pack sizes may be marketed
6.6 Special precautions for disposal
No special instructions for use/handling.
7 MARKETING AUTHORISATION HOLDER
Crescent Pharma Limited
Units 3 and 4 Quidhampton Business Units
Polhampton Lane
Overton
Hampshire
RG25 3ED
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20416/0073
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17th April 1989/18th October 2004
10 DATE OF REVISION OF THE TEXT
16/08/2013