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Ferrous Gluconate 300mg Tablets

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Ferrous Gluconate 300mg Tablets BP

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 sugar coated tablet contains 300mg Ferrous Gluconate Ph. Eur.

For excipients see section 6.1.

3 PHARMACEUTICAL FORM

Coated tablets

Red Coloured, Sugar Coated, Biconvex tablets.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

The tablets are for oral administration in the treatment and prophylaxis of iron deficiency anaemia.

4.2 Posology and method of administration

Adults:

Prophylactic: two tablets daily taken before food.

Therapeutic: four - six tablets daily in divided doses before food. Children 6 - 12 years:

Prophylactic & Therapeutic: one - three tablets daily taken before food.

4.3 Contraindications

Ferrous Gluconate should not be given for anaemia not caused by iron deficiency unless this is also present. Do not use when repeated blood transfusions are being given.

Ferrous Gluconate 300mg Tablets BP should not be given to patients with hypersensitivity to the active ingredient or any of the excipients.

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.

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 reach and sight of children, as overdose may be fatal.

This information will appear on the front of the pack within a rectangle in which there is no other information.

The product contains, as excipients, the colours E122 and E124. These can cause allergic type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

The product contains sucrose as an excipient. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction Iron has the following specific interactions:

Reduced absorption of bisphosphonates Reduced absorption of ciprofloxacin Reduced absorption of entacapone Absorption of levodopa may be reduced Absorption of levofloxacin is reduced by oral iron Magnesium trisilicate reduces absorption of oral iron Reduces hypotensive effect of methyldopa Reduced absorption of norfloxacin Reduced absorption of ofloxacin Reduced absorption of penicillamine Reduced absorption of tetracyclines Tetracyclines reduce the absorption of oral iron Trientine reduces absorption of oral iron

Reduced absorption of zinc Zinc reduces absorption of oral 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, but as with all drugs care should be exercised in administering this preparation during pregnancy and lactation.

4.7 Effects on ability to drive and use machines

Nil.

4.8 Undesirable effects

Gastro intestinal discomfort, diarrhoea and vomiting may occur in up to 20% of patients. Paradoxically continued use may cause constipation.

4.9 Overdose

Large amounts of Ferrous Gluconate are toxic but in adults rarely prove fatal. In children between 1 and 2 years of age as little as 1 to 2 grams of iron cause death.

Initial symptoms of iron over dosage include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and metabolic acidosis may also occur. If over dosage is suspected treatment should be implemented immediately. In severe cases a latent phase hepatocellular necrosis and renal failure.

The following steps are recommended to minimise or prevent further absorption of the medication.

Children

1.    Administer an emetic such as Syrup of Ipecac.

2.    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 - 100ml water, to be retained in the stomach. Inducing diarrhoea in children may be dangerous and should not be taken in young children. Keep the patient under constant surveillance to detect possible aspiration of vomit - maintain suction apparatus and standby emergency oxygen in case of need.

3.    Severe Poisoning: In the presence of shock and/or coma with high serum iron levels (serum iron 90 pmol/l) immediate supportive measures plus i.v. infusion of desferrioxamine should be instituted. Desferrioxamine 15mg/kg body weight should be administered every hour by slow i.v. infusion to a maximum 80mg/kg/24 hours. Warning: Hypotension may occur if the infusion rate is too rapid.

4.    Less severe poisoning:    i.m. desferrioxamine 1g. 4-6 hourly is

recommended.

5.    Serum iron levels should be monitored throughout.

Adults

1.    Administer an emetic.

2.    Gastric lavage may be necessary to remove drug already released into the stomach. This should be undertaken using 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 vomit. Maintain suction apparatus and standby emergency oxygen in case of need.

3.    A drink of mannitol or sorbitol should be given to induce small bowel emptying.

4.    Severe Poisoning: In the presence of shock and/or coma with high serum iron levels (serum iron 142 pmol/l) immediate supportive measures plus i.v. infusion of desferrioxamine should be instituted. Desferrioxamine 5mg/kg body weight should be administered every hour by slow i.v. infusion to a maximum 80mg/kg/24 hours. Warning: Hypotension may occur if the infusion rate is too rapid.

5.    Less severe poisoning i.m. desferrioxamine 50mg/kg up to a maximum dose of 4g should be given.

6.    Serum levels should be monitored throughout.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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 mitochondria 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 1mg 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 iron deficiency, when iron stores are depleted or when enythropoiesis is increased. Only 10% of total iron is lost per year from normal men that accounts for 1mg per day. Two thirds of this iron is excreted from the gastrointestinal tract as extravasated red cells, iron in the 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 loses 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 the female due to menstruation. While this averages about 0.5mg per day, 10% of normal menstruating females lose over 2mg 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

Maize Starch, & Talc.

Sugar-coat excipients: Sucrose, shellac, talc, and colours titanium dioxide (E171), dispersed red 15011 (E122, E124).

6.2 Incompatibilities

Not applicable.

6.3


Shelf life

60 Months.

6.4 Special precautions for storage

Do not store above 25 degrees 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.

Pack sizes: 28 & 1000 tablets.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Zanza Laboratories (Holdings) Limited

Unit 2A

Olympic Way

Sefton Business Park

LIVERPOOL

L30 1RD

8    MARKETING AUTHORISATION NUMBER(S)

PL 39874/0023

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

11.09.2008

10 DATE OF REVISION OF THE TEXT

15/11/2011