Summary of Product Characteristics (SmPC) - Ferrous Gluconate 300 mg tablets BP

1 NAME OF THE MEDICINAL PRODUCT

Ferrous Gluconate 300mg Tablets BP

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 300mg Ferrous Gluconate For the full list of excipients, see Section 6.1

3. PHARMACEUTICAL FORM

Coated tablet.

Appearance: Red, circular, biconvex, sugar coated, printed with APS and 1701.

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.

Ferrous gluconate tablets 300 mg are best taken about one hour before meals.

Method of administration

The route of administration for Ferrous Gluconate 300mg tablets is oral.

4.3. Contraindications

Hypersensitivity to the active ingredient 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 disease such as haemosiderosis or haemoglobinuria.
Iron is contraindicated in patients receiving repeated blood transfusions, or in patients receiving parenteral iron therapy or to patients with anaemias not produced by iron deficiency (some conditions, such as thalassemia may cause excess storage or iron)..
Alcoholism and hepatitis.
Iron preparations are contraindicated in active peptic ulcer, regional enteritis and ulcerative colitis.
Ferrous Gluconate Tablets should not be used in patients with anaemia not produced by iron deficiency unless iron deficiency is also present.

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. 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.

Care should be exercised in patients with iron absorption disease. 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.

Hypersensitivity reactions

Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/ anaphylactoid reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8).

These tablets contain sugar and should be administered with care to patients with diabetes.

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).

Excipients

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 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.

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 because of the formation of less soluble or insoluble complexes and should be administered at least 2 hours apart.

Penicillamine: Iron reduces the absorption of penicillamine, and may decrease the effect of penicillamine. Also the absorption of iron is impaired by penicillamine. A period of 2 hours should elapse between administration of penicillamine and iron.

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.

Vitamin E: 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.

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, co-careldopa.

Methyldopa: Administration of oral iron may reduce the hypotensive effect of methyldopa.

Mycophenolatemofetil: Iron reduces absorption of mycophenolatemofetil

Zinc and Aluminium: Iron salts may reduce the absorption of aluminium and zinc salts and 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 (contains tannic acid), eggs, milk or milk products and whole grain breads and cereals (contain phytic acid). 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.

Proton pump inhibitors may reduce absorption of oral iron.

Dimercaprol: Avoid concomitant administration of oral iron with dimercaprol or use of dimercaprol for treatment of tiron poisoning due to the formation of toxic compounds.

Carbidopa: Iron compounds impair the bioavailability of carbidopa.

In addition iron possibly reduces the absorption of eltrombopag (a period of 4 hours should elapse between administration of eltrombopag and iron) and nalidixic acid.

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. 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.

Prophylaxis of iron deficiency during the remainder of pregnancy is justified.

Iron is excreted in breast milk but not in significant amounts (about 0.5 mg/day).

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Gastro- intestinal disorders have been reported with large doses of Iron including gastro-intestinal discomfort, epigastric pain, anorexia, heartburn, vomiting, nausea, constipation and diarrhoea. These side effects have been reported to occur in up to 20% or more of patients treated and are related to the amount of elemental iron taken rather than the type of preparation. Continued administration of Ferrous gluconate may result in constipation and faecal impaction. Darkening of the stools may occur.

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.

Contact irritation can occur with high doses of ferrous gluconate tablets resulting in erosion or ulceration on the gastro-intestinal mucosa and necrosis and perforation may occur; stricture formation may subsequently follow particularly if they become lodged in the upper gastrointestinal tract.

Cardiac disorders:

Frequency ‘Not known’: Kounis Syndrome

Reporting of suspected adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

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 g of iron can cause death.

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 abdominal pain, haematemesis, rectal bleeding, cardiovascular disorders, such as hypotension, tachycardia and circulatory collapse, 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.

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
(2 g/l). This should then be followed by the instillation of desferrioxamine 5 g 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 patients under constant surveillance to detect possible aspiration of vomitus – 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 µmol/l) immediate supportive measures plus I.V. infusion of desferrioxamine should be instituted. Desferrioxamine 15 mg/kg body weight should be administered every hour by slow I.V. infusion to a maximum 80 mg/kg/24 hours. Warning: Hypotension may occur if the infusion rate is too rapid.
4.
Less severe poisoning I.M. desferrioxamine 1 g, 4 – 6 hourly is
recommended.
5. Serum iron levels should be monitored throughout.

Adults:

1. Administer an emetic.
2. 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. This should be undertaken using a desferrioxamine solution (2 g/l). Desferrioxamine 5 g in 50 – 100 ml water should be introduced to 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.
3. A drink of mannitol or sorbitol should be given to include small bowel emptying.
4.
Severe Poisoning: In the presence of shock and/or coma with high serum
Iron levels (140 µmol/l) immediate supportive measures plus I.V. infusion of desferrioxamine should be instituted without waiting for the results of the serum iron measurement. Desferrioxamine is a specific iron chelating agent which may be administered by intravenous injection. The dose should be adjusted according to the severity of the poisoning. 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. The recommended dose of desferrioxamine is 5 mg/kg/h by slow I.V. infusion to a maximum 80 mg/kg/24 hours. Warning: Hypotension may occur if the infusion rate is too rapid.
5. Less severe poisoning: I.M. desferrioxamine 50 mg/kg up to a maximum dose of 4 g should be given.
6. Serum levels should be monitored throughout.

Dimercaprol should not be used in the treatment of iron poisoning.

5 PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Anti-anemic 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 1 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 1 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

Not available

6.1. List of excipients

Core: Sodium starch glycollate Type A, stearic acid, colloidal anhydrous silica.

Sugar Coating Excipients: Sucrose, purified talc, calcium carbonate, acacia, titanium dioxide E171, Industrial Methylated Spirit Ponceau 4R, Opaglos 6000P

6.2 Incompatibilities

None known.

6.3 Shelf life

3 Years

6.4 Special precautions for storage

Do not store above 25ºC. Store in the original container. Keep the container tightly closed.

6.5 Nature and contents of container

Polypropylene tubes with low density polyethylene cap.

Pack sizes: 100, 250, 500, 1000 and 5000 tablets.

6.6 Special precautions for disposal

Not applicable

7 MARKETING AUTHORISATION HOLDER

BRISTOL LABORATORIES,

UNIT 3, CANALSIDE,

NORTHBRIDGE ROAD,

BERKHAMSTED HP4 1EG,

UNITED KINGDOM

8 MARKETING AUTHORISATION NUMBER(S)

PL 17907/0347

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

15/11/2024

10 DATE OF REVISION OF THE TEXT