Ferrous Fumarate 140mg/5ml Oral Suspension
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferrous Fumarate 140mg/5ml Oral Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of suspension contains 140mg ferrous fumarate.
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Oral Suspension
A smooth brown suspension with an odour of elderberry.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Prophylaxis and treatment of iron deficiency states.
For prophylaxis during pregnancy, a combination of iron and folic acid is usually recommended.
4.2 Posology and method of administration
Shake the bottle before use.
Adults and the elderly:
(a) Iron deficiency anaemia-Ferrous fumarate 140mg/5ml oral suspension two 5 ml spoonfuls twice a day
(b) prophylaxis- Ferrous fumarate 140mg/5ml oral suspension one 5 ml spoonful twice a day.
Children: Full term infants and young children-half to one 5ml spoonful twice a day. Premature infants: 0.6ml/kg day to 2.4 ml/kg/day.
Method of administration: Oral
4.3 Contraindications
Known hypersensitivity to any of the ingredients of the product.
Must not be used in anaemia’s other than those due to iron deficiency.
Iron preparations are contra-indicated in patients with:
• Paroxysmal nocturnal haemoglobinuria. Haemosiderosis, haemochromatosis.
• In patients with active peptic ulcer, regional enteritis and ulcerative colitis.
• In patients receiving repeated blood transfusions.
• When used concomitantly with parental iron therapy.
4.4. Special warnings and precautions for use
Before starting treatment, it is important to exclude any underlying cause of the anaemia (e.g. gastric erosion, colonic carcinoma).
Because anaemia due to combined iron and Vitamin Bi2 or folate deficiencies may be microcytic in type, patients with microcytic anaemia resistant to treatment with iron alone should be screened for Vitamin Bi2 or folate deficiency.
Duration of treatment of uncomplicated iron deficiency anaemia should not usually exceed 6 months (3 months after reversal of the anaemia has been achieved).
Oral iron, particularly modified-release preparations may exacerbate diarrhoea in patients with inflammatory bowel disease.
As with all iron preparations, ferrous fumarate should be used with care in patients with known or suspected gastrointestinal strictures or intestinal diverticular disease.
Some post-gastrectomy patients show poor absorption of iron.
Care is required when treating patients with iron deficiency anaemia who have treated or controlled peptic ulceration.
This product contains liquid glucose and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Long-term treatment with Ferrous Fumarate 140mg/5ml Oral Suspension can increase the risk of dental caries. Adequate dental hygiene must be maintained. Since Ferrous Fumarate 140mg/5ml oral suspension contains sugar, care must be exercised when using in patients with diabetes mellitus.
Aspiration of iron preparations induces inflammatory lesions at the site of iron deposit and may cause bronchial stenosis.
This product also contains Sodium metabisulphite and parahydroxybenzoates. Sodium metabisulphite may rarely cause severe hypersensitivity reactions and bronchospasm. Parahydroxybenzoates may cause allergic reactions (possibly delayed).
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 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 inhibits the absorption of tetracyclines from the gastrointestinal tract and tetracycline inhibits the absorption of iron. If both drugs must be given, tetracyclines should be taken three hours after or two hours before oral iron supplements.
Iron reduces the absorption of penicillamine, bisphosphonates, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine) (give at least 2 hours apart), moxifloxacin, mycophenolate, norfloxacin, ofloxacin, zinc.
Concurrent administration of oral iron preparations with tea, coffee, eggs, food or medications containing bicarbonates, carbonate, oxalates or phosphates, milk or milk products, whole grain breads and cereals and dietary fibre, may decrease iron absorption.
The absorption of ferrous fumarate is reduced by magnesium trisilicate, calcium salts, trientine and cholestyramine.
Chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Avoid concomitant use of iron with dimercaprol.
Ferrous fumarate also reduces the hypotensive effect of methyldopa.
Absorption of iron salts is enhanced by ascorbic acid and meat.
4.6. Pregnancy and Lactation
Pregnancy
Ferrous fumarate suspension can be used during pregnancy if clinically indicated. Lactation
No adverse effects of ferrous sulphate have been shown in breastfed infants of treated mothers. Ferrous fumarate suspension can be used during breast-feeding if clinically indicated.
4.7. Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
The commonest side effects relate to gastrointestinal irritation (nausea, epigastric pain, constipation or diarrhoea). In the event of these ADRs, it may be helpful to reduce the dose or switch to an alternative iron salt.
Darkening of stools, black discoloration of the teeth and allergic reactions (due to metabisulphite in the syrup vehicle) may also occur
4.9 Overdose Symptoms:
Ingestion of 20 mg/kg elemental iron is potentially toxic and 200-250 mg/kg is potentially fatal. No single method of assessment is entirely satisfactory - clinical features as well as laboratory analysis must be taken into account. The serum iron taken at about 4 hours after ingestion is the best laboratory measure of severity.
|
Serum Iron |
Severity |
|
< 3 mg/L (55 micromol/L) |
Mild toxicity |
|
3-5 mg/L (55-90 micromol/L) |
Moderate toxicity |
|
> 5 mg/L (90 micromol/L) |
Severe toxicity |
Early signs and symptoms include nausea, vomiting, abdominal pain and diarrhoea. The vomit and stools may be grey or black. In mild cases early features improve but in more serious cases there may be evidence of hypoperfusion (cool peripheries and hypotension), metabolic acidosis and systemic toxicity. In serious cases there can be recurrence of vomiting and gastrointestinal bleeding, 12 hours after ingestion. Shock can result from hypovolaemia or direct cardiotoxicity.
Evidence of hepatocellular necrosis appears at this stage with jaundice, bleeding, hypoglycaemia, encephalopathy and positive anion gap metabolic acidosis. Poor tissue perfusion may lead to renal failure. Rarely, gastric scarring causing stricture or pyloric stenosis (alone or in combination) may lead to partial or complete bowel obstruction 2-5 weeks after ingestion.
Management:
Supportive and symptomatic measures include ensuring a clear airway, monitor cardiac rhythm, BP and urine output, establishing IV access and administering sufficient fluids to ensure adequate hydration. Consider whole bowel irrigation. If metabolic acidosis persists despite correction of hypoxia and adequate fluid resuscitation, an initial dose of 50 mmol sodium bicarbonate may be given and repeated as necessary, for adults guided by arterial blood gas monitoring (aim for a pH of 7.4). Consider the use of desferrioxamine, if /the patient is symptomatic (other than nausea), serum iron concentration is between 3-5 mg/L (55-90 micromol/L) and still rising. Haemodialysis does not remove iron effectively but should be considered on a supportive basis for acute renal failure as this will facilitate removal of the iron-desferrioxamine complex.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code: B03A A02 Iron bivalent, oral preparations Iron is an essential constituent of the body, and is necessary for haemoglobin formation and for the oxidative processes of living tissues. Iron and iron salts should be given for the treatment or prophylaxis of iron deficiency anaemias.
Preparations of iron are administered by mouth, by intramuscular or intravenous injection.
Soluble ferrous salts are most effective by mouth. Ferrous fumarate is an easily absorbed source of iron for replacement therapy. It is a salt of ferrous iron with an organic acid and is less irritant to the gastro-intestinal tract than salts with inorganic acids.
5.2 Pharmacokinetic properties
In the acid conditions of the gastric contents, ferrous fumarate is dissociated and ferrous ions are liberated. These ions are absorbed in the proximal portion of the duodenum.
The ferrous iron absorbed by the mucosal cells of the duodenum is oxidised to the ferric form, and this is bound to protein to form Ferritin.
Ferritin in the mucosal cells releases iron into the blood, where it is bound to transferrin and passed into the iron stores - liver, spleen, and bone marrow.
These stores are a reserve of iron for synthesis of haemoglobin, myoglobin, and iron containing enzymes.
Iron is lost from the body through loss of cells in urine, faeces, hair, skin, sputum, nails, and mucosal cells, and through blood loss.
Ferrous fumarate has the same pattern of absorption and excretion as dietary iron.
5.3. Preclinical safety data
No further data.
6.1. List of excipients
Nipastat GL 75 Methylcellulose Glucose Liquid Sucrose
Granular Lecithin Elderberry flavour Sodium metabisulphite Purified water
6.2. Incompatibilities
None.
6.3. Shelf life
24 months
6.4. Special precautions for storage
Keep the bottle in the outer carton in order to protect from light. Do not store above 25°C.
6.5 Nature and contents of container
Amber glass bottle with polypropylene cap and melinex/pulpboard/aluminium wad containing 200 ml of oral solution.
6.6 Instruction for use and handling (, and disposal)
Shake the bottle before use.
7 MARKETING AUTHORISATION HOLDER
Mercury Pharmaceuticals Ltd,
Capital House,
85 King William Street,
London EC4N 7BL, UK
8. MARKETING AUTHORISATION NUMBER
PL 12762/0083
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/06/2010
10 DATE OF REVISION OF THE TEXT
21/03/2014