Ferrous Sulphate 200mg Coated Tablets Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferrous Sulphate 200mg Coated Tablets BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg Ferrous Sulphate dried Ph Eur equivalent to 65mg elemental iron.
Also contains sucrose, lactose and Ponceau 4R colorant (E124).
For full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Coated tablets
Ferrous sulphate 200mg tablets are red, circular, slightly convex coated tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of iron-deficiency anaemia
4.2 Posology and method of administration
Posology
Adults: one tablet 2-3 times daily
Paediatric population: Not recommended for children weighing less than 44kg. For children weighing over 44kg: one tablet twice daily. For children and adolescents weighing over 66kg: same as the adult dose.
The haemoglobin concentration should rise by about 2g/dL over 3-4 weeks. When the haemoglobin is in the reference range treatment should be continued for a further 3 months to replenish iron stores.
Special populations
Elderly (> 65 years): The usual adult dose can be administered.
Renal impairment: The usual adult dose can be administered. However, patients with chronic renal failure on haemodialysis may require iv iron therapy.
Method of administration
For oral use.
The tablets should be swallowed whole with a glass of water before food (see section 4.5)
The tablets should not be crushed or chewed.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients Patients receiving repeated blood transfusions Concomitant parenteral iron therapy Haemochromatosis and other iron overload syndromes
4.4 Special warnings and precautions for use
General: before starting treatment, it is important to exclude any underlying cause of the anaemia (e.g. gastric erosion, colonic carcinoma).
Administer with caution in patients with haemolytic anaemia, haemoglobinopathies, iron-storage or iron-absorption diseases, existing gastrointestinal disease.
This product contains lactose and sucrose. Patients with rare hereditary problems of galactose intolerance or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This product also contains Ponceau 4R colorant (E124) which may cause allergic reactions.
Iron preparations are a common cause of accidental overdose in children. 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
The absorption of iron salts is decreased in the presence of antacids, preparations containing zinc, calcium, phosphorus, trientine, or when taken with tea, coffee, milk, eggs and whole grain foods. Iron supplements should not be taken within one hour before or two hours after ingestion of these products.
Cholestyramine may bind to iron in the gastrointestinal tract, thus preventing its absorption.
Chloramphenicol can reduce the response to iron therapy in iron deficiency anaemia.
Absorption of iron salts is enhanced by ascorbic acid and meat.
Concurrent administration with tetracyclines may impair absorption of both agents.
The absorption of quinolones (e.g. ciprofloxacin, norfloxacin, levofloxacin and ofloxacin) is reduced by oral iron. Iron salts may reduce the bioavailability of methyldopa, levodopa, entacapone, penicillamine, levothyroxine and bisphosphonates the effectiveness of which might be reduced.
Dimercaprol forms a toxic complex with iron and should not be given concomitantly.
4.6 Fertility, pregnancy and lactation
Ferrous salts are recommended for use in pregnancy and lactation, and no contraindications to such are known. No special requirements are to be anticipated.
Iron supplementation should not be routinely offered to all pregnant women in the absence of a diagnosis of iron deficiency anaemia.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
The most frequent adverse reactions to treatment with ferrous sulphate are gastrointestinal in origin. Although iron preparations are best absorbed on an empty stomach, they may be taken after food to reduce gastrointestinal side-effects.
The following terms and frequencies are applied: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Gastrointestinal disorders:
Very common: nausea, epigastric or abdominal pain, constipation Common; diarrhoea, faeces discoloured, vomiting Immune system disorders:
Not known: hypersensitivity reaction Skin and subcutaneous tissue disorders:
Common: rash
Nausea and epigastric pain are dose-related but the relationship between dose and altered bowel habit (constipation, diarrhoea) is less clear. Iron preparations taken orally may have a constipating effect, particularly in older patients, occasionally leading to faecal impaction. Hypersensitivity reactions have been reported with parenteral iron administration, but the frequency of occurrence is not known with ferrous sulphate taken orally. Hypersensitivity reactions to parenteral iron range from rash, sometimes severe, to anaphylactic reaction.
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.
Peak serum levels in overdose are reached 4 to 6 hours following ingestion. Serum iron taken at about 4 hours after ingestion is the best laboratory measure of severity: less than 3 mg/L (55 micromol/L) means mild toxicity; 35 mg/L (55-90 micromol/L) means moderate toxicity; more than 5 mg/L (90 micromol/L) means severe toxicity.
Early features (less than 6 hours after ingestion) include nausea, vomiting, abdominal pain and diarrhoea; the vomit and stools may be grey or black.
In mild cases early features improve 6-12 hours after ingestion but in more serious cases there may be evidence of hypoperfusion (cool peripheries and hypotension), metabolic acidosis and systemic toxicity. There is often a latent phase with minimal symptoms which may last up to 24 hours and may be misinterpreted as an apparent recovery. In serious cases there can be recurrence of vomiting and gastrointestinal bleeding, 12 or more 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
Management depends on clinical findings, dose and time from ingestion. Supportive and symptomatic measures include ensuring a clear airway and adequate ventilation, monitoring cardiac rhythm, BP and urine output, establishing intravenous access and administering sufficient fluids to ensure adequate hydration. Routine urea, electrolytes, liver function tests and blood counts, glucose and gases should be checked. Whole bowel irrigation should be considered.
If metabolic acidosis persists despite correction of hypoxia and adequate fluid resuscitation, for adults an initial dose of 50 mmol sodium bicarbonate may be given and repeated as necessary, guided by arterial blood gas monitoring (aim for pH of 7.4)
Administration of deferrioxamine should be considered if the patient is symptomatic (other than nausea) and serum iron concentration is between 3-5 mg/L (55-90 micromol/L) or higher and still rising. Haemodialysis does not remove iron effectively but should be considered on supportive basis for acute renal failure as this will facilitate removal of the iron-desferrioxamine complex.
Paediatric population
Iron preparations are an important cause of accidental overdose in children.
As little as 20 mg/kg elemental iron is enough to lead to symptoms of toxicity.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: anti-anaemic preparations, iron preparations ATC Code: B03A A07 Mechanism of action
Administration of iron preparations corrects erythropoietic abnormalities caused by a deficiency of iron. Iron is an essential component in cells and has several vital functions. Ionic iron is a component of a number of enzymes necessary for energy transfer (e.g., cytochrome oxidase, xanthine oxidase, succinic dehydrogenase) and is also present in compounds necessary for transport and utilisation of oxygen (e.g., haemoglobin, myoglobin). Iron deficiency can interfere with these vital functions and lead to morbidity and mortality.
5.2 Pharmacokinetic properties
Absoption
Absorption of iron from a 200mg ferrous sulphate tablet is evident within 0.5 hours and reaches a peak concentration in plasma after 2-3 hours. Absorption occurs principally in the duodenum and proximal jejunum and is most efficient when iron is ingested in its ferrous rather than its ferric form, on an empty stomach. Gastric acid increases absorption by maintaining ferric iron in a soluble form.
Absorption of iron is influenced by many factors including the form in which it is administered, the dose, iron stores, the degree of erythropoiesis, and diet. The principal factor controlling absorption is the amount of iron stored in the body. Absorption increases when body iron stores are low and decreases when stores are sufficient or large. Increased erythrocyte production also can stimulate absorption. In iron-deficient individuals, 10 to 30% is absorbed, the amount being approximately proportional to the degree of deficiency, compared to 5 to 15% in non-iron deficient individuals.
Distribution
When taken orally, in food or as a supplement, iron passes through the mucosal cells in the ferrous state and is bound with the protein transferrin. Elimination
No physiological system of elimination exists for iron, and it can accumulate in the body to toxic amounts. Most of the iron liberated by destruction of haemoglobin is conserved and reused by the body. Excretion occurs principally through faeces and as desquamation of cells such as skin, GI mucosa, nails, and hair. Blood loss greatly increases iron loss.
5.3 Preclinical safety data
The long-established use of iron salts, including ferrous sulphate, in clinical practice, and the consequential abundance of data on the human effects of iron, renders the animal data on iron toxicity of secondary importance.
6 PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Core:
Maize starch Maltodextrin Calcium stearate Lactose monohydrate Cellulose powdered Copovidone Sucrose Macrogol 4000 Talc
Sodium starch glycolate Sodium dodecyl sulphate
Coating:
Sucrose
Colorant Ponceau 4R E124
Red lacquer Colour Ponceau 4R Lake E124
Povidone K-25
Talc
Calcium carbonate Titanium dioxide E171 Magnesium stearate Macrogol 4000 Theobroma oil Shellac
6.2 Incompatibilities
None known
6.3 Shelf life
36 months
6.4 Special precautions for storage
Store in the original packaging
6.5 Nature and contents of container
PVC/Aluminium blister pack Pack size: 28 tablets
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Quantum Generics
Crown House
2-8 Gloucester Road
Redhill
Surrey
RH1 1FH
8 MARKETING AUTHORISATION NUMBER(S)
PL 15894/0004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/06/2011 10/12/2014