Ferrous Sulphate Tablets Bp 200mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferrous Sulphate 200mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of Dried Ferrous Sulphate BP.
Excipients with known effect:
Lactose
Sucrose
Castor Oil No. 1
Methylhydroxybenzoate
Propylhydroxybenzoate
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM White sugar-coated tablets.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For the treatment and prophylaxis of iron deficiency anaemia.
4.2 Posology and method of administration
Posology
Adults
Prophylactic dose - one tablet daily. Therapeutic dose - one tablet 2-3 times daily.
Older people
The usual adult dose can be administered (see section 4.4).
Paediatric population Children 6-12 years
Children weighing > 22kg - one tablet daily.
Children weighing > 44kg - one tablet twice daily.
Children weighing > 66kg- one tablet three times daily.
A liquid preparation maybe more appropriate for children.
Children under 6 years or weighing less than 22kg This medicine is not recommended.
Method of administration:
For oral administration
4.3 Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- Patients receiving repeated blood transfusions
- Concomitant parenteral iron
- Haemochromatosis and other iron overload syndromes
4.4 Special warnings and precautions for use
Administer with caution in patients with haemolytic anaemia, haemoglobinopathies, iron storage or iron absorption diseases, existing gastrointestinal disease.
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.
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.
Before starting treatment, it is important to exclude any underlying cause of the anaemia (e.g. gastric erosion, colonic carcinoma).
4.5 Interaction with other medicinal products and other forms of interaction
Concurrent administration with tetracyclines may impair absorption of both agents.
The absorption of ciprofloxacin, norfloxacin and ofloxacin and bisphosphonates is reduced by oral iron.
Cholestyramine may bind iron to the gastrointestinal tract, thus preventing its absorption.
The absorption of iron salts is also decreased in the presence of antacids, preparations containing zinc, calcium, phosphorus, trientine, or when taken with tea, coffee, milk, eggs and whole grains. Iron supplements should not be taken within one hour before or two hours after ingestion of these products.
Iron salts may reduce the bioavailability of methyldopa. The absorption of levodopa and penicillamine may be reduced. Absorption of iron salts is enhanced by ascorbic acid and meat.
Dimercaprol: Avoid concomitant use of iron with dimercaprol.
Thyroid hormones: Oral iron reduces the absorption of levothyroxine (thyroxine) thus should be given at least 2 hours apart.
4.6 Fertility, pregnancy and lactation
Ferrous salts are recommended for use in pregnancy and lactation, and no contraindications to such are known.
4.7 Effects on ability to drive and use machines
Ferrous Sulphate 200mg Tablets have no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Although iron preparations are best absorbed on an empty stomach, they may be taken after food to reduce gastrointestinal side-effects.
|
System Organ Class |
Frequency |
Adverse Effects |
|
Immune system disorders |
Not known |
Anaphylactic reaction* |
|
Gastrointestinal disorders |
Not known |
Gastrointestinal tract irritation** Nausea** Vomiting** Abdominal pain upper** Diarrhoea** Constipation*** Faeces discoloured**** |
|
Skin and subcutaneous tissue disorders |
Not known |
Rash |
* Hypersensitivity reactions have been reported. These range from rashes, sometimes severe, to anaphylaxis.
** Large doses may produce gastrointestinal irritation, nausea, vomiting, epigastric pain, diarrhoea.
*** Constipation may be caused by continual administration, particularly in older patients, and may lead to faecal impaction.
**** iron supplementation may cause the blackening of stool.
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
Symptoms:
Acute iron overdosage can be divided into four stages. In the first phase, which occurs up to 6 hours after oral ingestion, gastrointestinal toxicity, notably vomiting and diarrhoea predominates. Other effects may include cardiovascular disorders such as hypotension and tachycardia, metabolic changes including acidosis and hyperglycaemia, and CNS depression ranging from lethargy to coma.
Patients with only mild to moderate poisoning do not generally pass this first phase. The second phase may occur at 6-24 hours after ingestion and is characterized by a temporary remission or clinical stabilization.
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.
Over-dosage of ferrous salts is particularly dangerous to young children.
Management:
Treatment consists of gastric lavage followed by the introduction of 5 g desferrioxamine into the stomach. Serum iron levels should be monitored and in severe cases iv desferrioxamine should be given together with supportive and symptomatic measures as required.
Gastric lavage with 5% sodium bicarbonate and saline cathartics (e.g. sodium sulphate 30g for adults); milk and eggs with 5g bismuth carbonate every hour as demulcents. Blood or plasma transfusion for shock, oxygen for respiratory embarrassment. Chelating agents (e.g. disodium calcium edetate) may be tried (500mg/500ml by continuous iv infusion). Dimercaprol should not be used since it forms a toxic complex with iron. Desferrioxamine is a specific iron chelating agent and severe acute poisoning in infants should always be treated
with desferrioxamine at a dose of 90mg/kg im followed by 15mg/kg per hour iv until the serum iron is within the plasma binding capacity.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: anti-anaemic preparations, iron preparations ATC code: B03A A07
Iron preparations have no intrinsic therapeutic activity except as a nutrient source: their use without evidence of iron deficiency, or reasonable expectation of its occurrence, is to be deprecated. Excessive iron is toxic and haemochromatosis can result from chronic injection of iron preparations used as tonics, especially in individuals with undiagnosed blood disorders. Patients with chronic anaemia are particularly at risk from iron storage disease. Recently a severe iron overload myopathy has been described in patients given prophylactic iron indiscriminately while receiving haemodialysis. Genetic factors probably contribute to the risk of an iron storage disease.
It should be clear that although iron deficiency is easily treated, its detection does not constitute a complete diagnosis. Every effort should be made to determine why the patient has a state of negative iron balance. Attention should be given to hidden sources of haemorrhage (which may indicate serious urinary or gastrointestinal conditions) and also the possibility of malabsorption of iron caused by latent disease of the small intestine.
5.2 Pharmacokinetic properties
Absorption
Iron is irregularly and incompletely absorbed from the gastrointestinal tract, the main sites of absorption being the duodenum and the jejunum. Absorption is aided by the acid secretion of the stomach or by dietary acids and is more readily affected when the iron is in the ferrous state or is part of the haem complex (haem-iron unit).
Absorption is also increased in conditions of iron deficiency or in the fasting state but decreased if the body stores are overloaded. Around 5-15% of the iron ingested in food is absorbed.
Distribution
Following absorption, the majority of iron is bound to transferrin and transported to the bone marrow where it is incorporated into haemoglobin.
Biotransformation
The remainder is stored within ferritin or haemosiderin or is incorporated into myoglobin with smaller amounts occurring in haem-containing enzymes or in plasma bound to transferrin.
Elimination
Only very small amounts are excreted as the body reabsorbs the iron after the haemoglobin has broken down.
5.3 Preclinical safety data
Not applicable
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Dextrose Monohydrate B.P.
Lactose B.P.
Maize Starch B.P.
Glycerol B.P.
Povidone B.P.
Industrial Methylated Spirits HSE Calcium Carbonate B.P
Magnesium Stearate B.P.
Shellac B.P.C.
Castor Oil No. 1 B.P.
Talc B.P.
Titanium Dioxide B.P. (E171)
Sucrose B.P.
Mineral Water Sugar B.P.
Purified Water B.P.
Methylhydroxybenzoate B.P.
Propylhydroxybenzoate B.P.
Acacia B.P.
Polyethylene Glycol 6000 B.P.
6.2. Incompatibilities
None known.
6.3. Shelf life
3 years (36 months).
6.4. Special precautions for storage
Store in a dry place, below 25°C. Protect from light.
6.5 Nature and contents of container
Polypropylene securitainers with tamper evident polypropylene caps. Pack sizes; 50, 100, 1000's.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Keep out of the site and reach of children.
7 MARKETING AUTHORISATION HOLDER
Mercury Pharmaceuticals Ltd Capital House,
85 King William Street,
London EC4N 7BL UK
8. MARKETING AUTHORISATION NUMBER(S)
PL: 12762/0111.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25th July 2001.
10 DATE OF REVISION OF THE TEXT
27/05/2015