Ferrous Sulphate Tablets Bp 200mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferrous Sulphate Tablets BP 200mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg Dried Ferrous Sulphate Ph.Eur. equivalent to 65mg
elemental iron.
This product also contains glucose, sucrose and lactose.
For full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Sugar-coated tablet.
White, circular, biconvex sugar-coated tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the prevention and treatment of iron-deficiency anaemias.
4.2 Posology and method of administration
Each 200mg ferrous sulphate tablet is equivalent to 65mg of ferrous iron.
Adults: Treatment: 130-195mg ferrous iron (2-3 tablets) daily in divided doses.
Prophylaxis: 65mg ferrous iron (1 tablet) daily.
Elderly: The usual adult dose can be administered (see section 4.4).
Children 6-12 years:
Treatment: Children weighing over 22 kg - one tablet daily.
Children weighing over 44 kg - one tablet twice daily.
Children weighing over 66 kg - one tablet three times daily.
Children under 6years or weighing less than 22kg: Not recommended.
Method of Administration For oral administration.
4.3 Contraindications
Hypersensitivity to any ingredients in the formulation; 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 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
Concurrent administration with tetracyclines may impair absorption of both agents. The absorption of ciprofloxacin, norfloxacin and ofloxacin 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.
4.6 Fertility, pregnancy and lactation
No special requirements are to be anticipated.
4.7 Effects on ability to drive and use machines
None known.
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; they may discolour (blacken) stools.
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.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
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 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.
Overdosage of ferrous salts is particularly dangerous to young children.
Treatment consists of gastric lavage followed by the introduction of 5g 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
ATC CODE: B03A A07
Ferrous sulphate is used in the treatment of iron deficiency anaemias.
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. Iron, in excess, is toxic and haemochromatosis may 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 iron overload.
It should be clear that although iron deficiency is readily treated, its detection does not constitute a complete diagnosis. Every effort should be made to determine why the patient has entered 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
Iron is irregularly and incompletely absorbed from the gastrointestinal tract, the main sites of absorption being the duodenum and jejunum. Absorption is aided by the acid secretion of the stomach or by dietary acids and is more readily effected when the iron is in the ferrous state or is part of the haem complex (haem-iron). Absorption is also increased in conditions of iron deficiency or in the fasting state but is decreased if the body stores are overloaded. Only about 5-15% of the iron ingested in food is normally absorbed. Following absorption, the majority of iron is bound to transferrin and transported to the bone marrow where it is incorporated into haemoglobin. 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. 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
The tablet core contains:
Spray dried liquid glucose Stearic acid Magnesium stearate Microcrystalline cellulose (101) (E460)
Lactose granules containing lactose Maize starch
Pregelatinised maize starch
The coating contains: Purified talc (E553)
Acacia (E414)
Gelatin
Sucrose
Titanium dioxide (E171)
The tablets may also contain: Yellow carnauba wax
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life
Two years from the date of manufacture.
Shelf-life after dilution/reconstitution Not applicable.
Shelf-life after first opening Not applicable.
6.4 Special precautions for storage
Store below 25°C in a dry place.
6.5 Nature and contents of container
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise, the alternative is amber glass containers with screw caps. An alternative closure for polyethylene containers is a polypropylene, twist on, push down and twist off child-resistant, tamper-evident lid.
A child resistant closure may be used for the 30’s pack size.
The product may also be supplied in blister packs and cartons:
a) Carton: Printed carton manufactured from white folding box board.
b) Blister pack: (i) 250pm white rigid PVC. (ii) Surface printed 20pm hard temper aluminium foil with 5-6g/M2 PVC and PVdC compatible heat seal lacquer on the reverse side.
c) Child Resistant Blister Pack: (i) 250pm white rigid PVC. (ii) 9pm soft aluminium/ 35g/m2 glassine paper.
Pack sizes: 28s, 30s, 50s, 56s, 60s, 84s, 100s, 112s, 250s, 500s, 1000s.
Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material.
Maximum size of bulk packs: 50,000.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Actavis UK Limited (Trading style: Actavis)
Whiddon Valley Barnstaple N Devon EX32 8NS
8 MARKETING AUTHORISATION NUMBER(S)
PL 00142/6422R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23/07/1990 / 31/03/2004
10 DATE OF REVISION OF THE TEXT
03/07/2015