Ferrous Sulphate 200mg Coated Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferrous Sulphate 200mg Coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ferrous Sulphate 200mg equivalent to 65mg of ferrous iron, Fe(II).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
White, sugar coated tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ferrous sulphate is used for iron-deficiency anaemia.
4.2 Posology and method of administration
For iron-deficiency anaemia:-
Adults:- Prophylaxis - One tablet daily
Therapeutic - One tablet 2-3 times daily
Elderly:- As for adults
Children:- This presentation is not recommended.
4.3 Contraindications
Hypersensitivity to the product and its ingredients; haemosiderosis and haemochromatosis; active peptic ulcer; repeated blood transfusion; haemolytic anaemia. Oral and parenteral iron preparations should not be used concomitantly.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine.
4.4 Special warnings and precautions for use
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. Care should be taken in patients with intestinal strictures or 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. These tablets contain sugar and should be administered with care to patients with diabetes. Patients suffering from iron overload are particularly susceptible to infection. Treatment of iron overload should be with caution.
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
Antacids and mineral supplements: Compounds containing calcium, magnesium (including antacids and mineral supplements), bicarbonates, carbonates, oxalates or phosphates may impair the absorption of iron. Administration of iron preparations with such compounds should be separated by at least 2 hours.
Antibacterials: Iron and tetracyclines reduce the absorption of each other when administered concomitantly. Administration of iron preparations and tetracyclines should be separated by 2 to 3 hours. Iron may reduce the absorption of quinolones. Administration of iron preparations and quinolones should be separated by at least 2 hours. Chioramphenicol delays plasma clearance of iron, incorporation into red blood cells by interfering with erythropoiesis.
Biphosphonates: The absorption of biphosphonates is reduced when taken concurrently with iron preparations. Administration should be separated by at least 2 hours.
Cholestyrarnine: Absorption of iron is impaired by cholestyrarnine.
Dimercaprol: Concomitant administration of oral iron preparations and dim ercaprol should be avoided.
Dopaminergics: Oral iron preparations may reduce the absorption of dopaminergics such as co-careldopa, entacapone and levodopa.
Food Products: Absorption of iron is impaired by tea, eggs or milk.
Methyldopa: Oral ilron preparations may antagonise the antihypertensive effect of methyldopa.
Mycophenolate mofetil: Oral iron preparations significantly reduce the absorption of mycophenolate mofetit
Penicillamine: Oral iron preparations can reduce the absorption of penicillamine. Also the absorption of iron is impaired by penicillamine.
Thyroid hormone: Ferrous sulphate reduces the absorption of levothyroxine and so should be taken at least 2 hours apart.
Trientine: the absorption of oral iron preparations is reduced by trientine. Administration should be separated by at least 2 hours.
Zinc: iron preparations and zinc preparations can reduce the absorption of each other.
4.6 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.
Prophylaxis of iron deficiency during the remainder of pregnancy is justified.
Effects on ability to drive and use machines
4.7
None known.
4.8 Undesirable effects
Gastro-intestinal disorders: abdominal pain, nausea and vomiting (these are usually dose related), constipation, diarrhoea and dark stools. Contact irritation can occur with ferrous sulphate tablets resulting in erosion or ulceration, particularly if they become lodged in the upper gastrointestinal tract.
Allergic reactions have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse drug 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
Iron overdosage is an acute emergency requiring urgent medical attention. An acute intake of 75 mg/kg of elemental iron is considered extremely dangerous in young children. Serum iron levels should be monitored. Symptoms and signs include abdominal pain, diarrhoea, nausea, vomiting (haematemesis is a possibility) and hyperglycaemia within 1-2 hours, followed by cardiovascular collapse and coma in some patients. Recovery follows this phase and in some patients this continues. In others deterioration occurs after about 15 hours characterised by pulmonary oedema, convulsions, renal failure, shock, metabolic acidosis, hypotension, tachycardia, coagulopathy and/or hypoglycaemia. There is a potential for gastrointestinal obstruction to occur weeks after iron ingestion, as a delayed effect. Treatment consists of supportive and symptomatic measures. Vomiting should be induced if patient presents early and gastric lavage should be considered using a solution of desferrioxamine. Parenteral injection of 2gm desferrioxamine should be given IV or IM and 5gm of desferrioxamine in 50-l00ml of fluid may also be left in the stomach. Recovery may be complicated by long term effects such as hepatic necrosis.
5.1 Pharmacodynamic properties
Ferrous sulphate contains iron. Most of the iron in the body is present as haemoglobin. The remainder is present in the storage forms of ferritin or haemosiderin, in the reticuloendothelial system or as myoglobin with smaller amounts occurring in haem-containing enzymes or in plasma bound to transferrin.
5.2 Pharmacokinetic properties
Iron is absorbed mainly in the small intestine, but can be absorbed along the entire length of the alimentary canal. It is absorbed most easily in the ferrous sulphate state, passing into and through the mucosal cells directly into the blood stream where it is immediately attached to transferrin.
5.3 Preclinical safety data
None available.
6.1 List of excipients
Tablet Core
Light kaolin Glucose monohydrate Povidone K30 Stearic acid Magnesium stearate Sodium lauryl sulphate Maize starch
Coating
Opaglos 6000P Purified talc
Titanium dioxide (E171) Povidone K30 Sucrose
6.2 Incompatibilities
None relevant known.
6.3 Shelf life
Screw cap plastic container: Two years Blister packs: Two years
6.4 Special precautions for storage
Do not store above 25oC
Screw cap container: Store in original container in order to protect from moisture. Blister packs: Store in the original package in order to protect from moisture.
6.5 Nature and contents of container
Packs of 50, 100, 250, 500 and 1000 contained in screw cap plastic containers.
Blister pack (white opaque PVC/PVDC film) containing 14 tablets. Pack size of 28 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd Ash Road North Wrexham.
LL13 9UF
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 29831/0220
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/07/2008
10 DATE OF REVISION OF THE TEXT
04/03/2015