Ferrous Sulphate 200mg Tablets (Sandoz Limited)

1. Name Of The Medicinal Product

Ferrous Sulphate Tablets BP 200mg.

2. Qualitative And Quantitative Composition

Each tablet contains: ferrous sulphate BP 200mg.

3. Pharmaceutical Form

Coated tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

Iron-deficiency anaemia.

4.2 Posology And Method Of Administration

Adults:	Prophylactic dose - one tablet daily. Therapeutic dose - one tablet 2-3 times daily.
Children:	This presentation is not recommended for children.

There is no evidence that the dosage should differ in the elderly.

4.3 Contraindications

Ferrous sulphate is contra-indicated in patients with a hypersensitivity to any of the ingredients in the formulation.

Iron preparations are contra-indicated in patients with haemochromatosis and haemosiderosis. Iron is contra-indicated in patients receiving repeated blood transfusions.

Oral iron preparations are contra-indicated when used concomitantly with parental iron therapy.

4.4 Special Warnings And Precautions For Use

Ferrous Sulphate tablets should be kept out of children's reach. Acute iron poisoning occurs rarely in adults, however it could happen if children swallow this medication.

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.

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

Ferrous sulphate reduces absorption of tetracyclines, ciprofloxacin, levofloxacin, norfloxacin, ofloxacin, bisphosphates, zinc salts and penicillamine. It may also reduce the absorption of entacapone and levodopa.

The absorbtion of ferrous sulphate is reduced by magnesium trisilicate, trientine, zinc and tetracyclines.

Ferrous sulphate also reduces the hypotensive effect of methyldopa.

4.6 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

None known.

4.8 Undesirable Effects

Large doses may produce gastro-intestinal irritation, nausea, vomiting, epigastric pain, diarrhoea;

Constipation may be caused by continual administration, iron supplementation may cause the blackening of stool.

Hypersensitivity reactions have been reported. These range from rashes, sometimes severe, to anaphylaxis.

4.9 Overdose

Symptoms include epigastric pain, nausea, vomiting, haematemesis and circulatory collapse. In severe cases, encephalopathy, acute hepatic necrosis and acute renal failure may develop. Treatment consists of gastric lavage, followed by the introduction of 5g desferrioxide into the stomach. Serum iron should be monitored and in severe cases IV desferrioxamine should be given with supportive and symptomatic measures.

5. Pharmacological Properties

5.1 Pharmacodynamic 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 state, passing into and through the mucosal cell directly into the blood stream where it is immediately attached to transferrin.

5.2 Pharmacokinetic Properties

Most of the iron in the body is present as haemoglobin. The remainder is present in the storage forms ferritin or haemosiderin, in the reticuloendothelial system or as myoglobin with smaller amounts occurring in haem-containing enzymes or in plasma bound to transferrin.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Core:

Stearic acid EP

Magnesium Stearate EP

Sodium Lauryl Sulphate EP

Microcrystalline cellulose EP

Croscarmellose Sodium EP

Coating:

Opaglos HSE

Titanium Dioxide EP

Sucrose EP

Calcium carbonate light EP

Acacia SD EP

Purified talc EP

Mastercote White SP0962 (HSE)

Wax Polish (HSE)

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store in a cool dry place.

6.5 Nature And Contents Of Container

Tamper evident containers made of polypropylene or polyethylene, with polyethylene closures.

Pack sizes: 28, 50, 100, 250, 500 and 1,000.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Sandoz Ltd

Woolmer Way

Bordon

Hampshire

GU35 9QE

8. Marketing Authorisation Number(S)

PL 04416/0216

9. Date Of First Authorisation/Renewal Of The Authorisation

12 January 1993

10. Date Of Revision Of The Text

22 July 2005