Alcoholic Iodine Solution BP

Iodine Tincture BP

Iodine 2.5% w/v, Potassium Iodide 2.5% w/v

Cutaneous solution.

A dark brown, clear, mobile liquid.

As an antiseptic for use on minor wounds, cuts and abrasions.

For cutaneous use.

The product is suitable for use by adults, children and the elderly.

Apply to the affected part with cotton wool or a small brush.

Contraindicated for patients hypersensitive to iodine or iodides.

Contradicted for use in newborn infants.

Contradicted in patients with thyroid disorders or those receiving lithium therapy.

Avoid prolonged use.

For external use only.

Keep all medicines out of the reach and sight of children.

Solutions of iodine applied to the skin should not be covered with occlusive dressings, (otc packs to state the shortened warning, “DO NOT COVER”).

Do not use on large, open wounds.

Administration of this product may interfere with tests of thyroid function.

Use with caution during pregnancy and lactation. Iodides cross the placenta and are excreted in breast milk.

None or negligible influence.

May cause allergic reactions, including urticaria, angioedema, cutaneous haemorrhage or purpuras, fever, arthralgia, lymphadenopathy and eosinophilia.

This product is not intended for internal use.

Symptoms of acute poisoning from ingestion of iodine include a disagreeable metallic taste, vomiting, abdominal pain and diarrhoea, thirst and headache may occur. The fatal dose of iodine is 2 to 3g. Symptomatic treatment for allergic reactions and iodism may be required, although symptoms usually subside rapidly when administration of iodine or iodide is stopped.

In acute poisoning copious draughts of milk and starch mucilage should be given.

Lavage should probably not be attempted and certainly not unless iodine had been ingested in sufficiently dilute form not to produce gastrointestinal corrosion. Other treatments include activated charcoal and sodium thiosulphate solution 1% or 5% to reduce iodine to the less toxic iodides. Electrolyte and water losses should be replaced and the circulation should be maintained. Pethidine or morphine sulphate may be given for pain, under medical supervision. A tracheotomy may become necessary.

Provided the product is not applied to large, open wounds or used for prolonged periods, clinically significant systemic absorption is unlikely. Systemic toxicity may lead to shock, tachycardia, fever, metabolic acidosis and renal impairment Death may be due to circulatory failure, oedema of the epiglottis resulting in asphyxia, aspiration pneumonia or pulmonary oedema. Oesophageal stricture may occur if the patient survives the acute stage.

D08A G03 - Antiseptics and disinfectants, iodine products

Iodine has a powerful bactericidal action and is used for disinfecting unbroken skin before operations. Iodine is active against fungi, viruses, protozoa, cysts and spores.

Iodine is only slightly absorbed when applied to the skin.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Purified water

Ethanol (96%)

None known.

Store below 25°C in a well closed container.

None.

L.C.M. Ltd.,

Linthwaite Laboratories

Huddersfield

HD7 5QH

PL 12965/0019

25^th August 1993

06/08/2009