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Information leaflet

                                                     Irish Medicines Board

                                  Summary of Product Characteristics

 Betadine 100 mg/ml Antiseptic Paint


 Iodinated Povidone 10% w/v (yielding 1.1% w/v available iodine).

 For a full list of excipients see section 6.1.


 Cutaneous solution
 Glass bottle with applicator brush containing a brown coloured solution with an odour of alcohol.


 4.1 Therapeutic Indications

 As a topical antiseptic in the prevention and treatment of topical cutaneous infections.

 4.2 Posology and method of administration

 For topical administration.

 Apply to the affected area once or twice daily or as directed.

 Apply directly to the affected area and allow to dry. Cover with a dressing if desired.

 4.3 Contraindications

 Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient. History of abnormal thyroid function or goitre (in
 particular nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis). Use in children under two years of age.
 Regular use should be avoided in patients on concurrent lithium therapy.

 4.4 Special warnings and precautions for use

 Use of this preparation may interfere with tests of thyroid function. Iodine is absorbed through burns and broken skin
 and to a lesser extent through intact skin and may lead to toxic levels of iodine in the blood, particularly in patients with
 renal insufficiency. If symptoms occur suggesting changes in thyroid function, these should be investigated. In patients
 with impaired renal function, blood levels of iodine should be monitored.
 This preparation contains alcohol and is flammable. Allow to dry after use and avoid exposure to sources of ignition.

 If local irritation and hypersensitivity develop, then discontinue treatment. Refer to section 4.8 for further information.
 Betadine Antiseptic Paint can permanently discolour white gold jewellery and it is recommended that this type of
 jewellery should be removed before using Betadine Antiseptic Paint.

Date Printed 22/12/2011                               CRN 2106427                                         page number: 1
                                                   Irish Medicines Board

 4.5 Interaction with other medicinal products and other forms of interaction

 Use with concurrent lithium therapy has been shown to exhibit additive hypothyroidic effects. Absorption of iodine
 from povidone iodine through either intact skin or broken skin may interfere with thyroid function tests. Contamination
 with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce
 false-positive results.

 4.6 Fertility, pregnancy and lactation

 Iodine freely crosses the placenta and is secreted in breast milk. Thyroid function disorders have been reported in the
 offspring of mothers exposed to pharmacological doses of iodine. Povidone iodine should not be used regularly during
 pregnancy unless there is no alternative treatment available.

 4.7 Effects on ability to drive and use machines

 None stated.

 4.8 Undesirable effects

 Local irritation, skin burns and sensitivity reactions have been reported rarely. Anaphylactic reactions, anaphylactoid
 reactions and anaphylactic shock have been reported uncommonly with products containing povidone-iodine or
 Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Such effects have occasionally been seen
 with extensive or prolonged use of povidone iodine. Other effects that have been reported are metabolic acidosis and
 acute renal failure.

 4.9 Overdose

 Deliberate or accidental ingestion of large quantities of povidone iodine will result in high blood concentrations of
 iodine and gastrointestinal corrosive effects including vomiting, diarrhoea and abdominal pain. Systemic toxicity may
 result in shock, hypotension, tachycardia, fever, metabolic acidosis and renal impairment. Symptomatic and supportive
 treatment should be started with special attention to monitoring electrolyte balance, renal function, thyroid function and
 liver function. Haemodialysis effectively clears iodine and should be employed in severe cases of iodine poisoning
 particularly if renal failure is present. Continuous venovenous haemodiafiltration is less effective than haemodialysis.


 5.1 Pharmacodynamic properties

 Iodinated povidone is a complex of iodine which shows all the broad spectrum germicidal activity of elemental iodine.
 The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue. It is effective in the
 treatment of infections caused by bacteria, fungi, yeasts and viruses (e.g. Herpes Virus Types I and II).

 5.2 Pharmacokinetic properties

 None stated.

 5.3 Preclinical safety data

 None stated.

Date Printed 22/12/2011                               CRN 2106427                                         page number: 2
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