SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Standardised Betadine Antiseptic Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Povidone Iodine 10.00 % w/v

3 PHARMACEUTICAL FORM

Aqueous Solution

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For use as a pre-operative and post-operative antiseptic skin cleanser for major and minor surgical procedures.

4.2    Posology and method of administration

Topical administration.

Adults, the elderly and children: Apply full strength as a pre-operative and

post-operative antiseptic skin cleanser. Avoid pooling both under the patients

and in the skin folds. Wash off excess solution before using occlusive dressings.

4.3    Contraindications

Hypersensitivity to iodine, polyvinylpyrrolidine or to any excipient. History of abnormal thyroid function or goitre (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis). 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 used for long periods thyroid function tests should be performed. Particular care should be taken when treating patients with excessive burns. Use of this preparation In patients with renal impairment may possibly result in the development of toxic levels of iodine" Therefore, iodine levels should be monitored in these patients. Particular care should also be taken when treating neonates and very low birth weight infants.

Standardised Betadine Antiseptic Solution can permanently discolour white gold jewellery and it is recommended that this type of jewellery should be removed before using Standardised Betadine Antiseptic Solution.

Avoid contact with eyes. In case of contact with the eyes, immediately flush the eyes liberally with water for at least 15 minutes and seek medical attention. If easy to do, remove contact lenses.

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 falsepositive results.

4.6    Pregnancy and lactation

Iodine freely crosses the placenta and is secreted in breast milk. Therefore it is recommended that breastfeeding should stop during treatment, unless no alternative is possible. 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 known.

4.8 Undesirable effects

Local irritation, skin bums and sensitivity reactions have been reported rarely. Anaphylactic reactions, anaphylactoid reactions and anaphylactic shock have been reported uncommonly with products containing povidone-iodine or povidone.

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

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects: Metallic taste in mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and renal impairment.

Deliberate or accidental ingestion of large quantities of povidone iodine will result in high blood levels of iodine and gastrointestinal toxicity including vomiting and diarrhoea. Symptomatic and supportive treatment should be started with special attention to monitoring electrolyte balance, renal function, thyroid function and liver function. Iodine can be removed by dialysis.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Standardised Betadine Antiseptic Solution contains povidone-iodine, 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. Standardised

Betadine Antiseptic Solution kills bacteria, viruses, fungi, spores and protozoa.

5.2 Pharmacokinetic properties

The product is intended for topical application.

Preclinical safety data

There are no pre-clinical safety data available for this product.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glycerol Nonoxynol 9

Dibasic Sodium Phosphate (Anhydrous) Citric Acid monohydrate Sodium Hydroxide Potassium Iodate Purified Water

6.2 Incompatibilities

None.

6.3 Shelf life

36 Months unopened

6.4 Special precautions for storage

Store at a temperature not exceeding 25°C

6.5 Nature and contents of container

High density polyethylene bottle containing either 500 ml or 5000 ml of product, fitted with a white polypropylene cap with a steran-lined wad.

6.6 Special precautions for disposal

None stated

7    MARKETING AUTHORISATION HOLDER

Ayrton Saunders Ltd 9 Arkwright Road,

Astmoor Industrial Estate,

Runcorn,

Cheshire,

WA7 1NU,

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 16431/0197

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14 March 2005

10 DATE OF REVISION OF THE TEXT

28/06/2012