This information is intended for use by health professionals

1. Name of the medicinal product

Betadine Dry Powder Spray.

2. Qualitative and quantitative composition

Povidone iodine 2.5 %w/w.

For excipients, see section 6.1

3. Pharmaceutical form

Pressurised aerosol spray.

4. Clinical particulars
4.1 Therapeutic indications

Antiseptic for the treatment and prevention of infection in wounds including ulcers, burns, cuts and other minor injuries.

4.2 Posology and method of administration

For topical use only.

Adults and children aged 2 years and older

Shake the can well before use. Spray the required area from a distance of 6-10 inches (15-25cm) until a dusting of powder is deposited. If necessary, the treated area may be covered with a dressing.

Not to be used on children under 2 years of age.

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). Use in children under two years of age. Regular use should be avoided in patients on concurrent lithium therapy. Avoid inhaling or spraying into the eyes. Betadine Dry Powder Spray should not be used in serious cavities.

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.

If local irritation and hypersensitivity develop, then discontinue treatment.

Refer to section 4.8 for further information.

Betadine Dry Powder Spray can permanently discolour white gold jewellery and it is recommended that this type of jewellery should be removed before using Betadine Dry Powder Spray.

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.

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 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.

Reporting of suspected adverse reactions

Reporting suspected adverse 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

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. Pharmacological properties
5.1 Pharmacodynamic properties

ATC code: D08AG02 – Antiseptics and disinfectants

Povidone iodine is a complex of iodine, which retains the broad-spectrum germicidal activity of the elemental iodine without its disadvantages. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

None stated.

6. Pharmaceutical particulars
6.1 List of excipients

Isopropyl myristate

N-pentane

Butane 40

Soya lecithin.

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months unopened.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Aerosol cans, containing 50, 100 or 150ml of product.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

Ayrton Saunders Ltd

9 Arkwright Road,

Astmoor Industrial Estate,

Runcorn,

Cheshire,

WA7 1NU,

UK

8. Marketing authorisation number(s)

PL 16431/0190

9. Date of first authorisation/renewal of the authorisation

19 April 2006

10. Date of revision of the text

24/09/2015