BETADINE ANTISEPTIC PAINT

Active substance: POVIDONE-IODINE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Betadine Antiseptic Paint
Brush Off Cold Sore Lotion

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone Iodine USP 10.0% w/v

3

PHARMACEUTICAL FORM
Cutaneous Solution

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Betadine Antiseptic Paint: As a general antiseptic paint in the prevention and
treatment of infections.
Brush Off Cold Sore Lotion: For the treatment of cold sores.

4.2

Posology and method of administration
For topical administration.
Adults, the elderly and children over 2 years of age:
Betadine Antiseptic Paint
Apply Betadine Antiseptic Paint undiluted as necessary to the affected area
and allow to dry.
Rinse the brush thoroughly after use.
Brush Off Cold Sore Lotion:
Apply twice daily to the affected area and allow to dry.
Not to be used on children under 2 years of age.

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.
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.

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
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
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
Povidone-iodine 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, yeast and viruses (e.g.
Herpes Virus Types I and II).

5.2

Pharmacokinetic properties
None stated.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Glycerol
Nonoxynol 9
Disodium hydrogen phosphate (anhydrons)
Citric acid monohydrate
Industrial methylated spirit
Sodium hydroxide (5% solution)
Purified water

6.2

Incompatibilities
None stated.

6.3

Shelf life
36 months unopened.

6.4

Special precautions for storage
Store below 25°C.

6.5

Nature and contents of container
Glass bottle with a white polypropylene cap and applicator brush containing
8ml of product.

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
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 16431/0188

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28th April 1993 / 19th November 1998

10

DATE OF REVISION OF THE TEXT
24/05/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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