Betadine 10% w/w Ointment

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
IODINATED POVIDONE PH.EUR.
Available from:
Ayrton Saunders Ltd
ATC code:
D08AG; D08AG02
INN (International Name):
IODINATED POVIDONE PH.EUR.
Dosage:
10 percent weight/weight
Pharmaceutical form:
Ointment
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Iodine products; povidone-iodine
Authorization status:
Not marketed
Authorization number:
PA0501/006/006
Authorization date:
1983-04-01

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Betadine 10% w/w Ointment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Iodinated Povidone 10% w/w (yielding 1% w/w available iodine)

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Ointment

Smooth, uniform, dark brown ointment.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

As a topical antiseptic for management of minor trauma or infection of the skin.

4.2 Posology and method of administration

Apply to the affected area, once or twice daily for a maximum of 14 days.

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, “Undesirable effects”

for further information.

Betadine Ointment can permanently discolour white gold jewellery and it is recommended that this type of jewellery

should be removed before using Betadine Ointment.

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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 known

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 povidine 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 povidine 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.

Betadine 10% w/w Ointment contains Iodinated povidone, 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.

Iodinated povidone kills bacteria, viruses, fungi, spores and protozoa.

5.2 Pharmacokinetic properties

Not applicable.

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5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Macrogol 400

Macrogol 1000

Macrogol 1500

Macrogol 4000

Sodium hydrogen carbonate (E500)

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25ºC.

6.5 Nature and contents of container

Triple epoxy lacquered aluminium tubes containing 40 or 80 g of product closed with HDPE caps and presented in

cardboard cartons.

Foil lined sachets containing 1g of product.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Ayrton Saunders Ltd

9 Arkwright Road

Astmoor Industrial Estate

Runcorn

Cheshire WA7 1NU

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA 0501/006/006

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9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 01 April 1983

Date of last renewal: 01 April 2008

10 DATE OF REVISION OF THE TEXT

December 2011

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