BETASEPT ANTISEPTIC GARGLE AND MOUTHWASH CONCENTRATE
Active substance(s): POVIDONE-IODINE
NAME OF THE MEDICINAL PRODUCT
Betadine Gargle and Mouthwash
Betasept Antiseptic Gargle and Mouthwash Concentrate
QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone Iodine USP 1.0% w/v (equivalent to 0.1% w/v of available iodine)
Betadine: For the treatment of Acute Mucosal Infections of the mouth and
pharynx e.g. gingivitis, mouth ulcers, for oral hygiene prior to, during, and
after dental and oral surgery.
Betasept: For the treatment of Acute Mucosal Infections of the mouth and
pharynx e.g. gingivitis, mouth ulcers.
Posology and method of administration
Route of administration: Oral, as a gargle and mouthwash.
should not be swallowed.
Adults, the elderly and children over 6 years of age: Use undiluted with an
equal volume of warm water. Gargle or rinse with up to 10mls for up to 30
seconds without swallowing. Repeat up to four times daily, for up to 14
consecutive days, or as directed.
Not to be used in children of 6 years and under.
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. Do not use in children of 6 years and
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.
Do not use for more than 14 days.
If local irritation and hypersensitivity develop, then discontinue treatment.
Refer to section 4.8 for further information.
Betadine Gargle and Mouthwash can permanently discolour white gold
jewellery and it is recommended that this type of jewellery should be removed
before using Betadine Gargle and Mouthwash.
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.
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.
Effects on ability to drive and use machines
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.
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
Betadine Gargle & Mouthwash contains povidone-iodine, a complex of iodine
which shows all the broad spectrum germicidal activity of povidone iodine.
The germicidal activity is maintained in the presence of blood, pus, serum and
necrotic tissue. Betadine Gargle and Mouthwash kills bacteria, viruses, fungi,
spores and protozoa.
The product is intended for topical application to the mouth and buccal cavity.
Preclinical safety data
List of excipients
36 Months unopened
Special precautions for storage
Store in a dry place below 25°C. Protect from light.
Nature and contents of container
Amber soda-lime-silica glass bottle (USP Type III), fitted with an externally
ribbed white urea cap, with a steran faced wad or with a waddles
polypropylene cap containing either 100ml, 150ml or 250ml of product.
Special precautions for disposal
This product should not be swallowed.
MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd
9 Arkwright Road,
Astmoor Industrial Estate,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
28th April 1993 / 19th November 1998
DATE OF REVISION OF THE TEXT