BOOTS ANAESTHETIC & ANTIBIOTIC THROAT LOZENGES
Active substance(s): BENZOCAINE / TYROTHRICIN
NAME OF THE MEDICINAL PRODUCT
Boots Anaesthetic & Antibiotic Throat Lozenges
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzocaine BP Fine Pdr Ph Eur
For the relief of sore throats.
For oral administration.
Posology and method of administration
Adults and. children over 12 years: one lozenge to be sucked slowly as
required. Not more than eight lozenges to be taken in any one day.
Children under 12 years: not suitable for children under 12 years.
Elderly: The normal adult dose is still appropriate in the elderly.
Hypersensitivity to ester type local anaesthetics or the antibiotic tyrothricin, or
any of the other ingredients.
Special warnings and precautions for use
This product should be used with caution in patients with myasthenia gravis, patients
with low plasma cholinesterase concentrations or in those receiving
If symptoms persist consult your doctor.
Warning: do no exceed the stated dose.
Keep all medicines out of the reach of children.
Interactions with other medicinal products and other forms of interaction
These lozenges may interfere with the action of sulphonamides.
Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established.
As local anaesthetics can cross the placenta, it is recommended that this product is not
taken during pregnancy.
No information on the use of this product in lactation is available and it is
recommended that this product is not taken whilst breast feeding.
Effects on ability to drive and use machines
No adverse effects known.
Occasional hypersensitivity reaction and soreness of the tongue.
Methaemoglobinaemia can rarely occur.
Overdosage with this product will produce excessive anaesthesia in the upper
alimentary tract. Treatment should be symptomatic and supportive. Gastric lavage
and emesis may be required.
In severe overdosage, methaemoglobinaemia may occur and should be treated by
intravenous administration of 1% solution of methylene blue in a dose of 1-4 mg per
kg of bodyweight.
Tyrothricin is an antibiotic. It is a mixture consisting of gramicidin and
tyrocidine, both components being mixtures of polypeptides. It is active
against many gram positive bacteria.
Benzocaine is a local anaesthetic of the ester type, used exclusively for surface
Preclinical safety data
List of excipients
Industrial methylated spirit
Acacia pdrd sieved
Clove leaf oil
Star anise oil
Carmine extract OF63
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
A push-through blister pack consisting of a clear PVC blister beat sealed to
aluminium foil, each carton contains 24 lozenges contained in a cardboard
Instructions for use and handling
MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
19 November 1990
DATE OF REVISION OF THE TEXT