Medication Guide App

BOOTS ANAESTHETIC & ANTIBIOTIC THROAT LOZENGES

Active substance: TYROTHRICIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Anaesthetic & Antibiotic Throat Lozenges

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Tyrothricin USP
Benzocaine BP Fine Pdr Ph Eur

3.

1.0 mg/lozenge
5.0 mg/lozenge

PHARMACEUTICAL FORM
Tablet

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
For the relief of sore throats.
For oral administration.

4.2.

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.

4.3.

Contra-indications

Hypersensitivity to ester type local anaesthetics or the antibiotic tyrothricin, or
any of the other ingredients.

4.4

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
anticholinesterases.

If symptoms persist consult your doctor.

Warning: do no exceed the stated dose.

Keep all medicines out of the reach of children.

4.5.

Interactions with other medicinal products and other forms of interaction
These lozenges may interfere with the action of sulphonamides.

4.6

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.

4.7.

Effects on ability to drive and use machines
No adverse effects known.

4.8.

Undesirable effects

Occasional hypersensitivity reaction and soreness of the tongue.
Methaemoglobinaemia can rarely occur.

4.9

Overdose

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.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
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
anaesthesia.

5.2.

Pharmacokinetic properties
Not applicable

5.3.

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium Chloride
Icing Sugar
Industrial methylated spirit
Acacia pdrd sieved
Purified water

Clove leaf oil
Star anise oil
Isopropyl alcohol
Magnesium stearate
Carmine extract OF63
6.2.

Incompatibilities
Not applicable

6.3.

Shelf life
24 months

6.4.

Special precautions for storage
Do not store above 25°C.

6.5.

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
carton.

6.6.

Instructions for use and handling
Not applicable.

7.

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA

8.

MARKETING AUTHORISATION NUMBER
PL 0014/5172R

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19 November 1990

10

DATE OF REVISION OF THE TEXT
21/02/2011

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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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