SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Tyrozets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Tyrothricin EP 1mg Benzocaine BP/EP 5mg

3    PHARMACEUTICAL FORM

Lozenges

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

As an antibiotic and local analgesic-anaesthetic. For minor mouth and throat irritations; secondary irritation following tonsillectomy and other mouth and throat surgery.

4.2    Posology and method of administration

Adults : 1 lozenge to be dissolved slowly in the mouth every three hours. Do not exceed 8 lozenges in 24 hours.

Children aged 3 years and older : dosage should be reduced in children. Maximum 6 lozenges in 24 hours. Tyrozets are not recommended for children under the age of three years.

If an adequate response is not evident within two days, consider stopping Tyrozets. Do not use for longer than five consecutive days.

To allow maximum contact with inflamed tissues, Tyrozets should not be chewed or swallowed whole, but allowed to dissolve slowly in the mouth.

4.3 Contraindications

Hypersensitivity to tyrothricin or to benzocaine. If evidence of sensitivity occurs during therapy, Tyrozets should be discontinued.

4.4 Special warnings and precautions for use

The use of antibiotics may cause over-growth of non-susceptible organisms. If new infections due to bacteria or fungi appear during therapy, Tyrozets should be stopped and appropriate measures taken.

Topical use of Tyrozets as an aid to prevention of local infection in no way alters the need for adequate systemic therapy of an infection should develop.

Tyrozets contain sucrose, which may produce dental caries and destabilise otherwise well-controlled diabetes.

Due to the local anaesthetic property of Tyrozets, it may be necessary either to avoid food when anaesthesia is at its maximum, or to rinse the mouth with water after eating, to prevent any further trauma to the mucous membranes.

4.5 Interaction with other medicinal products and other forms of interaction

There have been no reports of any interactions.

4.6 Pregnancy and lactation

No special precautions.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

Blackness or soreness of the tongue may occur, but usually disappears when therapy is stopped. Skin rashes have been reported to occur after benzocaine administration. Methaemoglobinaemia has been reported to occur rarely in infants and children after benzocaine absorption.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Tyrozets should only be sucked in the mouth. Insertion into the nasal cavity can damage the sensory epithelium with risk of prolonged loss of smell. Parenteral use may result in haemolysis, liver and kidney damage.

No antidote to either tyrothricin or benzocaine is available. Treatment of overdosage should be symptomatic and supportive; emesis should be induced or gastric lavage performed.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Tyrothricin from Bacillus brevis is a complex mixture of several polypeptides and its main action stems from the content of neutral gramicidins (20%), which neutralise the phosphorylation of the respiration chains. It is effective mainly against gram positive bacteria and cocci, against some fungi and some gram negative bacteria.

Benzocaine is a local anaesthetic of the ester type which remains localised for long periods of time to produce anaesthetic action. It is poorly absorbed in water.

Pharmacokinetic properties

Tyrozets lozenges act locally in the mouth and throat and it is expected that only small amounts are absorbed by the buccal tissues.

5.3 Preclinical safety data

No specific information.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Acacia, magnesium stearate, maize starch, sodium chloride, sucrose, anethole, erythrosine (E127), peppermint oil, ethanol (ND), purified water (ND).

6.2    Incompatibilities

None known.

6.3    Shelf life

36 months.

6.4    Special precautions for storage

Do not store above 25^oC. Protect from light.

6.5    Nature and contents of container

Vials of 12, 24 and 36 lozenges in cardboard outers.