McNeil Healthcare (Ireland) Ltd

TYROZETS

Tyrothricin 1mg

Benzocaine 5mg

Excipient: Sucrose 989.19mg

For a full list of excipients, see section 6.1.

Lozenge

Pink, aniseed flavoured, flat bevelled edge lozenge imprinted on both sides.

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

Adults: One 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 aged 3-11. 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.

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

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 if 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.

There have been no reports of any interactions.

No special precautions.

None known.

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.

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 of tyrothricin 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.

Pharmacotherapeutic group: Throat preparations, ATC code: R02A A.

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 soluble in water.

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

No specific information.

Acacia spray dried

Magnesium stearate

Maize starch

Sodium chloride

Sucrose

Anethole

Erythrosine (E127)

Peppermint oil.

Not applicable.

3 years.

Do not store above 25°C. Store in the original package.

Packs of 12, 24 and 36 lozenges as one, two or three plastic tubes of 12 in cardboard cartons.

Not all pack sizes may be marketed.

No special requirements.

McNeil healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/54/1

Date of first authorisation: 01 April 1997

Date of last renewal: 01 April 2007

February 2009