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McNeil Healthcare (Ireland) Ltd

Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 5316


Summary of Product Characteristics last updated on medicines.ie: 22/05/2009
SPC Tyrozets



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1. NAME OF THE MEDICINAL PRODUCT

TYROZETS


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Tyrothricin 1mg

Benzocaine 5mg

Excipient: Sucrose 989.19mg

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Lozenge

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


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4. CLINICAL PARTICULARS

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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.


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4.2 Posology and method of administration

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.


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4.3 Contraindications

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


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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 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.


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4.5 Interaction with other medicinal products and other forms of interaction

There have been no reports of any interactions.


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4.6 Pregnancy and lactation

No special precautions.


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4.7 Effects on ability to drive and use machines

None known.


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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.


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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 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.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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.


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5.2 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.


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5.3 Preclinical safety data

No specific information.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Acacia spray dried

Magnesium stearate

Maize starch

Sodium chloride

Sucrose

Anethole

Erythrosine (E127)

Peppermint oil.


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

3 years.


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6.4 Special precautions for storage

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


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6.5 Nature and contents of container

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.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

McNeil healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland


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8. MARKETING AUTHORISATION NUMBER(S)

PA 823/54/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 01 April 1997

Date of last renewal: 01 April 2007


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10. DATE OF REVISION OF THE TEXT

February 2009



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Active Ingredients

 
   Benzocaine
   Tyrothricin