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THE BOOTS COMPANY PLC
1 Thane Road West, Beeston, Nottingham, NG2 3AA Telephone: +44 (0)1159 595 165 Fax: +44 (0)1159 592 565 Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 04/05/2011

SPC	Boots Anaesthetic and Antibiotic Throat Lozenges

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Boots Anaesthetic and Antibiotic Throat Lozenges

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient
Tyrothricin USP	1.0 mg/lozenge
Benzocaine BP Fine Pdr Ph Eur	5.0 mg/lozenge

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3. PHARMACEUTICAL FORM

Tablet

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the relief of sore throats.

For oral administration.

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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.

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4.3 Contraindications

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

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4.4 Special warnings and precautions for use

Boots Anaesthetic and Antibiotic Throat Lozenges 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.

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4.5 Interaction with other medicinal products and other forms of interaction

These lozenges may interfere with the action of sulphonamides.

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4.6 Pregnancy and lactation

The safety of Boots Anaesthetic and Antibiotic Throat Lozenges 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.

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4.7 Effects on ability to drive and use machines

No adverse effects known.

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4.8 Undesirable effects

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

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4.9 Overdose

Overdosage with Boots Anaesthetic and Antibiotic Throat Lozenges 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.

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5. PHARMACOLOGICAL PROPERTIES

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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.

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5.2 Pharmacokinetic properties

Not applicable

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5.3 Preclinical safety data

Not applicable

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6. PHARMACEUTICAL PARTICULARS

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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

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6.2 Incompatibilities

Not applicable

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6.3 Shelf life

24 months

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6.4 Special precautions for storage

Do not store above 25EC.

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6.5 Nature and contents of container

A push-through blister pack consisting of a clear PVC blister heat sealed to aluminium foil, each carton contains 24 lozenges contained in a cardboard carton.

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6.6 Special precautions for disposal and other handling

Not applicable.

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7. MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

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8. MARKETING AUTHORISATION NUMBER(S)

PL 0014/5172R

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