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 1.0 mg/lozenge 5.0 mg/lozenge
3.
PHARMACEUTICAL FORM Tablet
4. 4.1.
CLINICAL PARTICULARS 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. 5.1.
PHARMACOLOGICAL PROPERTIES 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
6.1
PHARMACEUTICAL PARTICULARS
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 25C.
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
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 1.0 mg/lozenge 5.0 mg/lozenge
3.
PHARMACEUTICAL FORM Tablet
4. 4.1.
CLINICAL PARTICULARS 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. 5.1.
PHARMACOLOGICAL PROPERTIES 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
6.1
PHARMACEUTICAL PARTICULARS
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 25C.
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
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
