BOOTS SORE THROAT RELIEF LOZENGES ORANGE AND MENTHOL FLAVOUR
Active substance: AMYLMETACRESOL
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Boots Sore Throat Relief Lozenges Orange and Menthol Flavour
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient Amylmetacresol BP mg/lozenge 0.6 mg
3
PHARMACEUTICAL FORM
Lozenge.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications
For the short-term symptomatic relief of sore throats.
4.2
Posology and method of administration Adults and children over One throat drop to be sucked when required, 12 years: up to a maximum of 8 throat drops in 24 hours. Children 5-12 years: One throat drop to be sucked when required to a maximum of 4 throat drops in 24 hours.
Not suitable.
Children under 5 years:
For oral administration.
4.3
Contraindications
Hypersensitivity to any of the ingredients.
4.4
Special warnings and precautions for use
Keep all medicines out of the reach of children.
Do not exceed the stated dose. If symptoms persist or worsen see your doctor.
4.5
Interaction with other medicinal products and other forms of interaction
No clinically significant interactions are known.
4.6
Pregnancy and lactation
The safety of this product has not been established in pregnancy and lactation, but is not expected to constitute a hazard. As with all drugs try to avoid taking them during pregnancy or lactation.
4.7
Effects on ability to drive and use machines
No adverse effects are known.
4.8
Undesirable effects
Occasional hypersensitivity reactions and soreness of the tongue are a possibility.
4.9
Overdose Slight overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic. In cases of severe overdosage, empty the stomach by gastric lavage. Administer a saline laxative and a activated charcoal by mouth.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Amylmetacresol has antiseptic properties.
5.2
Pharmacokinetic properties
No data available.
5.3
Preclinical safety data
None stated.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients
Levomenthol (natural or synthetic) Solids from Liquid Sugar for confectionery Solids from Liquid Glucose Malic Acid Sweet Orange Oil Special IFF Annatto WSA acid stab colour Ascorbic Acid RD-26216 Sodium Ascorbate
6.2
Incompatibilities
None stated.
6.3
Shelf life
PVC/PVdC blister: 24 months Laminate wrapper/cellophane bag/carton: 36 months.
6.4
Special precautions for storage
PVC/PVdC blister: Do not store above 25C. Store in the original package. Laminate wrapper/Cellophane bag/Carton: None
6.5
Nature and contents of container a) PVC/PVdC blisters heat sealed to hard tempered 20 micron aluminium foil. Pack sizes: 16, 24 lozenges or b) Individually wrapped in laminate; 20 lozenges sealed into a cellophane bag and packed into a carton.
6.6
Special precautions for disposal None.
7
MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
8
MARKETING AUTHORISATION NUMBER(S)
PL 00014/0458
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30 March 1995 /
10
DATE OF REVISION OF THE TEXT
07/08/2008
1
NAME OF THE MEDICINAL PRODUCT
Boots Sore Throat Relief Lozenges Orange and Menthol Flavour
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient Amylmetacresol BP mg/lozenge 0.6 mg
3
PHARMACEUTICAL FORM
Lozenge.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications
For the short-term symptomatic relief of sore throats.
4.2
Posology and method of administration Adults and children over One throat drop to be sucked when required, 12 years: up to a maximum of 8 throat drops in 24 hours. Children 5-12 years: One throat drop to be sucked when required to a maximum of 4 throat drops in 24 hours.
Not suitable.
Children under 5 years:
For oral administration.
4.3
Contraindications
Hypersensitivity to any of the ingredients.
4.4
Special warnings and precautions for use
Keep all medicines out of the reach of children.
Do not exceed the stated dose. If symptoms persist or worsen see your doctor.
4.5
Interaction with other medicinal products and other forms of interaction
No clinically significant interactions are known.
4.6
Pregnancy and lactation
The safety of this product has not been established in pregnancy and lactation, but is not expected to constitute a hazard. As with all drugs try to avoid taking them during pregnancy or lactation.
4.7
Effects on ability to drive and use machines
No adverse effects are known.
4.8
Undesirable effects
Occasional hypersensitivity reactions and soreness of the tongue are a possibility.
4.9
Overdose Slight overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic. In cases of severe overdosage, empty the stomach by gastric lavage. Administer a saline laxative and a activated charcoal by mouth.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Amylmetacresol has antiseptic properties.
5.2
Pharmacokinetic properties
No data available.
5.3
Preclinical safety data
None stated.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients
Levomenthol (natural or synthetic) Solids from Liquid Sugar for confectionery Solids from Liquid Glucose Malic Acid Sweet Orange Oil Special IFF Annatto WSA acid stab colour Ascorbic Acid RD-26216 Sodium Ascorbate
6.2
Incompatibilities
None stated.
6.3
Shelf life
PVC/PVdC blister: 24 months Laminate wrapper/cellophane bag/carton: 36 months.
6.4
Special precautions for storage
PVC/PVdC blister: Do not store above 25C. Store in the original package. Laminate wrapper/Cellophane bag/Carton: None
6.5
Nature and contents of container a) PVC/PVdC blisters heat sealed to hard tempered 20 micron aluminium foil. Pack sizes: 16, 24 lozenges or b) Individually wrapped in laminate; 20 lozenges sealed into a cellophane bag and packed into a carton.
6.6
Special precautions for disposal None.
7
MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
8
MARKETING AUTHORISATION NUMBER(S)
PL 00014/0458
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30 March 1995 /
10
DATE OF REVISION OF THE TEXT
07/08/2008
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.
