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BOOTS SORE THROAT RELIEF LOZENGES ORANGE AND MENTHOL FLAVOUR

Active substance: AMYLMETACRESOL

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Transcript
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

3

mg/lozenge
0.6 mg

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.

Children under 5 years:

Not suitable.

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

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Amylmetacresol has antiseptic properties.

5.2

Pharmacokinetic properties
No data available.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

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 25°C. 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

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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