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BOOTS SORE THROAT RELIEF LOZENGES BLACKCURRANT FLAVOUR SUGAR FREE

Active substance(s): AMYLMETACRESOL / AMYLMETACRESOL

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Sore Throat Relief Lozenges Blackcurrant Flavour Sugar Free

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient

mg/lozenge

Amylmetacresol BP

3.

0.6

PHARMACEUTICAL FORM
Lozenge

4

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
For the short-term symptomatic relief of sore throats.

4.2.

Posology and Method of Administration
For oral administration.
Adults, elderly and children over 12 years
One throat drop to be sucked when required up to a maximum of 8 throat
drops in 24 hours.
Children 5-12 years
One throat drop to be sucked when required up to a maximum of 4 throat
drops in 24 hours.
Children under 5 years
Not suitable.

4.3

Contra-Indications
Hypersensitivity to any of the ingredients.

4.4.

Special Warnings and Special 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 during pregnancy and
lactation, but is not expected to constitute a hazard. As with all drugs try to
avoid taking the product during pregnancy or lactation.

4.7.

Effects on Ability to Drive and Use Machines
No adverse effects are known.

4.8.

Undesirable Effects
Occasionally 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
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
There are no preclinical data of relevance to the prescriber which are
additional to that already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Isomalt
Levomenthol
Anthocyanin (E163)
Blackcurrant Flavour
Malic acid
Aspartame

6.2.

Incompatibilities
Not applicable.

6.3.

Shelf Life
PVC/PVdC strip: 24 months
Bag: 36 months

6.4.

Special Precautions for Storage
PVC/PVdC strip:

Do not store above 25°C

Store in the original package
Bag: None

6.5.

Nature and Content of Container
a)

PVC/PVdC blister heat sealed to hard tempered aluminium foil:
Blister packed in cardboard carton.

b)

Individually wrapped in laminate: Lozenges sealed in a cellophane bag and packed
into a carton.
Pack sizes: 6, 8, 10, 12, 16, 18, 20, 24, 30, 32, 36

6.6.

Instructions for Use, Handling and Disposal
None.

7.

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA

8.

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0603

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
26 February 1998

10

DATE OF REVISION OF THE TEXT

24/09/2010

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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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