BOOTS SORE THROAT RELIEF LOZENGES LEMON FLAVOUR

Active substance: AMYLMETACRESOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Sore Throat Relief Lozenges Lemon Flavour

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Amylmetacresol BP

3.

mg/lozenge
0.6mg

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
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.
For oral administration.

4.3.

Contra-indications
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.

Interactions with other Medicaments 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 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
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 pre-clinical data of relevance to the prescriber which are
additional to that already included.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

6.2.

Terpeneless Lemon Oil
Star Anise Oil
Levomenthol Natural or Synthetic
Dry Matter Liquid Sugar Demineralised
or Glucose Syrup Liquid
Malic Acid
Beta Carotene
Incompatibilities
None stated.

6.3

Shelf life
PVC/PVDC Blister: 24 months
Laminate wrapper/Cellophane Bag/Carton: 18 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 card carton containing push through PVC/PVdC blisters heat-sealed to hardtempered aluminium foil.
Pack sizes: 16, 24 lozenges
or a card carton, having a cellophane inner bag containing lozenges
individually wrapped in laminate.
Pack size: 20 lozenges

6.6.

Instruction for use and handling
None stated.

7.

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

8.

MARKETING AUTHORISATION NUMBER
PL 00014/0214

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
3 November 1978 / 11 April 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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