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BOOTS SORE THROAT RELIEF DUAL ACTION LOZENGES BLACKCURRANT FLAVOUR

Active substance(s): HEXYLRESORCINOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Sore Throat Relief Dual Action Lozenges Blackcurrant Flavour

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Hexylresorcinol Ph Eur 2.4mg
For excipients, see 6.1

3

PHARMACEUTICAL FORM
Lozenge

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
As an antiseptic and local anaesthetic for the relief of sore throat and its
associated pain.

4.2

Posology and method of administration
For oral administration
Adults, the elderly and children 6 years and over: One lozenge dissolved
slowly in the mouth every three hours or as required.
Do not take more than 12 lozenges in 24 hours.
Not to be given to children under 6 years.

4.3

Contraindications
Hypersensitivity to any of the ingredients

4.4

Special warnings and precautions for use
The label will convey:
Do not exceed the stated dose.
Keep out of the reach of children.
Not to be given to children under 6 years.
This product is unsuitable in hereditary fructose intolerance, glucose-galactose
malabsorption syndrome, or sucrose-isomaltase deficiency.

4.5

Interaction with other medicinal products and other forms of interaction

None known
4.6

Pregnancy and lactation
There is a lack of evidence of safety of the product in human pregnancy. But
hexylresorcinol has been used widely for many years without apparent ill
consequence. However, as with all medicines, caution should be exercised
during pregnancy and lactation.

4.7

Effects on ability to drive and use machines
No adverse effects known

4.8

Undesirable effects
None known
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at
http://www.mhra.gov.uk/yellowcard

4.9

Overdose
Hexylresorcinol overdosage may cause minor gastrointestinal irritation.
Treatment would be withdrawal of the product and symptomatic measures as
appropriate.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Hexylresorcinol is a local anaesthetic for topical use on the mucous
membranes of the mouth and throat. Mild antiseptic activity has also been
demonstrated.
The product base has a demulcent action.

5.2

Pharmacokinetic properties
Pharmacokinetic considerations do not arise since the pharmacological action
is local to the oropharyngeal cavity.

5.3

Preclinical safety data
There are no pre-clinical data available specific to the product.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Liquid sucrose
Liquid glucose

Blackcurrant flavour
Levomenthol
Carmoisine edicol (E122)
Patent blue V (E131)
6.2

6.3

Incompatibilities
Not applicable
Shelf life
24 months

6.4

Special precautions for storage
Do not store above 25°C

6.5

Nature and contents of container
Blister packs of 250 micron PVC coated 40gsm PVdC with 20 micron hard
temper aluminium foil, heat sealed to the PVC/PVdC blister
Pack sizes: 16, 24, 36 lozenges

6.6

Special precautions for disposal
None specific to the product/ pack

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0649

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/09/2004

10

/

23/02/2011

DATE OF REVISION OF THE TEXT
18/08/2016

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