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BOOTS HEXYLRESORCINOL 2.4MG THROAT LOZENGES BLACKCURRANT

Active substance(s): HEXYLRESORCINOL

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Boots Hexylresorcinol 2.4mg Throat Lozenges Blackcurrant

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
mg per lozenge
Hexylresorcinol

2.4

For full list of excipients, see Section 6.1

3

PHARMACEUTICAL FORM
Lozenge.
A round purple 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.
Do not give 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 all medicines out of the sight and reach of children

Not to be given to children under 6 years.
Each lozenge contains 1.1g of glucose and 1.4g of sucrose. This should be taken into
account in patients with diabetes mellitus.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose
malabsorbtion or sucrase-isomaltase insufficiency should not take this medicine.
The colour carmoisine (E122) may cause an allergic reactions.

4.5

Interaction with other medicinal products and other forms of interaction
None known

4.6

Fertility, 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

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 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.
ATC code: R02A A12

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

Incompatibilities
Not applicable.

6.3

Shelf life
24 months

6.4

Special precautions for storage
Do not store above 25oC

6.5

Nature and contents of container
Blister packs of 250 micron PVC / 40 gsm PVdC heat sealed to 20 micron hard
temper aluminium foil.
Pack size: 24 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 00014/0661

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02/12/2010

10

DATE OF REVISION OF THE TEXT
02/12/2010

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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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