BOOTS HEXYLRESORCINOL 2.4MG THROAT LOZENGES BLACKCURRANT
Active substance(s): HEXYLRESORCINOL / HEXYLRESORCINOL / HEXYLRESORCINOL
NAME OF THE MEDICINAL PRODUCT
Boots Hexylresorcinol 2.4mg Throat Lozenges Blackcurrant
QUALITATIVE AND QUANTITATIVE COMPOSITION
mg per lozenge
For full list of excipients, see Section 6.1
A round purple lozenge
As an antiseptic and local anaesthetic for the relief of sore throat and its associated
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.
Hypersensitivity to any of the ingredients.
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.
Interaction with other medicinal products and other forms of interaction
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.
Effects on ability to drive and use machines
No adverse effects known.
Hexylresorcinol overdosage may cause minor gastrointestinal irritation. Treatment
would be withdrawal of the product and symptomatic measures as appropriate.
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
Pharmacokinetic considerations do not arise since the pharmacological action is local
to the oropharyngeal cavity.
Preclinical safety data
There are no pre-clinical data available specific to the product.
List of excipients
Carmoisine edicol (E122)
Patent blue V (E131)
Special precautions for storage
Do not store above 25oC
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.
Special precautions for disposal
None specific to the product/pack
MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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