Summary of Product Characteristics (SmPC) - Boots Triple Action Sore Throat Relief Cherry Flavour 2.4 mg lozenges.
1. NAME OF THE MEDICINAL PRODUCT
Boots Triple Action Sore Throat Relief Cherry Flavour 2.4 mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hexylresorcinol 2.4 mg per lozenge
Excipients with known effect:
sucrose/glucose 2.4g
Carmoisine E122
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Lozenge.
Clear, red 3/4" diameter, round, biconvex, brittle lozenge with a glossy surface.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
As an antiseptic, demulcent and local anaesthetic for the relief of sore throat and its associated pain.
4.2 Posology and method of administration
Posology
For adults and children aged 6 years and over:
One lozenge dissolved slowly in the mouth every 3 hours or as required. Do not take more than 12 lozenges in 24 hours.
Not to be given to children under 6 years.
For the elderly:
The normal adult dose may be taken.
Method of administration
Oral
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Labelling: If symptoms persist consult your doctor. Not to be given to children under 6 years.
Contains 2.4g sucrose and liquid glucose solids per lozenge. Unsuitable in hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency.
E122 can cause allergic-type reactions including asthma. Allergy is more common in those peolple who are allergic to aspirin.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
Pregnancy
There is no or inadequate evidence of the safety of the active ingredient in this medicine in human pregnancy. The potential risk for humans is unknown.
In the absence of sufficient data, the use during pregnancy is not recommended.
Lactation
It is not known whether the active ingredient of this product is excreted in human breast milk. In the absence of sufficient data, the use during lactation is not recommended.
Fertility
Studies of the effects on fertility have not been investigated.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Reports of hypersensitivity reaction, including rash, urticaria and angioedema, are extremely rare. There have been very rare reports of tongue soreness.
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: www.mhra.gov.uk/yellowcard
4.9 Overdose
Hexylresorcinol overdose may cause minor gastrointestinal irritation. Treatment would be withdrawal of the product and symptomatic measures as appropriate.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: R02 AA12
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 oro-pharangeal cavity.
5.3 Preclinical safety data
None available specific to the product.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Menthol
Cherry flavour 500880E
Carmoisine E122
Sucrose
Liquid Glucose
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Blister strips of 250µm PVC coated 60g/m2 PVDC with 20µm hard temper aluminium foil in a carton or laminate flowrap.
Pack sizes:
6, 8, 10,12, 16, 24, 30, 32, 36 lozenges.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Ernest Jackson & Co Ltd
High Street
Crediton
Devon
EX17 3AP,
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00094/0254
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/03/2017
10 DATE OF REVISION OF THE TEXT
07/07/2017