Summary of Product Characteristics (SmPC) - Boots Triple Action Sore Throat Relief Honey and Lemon Flavour 2.4 mg lozenges
1. NAME OF THE MEDICINAL PRODUCT
Boots Triple Action Sore Throat Relief Honey & Lemon Flavour 2.4 mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hexylresorcinol 2.4 mg per lozenge
Excipients with known effect:
sucrose/glucose 2.4g
Sunset Yellow E110
Carmoisine E122
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Lozenge
Orange-brown round lozenge
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.
For the elderly:-
The normal adult dosage 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. Do not take if you suffer from fructose intolerance or a related metabolic disorder
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 angiodema, are extremely rare. There have been isolated 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 gastro-intestinal 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
Propylene Glycol
Honey Flavour 510167E
Lemon Flavour SS40/C
Sunset Yellow E110
Green S E142
Quinoline Yellow E104
Carmoisine E122
Sucrose
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 packaging.
6.5 Nature and contents of container
Blister strips of PVC coated 40g/m2 PVDC with 20µm hard temper aluminium foil packed in a carton or overwrap. 6, 8, 10 or 12 lozenges per blister strip.
Pack sizes:
Carton (blister strips per carton): 6, 8, 10, 12, 16, 20, 24, 30, 36 lozenges
Overwrap (blister strips per overwrap): 6, 8, 10, 12 lozenges.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Ernest Jackson & Co Ltd
High Street
Crediton
Devon
EX17 3AP
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00094/0253
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/03/2017
10 DATE OF REVISION OF THE TEXT
07/07/2017