Summary of medicine characteristics - ERNEST JACKSON CHERRY FLAVOUR SORE THROAT RELIEF 2.4 MG LOZENGES
1 NAME OF THE MEDICINAL PRODUCT
Ernest Jackson Cherry Flavour Sore Throat Relief 2.4mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hexylresorcinol 2.4 mg per lozenge
For the 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.
Paediatric population
Not to be given to children under 6 years.
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
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 sucraseisomaltase deficiency.
E122 can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
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.
Breast-feeding
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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseHexylresorcinol 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
5.3 Preclinical safety dataNone 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 250pm PVC coated 60g/m2 PVDC with 20pm 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.