Superdrug Extra Strength Throat Lozenges
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Halls Max Strength Sore Throat Relief Original Lozenges Throaties Max Strength Sore Throat Relief Original Lozenges Superdrug Extra Strength Throat Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hexylresorcinol 2.5mg and Benzalkonium Chloride Solution 1.2mg
3 PHARMACEUTICAL FORM
Lozenge
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic relief of sore throat, the associated pain and pharyngitis.
4.2 Posology and method of administration
Adults (including the elderly) and children over the age of 12: One lozenge dissolved slowly in the mouth every three hours or as required. Do not take more than 8 lozenges in 24 hours.
Children aged 7 to 12 years: One lozenge dissolved slowly in the mouth every three hours or as required. Do not take more than 4 lozenges in 24 hours. Not to be given to children under 7 years.
4.3 Contraindications
Patients with hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Keep out of reach & sight of children. If symptoms persist, consult your doctor. Contains a total of 2.4g of sucrose and liquid glucose solid per lozenge. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
None
4.6 Pregnancy and lactation
There is a lack of evidence of safety of the product in human pregnancy and in animals, but both hexylresorcinol and benzalkonium chloride have been used widely in lozenges 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
None
4.8 Undesirable effects
Isolated cases of hypersensitivity reaction, including rash, urticaria and angioedema, have been reported. There have been isolated reports of tongue soreness.
4.9 Overdose
The oral toxic dose of benzalkonium chloride is between 1 and 3g, symptoms of overdose are unlikely with a product containing such a low level.
An overdose of hexylresorcinol may cause minor gastrointestinal irritation.
After withdrawal of the product, treatment is symptomatic.
Theoretically symptoms are possible in children if at least 50 lozenges are consumed in a short space of time. In such extreme overdose, related to menthol ingestion, symptoms may include nausea, vomiting diarrhoea, profuse sweating and intense thirst.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Hexylresorcinol is a local anaesthetic effective for topical use on the mucous membranes of the mouth and throat. Mild antiseptic activity has also been demonstrated.
Benzalkonium chloride is a quaternary ammonium compound with antiseptic activity typical of this group
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
There are no preclinical data of any relevance additional to that already included in other sections of the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose, liquid glucose, propylene glycol, eucalyptus oil and levomenthol
6.2 Incompatibilities
Benzalkonium chloride is incompatible with other anionic surfactants, citrates, iodides, nitrates, permanganates, salicylates, tartrates and alkalis. Incompatibilities have also been reported with other substances including aluminium, hydrogen peroxide, kaolin and some sulphonamides.
Hexylresorcinol is also incompatible with alkalis and oxidising agents.
6.3 Shelf life
Three years
6.4 Special precautions for storage
Do not store above 30°C
6.5 Nature and contents of container
Blister strips of PVC 250 microns/PVdC 60 gsm/Aluminium 20 microns.
Pack sizes: 8 (1x8), 10 (1x10), 12 (1x12), 16 (2x8), 20 (2x10), 24 (2x12), 30 (
3x10), 32 (4x8), 36 (3x12) 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
United Kingdom
8 MARKETING AUTHORISATION NUMBER
PL 00094/0046
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16/03/2009
10 DATE OF REVISION OF THE TEXT
12/04/2012