Summary of Product Characteristics (SmPC) - Beechams Max strength Sore Throat Lemon and Honey Flavour lozenges
1 NAME OF THE MEDICINAL PRODUCT
Beechams Max Strength Sore Throat Lemon and Honey Flavour 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
Hypersensitivity to any of the active ingredients or excipients.
Patients with metabolic disorders relating to glucose/sucrose ingestion or fructose intolerance
4.4 Special warnings and precautions for use
Keep out of the reach and sight of children
If symptoms persist consult your doctor.
Do not exceed the stated dose
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Contains 2.5 g of total glucose and sucrose per lozenge. This should be taken into account in patients with diabetes mellitus.
4.5 Interaction with other medicinal products and other forms of interaction
None
4.6 Fertility, 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
Gastrointestinal Disorders: Local irritations or inflammations in the mouth and throat.
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
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, levomenthol, propylene glycol, honey flavour, lemon flavour, caramel, beta-carotene and liquid glucose.
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
Two years
6.4 Special precautions for storage
Do not store above 25oC.
6.5 Nature and contents of container
Blisters (PVC 250 microns/PVdC 60 microns/Aluminium 20 microns) Pack sizes 10, 12, 20.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Haleon UK Trading Limited
The Heights
Weybridge
Surrey
KT13 0NY
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44673/0026
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
26 April 2002
10 DATE OF REVISION OF THE TEXT
24/08/2023