Beechams Max Strength Sore Throat Relief Blackberry Lozenges.

Hexylresorcinol 2.5mg and Benzalkonium Chloride Solution 1.2mg

Lozenge

Symptomatic relief of sore throat, the associated pain and pharyngitis.

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.

Hypersensitivity to any of the active ingredients or excipients.

Patients with metabolic disorders relating to glucose/sucrose ingestion or fructose intolerance

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.

None

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.

None

Gastrointestinal Disorders: Local irritations or inflammations in the mouth and throat.

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.

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.

Not applicable.

There are no preclinical data of any relevance additional to that already included in other sections of the SmPC.

Citric acid monohydrate, sucrose, liquid glucose, propylene glycol, blackberry flavour, levomenthol, Ponceau Red E124, Brilliant Black E151

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.

Three years

None

Blisters (PVC 250 microns/PVdC 60 microns/Aluminium 20 microns)

Pack sizes 10, 12, 20.

Not all pack sizes may be marketed.

None

Beecham Group Plc

908 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, Middlesex, TW8 9GS, U.K.

PL 00079/0386

26 April 2002

26/01/2011