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