4.1. Therapeutic indications

As an antiseptic and local anaesthetic for the relief of sore throat and its associated pain

4.2. Posology and method of administration

For oral administration.

Adults, the elderly and children 6 years and over: One lozenge dissolved slowly in the mouth every three hours or as required.

Do not take more than 12 lozenges in 24 hours.

Not to be given to children under 6 years.

4.3. Contraindications

Hypersensitivity to any of the ingredients

4.4. Special warnings and precautions for use

The label will convey:

Keep out of the reach and sight of children.

If symptoms persist consult your doctor.

Not to be given to children under 6 years.

Important information about some of the ingredients of this medicine:

• This medicine contains only very low levels of gluten (from wheat starch). It is regarded as 'gluten-free' and is very unlikely to cause problems if you have coeliac disease. One lozenge contains no more than 22.46 micrograms of gluten. If you have wheat allergy (different from coeliac disease) you should not take this medicine.

• This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.

• This medicine contains 5.37 mg propylene glycol in each lozenge.

• This medicine contains Benzyl benzoate (present as part of cherry flavour) which may cause local irritation.

• This medicine contains fragrance with Citronellol and Geraniol. Citronellol and Geraniol may cause allergic reactions.

• This medicine contains Carmoisine (E122) which may cause allergic reactions.

• Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

• This medicine contains Sulphites – Sulphur Dioxide present in liquid glucose which may rarely cause severe hypersensitivity reactions and bronchospasm.

4.5. Interaction with other medicinal products and other forms of interaction

None known

4.6. Pregnancy and lactation

There is lack of evidence of safety of the product in human pregnancy and in animals, but hexylresorcinol has 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 known

4.8. Undesirable effects

System Organ Class

Frequency

Adverse Events

Immune System Disorders

Not known

Hypersensitivity1

1 Hypersensitivity reactions may include rash, urticaria and angioedema, which may include swelling of the face, neck, throat or tongue that could affect breathing.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Hexylresorcinol overdosage may cause minor gastrointestinal irritation. Treatment would be withdrawal of the product and symptomatic measures as appropriate.