BOOTS SORE THROAT RELIEF DUAL ACTION LOZENGES BLACKCURRANT FLAVOUR - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Boots Sore Throat Relief Dual Action Lozenges Blackcurrant Flavour

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Hexylresorcinol Ph Eur 2.4mg

For excipients, see 6.1

3 PHARMACEUTICAL FORM

Lozenge

4 CLINICAL PARTICULARS

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:

Do not exceed the stated dose.

Keep out of the reach of children.

Not to be given to children under 6 years.

This product is unsuitable in hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrose-isomaltase deficiency.

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6 Pregnancy and lactation

There is a lack of evidence of safety of the product in human pregnancy. But hexylresorcinol has been used widely 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

No adverse effects known

4.8 Undesirable effects

None known

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 http://www.mhra.gov.uk/yellowcard

4.9 Overdose

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

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Hexylresorcinol is a local anaesthetic for topical use on the mucous membranes of the mouth and throat. Mild antiseptic activity has also been demonstrated.

The product base has a demulcent action.

5.2 Pharmacokinetic properties

Pharmacokinetic considerations do not arise since the pharmacological action is local to the oropharyngeal cavity.

5.3 Preclinical safety data

There are no pre-clinical data available specific to the product.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Liquid sucrose

Liquid glucose

Blackcurrant flavour

Levomenthol

Carmoisine edicol (E122)

Patent blue V (E131)

6.2 Incompatibilities

Not applicable

6.3 Shelf life

24 months

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

Blister packs of 250 micron PVC coated 40gsm PVdC with 20 micron hard temper aluminium foil, heat sealed to the PVC/PVdC blister

Pack sizes: 16, 24, 36 lozenges

6.6 Special precautions for disposal

None specific to the product/ pack

7 MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West

Nottingham

NG2 3AA

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 00014/0649

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

22/09/2004 / 23/02/2011