BOOTS TRIPLE ACTION SORE THROAT RELIEF HONEY AND LEMON FLAVOUR 2.4 MG LOZENGES - summary of medicine characteristics

1. NAME OF THE MEDICINAL PRODUCT

Boots Triple Action Sore Throat Relief Honey & Lemon Flavour 2.4 mg Lozenges

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Hexylresorcinol 2.4 mg per lozenge

Excipients with known effect:

sucrose/glucose 2.4g

Sunset Yellow E110

Carmoisine E122

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Lozenge

Orange-brown round lozenge

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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

4.2 Posology and method of administration

Posology

For adults and children aged 6 years and over:-

One lozenge dissolved slowly in the mouth every 3 hours or as required

Do not take more than 12 lozenges in 24 hours.

For the elderly:-

The normal adult dosage may be taken

Method of administration

Oral

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Labelling: If symptoms persist consult your doctor. Not to be given to children under 6 years. Do not take if you suffer from fructose intolerance or a related metabolic disorder

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is no or inadequate evidence of the safety of the active ingredient in this medicine in human pregnancy. The potential risk for humans is unknown.

In the absence of sufficient data, the use during pregnancy is not recommended.

Lactation

It is not known whether the active ingredient of this product is excreted in human breast milk.

In the absence of sufficient data, the use during lactation is not recommended.

Fertility

Studies of the effects on fertility have not been investigated.

4.7 Effects on ability to drive and use machines None known.

4.8 Undesirable effects

Reports of hypersensitivity reaction, including rash, urticaria and angiodema, are extremely rare. There have been isolated reports of tongue soreness.

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

Hexylresorcinol overdose may cause minor gastro-intestinal irritation. Treatment would be withdrawal of the product and symptomatic measures as appropriate.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: R02 AA12

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 oro-pharangeal cavity.

5.3 Preclinical safety data

None available specific to the product.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Menthol

Propylene Glycol

Honey Flavour 510167E

Lemon Flavour SS40/C

Sunset Yellow E110

Green S E142

Quinoline Yellow E104

Carmoisine E122

Sucrose

Glucose

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C. Store in the original packaging.

6.5 Nature and contents of container

Blister strips of PVC coated 40g/m2 PVDC with 20^m hard temper aluminium foil packed in a carton or overwrap. 6, 8, 10 or 12 lozenges per blister strip.

Pack sizes:

Carton (blister strips per carton): 6, 8, 10, 12, 16, 20, 24, 30, 36 lozenges

Overwrap (blister strips per overwrap): 6, 8, 10, 12 lozenges.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Ernest Jackson & Co Ltd

High Street

Crediton

Devon

EX17 3AP

UK