SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Superdrug Honey & Lemon Sore Throat Dual Action Lozenges

Morrisons Dual Action Antiseptic Throat Lozenges Honey & Lemon Flavour

Boots Sore Throat Relief Double Action 2.4 mg Lozenges Honey and Lemon Flavour

Tesco Dual Action Honey & Lemon Flavour 2.4mg Lozenges

Asda Dual Action Honey and Lemon Flavour 2.4 mg Throat Lozenges

Halls Sore Throat Relief Dual Action Honey & Lemon Flavour 2.4mg Lozenges

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Hexylresorcinol 2.4 mg per lozenge

3    PHARMACEUTICAL FORM

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

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.

4.3 Contraindications

Hypersensitivity to any of the ingredients

4.4 Special warnings and precautions for use

Labelling: Keep out of reach of children. 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 ingredients 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 ingredients of this product are excreted in human breast milk.

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

Fertility

Studies on 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.

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

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

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 20pm 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

None