Boots Sore Throat Relief Dual Action Lozenges Honey and Lemon Flavour

1. Name Of The Medicinal Product

Mac Dual Action Honey Lemon Sore Throat Lozenges

Mac Dual Action Honey Lemon Flavour

Superdrug Honey & Lemon Sore Throat Dual Action Lozenges

Safeway Medicated Lozenges Honey & Lemon Flavour

Safeway Dual Action Lozenges Honey & Lemon Flavour

Benylin Sore Throat Honey & Lemon Lozenges.

Morrisons Dual Action Antiseptic Lozenges Honey & Lemon

Boots Sore Throat Relief Dual Action Lozenges Honey and Lemon Flavour

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 Pregnancy And Lactation

The product is not contraindicated in pregnancy or lactation. However, as with all medicines during this period, caution should be exercised.

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.

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

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 20μm 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, 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 And Other Handling

None

7. Marketing Authorisation Holder

Ernest Jackson & Co Ltd

High Street

Crediton,

Devon,

EX17 3AP,

UK

8. Marketing Authorisation Number(S)

00094/0036

9. Date Of First Authorisation/Renewal Of The Authorisation

29 July 1999

10. Date Of Revision Of The Text

31/03/2009