Anbesol Adult Strength Gel

1. Name Of The Medicinal Product

Anbesol Adult Strength Gel

2. Qualitative And Quantitative Composition

Lidocaine Hydrochloride 2.0% w/w

Chlorocresol 0.1% w/w

Cetylpyridinium Chloride 0.02% w/w

3. Pharmaceutical Form

Gel for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of pain caused by recurrent mouth ulcers, denture irritation.

4.2 Posology And Method Of Administration

Adults, the elderly and children over 12 years: apply a small amount to the affected area with a clean fingertip. One application should be sufficient. Use up to four times a day.

Not for use in children under 12 years.

4.3 Contraindications

In patients with a known history of hypersensitivity or allergic type reactions to any of the constituents of the product.

4.4 Special Warnings And Precautions For Use

If symptoms persist for more than 7 days or recur frequently, consult your doctor, pharmacist or dentist.

Keep all medicines out of the reach and sight of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions required.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

There have been reports of non-specific ulceration following oral cetylpyridinium chloride therapy.

4.9 Overdose

Overdose is extremely unlikely considering the small size of the tube used for sale.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Lidocaine hydrochloride: Lidocaine is a local anaesthetic of the amide type which acts by reversible inhibition of nerve impulse generation and transmission.

Chlorocresol: Chlorocresol has a disinfectant action.

Cetylpyridinium chloride: Cetylpyridinium chloride has a disinfectant action.

5.2 Pharmacokinetic Properties

Lidocaine hydrochloride: Lidocaine is readily absorbed from mucous membranes and through damaged skin. Lidocaine undergoes first-pass metabolism in the liver and about 90% is dealkylated to form monoethylglycinexylidide and glycinexylidide. Further metabolism occurs and the metabolites are excreted in the urine with less than 10% as unchanged lidocaine.

Chlorocresol: There is no significant absorption of chlorocresol through the skin or mucous membranes.

Cetylpyridinium chloride: There is no significant absorption of cetylpyridinium chloride through the skin or mucous membranes.

5.3 Preclinical Safety Data

The active ingredients in Anbesol Adult Strength Gel have a well established safety record.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Alcohol 96%

Glycerin

Clove Oil

Sodium Saccharin

Hydroxypropyl Cellulose

Ponceau 4R (E124)

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

Membrane sealed lacquered aluminium tubes fitted with plastic caps containing 10g gel.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

UK

8. Marketing Authorisation Number(S)

PL 16853/0127

9. Date Of First Authorisation/Renewal Of The Authorisation

14 December 1998

10. Date Of Revision Of The Text

29^th July 2011