Lypsyl Cold Sore Gel

1. Name Of The Medicinal Product

Lypsyl ® Cold Sore Gel

2. Qualitative And Quantitative Composition

Lidocaine hydrochloride 2.0% w/w

Zinc sulphate 1.0% w/w

Cetrimide 0.5% w/w

For excipients see 6.1

3. Pharmaceutical Form

Gel

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of cold sores.

Route of administration:

Topical.

4.2 Posology And Method Of Administration

Adults and children over 12 years: Apply a small amount to the affected area with your fingertips 3-4 times daily.

Children under 12 years: Not recommended.

4.3 Contraindications

Patients with a known hypersensitivity to lidocaine hydrochloride, zinc sulphate or cetrimide should not use the product.

Contact with the eyes should be avoided.

Not recommended for children under 12 years.

4.4 Special Warnings And Precautions For Use

For external use only.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No known interactions with other drugs.

4.6 Pregnancy And Lactation

None known.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Skin irritation and occasional sensitisation may occur.

4.9 Overdose

None stated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Lidocaine hydrochloride is a local anaesthetic of the amide type which is widely used for local application to mucous membranes. It produces surface anaesthesia by diminishing or preventing the conduction of sensory nerve impulses.

Cetrimide is a quaternary ammonium disinfectant. As well as having emulsifying and detergent properties, it is active against gram-positive and some gram-negative organisms.

Zinc sulphate has astringent properties.

5.2 Pharmacokinetic Properties

Lidocaine hydrochloride is effectively absorbed from mucous membranes.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Hydroxyethylmethylcellulose 3000

Polysorbate 20

Nonoxynol 9

Propylene glycol

Menthol

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 30°C.

6.5 Nature And Contents Of Container

Laminated tube consisting of aluminium foil coated internally and externally with low density polyethylene or high density polyethylene.

Pack size: 3g

6.6 Special Precautions For Disposal And Other Handling

Medicines should be kept out of the reach of children.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0120

9. Date Of First Authorisation/Renewal Of The Authorisation

23 January 1991.

10. Date Of Revision Of The Text

29 January 2003

Legal category: GSL