Lamisil AT 1% Cream

1. Name Of The Medicinal Product

Lamisil AT ® 1% Cream

2. Qualitative And Quantitative Composition

Terbinafine hydrochloride 1% w/w

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch/jock itch) caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

4.2 Posology And Method Of Administration

Adults

Lamisil AT 1% Cream is applied once daily.

The affected area should be cleaned and dried thoroughly before application of Lamisil AT 1% Cream. The cream should be applied to the affected skin and surrounding area in a thin layer and rubbed in lightly. In the case of intertriginous infections (interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night.

Duration of treatment is one week for tinea pedis and tinea cruris. Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified by a physician.

Children

The experience with topical Lamisil AT 1% Cream in children is still limited and its use in children under 16 years cannot therefore be recommended.

Use in the elderly

There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.

Method of administration

Topical administration.

4.3 Contraindications

Hypersensitivity to terbinafine or any of the excipients contained in the cream.

4.4 Special Warnings And Precautions For Use

Lamisil AT 1% cream is for external use only. Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known drug interactions with Lamisil AT 1% Cream.

4.6 Pregnancy And Lactation

Foetal toxicity and fertility studies in animals suggest no adverse effects.

There is no clinical experience with Lamisil AT 1% Cream in pregnant women. Therefore, unless the potential benefits outweigh any potential risks, Lamisil AT 1% Cream should not be administered during pregnancy.

Terbinafine is excreted in breast milk, and therefore mothers should not receive Lamisil AT 1% Cream whilst breast-feeding. Infants should also not be allowed to come into contact with any treated skin, including the breast.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Redness, itching or stinging occasionally occur at the site of application; however, treatment rarely has to be discontinued for this reason. These harmless symptons must be distinguished from allergic reactions such as pruritus, rash, bullous eruptions and hives, which are rare but require discontinuation.

4.9 Overdose

No adverse events in relation to ingestion of Lamisil AT 1% Cream have been reported to the company. However, if accidental ingestion of Lamisil AT 1% Cream occurs, an appropriate method of gastric emptying may be used if considered appropriate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Terbinafine is an allylamine that has a broad spectrum of antifungal activity. At low concentrations Terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi.

Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane.

The enzyme squalene epoxidase is not linked to the cytochrome P-450 system. Terbinafine does not influence the metabolism of hormones or other drugs.

Terbinafine provides long-lasting protection. More than 90% of patients with interdigital tinea pedis (athlete's foot) treated with Terbinafine 1 % cream for one week show no mycological evidence of relapse or re-infection by three months after start of treatment. No such data on tinea cruris are available.

5.2 Pharmacokinetic Properties

Less than 5% of the dose is absorbed after topical application to humans: systemic exposure is therefore very slight.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium hydroxide

benzyl alcohol

sorbitan stearate

cetyl palmitate

cetyl alcohol

stearyl alcohol

polysorbate 60

isopropyl myristate

purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Aluminium tube: 5 years

Polypropylene dispenser: 3 years

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Aluminium tube with membrane, with an interior coating of phenol-epoxy based lacquer, closed with a polypropylene cap, containing 7 g, 7.5 g, 10 g, or 15 g Lamisil AT 1% Cream.

Polypropylene dispenser tube with polypropylene screw-cap closure containing 7 g, 7.5 g, 10 g, or 15 g LAMISIL AT.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd, trading as Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

8. Marketing Authorisation Number(S)

PL 00030/0144

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 18 August 2000

Date of last renewal: 10 February 2009.

10. Date Of Revision Of The Text

27 April 2009.

Legal Category GSL