Lamisil Cream

1. Name Of The Medicinal Product

LAMISIL® Cream

2. Qualitative And Quantitative Composition

Terbinafine hydrochloride 1.0% w/w

3. Pharmaceutical Form

White, smooth or almost smooth glossy cream

4. Clinical Particulars

4.1 Therapeutic Indications

Fungal infections of the skin caused by Trichophyton (eg. T. Rubrum, T.Mentagrophytes, T. Verrucosum, T. Violaceum), Microsporum canis and Epidermophyton floccosum.

Yeast infections of the skin, principally those caused by the genus Candida (eg. C. albicans).

Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur).

4.2 Posology And Method Of Administration

LAMISIL can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of LAMISIL. Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night.

The likely durations of treatment are as follows:

Tinea corporis, cruris: 1 to 2 weeks

Tinea pedis: 1 week

Cutaneous candidiasis: 2 weeks

Pityriasis versicolor: 2 weeks

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.

Children

The experience with topical LAMISIL in children is still limited and its use 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

Via the topical route.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

LAMISIL 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 Cream.

4.6 Pregnancy And Lactation

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

There is no clinical experience with LAMISIL Cream in pregnant women, therefore, unless the potential benefits outweigh any potential risks, LAMISIL Cream should not be administered during pregnancy.

Terbinafine is excreted in breast milk and therefore mothers should not receive LAMISIL 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. This must be distinguished from allergic reactions such as pruritus, rash, bullous eruptions and hives which are very rare but require discontinuation.

4.9 Overdose

The low systemic absorption of topical terbinafine cream renders overdosage extremely unlikely. Accidental ingestion of the contents of one 30g tube of LAMISIL Cream, which contains 300mg terbinafine hydrochloride, is comparable to one LAMISIL 250mg tablet (adult oral unit dose).

No case of overdosage has been reported with LAMISIL Cream. However, should a larger amount of LAMISIL Cream be inadvertently ingested, adverse effects similar to those observed with an overdosage of LAMISIL tablets are to be expected. These include headache, nausea, epigastric pain and dizziness.

The recommended treatment of overdosage consists of eliminating the drug, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy, if needed.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antifungal for topical use (ATC code D01A E15)

Terbinafine is an allylamine which has a broad spectrum of antifungal activity. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. The activity versus yeasts is fungicidal or fungistatic depending of the species.

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 epoidase is not linked to the cytochrome P450 system.

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

None stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, demineralised water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Aluminium tube: 5 years.

Polypropylene dispenser tube: 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 15g or 30g LAMISIL Cream.

Polypropylene dispenser tube with polypropylene screw-cap closure containing 15 or 30g LAMISIL cream

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH 12 5AB

United Kingdom

8. Marketing Authorisation Number(S)

PL 00030/0421

9. Date Of First Authorisation/Renewal Of The Authorisation

3 October 1990 / 18 April 2001

10. Date Of Revision Of The Text

27^th April 2009

Legal category: POM