SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Terbinafine Hydrochloride 1 % Cream Lloydspharmacy Athlete's Foot 1% w/w Cream Cuplex Athlete’s Foot 1% w/w Cream

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Excipient(s) with known effect: 10 mg terbinafine hydrochloride (equivalent to 8.89 mg terbinafine) in 1 g cream.

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Cream

White or almost white cream, with slight almond odour.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

The treatment of tinea pedis (Athlete’s foot) and tinea cruris (jock itch) caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes) and Epidermophyton floccosum.

4.2 Posology and method of administration

Posology

Terbinafine cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of Terbinafine cream. Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly.

The likely durations of treatment are as follows:

Tinea cruris: 1 to 2 weeks Tinea pedis: 1 week

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.

Paediatric population

The experience with topical Terbisil in children aged 16 and under is still limited and its use cannot therefore be recommended.

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 the active substance or to any of the excipients listed in section 6.1.

4.4    Special warnings and precautions for use

Terbinafine cream is for external use only. It may be irritating to the eyes. In case of accidental contact with the eyes, rinse eyes thoroughly with running water and contact to oculist if necessary. Terbinafine cream should be kept out of the reach of children.

The cream contains cetyl alcohol and stearyl alcohol which may cause local skin reactions (i.e. contact dematitis).

4.5    Interaction with other medicaments and other forms of interaction

No drug interactions are known with the topical forms of terbinafine.

Paediatric population

Interaction studies have only been performed in adults.

4.6    Fertility, pregnancy, and lactation

Pregnancy

There is no clinical experience with Terbinafine cream in pregnant women. Foetal toxicity and fertility studies in animals suggest no adverse effects of terbinafine (see section 5.3.

Terbinafine cream should not be used during pregnancy unless clearly necessary. Breast-feeding

Terbinafine is excreted in breast milk. Terbinafine cream should not be used during breast-feeding. In addition, infants must not be allowed to come into contact with any treated skin, including the breast.

Fertility

No effect of terbinafine on fertility have been seen in animal studies (see section 5.3).

4.7    Effects on ability to drive and use machines

Terbinafine has no influence on the ability to drive and use machines.

4.8    Undesirable effects

Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema, scab, etc. may occur at the site of application. These harmless symptoms must be distinguished from hypersensitivity reactions including rash, which are reported in sporadic cases and require discontinuation of therapy. In case of accidental contact with the eyes terbinafine may be irritating to the eyes. In rare cases the underlying fungal infection may be aggravated.

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (> 1/10); common (> 1/100 to < 1/10); uncommon (> 1/1,000 to < 1/100); rare (> 1/10,000 to < 1/1,000); very rare (< 1/10,000), or not known (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Immune system disorders

Not known    Hypersensitivity*

Eye disorders

Rare    Eye irritation

Skin and subcutaneous tissue disorders

Common    Skin exfoliation,    pruritus

Uncommon    Skin lesion, scab, skin disorder, pigmentation disorder,

erythema, skin burning sensation Rare    Dry skin, dermatitis contact, eczema

Unknown    Rash*

General disorders and administration site conditions

Uncommon Pain, application site pain, application site irritation

Rare Condition aggravated

*: Based on post-marketing experience

4.9    Overdose

The low systemic absorption of topical terbinafine renders overdosage extremely unlikely.

Accidental ingestion of one 30 g tube of terbinafine cream, which contains 300 mg terbinafine hydrochloride, is comparable to ingestion of one terbinafine 250 mg tablet (adult oral unit dose).

Should a larger amount of terbinafine cream be inadvertently ingested, adverse effects similar to those observed with an overdosage of terbinafine tablets are to be expected.

These include headache, nausea, epigastric pain and dizziness.

Treatment of overdose

If accidentally ingested, the recommended treatment of overdosage consists of eliminating the active substance, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy if needed.

5.    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Antifungals for topical use; ATC code: D01A E15

Terbinafine is an antimycotic with a broad-spectrum of anti-fungal activity belonging to the allylamine group. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. The activity against yeasts, e.g. Candida species is fungicidal or fungistatic depending on the species.

Terbinafine interferes with fungal sterol biosynthesis by the inhibition of squalene epoxidase in the fungal cell membrane, which leads to an intracellular accumulation of squalene, resulting in fungal cell death.

Terbinafine is used for the treatment of fungal infections of the skin and nails, which is caused by Trichophyton (e.g. T. rubrum, T.mentagrophytes) and Epidermophyton floccosum. The following table outlines the range of minimum inhibitory concentrations (MIC) against the dermatophytes.

Organism	MIC range (hg/ml)
Trichophyton rubrum	0.001 - 0.15
Trichophyton mentagrophytes	0.0001 - 0.05
Edidermorphyton fluccosum	0.001 - 0.05

5.2    Pharmacokinetic properties

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

5.3    Preclinical safety data

Not applicable

6.1 List of excipients

Sodium hydroxide, Benzyl alcohol, Sorbitan stearate, Cetyl palmitate, Cetyl alcohol, Cetostearyl alcohol, Polysorbate 60, Isopropyl myristate, Water purified.

6.2 Incompatibilities

None known.

6.3 Shelf life

4 years

Shelf life after opening: 1 month

6.4 Special precautions for storage

No special precautions for storage. Store in original container.

6.5 Nature and contents of container

Aluminium tube closed by polyethylene cap. The tubes are containing 7.5 g and 15 g cream.