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

Adults

Xeerun 1% Spray is applied once daily, for one week.

Duration and frequency of treatment:

Interdigital type tinea pedis, and tinea cruris: Once a day for one 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, a physician should be consulted.

Dosing in special populations:

Pediatric population Not to be used in children under 16 years of age. Experience with Xeerun 1% Spray in children is limited and its use cannot, therefore, be recommended.

Elderly patients

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

Method of Administration

For cutaneous use.

Cleanse and dry the affected areas thoroughly before applying Xeerun 1% Spray from a distance of 5 to 10 cm. A sufficient amount of spray solution should be applied to wet the treatment area(s) thoroughly, and to cover the affected skin and surrounding area.

Xeerun 1% Spray should be used with caution in patients with lesions where alcohol could be irritating.

Xeerun 1% Spray is for external use only. It may be irritating to the eyes. Xeerun 1% Spray should not be used on the face.

In case of accidental contact with the eyes, rinse eyes thoroughly with running water. Avoid inhalation. In case of accidental inhalation, consult a physician if any symptoms develop or persist.

Xeerun 1% Spray contains propylene glycol, which may cause skin irritation.

No drug interactions are known with Xeerun 1% Spray, however as a precaution it is recommended that other medicinal products are not applied on the treated areas.

Pregnancy

Animal studies did not reveal any teratogenic or embryofoetotoxic potential of terbinafine. No cases of malformations in humans have been reported with Xeerun to date. There is limited clinical experience in pregnant women. Foetal toxicity studies in animals suggest no adverse effects (see section 5.3).

Xeerun 1% Spray should not be used during pregnancy unless clearly necessary.

Lactation:

Terbinafine is excreted in breast milk. Therefore, mothers should not receive Xeerun 1% Spray whilst breast-feeding. 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).

Xeerun 1% Spray has no influence on the ability to drive and use machines.

Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema and scab may occur at the site of application.

These minor symptoms must be distinguished from hypersensitivity reactions such as widespread pruritus, rash, bullous eruptions and hives, which are reported in sporadic cases and require discontinuation.

In case of accidental contact with the eyes terbinafine hydrochloride 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 (cannot 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

Not known: Rash

General disorders and administration site conditions

Uncommon: Pain, application site pain, application site irritation

Rare: Condition aggravated

The low systemic absorption of topical terbinafine renders overdosage extremely unlikely. Accidental ingestion of the contents of one 30 ml bottle of Xeerun 1% Spray, solution, which contains 300 mg terbinafine hydrochloride, is comparable to ingestion of one Xeerun 250 mg tablet (adult oral unit dose).

Should a larger amount of Xeerun 1% Spray be inadvertently ingested, adverse effects similar to those observed with an overdosage of Xeerun tablets are to be expected. These include headache, nausea, epigastric pain and dizziness.

In case of accidental oral ingestion, the alcohol content has to be considered. Xeerun 1% Spray contains 23.5%w/w alcohol.

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.

Pharmacotherapeutic group: Antifungal for topical use (ATC code D01AE15) Terbinafine is an allylamine which has a broad spectrum of antifungal activity in fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canisand Epidermophyton floccosum. At low concentrations terbinafine is fungicidal against dermatophytes and moulds. The activity against yeasts is fungicidal (e.g. Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on 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 epoxidase is not linked to the cytochrome P450 system. Terbinafine does not influence the metabolism of hormones or other drugs.

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

Not applicable.

Polyoxyl 40 Hydrogenated castor oil.

Ethanol.

Propylene glycol.

Highly Purified water.

Not applicable

Do not store above 30 o C, Do not freeze or store in the fridge.

30 ml of Xeerun will be marketed in 50 ml aluminum can crimped by a valve on which a flexible multilayer laminated bag with topical actuator.

Do not store above 30°C. Do not refrigerate.