Terbisil

The treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch/jock itch)

Fungal infections of the skin caused by dermatophytes such as species of Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.

Infections of the skin caused by Candida (e.g. Candida albicans).

Pityriasis (tinea) versicolor caused by Pityrosporum orbiculare (Malassezia furfur).

Posology

Adults and adolescents (>12 years of age)

Duration and frequency of treatment:

Terbisil can be applied once or twice daily.

The likely duration of each treatment is as follows:

Tinea pedis: 1 week.

Tinea cruris and Tinea corporis: 1 to 2 weeks.

Cutaneous candida: 2 weeks.

Pityriasis versicolor: 2 weeks.

Relief of symptoms is usually obtained within a few days.

Irregular use or an inadequate treatment period increases the risk of the symptoms returning. If no improvement is obtained after 2 weeks, the diagnosis should be re-evaluated.

Elderly

There has been nothing to indicate that elderly patients require a different dosage or have a side effects profile different from younger patients.

Paediatric population

Terbisil 1 % Cream is not recommended for children below 12 years of age due to insufficient data on safety. The experience in children is limited.

Method of administration

For cutaneous use.

The skin should be clean and dry. The cream should be applied in a thin layer on and around the affected skin and rubbed in gently. In cases of reddened and weeping infection (under the breasts, between the fingers, buttocks or in the groin) the skin may be covered with a sterile compress after application of the cream, especially at night.

Tapentadol

Terbisil 1 % Cream cream is for external use only.

Terbisil 1 % Cream cream may be irritating to the eyes. Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse eyes thoroughly with running water.

Terbisil cream should be kept out of the reach of children.

In the event of allergic reaction, the cream should be removed and the treatment interrupted.

Candidiasis: It is not recommended to use acid pH soap. (This provides favourable growth conditions for Candida spp.

Excipients

The cream contains cetyl alcohol and cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

Terbisil 1 % Cream cream 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, 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 Terbisil 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 the 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), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

* Based on post-marketing experience

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

Symptoms

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

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

Treatment

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 D01A E15)

Terbisil is an allylamine that has a broad spectrum of antimycotic activity. It has an antimycotic effect on fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epdermophyton floccosum. At low concentrations Terbisil has a fungicidal effect against dermatophytes and moulds. Its activity against yeasts is fungicidal (e.g. Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.

Terbisil 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. Terbisil acts by inhibition of squalene epoxidase in the fungal cell membrane.

The enzyme squalene epoxidase is not linked to the cytochrome P-450 system. Terbisil 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 low.

Not applicable.

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain

Adverse reactions possible when combined with:

• Benzodiazepines

• CNS depressants

• Antidepressants

• MAO inhibitors

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain