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Athlete Foot Cream 1%

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Athlete Foot Cream 1%

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

10mg terbinafine hydrochloride (equivalent to 8.89mg terbinafine) in 1g cream.

Excipient: 80mg cetyl alcohol and cetostearyl alcohol in 1g cream.

For a 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‚Äôs 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

Athlete Foot Cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of Athlete Foot 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.

Children

The experience with topical Terbisil in children aged 16 and under 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

Known hypersensitivity to the active substance or any of the excipients.

4.4. Special warnings and precautions for use

Athlete Foot Cream is for external use only. Contact with the eyes should be avoided. If it gets into the eyes accidentally, the eyes should be washed with plenty of water and the patient should turn to an ophthalmologist if necessary. The cream contains cetyl alcohol and cetostearyl alcohol which may cause local reactions (i.e. contact dematitis).

The product should be kept out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

There are no known drug interactions with Athlete Foot Cream.

4.6. Pregnancy and lactation

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

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

Athlete Foot Cream is excreted in breast milk and therefore mothers should not receive Athlete Foot Cream whilst breast-feeding. In addition, infants must not be allowed to come into contact with any treated skin, including the breast.

4.7 Effects on ability to drive and use machines

There are no data available that Athlete Foot Cream would affect driving ability or any other activity requiring concentration.

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 incl. 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.

The frequencies of adverse events are ranked according to the following: 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.

In the Therapeutic equivalence study with Terbisil 1% cream and Lamisil 1% cream (EQUATE) a total of 733 patients were exposed to either Terbisil (n=366) or Lamisil (n=367) during the 1 week of the treatment period, where 10.1% of the patients (74 patients) experienced at least one adverse event. A total number of adverse events related to the study medications was 20 events during the study.

Immune system disorders Not known: Hypersensitivity*

Eye disorders Rare: Eye irritation

Skin and subcutaneous tissue disorders Common: Skin exfoliation, pruritus, erythema

Uncommon: Skin lesion, scab, skin disorder, pigmentation disorder, 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 *Based on post-marketing experience

4.9 Overdose

Athlete Foot Cream is for external use only. If accidental ingestion of the cream occurs, appropriate method of gastric lavage can be used.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Antifungals for topical use ATC code: D01A E15

Athlete Foot Cream is an antimycotic with a broad-spectrum of anti-fungal activity belonging to the allylamine group. At low concentrations Athlete Foot

Cream 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.

Athlete Foot Cream 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.

Athlete Foot Cream 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

(pg/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    PHARMACEUTICAL PARTICULARS

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 7.5g and 15g cream.

6.6    Special precautions for disposal

No special instructions.

7    MARKETING AUTHORISATION HOLDER

ratiopharm GmbH, Graf-Arco-Str.3, 89079 Ulm, Germany

8    MARKETING AUTHORISATION NUMBER(S)

PL 15773/0647

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

04/09/2007

10 DATE OF REVISION OF THE TEXT

09/04/2013