Terbinafine Hydrochloride 1% Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Terbinafine Hydrochloride 1% Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Terbinafine hydrochloride 1% w/w
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Dermatomycoses caused by dermatophytes such as Trichophyton (e.g. T. tubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.
Yeast infections of the skin, principally those caused by the genus Candida (e.g. C. albicans).
Pityriasis versicolor due to Malassezia furfur.
4.2 Posology and method of administration Adults and the Elderly
Terbinafine Hydrochloride 1% Cream is applied once or twice daily to the affected skin and surrounding area in a thin layer and rubbed in gently. Before application the affected skin areas should be cleansed and dried thoroughly. In the case of intertriginous infections (submammary, interdigital. intergluteal, inguinal) the application may be covered with a gauze strip, especially at night.
Duration of treatment:
Depending on the indication and severity of the fungal skin infection, the likely durations of treatment are as follows:
1 week 1 to 2 weeks
2 weeks 2 weeks
■ Tinea pedis:
■ Tinea corporis & cruris:
■ Cutaneous candidosis:
■ Pityriasis versicolor:
Relief of 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 terbinafine in children is still limited and its use in children under 16 years cannot therefore be recommended.
Method of administration
Topical administration
4.3
4.4
Contraindications
Hypersensitivity to terbinafine or any of the excipients in the cream.
Special warnings and precautions for use
This product is for external use only. Contact with the eyes should be avoided.
This product contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis)
Interaction with other medicinal products and other forms of interaction
There are no known drug interactions with terbinafine cream 1%.
Pregnancy and lactation
4.6
Foetal toxicity and fertility studies suggest no adverse effects.
There is no clinical experience with Terbinafine Hydrochloride 1% Cream in pregnant women, therefore, unless the potential benefits outweigh any potential risks, Terbinafine Hydrochloride 1% Cream should not be administered during pregnancy.
Terbinafine is excreted in breast milk and therefore breast-feeding mothers should not use Terbinafine Hydrochloride 1% Cream.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Occasionally, redness, itching or stinging occur at the site of application: However, treatment rarely has to be discontinued for this reason. This must be distinguished from allergic reactions, which occur rarely but require discontinuation.
4.9 Overdose
No adverse events in relation to ingestion of terbinafine 1% cream has been reported to date. However, if accidental ingestion occurs, gastric emptying may be needed if considered appropriate. Adverse reactions similar to those possible after oral administration of terbinafine tablets (e.g. headache, nausea, dizziness and upper gastrointestinal complaints) may occur following accidental ingestion of the cream.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group (ATC code)
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 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 drug substances.
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
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium hydroxide Benzyl alcohol Sorbitan stearate Cetyl palmitate Cetyl alcohol Stearyl alcohol Polysorbate 60 Isopropyl myristrate Purified water
6.2 Incompatibilities
None known.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
Aluminium tube with tamper-evident membrane seal, internal lacquer coating and HDPE screw cap containing 7.5 g, 15 g or 30 g of cream.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas,
PC. 1060 Nicosia.
Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 28444/0040
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22/08/2006
10
DATE OF REVISION OF THE TEXT
05/07/2012