Fungster 10mg/G Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
FUNGSTER 10mg/g cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 10mg terbinafine hydrochloride (equivalent to 8.89mg terbinafine).
Excipients: Each gram of cream contains 80mg cetyl alcohol and cetostearyl alcohol.
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
FUNGSTER is indicated for treatment of the following superficial fungal infections of the skin:
- Dermatophyte infections: Tinea pedis, Tinea cruris and Tinea corporis
(see section 5.1).
- Cutaneous candidiasis
- Pityriasis versicolor.
Dermatophyte infections such as Tinea capitis and Tinea unguium are not susceptible of being treated with topical products (see section 4.4).
4.2 Posology and method of administration
FUNGSTER cream can be applied one or twice daily. Cleanse and dry the affected areas thoroughly before application of FUNGSTER cream. Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night.
The likely durations of treatment are as follows:
Tinea corporis, Tinea cruris: 1 week Tinea pedis : 1 week Cutaneous candidiasis: 1 to 2 weeks Pityriasis versicolor: 2 weeks
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
FUNGSTER is not recommended for use in children below 18 years old due to insufficient data on safety and efficacy.
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
Hypersensitivity to the active substance (terbinafine) or any of the excipients.
4.4 Special warnings and precautions for use
FUNGSTER is not recommended to treat hyperkeratotic chronic plantar Tinea pedis (moccasin type).
FUNGSTER 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 dermatitis).
In the event of allergic reactions, the cream should be removed and the treatment interrupted.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
The co-administration of other products intended to treat the same areas is not recommended.
4.6 Fertility, pregnancy and lactation
Foetal toxicity and fertility studies in animals suggest no adverse effects (see section 5.3).
There is no clinical experience with FUNGSTER cream in pregnant women therefore, unless the potential benefits outweigh any potential risks, FUNGSTER cream should not be administered during pregnancy.
Terbinafine is excreted in breast milk and therefore mothers should not receive FUNGSTER cream whilst breast-feeding.
4.7 Effects on ability to drive and use machines
FUNGSTER has no influence on the ability to drive and use machines.
4.8 Undesirable effects
In the Therapeutic equivalence study with Fungster 1% cream and Lamisil 1% cream (EQUATE) a total of 733 patients were exposed to either Fungster (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.
The frequencies of undesirable effects are listed 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 (frequency cannot be estimated from the available data)
|
Primary System |
MedRA |
Adverse reaction |
Frequency |
|
Organ Class |
Frequency | ||
|
Very common |
Application site irritation |
15.6% | |
|
Application site pruritus |
3.6% | ||
|
General |
Common |
Application site warmth |
2.4% |
|
disorders and |
Application site pain |
1.2% | |
|
administration |
Application site erythema |
1.2% | |
|
site conditions |
Pain* | ||
|
Not known |
Application site hypersensitivity* |
* These adverse reactions did not occur during the study « Equate ».
Erythema, pruritus, warmth, pain or irritation (stinging, burning sensation) occasionally occur at the site of application. Treatment generally does not have to be discontinued for this reason. These symptoms must be distinguished from application site hypersensitivity reactions, which are rare but require discontinuation of therapy.
4.9 Overdose
Overdose is unlikely considering the nature of the formulation. In case of accidental ingestion, adverse effects similar to those observed with an overdose of terbinafine tablets (e.g. headache, nausea, epigastric pain and dizziness) are to be expected. In this case, appropriate method of gastric lavage can be used.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other antifungals for topical use ATC code: D01A E15.
Terbinafine is an allylamine that 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.
Terbinafine 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 canis and Epidermophytonfloccosum. At low concentrations terbinafine is fungicidal against dermatophytes and moulds. The activity against yeasts is fungicidal (e.g. Candida species, Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.
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
In long-term studies (up to 1 year) in rats and dogs no marked toxic effects were seen in either species up to oral doses of about 100 mg/kg a day. At high oral doses, the liver and possibly also the kidneys were identified as potential target organs.
In a two-year oral carcinogenicity study in mice, no neoplastic or other abnormal findings attributable to treatment were made up to doses of 130 (males) and 156 (females) mg/kg a day. In a two-year oral carcinogenicity study in rats at the highest dose level, 69 mg/kg a day, an increased incidence of liver tumours was observed in males. The changes, which may be associated with peroxisome proliferation, have been shown to be species-specific since they were not seen in the carcinogenicity study in mice or in other studies in mice, dogs or monkeys.
During the studies of high dose oral terbinafine in monkeys, refractile irregularities were observed in the retina at the higher doses (non-toxic effect level was 50 mg/kg). These irregularities were associated with the presence of a terbinafine metabolite in ocular tissue and disappeared after drug discontinuation. They were no associated histological changes.
A standard battery of in vitro and in vivo genotoxicity tests revealed no evidence of a mutagenic or clastogenic potential for the drug.
No adverse effects on fertility or other reproduction parameters were observed in studies in rats or rabbits.
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
Not applicable.
6.3 Shelf life
4 years
Shelf life after opening: 1 month
6.4 Special precautions for storage
This medicinal product does not require any special temperature storage conditions.
Store in the original package.
6.5 Nature and contents of container
Aluminium tube closed by polyethylene screw cap. The tubes are containing
7.5 g, 15 g or 30 g cream. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
PIERRE FABRE DERMATOLOGIE
45, PLACE ABEL GANCE
92100 BOULOGNE
BOULOGNE
92100
FRANCE
8 MARKETING AUTHORISATION NUMBER(S)
PL 20693/0008
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16/04/2007
10 DATE OF REVISION OF THE TEXT
25/11/2011