Summary of medicine characteristics - SCHOLL ADVANCE ATHLETES FOOT CREAM
1 NAME OF THE MEDICINAL PRODUCT
Scholl Advance Athlete’s Foot Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 10mg/ 1% w/w of terbinafine hydrochloride
Excipients with known effect
Benzyl alcohol 1 %w/w
Stearyl alcohol 4 %w/w
Cetyl alcohol 4 %w/w
For a full list of excipients, see 6.1
3 PHARMACEUTICAL FORM
Cream
White homogenous cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The treatment of tinea pedis (athlete's foot) caused by Trichophyton (e.g. T.rubrum, T.mentagrophytes, T.verrucosum, T.violaceum) and
Epidermophyton floccosum.
4.2 Posology and method of administrationMethod of administration
Cutaneous use
Scholl Advance Athlete’s Foot 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 (interdigital) the application may be covered with a gauze strip, especially at night.
Duration of treatment is one week for tinea pedis. 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 by a physician.
Scholl Advance Athlete’s Foot Cream is not recommended for use in children below 16 years due to insufficient data on safety and efficacy. See section 5.1 and 5.2.
4.3 Contraindications
Hypersensitivity to terbinafine or any of the excipients in the cream.
4.4 Special warnings and precautions for use
This product is for external use only. Contact with the eyes, face and mucous membranes should be avoided.
This product contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Contact with skin lesions should be avoided.
This medicine contains 10mg benzyl alcohol in 1g-cream. Benzyl alcohol may cause allergic reactions and mild local irritation.
Discontinue use if irritation occurs.
4.5 Interaction with other medicinal products and other forms of interaction
There are no known drug interactions with terbinafine cream.
4.6 Pregnancy and lactation
Foetal toxicity and fertility studies suggest no adverse effects.
There is no clinical experience with terbinafine cream in pregnant women. Therefore, unless the potential benefits outweigh any potential risks, Scholl Advance Athlete's Foot Cream should not be administered during pregnancy.
Terbinafine is excreted in breast milk and therefore breast-feeding mothers should not use Scholl Advance Athlete's Foot Cream.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Adverse events which have been associated with terbinafine hydrochloride are given below, tabulated by system organ class and frequency.
Frequencies are defined as very common >1/10; common >1/100 <1/10; uncommon >1/1000 <1/100; rare >1/10,000 <1/1000; very rare <1/10,000. Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| System Organ Class | Frequency | Adverse Events |
| Immune System Disorders | Rare | Hypersensitivity1, 2 |
| Skin and Subcutaneous Tissue Disorders | Uncommon | Pruritus, erythema |
| Not known | Skin burning sensation | |
| General Disorders and Administration Site Conditions | Uncommon | Stinging |
| Not known | ----2----2-------, -, ----2----------------------- Application site irritation2 |
1
Hypersensitivity reactions include rash or urticaria.
2
2 Treatment has to be rarely discontinued for allergic reactions at the site of application. However if hypersensitivity reactions occur treatment must be discontinued.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 OverdoseSymptoms
4.9 OverdoseSymptomsTopical terbinafine undergoes poor systemic absorption so overdose is unlikely.
No adverse events in relation to ingestion of terbinafine cream have been reported to date. 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.
Management
Treatment should be supportive and symptomatic. If accidentally ingested use of activated charcoal should be considered.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other antifungals for topical use
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 treatment effect of terbinafine is long-lasting: Less than 10% of patients suffering from tinea pedis and treated with terbinafine 1% cream for one week experienced a relapse or re-infection within three months after start of treatment.
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
5.3 Preclinical safety dataThere 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 myristate
Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
Unopened: 2 Years
Opened: 2 Weeks
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Aluminium tube with tamper-evident membrane seal, internal lacquer coating and HDPE screw cap containing 7.5g or 15g of cream.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements
7 MARKETING AUTHORISATION HOLDER
Scholl Consumer Products Ltd
103–105 Bath Road,
Slough,
SL1 3UH, United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00587/0242