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- Scholl Advance Athlete's Foot Cream
Scholl Advance Athletes Foot
Summary of product characteristics
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
For a full list of excipients, see 6.1
3. Pharmaceutical form
Cream
White homogenous cream
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 administration
Method of administration
Cutaneous use
Adults and the Elderly
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.
Children
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 should be avoided.
This product contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
4.5. Interaction with other medicinal products and other forms of interaction
There are no known drug interactions with terbinafine cream.
4.6. Fertility, 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 reactions have been ranked under headings of frequency using the following convention:
| 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
|
| Unknown:
| cannot be estimated from the available data
|
| System Organ Class
| Adverse reaction
| Frequency
|
| Immune System Disorders
| Redness, itching and stinging
| Uncommon
|
| Hypersensitivity
| Rare
|
Treatment has to be rarely discontinued for allergic reactions at the site of application. However if hypersensitivity reactions occur treatment must be discontinued.
4.9. Overdose
No adverse events in relation to ingestion of terbinafine cream have been reported to date. However, if accidental ingestion occurs, gastric emptying may be used 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.
5.1. 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
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
6.1. 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 and other handling
No 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
9. Date of first authorisation/renewal of the authorisation
06/10/2017
10. Date of revision of the text
28/03/2018
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 administration
Method of administration
Cutaneous use
Adults and the Elderly
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.
Children
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 should be avoided.
This product contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
4.5 Interaction with other medicinal products and other forms of interaction
There are no known drug interactions with terbinafine cream.
4.6 Fertility, 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 reactions have been ranked under headings of frequency using the following convention:
| 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
|
| Unknown:
| cannot be estimated from the available data
|
| System Organ Class
| Adverse reaction
| Frequency
|
| Immune System Disorders
| Redness, itching and stinging
| Uncommon
|
| Hypersensitivity
| Rare
|
Treatment has to be rarely discontinued for allergic reactions at the site of application. However if hypersensitivity reactions occur treatment must be discontinued.
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The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.
Medthority will not be held liable for explicit or implicit errors, or missing data.
Drug Licencing
Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).