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SCHOLL ADVANCE ATHLETES FOOT CREAM

Active substance(s): TERBINAFINE HYDROCHLORIDE

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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

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 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

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:
Common:
Uncommon:
Rare:
Very Rare:
Unknown:

≥ 1/10
≥ 1/100 to < 1/10
≥ 1/1,000 to < 1/100
≥ 1/10,000 to <1/1,000
< 1/10,000
cannot be estimated from the available data

System Organ Class
Immune System
Disorders

Adverse reaction
Redness, itching and stinging
Hypersensitivity

Frequency
Uncommon
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

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
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 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
No special requirements

7

MARKETING AUTHORISATION HOLDER
Scholl Consumer Products Ltd
103-105 Bath Road,
Slough,
SL1 4AQ,
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

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