Summary of medicine characteristics - SCHOLL ATHLETES FOOT SPRAY LIQUID
1 NAME OF THE MEDICINAL PRODUCT
Scholl Athlete’s Foot Spray Liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolnaftate 0.068%w/w (to deliver 1% to the skin).
Excipients with known effects:
Ethanol 35.8 % w/w
Butylated hydroxytoluene (E321) 0.007% w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Topical spray
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Prevention and treatment of Athlete’s Foot
4.2 Posology and method of administration
Posology
Adults:
Recommended Dose: Twice daily, in the morning and at night.
Treatment should continue for up to two weeks after the symptoms disappear.
Paediatric population:
No distinction is made between different categories of patient.
Method of administration
Topical.
For best results the feet should be washed and dried before use. Shake can before use. Point nozzle towards the affected area, holding it 10–15cm away. Spray liberally over the affected area.
Wear clean socks or hosiery.
4.3 Contraindications
Contraindicated in nail or scalp infections.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
For external use only
Keep out of eyes
If symptoms do not improve within 10 days, discontinue use and consult your doctor.
Flammable, pressurised container. Protect from direct sunlight and do not expose to temperatures exceeding 50°C. Do not spray on naked flame or incandescent material. Do not pierce or burn even after use.
Contains butylated hydroxytoluene (E321). May cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
This medicine contains 35.8% w/w alcohol (ethanol). It may cause burning sensation on damaged skin.
If irritation or rash occurs, use of the product should be discontinued and medical advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction None stated.
4.6 Pregnancy and lactation No known restrictions.
4.7
Effects on ability to drive and use machines None stated.
4.8
Adverse reactions which have been associated with Tolnaftate have been ranked under headings of system organ class and frequency. Frequencies are defined 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 |
| Not known | (cannot be estimated from the available data) |
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
| System Organ Class | Frequency | Adverse Events |
| Skin and Subcutaneous Tissue Disorders | Not Known | Skin reaction, skin irritation, pruritus, dermatitis contact. |
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
4.9
Overdose
Symptoms:
There have been no reports of over dosage with the use of this product.
Management:
In the case of over dosage, treatment should be symptomatic and supportive.
PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Dermatologicals, Antifungals for Dermatological use, Antifungals for Topical use, Other Antifungals for Topical use.
ATC Classification: D01A E18
Tolnaftate is a topical antifungal agent
5.2 Pharmacokinetic properties
Not applicable for a topical dosage form.
5.3 Preclinical safety data
5.3 Preclinical safety dataNone stated
6.1
Butylated Hydroxytoluene (E321)
Polyethylene – polypropylene glycol monobutyl ether
Ethanol
Butane
Propane
Iso-butane
6.2
None stated.
6.3
48 months unopened.
6.4 Special precautions for storage
Warnings for the labelling:
Pressurised container: May burst if heated.
Keep away from heat/sparks/open flames/hot surfaces. – No smoking.
Do not spray on open flame or other ignition source.
Pressurised container: Do not pierce or burn, even after use.
Protect from sunlight. Do not expose to temperatures exceeding 50° C / 122° F.
Danger. Extremely Flammable Aerosol (and logo)
6.5 Nature and contents of container
Tinplate aerosol can, epoxy coated internally with valve assembly and overcap. Can sizes: 150ml.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNone stated
7 MARKETING AUTHORISATION HOLDER
Scholl Consumer Products Ltd
103–105 Bath Road
Slough
SL1 3UH
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00587/0008