Summary of medicine characteristics - SUPERDRUG ATHLETES FOOT POWDER, SCHOLL ATHLETES FOOT POWDER
1 NAME OF THE MEDICINAL PRODUCT
Scholl Athletes Foot Powder
Superdrug Athletes Foot Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolnaftate 1.0%w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for topical application
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the prevention and treatment of Athlete’s Foot.
4.2 Posology and method of administration
Posology
Adults: Apply twice daily or as directed by your doctor. Continue treatment for two weeks after symptoms disappear.
Paediatric population: As above for adults.
Method of administration
Topical application only. Wash and dry infected area before applying. Dust feet liberally, especially between toes. Wear clean socks or hosiery. For added protection dust on socks, hosiery and inside shoes.
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
Keep out of the sight and reach of children
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
Not relevant to topical use
4.6 Pregnancy and lactation No known restrictions.
4.7 Effects on ability to drive and use machines None stated.
4.8 Undesirable effects
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.
5 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 of this type
5.3 Preclinical safety data
5.3 Preclinical safety dataNone stated
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Talc
Starch
6.2 Incompatibilities
None stated.
6.3 Shelf life
24 months, unopened
Once opened, use within 6 months
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
High density poly-ethylene container with sifter assembly. 75g of product
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special precautions required