Scholl Athlete’s Foot Powder

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Tolnaftate

Disponibil de la:

Reckitt Benckiser Ireland Ltd

Codul ATC:

D01AE; D01AE18

INN (nume internaţional):

Tolnaftate

Dozare:

1 percent weight/weight

Forma farmaceutică:

Cutaneous powder

Zonă Terapeutică:

Other antifungals for topical use; tolnaftate

Statutul autorizaţiei:

Not marketed

Data de autorizare:

1986-11-19

Prospect

ATHLETE’S FOOT
POWDER
TOLNAFTATE 1% W
/
W
ANTI-FUNGAL
TREATS ATHLETE’S FOOT FUNGI
1. What is this powder for?
Scholl Athlete’s Foot Powder is a topical antifungal for the
treatment of Athlete’s Foot.
Contains Tolnaftate, an antifungal medication for treating Athlete’s
Foot Fungi.
2. Before using this powder
Do not use...
•
If you are allergic to Tolnaftate or any of the other ingredients. See
‘What this powder
contains’.
•
For nail and scalp infections
3. How to use this powder
For EXTERNAL use only. Keep out of eyes.
•
Wash and dry infected area and apply liberally twice each day, or as
directed by a
doctor. Dust feet liberally, especially between toes. For added
protection dust on socks,
hosiery and inside shoes.
•
Continue treatment for 2 weeks after symptoms disappear. If symptoms
do not
improve within 10 days, stop use and speak to your doctor.
4. Possible side effects
Occasional itching, irritation or a rash may occur. If it is severe
stop use. If any other
side effects occur speak to your doctor.
5. How to store this powder
Keep out of the sight and reach of children.
Do not store above 25˚C.
Do not use after expiry date shown.
6. What this powder contains
Active ingredients: Tolnaftate 1 % w/w
Other ingredients: corn starch and talc
Marketing Authorisation Holder: Reckitt Benckiser Ltd, 7 Riverwalk,
Citywest Business
Campus, Dublin 24, Ireland.
Manufacturer:
SSL
International
Plc, Traynor Way, Peterlee, SR8 2RU, UK and
FAMAR Lyon ,29 avenue Charles de Gaule, 69230, Saint-Genis-Laval,
France
Text revision: February 2019.
ROI TEL: [phone]
Scholl and the Scholl Logo are trade marks.
(Contents tend to settle after filling)

Caracteristicilor produsului

Health Products Regulatory Authority
22 March 2019
CRN008RM8
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Scholl Athlete’s Foot Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolnaftate 1.00 % w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous powder.
A white fine, free flowing powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a fungistat in the topical treatment of infections due to
dermatophytes sensitive to this agent including microspora,
epidermophyta and trichophyta.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Adults: Recommended dose: applyliberally on affected area twice daily
or as directed bya
doctor. Continue treatment for two weeks after symptoms disappear.
Paediatric population: As above for adults.
METHOD OF ADMINISTRATION:
Cutaneous Use. Topical application only. Wash and drythe affected area
before applying.
Wear clean socks or hosiery.
4.3 CONTRAINDICATIONS
Contraindicated in nail or scalp infections.
Hypersensitivityto the active substance or to anyof the excipients
listed in Section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Keep out of eyes.
Ifsymptoms do not improve within 10 days, discontinue use and consult
your doctor. Keep out of 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
INTERACTIONS
Not relevant to topical use.
Health Products Regulatory Authority
22 March 2019
CRN008RM8
Page 2 of 3
4.6 FERTILITY, PREGNANCY AND LACTATION
PREGNANCY
No effects during pregnancyare anticipated since systemic exposure to
Tolnaftate inegligible. Tolnaftate can be used during
pregnancy.
BREAST-FEEDING
It is unknown whether Tolnaftate and Tolnaftate metabolites are
excreted in human milk.
FERTILITY
No data on human fertilityis available.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
This medication has no known effects on the ability to driv