Canesten Athlete’s Foot Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clotrimazole

Available from:

Bayer Limited

ATC code:

D01AC; D01AC01

INN (International Name):

Clotrimazole

Dosage:

1 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Imidazole and triazole derivatives; clotrimazole

Authorization status:

Not marketed

Authorization date:

2015-02-20

Patient Information leaflet

BCH22024
PATIENT LEAFLET: INFORMATION FOR THE USER
CANESTEN® ATHLETE’S FOOT CREAM
Clotrimazole 1% w/w
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your pharmacist has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
•
You must contact a doctor if your symptoms worsen or do not improve.
WHAT IS IN THIS LEAFLET
1. What is Canesten Athlete’s Foot Cream and what is it used for
2. What you need to know before you use Canesten Athlete’s Foot
Cream
3. How to use Canesten Athlete’s Foot Cream
4. Possible side effects
5. How to store Canesten Athlete’s Foot Cream
6. Contents of the pack and other information
1. WHAT IS CANESTEN® ATHLETE’S FOOT CREAM AND WHAT IS IT USED FOR
Canesten Athlete’s Foot Cream is used to treat athlete’s foot.
If you are unsure whether you have athlete’s foot, seek the advice
of your doctor or pharmacist.
The active substance in Canesten Athlete’s Foot Cream is
clotrimazole. Clotrimazole belongs to a
group of medicines called imidazoles and is an antifungal agent which
fights the cause of fungal
skin infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BEFORE YOU USE
CANESTEN® ATHLETE’S FOOT CREAM
DO NOT USE CANESTEN® ATHLETE’S FOOT CREAM:
•
• If you are allergic (hypersensitive) to clotrimazole or any of the
other ingredients including
cetostearyl alcohol or benzyl alcohol, of Canesten Athlete’s Foot
Cream (listed in section 6).
CANESTEN ATHLETE’S FOOT CREAM CONTAINS CETOSTEARYL ALCOHOL AND
BENZYL ALCOHOL.
This product contains cetostearyl alcohol which may cause local skin
irritation (e.g. rash, itching
or redness). This product contains 20 mg benzyl alcohol in each gram
of cream. Benzyl al

Summary of Product characteristics

Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten Athlete’s Foot Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 10mg Clotrimazole equivalent to 1% w/w.
Excipients with known effect:
Cetostearyl alcohol 100mg in each gram of cream
Benzyl alcohol 20mg in each gram of cream
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
A white oil-in-water type cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of Tinea pedis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Canesten Cream should be applied to the affected area 2 or 3 times
daily. To prevent relapse, treatment should be continued
for at least two weeks after the disappearance of all signs of
infection.
Patients should notify their physician if there is no improvement
after 4 weeks of treatment.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
All possibly infected areas should be treated at the same time.
This product contains cetostearyl alcohol, which may cause local skin
reactions (e.g. contact dermatitis). The product also
contains benzyl alcohol which may cause allergic reactions and mild
local irritation.
Avoid contact with eyes and do not swallow.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction studies have been performed.
4.6 FERTILITY, PREGNANCY AND LACTATION
Pregnancy:
Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 2 of 5
There are limited data available from the use of clotrimazole in
pregnant women. Animal studies with clotrimazole have shown
reproductive toxicity at high oral doses (see section 5.3). At the low
systemic exposures of clotrimazole following topical
treatment, harmful effects are considered unlikely. Clotrimazole can
be used during pregnancy, but only under the direction of
a doctor or