Canesten Hydrocortisone Athlete's Foot 1% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone acetate; Clotrimazole

Available from:

Bayer Plc

ATC code:

D01AC20

INN (International Name):

Hydrocortisone acetate; Clotrimazole

Dosage:

10mg/1gram ; 10mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000; GTIN: 5010605054327

Patient Information leaflet

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PIL 148 x 210 (P041)
Canesten
Hydrocortisone
Cream
Leaflet
UK
Cutter
Guides
Technical & Non Printing Items
BAYER ARTWORK PANEL
Leaflet N/A
Main Text (body copy):
Height (based on lower case x):
7.25 pt
1.4
mm
FONT SIZE PANEL
1
LTH
PANTONE 485 C
2
LTH
PANTONE Cool Gray 11 C
3
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Process Black
Colours
12/11/19
J
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Generic Bayer
White Paper
CANESTEN
READ ALL OF THIS LEAFLET CAREFULLY CAREFULLY BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription.
However, you still need to use Canesten Hydrocortisone
Athlete's Foot 1%, 1% w/w cream carefully to get the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or
advice.
•
You must contact a doctor or pharmacist if your
symptoms worsen or do not improve after 7 days.
•
If you have any unusual effects after using this
product, tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What is Canesten Hydrocortisone Athlete's Foot cream
and what is it used for?
2.
Before you use Canesten Hydrocortisone Athlete's
Foot cream
3.
How to use Canesten Hydrocortisone Athlete's Foot
cream
4.
Possible side effects
5.
How to store Canesten Hydrocortisone Athlete's Foot
cream
6.
Further information
1. WHAT IS CANESTEN
®
HYDROCORTISONE ATHLETE'S FOOT
CREAM AND WHAT IS IT USED FOR?
Canesten Hydrocortisone Athlete's Foot cream is used to
treat athlete's foot and fungal infected skin folds when
there are additional symptoms of inflammation (such as
swelling, redness and itching).
Canesten Hydrocortisone Athlete's Foot cream treats the
fungal skin infection and reduces the swelling and itching
caused by it.
IF YOU ARE UNSURE WHETHER YOU HAVE ONE OF THESE
FUNGAL SKIN INFECTIONS, SEEK THE ADVICE OF YOUR DOCTOR
OR PHARMACIST
The active substances in Canesten Hydrocortisone
Athlet

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Canesten Hydrocortisone
Canesten Hydrocortisone Athlete’s Foot 1%, 1% w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 10mg clotrimazole and 11.2mg
hydrocortisone acetate
(equivalent to 10mg hydrocortisone).
Excipient with known effect:
Cetostearyl alcohol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
White cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Canesten Hydrocortisone is indicated for the treatment of the
following skin
infections where co-existing symptoms of inflammation, e.g. itching,
require
rapid relief:
(i)
Athlete's foot.
(ii)
Candidal intertrigo.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Adults, elderly and children age 10 years and over:
Canesten Hydrocortisone should be thinly and evenly applied to the
affected area
twice daily and rubbed in gently. The maximum period of treatment is
seven
days.
A total daily dose of 10 mg cream per kg body weight should not be
exceeded.
For an adult weighing 50 kg the maximum daily dose is 500 mg cream
which
equals approximately 2 cm of cream to be divided into 2 applications
per day.
Treatment duration:
If the acute symptoms have subsided after about 7 days but treatment
is still
required, this may be carried out with the corticoid-free preparation
intended
for this purpose.
4.3
CONTRAINDICATIONS
Canesten Hydrocortisone is contra-indicated in the following cases:
•
Hypersensitivity to the active substances or to any of the excipients
listed in
section 6.1
•
Use on broken skin.
•
Use on large areas of skin.
•
Use for periods of longer than seven days.
•
To treat cold sores or acne.
•
Use on the face, eyes, mouth or mucous membranes.
•
Children under 10 years of age, unless prescribed by a doctor.
•
Pregnancy and lactation, unless prescribed by a doctor.
•
Use on the ano-genital area, unless prescribed by a doctor.
•
To treat ringworm, unless prescribed by a doctor.
•
To treat secondarily