Canesten Bifonazole Once Daily Athlete's Foot 1% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bifonazole

Available from:

Bayer Plc

ATC code:

D01AC10

INN (International Name):

Bifonazole

Dosage:

10mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100200; GTIN: 5010605055119

Patient Information leaflet

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PIL 148 x 210 (P041)
Canesten
Cream
Bifonazole
Leaflet
UK
Cutter
Guides
Technical & Non Printing Items
BAYER ARTWORK PANEL
20 g
Main Text (body copy):
Height (based on lower case x):
7.25 pt
1.42 mm
FONT SIZE PANEL
1
LTH
PANTONE 485 C
2
LTH
Process Black
3
LTH
PANTONE Cool Gray 11 C
Colours
08/11/19
L
N/A
N/A
N/A
N/A
N/A
Generic Bayer
White Paper
CANESTEN
BIFONAZOLE ONCE DAILY ATHLETE'S FOOT 1% W/W CREAM
Bifonazole
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you
still need to use Canesten Bifonazole Once Daily Athlete’s Foot
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 within 7 days.
•
If you have any unusual effects after using this product,
tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What is Canesten Bifonazole Once Daily cream and what is
it used for?
2.
Before you use Canesten Bifonazole Once Daily cream
3.
How to use Canesten Bifonazole Once Daily cream
4.
Possible side effects
5.
How to store Canesten Bifonazole Once Daily cream
6.
Further information
1.
WHAT IS CANESTEN
®
BIFONAZOLE ONCE
DAILY CREAM AND WHAT IS IT USED FOR?
Canesten Bifonazole Once Daily cream is an effective once
daily treatment of 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 Bifonazole Once Daily cream
is bifonazole. Bifonazole belongs to a group of medicines
called imidazoles and is an antifungal agent which fights the
cause of fungal skin infections.
2.
BEFORE YOU USE CANESTEN
®
BIFONAZOLE ONCE DAILY CREAM
DO NOT USE CANESTEN BIFONAZOLE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Canesten Bifonazole Once Daily 1% w/w Cream
Canesten Bifonazole Once Daily Athlete’s Foot 1% w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The cream contains 1% w/w bifonazole.
Excipient with known effect: cetostearyl alcohol.
For excipients see section 6.1.
3
PHARMACEUTICAL FORM
A white cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of athlete’s foot.
The preparation is not for vaginal use.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The cream should be thinly applied and rubbed into the affected areas
once daily,
preferably at night before retiring, for two to three weeks.
The affected areas should be washed and dried thoroughly before the
cream is
applied.
A physician or pharmacist should be consulted if symptoms do not
improve within
seven days.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Treatment of infants with nappy rash.
Treatment of nail and scalp infections.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product contains cetostearyl alcohol which may cause local skin
reactions
(e.g. contact dermatitis).
If unsure of diagnosis, the patient should seek the advice of a doctor
or
pharmacist before using this product.
Patients
with
a
history
of
hypersensitivity
reactions
to
other
imidazole
antifungal
agents
(e.g.
econazole,
clotrimazole,
miconazole)
must
take
bifonazole-containing products with caution.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Limited data suggest that an interaction between topical bifonazole
and warfarin
may be possible, leading to increases in INR. If bifonazole is used in
a patient on
warfarin therapy they should be appropriately monitored.
Closer monitoring may be required in cases of occlusion and/or
application to a
large surface area or to broken and damaged skin.
4.6
FERTILITY, PREGNANCY AND LACTATION
PREGNANCY
There are no clinical data from the use of bifonazole in pregnant
wom