Canesten Dermatological 1% spray

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clotrimazole

Available from:

Bayer Plc

ATC code:

D01AC01

INN (International Name):

Clotrimazole

Dosage:

10mg/1ml

Pharmaceutical form:

Spray

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100200; GTIN: 5010605054211

Patient Information leaflet

Page 1 of 2
DERMATOLOGICAL SPRAY
Clotrimazole 1% w/v
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
Dermatological Spray 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 if your symptoms
worsen or do not improve.
•
If you have any unusual effects after using
this product, tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What is Canesten Dermatological Spray and
what is it used for?
2.
Before you use Canesten Dermatological Spray
3.
How to use Canesten Dermatological Spray
4.
Possible side effects
5.
How to store Canesten Dermatological Spray
6. Further information
1.
WHAT IS CANESTEN
®
DERMATOLOGICAL SPRAY AND
WHAT IS IT USED FOR?
Canesten Dermatological Spray is used to treat
fungal skin infections such as ringworm, athlete’s
foot, jock itch and fungal infected skin folds.
IF YOU ARE UNSURE WHETHER YOU HAVE ONE OF
THESE FUNGAL SKIN INFECTIONS, SEEK THE ADVICE
OF YOUR DOCTOR OR PHARMACIST.
The atomiser spray is particularly suitable for
infections covering large or hairy areas.
The active substance in Canesten Dermatological
Spray 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.
BEFORE YOU USE CANESTEN
®
DERMATOLOGICAL SPRAY
DO NOT USE CANESTEN
® DERMATOLOGICAL SPRAY:
•
If you are allergic (hypersensitive) to
clotrimazole or any of the other ingredients,
including propylene glycol, of Canesten
Dermatological Spray.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS:
This medicine contains 546 mg propylene glycol
in each 1 ml of spray. Propylene glycol may
cause skin irritation.
Do not use this medicine in babies less than 4 weeks
old with open wounds or large areas of broken
or damaged skin (such as burns) without talking
to yo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Canesten Dermatological Spray
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1% w/v.
Excipient with known effect: propylene glycol 546mg in each 1ml of
spray.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
A colourless solution for topical administration by an atomiser
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Recommended for the treatment of:
(i)
All dermatomycoses due to moulds and other fungi, (e.g. _Trichophyton_
species).
(ii)
All dermatomycoses due to yeasts (_Candida_ species).
(iii)
Skin diseases showing secondary infection with these fungi.
The spray is particularly suitable for infections covering large
and/or hairy areas.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The
spray
should
be
applied
thinly
2-3
times
daily
for
at
least
one
month
for
dermatophyte infections, and at least two weeks for candidal and
_Pityriasis versicolor_
infections.
There is no separate dosage schedule for the young or elderly.
Method of administration
If the feet are infected they should be washed and dried, especially
between the toes,
before applying.
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
Canesten Dermatological Spray should not be used near a naked flame,
should not be
allowed to come into contact with the eyes, ears or mucous membranes
and should not
be inhaled.
This product contains propylene glycol, which may cause skin
irritation.
Do not use this medicine in babies less than 4 weeks old with open
wounds or large areas
of broken or damaged skin (such as burns) without talking to your
doctor or pharmacist.
Because this medicine contains propylene glycol, do not use it on open
wounds or large
areas of broken or damaged skin (such as burns) without checking with
your doctor or
pharmacist.
Instruct patients not to smoke or go near naked flames - risk of
severe burns. Fabric
(clothing, beddin