Canesten Dermatological Spray

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

CLOTRIMAZOLE

Inapatikana kutoka:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

ATC kanuni:

D01AC01

INN (Jina la Kimataifa):

CLOTRIMAZOLE 1 % (W/V)

Dawa fomu:

CUTANEOUS SPRAY, SOLUTION

Tungo:

CLOTRIMAZOLE 1 % (W/V)

Dawa ya aina:

OTC

Eneo la matibabu:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2006-03-02

Taarifa za kipeperushi

148 x 210 mm
7 pt
2
06.04.2018
Pantone 200
Schwarz
Kontur
GI CANESTEN SPRAY DERM
Page 1 of 2
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 sweat rash.
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 of Canesten Dermatological Spray.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS:
This product contains propylene glycol which may cause
skin irritation (e.g. rash, itching or redness) in some people.
PREGNANCY AND BREAST-FEEDING:
If you are pregnant, breast-feeding or trying for a baby,
tell your doctor or midwife before using Canesten
Dermato

Tabia za bidhaa

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.
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.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6
FERTILITY, PREGNANCY AND LACTATION
Fertility:
No human studies of the effects of clotrimazole on fertility have been
performed;
however, animal studies have not demonstrated any effects of the drug
on fertility.
Pregnancy:
There is a limited amount of data from the use of clotrimazole in
pregnant women.
Animal studies with clotrimazole have shown reproductive toxicity at
high oral doses
(see se