Canesten Antifungal cream

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
31-10-2022
Tabia za bidhaa Tabia za bidhaa (SPC)
31-10-2022

Viambatanisho vya kazi:

Clotrimazole

Inapatikana kutoka:

Bayer Plc

ATC kanuni:

D01AC01

INN (Jina la Kimataifa):

Clotrimazole

Kipimo:

10mg/1gram

Dawa fomu:

Cutaneous cream

Njia ya uendeshaji:

Cutaneous

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 13100200; GTIN: 5010605106026

Taarifa za kipeperushi

                                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 Solution
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 Solution and what is it used
for?
2. Before you use Canesten Solution
3. How to use Canesten Solution
4. Possible side effects
5. How to store Canesten Solution
6. Further information
1. WHAT IS CANESTEN
® SOLUTION
AND WHAT IS IT USED FOR?
Canesten Solution is used to treat fungal skin
infections such as ringworm, athlete’s foot,
fungal infected skin folds (intertrigo) and fungal
infections of the outer and middle ear.
IF YOU ARE UNSURE WHETHER YOU HAVE ONE OF
THESE FUNGAL SKIN INFECTIONS, SEEK THE ADVICE
OF YOUR DOCTOR OR PHARMACIST.
The solution is particularly suitable for use on
hairy skin.
The active substance in Canesten Solution is
clotrimazole. Clotrimazole belongs to a group of
medicines called imidazoles and is an antifungal
agent which fights the cause of fungal skin and
ear infections.
2. BEFORE YOU USE CANESTEN
®
SOLUTION
DO NOT USE CANESTEN SOLUTION:
•
If you are allergic (hypersensitive) to
clotrimazole or the other ingredient of
Canesten Solution, macrogol 400.
USING OTHER MEDICINES:
Canesten Solution and Sofradex drops may
cause a heat reaction when used together.
Consult your doctor before using these products
together in the ear.
PREGNANCY AND BREAST-FEEDING:
If you are pregnant, breast-feeding or trying for
a baby, tell your doctor or midwife before using
Canesten Solution.
If you have informed your doctor or midwife
already, follow his/her instructions carefully.
3. HOW TO USE CANESTEN
®
SOLUTION
If Canesten Solution has been prescribed for
you b
                                
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Tabia za bidhaa

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Canesten Antifungal Cream
Canesten Fungal Infection 1% w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 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 cream for cutaneous use
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
(iv)
Candidal nappy rash, vulvitis and balanitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Canesten Antifungal Cream should be applied thinly 2 or 3 times daily
and
rubbed in gently. A strip of cream (½ cm long) is enough to treat an
area of about
the size of the hand. Treatment should be continued for at least one
month for
dermatophyte infections and at least two weeks for candidal
infections.
If the feet are infected they should be washed and dried, especially
between the
toes, before applying the cream.
There is no separate dosage schedule for the young or elderly.
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
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.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Laboratory tests have suggested that, when used together, this product
may cause
damage to latex contraceptives. Consequently the effectiveness of such
contraceptives may be reduced. Patients should be advised to use
alternative
precautions for at least five days after using this product.
4.6
FERTILITY, PREGNANCY 
                                
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