Canesten Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clotrimazole

Available from:

LTT Pharma Limited

ATC code:

D01AC; D01AC01

INN (International Name):

Clotrimazole

Dosage:

1 percent

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Imidazole and triazole derivatives; clotrimazole

Authorization status:

Authorised

Authorization date:

2016-11-11

Patient Information leaflet

CANESTEN CREAM
(clotrimazole 1% w/w)
PATIENT INFORMATION LEAFLET
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 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 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
What is Canesten Cream and what is it used for?
Before you use Canesten Cream
How to use Canesten Cream
Possible side effects
How to store Canesten Cream
Further information
WHAT IS CANESTEN CREAM AND WHAT IS IT USED FOR?
Canesten Cream is used to treat fungal skin infections such as
ringworm,
athlete's foot, fungal nappy rash and fungal sweat rash. lt is also
used to
relieve irritation of the vulva (external thrush) or the end of the
penis, which
may be associated with thrush.
LF YOU ARE UNSURE WHETHER YOU (OR YOUR BABY IF TREATING NAPPY RASH)
HAVE
ONE OF THESE FUNGAL SKIN INFECTIONS, SEEK THE ADVICE OF YOUR DOCTOR OR
PHARMACIST.
The active substance in Canesten Cream is clotrimazole. Clotrimazole
belongs to a group of medicines called imidazoles and is an antifungal
agent
which fights the cause of fungal skin infections.
BEFORE YOU USE CANESTEN CREAM
DO NOT USE CANESTEN CREAM:
*
If you (or your baby if treating nappy rash) are allergic
(hypersensitive) to
clotrimazole, or any of the other ingredients of Canesten Cream.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS:
This product contains cetostearyl alcohol which may cause local skin
reactions (e.g. contact dermatitis).
SPECIAL PRECAUTIONS:
As with other creams, Canesten Cream may reduce the effectiveness of
rubber contraceptives, such as condoms or diaphragms. Consequently, if
you
are using this cream on the vulva or penis, you should use alternative
precautions for at least five days

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains clotrimazole 1% w/w (equivalent to 10mg/g).
Excipients with known effect: cetostearyl alcohol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
_Product imported from the United Kingdom_
A white oil-in-water type cream.
4 CLINICAL PARTICULARS
As per PA1410/039/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/039/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Benzyl alcohol
Polysorbate 60
Sorbitan Stearate
Cetyl Palmitate
Cetostearyl alcohol
Octyldodecanol
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the tube and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original package.
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6.5 NATURE AND CONTENTS OF CONTAINER
Tubes with screw on caps containing 20 g cream. Each tube is contained
within a cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
Medicines should not be disposed of via wastewater or household waste.
Ask your pharm