Canesten Thrush Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clotrimazole

Available from:

Imbat Limited

ATC code:

G01AF; G01AF02

INN (International Name):

Clotrimazole

Dosage:

2 percent weight/weight

Pharmaceutical form:

Vaginal cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Imidazole derivatives; clotrimazole

Authorization status:

Authorised

Authorization date:

2016-10-07

Patient Information leaflet

PATIENT INFORMATION LEAFLET
CANESTEN
® THRUSH CREAM
(CLOTRIMAZOLE)
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 THRUSH CREAM CAREFULLY TO GET THE
BEST RESULTS FROM IT.

Keep this leaflet. You may need to read it again.

Ask you pharmacist if you need more information or
advice.

You must contact a doctor if your symptoms worsen or
do not improve in 7 days.

If you have any unusual effects after using this product,
tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What is Canesten Thrush Cream and what is it used for?
2.
Before you use Canesten Thrush Cream
3.
How to use Canesten Thrush Cream
4.
Possible side effects
5.
How to store Canesten Thrush Cream
6.
Further information and contents of the pack
1.
WHAT IS CANESTEN THRUSH CREAM AND
WHAT IS IT USED FOR?
Canesten Thrush Cream relieves irritation of the vulva
(vulvitis) which is caused by vaginal thrush (candidiasis).
Although this cream provides relief from the external irritation
caused by vaginal thrush, it cannot treat any internal
(vaginal) cause of the infection. Ask your doctor or
pharmacist to recommend a treatment for this.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY
DIAGNOSED BY YOUR DOCTOR AS HAVING VAGINAL THRUSH.
Some women suffer from recurrent attacks of thrush. To
reduce the frequency of these attacks, the sexual partner’s
penis can be treated with this cream to prevent reinfection,
even if they have no symptoms of thrush.
The active substance in Canesten Thrush Cream is
clotrimazole. Clotrimazole belongs to a group of medicines
called azoles and is an antifungal agent which fights the
cause of infections such as vaginal thrush.
2.
BEFORE YOU USE CANESTEN THRUSH
CREAM
DO NOT USE CANESTEN THRUSH CREAM:

If you are allergic (hypersensitive) to clotrimazole or any
of the other ingredients of Canesten Thrush Cream _(see _
_Section 6. Further Information and contents of the pack)_
BEFORE USING CANE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten Thrush Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 20mg clotrimazole (2% w/w)
Excipient with know effect: Cetostearyl alcohol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal Cream
_Product imported from Spain_
A white oil-in water type cream
4 CLINICAL PARTICULARS
As per PA1410/039/012
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/039/012
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Benzyl alcohol
Polysorbate 60
Sorbitan stearate
Cetyl palmitate
Cetostearyl alcohol
Octyldodeconol
Purifed water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage conditions
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6.5 NATURE AND CONTENTS OF CONTAINER
Tube (20g) with a screw top.
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
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Ltd,
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL