Canesten Thrush Cream

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Clotrimazole

Fáanlegur frá:

PCO Manufacturing Ltd.

ATC númer:

G01AF02

INN (Alþjóðlegt nafn):

Clotrimazole

Skammtar:

20 milligram(s)/gram

Lyfjaform:

Vaginal cream

Gerð lyfseðils:

Product not subject to medical prescription

Lækningarsvæði:

clotrimazole

Leyfisstaða:

Authorised

Leyfisdagur:

2010-05-07

Upplýsingar fylgiseðill

_ _
_ _
_ _
_ _
_ _
PATIENT LEAFLET: INFORMATION FOR THE USER
CANESTEN
® THRUSH CREAM
clotrimazole 2% w/w
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
Always use this medicine exactly as described in this leaflet or
as your pharmacist has told you.
–
Keep this leaflet. You may need to read it again.
–
Ask your pharmacist if you need more information or
advice.
–
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
–
You must talk to a doctor if you do not feel better or if you
feel worse after seven days.
WHAT IS IN THIS LEAFLET
1.
What is Canesten Thrush Cream and what is it used for
2.
What you need to know 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.
Contents of the pack and other information
1.
WHAT IS CANESTEN THRUSH CREAM AND WHAT IT
IS 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.
Canesten Thrush Cream is used to treat adults and children
aged 12 years and over.
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.
WHAT YOU NEED TO KNOW BEFORE YOU USE
CANESTEN THRUSH CREAM
DO

Vara einkenni

Health Products Regulatory Authority
10 June 2022
CRN00CZ77
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten Thrush Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 20 mg clotrimazole (2%w/w)
Excipient(s) with known effect: cetostearyl alcohol, benzyl 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
Octyldodecanol
Purified 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
Do not store above 25 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium tubes (20g) with a stopper and a screw top.
Health Products Regulatory Authority
10 June 2022
CRN00CZ77
Page 2 of 2
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
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/048/004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 7
th
May 2010
10 DATE OF REVISION OF THE TEXT
June 2022