Canesten 2% thrush cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clotrimazole

Available from:

DE Pharmaceuticals

ATC code:

G01AF02

INN (International Name):

Clotrimazole

Dosage:

20mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07020200

Patient Information leaflet

PATIENT INFORMATION LEAFLET
CANESTEN® 2% THRUSH CREAM
(clotrimazole 2% w/w)
The name of your medicine is Canesten 2% Thrush Cream, but
will be referred to as Canesten Thrush Cream throughout the
remainder of the 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 Thrush 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 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
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 re-infection, 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Canesten Thrush External Cream 2% w/w cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 2% w/w.
Excipient with known effect: cetostearyl alcohol
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Cream for topical use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Canesten Thrush External Cream is recommended for the treatment of
candidal
vulvitis. It should be used as an adjunct to treatment of candidal
vaginitis.
It can also be used for treatment of the sexual partner’s penis to
prevent re-
infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Canesten Thrush External Cream should be applied to the vulva and
surrounding
area.
It can also be applied to the sexual partner’s penis to prevent
re-infection.
Adults
The cream should be applied thinly two or three times daily and rubbed
in gently.
Treatment should be continued until symptoms of the infection
disappear.
However, if after concomitant treatment of the vaginitis, the symptoms
do not
improve within seven days, the patient should consult a doctor.
If the cream is being used for treatment of the sexual partner’s
penis it should be
applied two or three times daily for up to two weeks.
Children
There is no clinical experience in the use of Canesten Thrush External
Cream in
children.
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
Medical
advice
should
be
sought
if
this
is
the
first
time
the
patient
has
experienced symptoms of candidal vaginitis.
Before using Canesten Thrush External Cream medical advice must be
sought if
any of the following are applicable:
-
more than two infections of candidal vaginitis in the last six months
-
previous history of a sexually transmitted disease or exposure to
partner
with sexually transmitted disease
-
pregnancy or suspected pregnancy
-
aged under 16 or over 60 years
-
known
hypersensitivity
to
imidazoles
or
other
vaginal
antifungal