Canesten Thrush Combi 500mg pessary & External 2% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Available from:

Bayer Plc

ATC code:

G01AF02

Pharmaceutical form:

Not applicable

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07020200; GTIN: 5010605620645

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 Combi Pessary & 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 Combi and what is it used for?
2. Before you use Canesten Combi
3. How to use Canesten Combi
4. Possible side effects
5. How to store Canesten Combi
6. Further information
1. WHAT IS CANESTEN
® COMBI AND WHAT
IS IT USED FOR?
Canesten Combi Pessary & Cream is a complete treatment for
vaginal thrush because it treats both the internal cause and
external symptoms.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED
BY YOUR DOCTOR AS HAVING VAGINAL THRUSH.
The active substance in Canesten Combi Pessary & 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
® COMBI
DO NOT USE CANESTEN
® COMBI PESSARY & CREAM:
•
If you are allergic (hypersensitive) to clotrimazole or any
of the other ingredients, including cetostearyl alcohol, of
Canesten Combi Pessary & Cream (_see Section 6. Further _
_Information_).
•
During your period as it may be less effective.
•
To treat nail and scalp infections.
BEFORE USING CANESTEN
® COMBI PESSARY & CREAM, YOU
SHOULD SEE YOUR DOCTOR IF:
•
You are unsure whether you have thrush or this is the
first time you have had these symptoms.
•
You have had more than two infections of thrush in the last
six months.
•
You or your partner have ever had a sexually
transmitted disease.
•
You are aged under 16 or over 60.
•
You have ever had an allergic reaction to Canesten or a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Canesten Thrush Combi Pessary & External Cream 500mg / 2% w/w pessary
& cream
2
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Canesten Thrush Pessary contains Clotrimazole 500mg.
Canesten Thrush External Cream contains Clotrimazole 2% w/w.
Excipient with known effect:
Cream: cetostearyl alcohol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pessary and cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The pessary is recommended for the treatment of candidal vaginitis.
The cream is recommended for the treatment of candidal vulvitis. It
should be
used as an adjunct to treatment of candidal vaginitis.
These products should only be used if candidal vulvovaginitis (thrush)
was
previously diagnosed by a doctor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
One pessary should be inserted into the vagina at night. Using the
applicator
provided, the pessary should be inserted as high as possible into the
vagina. This is
best achieved when lying back with legs bent up.
Canesten
pessaries
need
moisture
in
the
vagina
in
order
to
dissolve
completely,
otherwise undissolved pieces of the pessary might crumble out of the
vagina. Pieces of
undissolved pessary may be noticed by women who experience vaginal
dryness. To help
prevent this it is important that the pessary is inserted as high as
possible in to the vagina
at bedtime.
Treatment during the menstrual period should be avoided due to the
risk of the pessary
being washed out by the menstrual flow. The treatment should be
finished before the
onset of menstruation.
Do not use tampons, intravaginal douches, spermicides or other vaginal
products
while using this product.
The cream should be thinly applied to the vulva and surrounding area,
two or three times
daily and rubbed in gently.
Treatment
with
the
cream
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 patie