Canesten Soft Gel Pessary Combi 500mg Soft Gel Pessary & 2% w/w Cream

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLOTRIMAZOLE

Available from:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

ATC code:

G01AF02

INN (International Name):

CLOTRIMAZOLE 2 % (W/W)

Pharmaceutical form:

VAGINAL CREAM VAGINAL SOFT CAPSULE

Composition:

CLOTRIMAZOLE 2 % (W/W)

Prescription type:

OTC

Therapeutic area:

GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS

Authorization status:

Withdrawn

Authorization date:

2013-07-30

Patient Information leaflet

Black
Pantone 485 U
Pantone Cool
Gray 11 U
Kontur
CAN Soft Gel Pessary Combi GB
210 x 297 mm
Verlag Book, Book Italic, Bold, Bold Italic; Zapf Dingbats Regular;
Bliss Pro Medium
9 pt
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 Combi Soft Gel Pessary and External 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 Combi and what is it used for?
2. Before you use Canesten Thrush Combi
3. How to use Canesten Thrush Combi
4. Possible side effects
5. How to store Canesten Thrush Combi
6. Further information
1. WHAT IS CANESTEN® THRUSH COMBI
AND WHAT IS IT USED FOR?
Canesten Thrush Combi Soft Gel Pessary and External 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 Thrush Combi 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
COMBI
DO NOT USE CANESTEN® THRUSH COMBI SOFT GEL PESSARY AND EXTERNAL
CREAM:
•
If you are allergic (hypersensitive) to clotrimazole or any of the
other
ingredients, including cetostearyl alcohol, of Canesten Thrush
Combi Soft Gel Pessary and External Cream (_see Section 6. _
_Further Information_).
•
To treat nail and scalp infections.
BEFORE USING CANESTEN® THRUSH COMBI SOFT GEL PESSARY AND EXTERNAL
CREAM, YOU SHOULD SEE YOUR DOCTOR IF:
•
You are unsure whether you have thrush or

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Canesten Thrush Combi Soft Gel Pessary & External Cream 500mg / 2% w/w
vaginal capsule & cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Canesten Thrush Soft Gel Pessary contains Clotrimazole 500mg.
Canesten Thrush External Cream contains Clotrimazole 2% w/w.
Excipient with known effect:
Cream: Cetostearyl alcohol
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal capsule, soft
Yellow teardrop-shaped soft capsule
Cream
White cream
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The soft gel pessary is indicated for the treatment of candidal
vaginitis.
The cream is indicated 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 soft gel pessary should be inserted into the vagina at night.
Using the applicator provided, the
soft gel pessary should be inserted as high as possible into the
vagina. This is best achieved when
lying back with legs bent up.
Treatment during the menstrual period should be avoided due to the
risk of the soft gel 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.
2
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 patient
should consult a physician.
Vaginal intercourse should be avoided in case of vaginal infection and
while using this product
because the partner could become infected.
Children
Not for use in children under 16.
4.3
CONTRAINDICATIONS
Hyp