Canesten Thrush Soft Gel Pessary 500mg vaginal capsule

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 500 mg

Pharmaceutical form:

VAGINAL SOFT CAPSULE

Composition:

CLOTRIMAZOLE 500 mg

Prescription type:

OTC

Therapeutic area:

GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS

Authorization status:

Withdrawn

Authorization date:

2013-07-30

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 Thrush Soft Gel Pessary 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 Soft Gel Pessary and what is it used for?
2. Before you use Canesten Thrush Soft Gel Pessary
3. How to use Canesten Thrush Soft Gel Pessary
4. Possible side effects
5. How to store Canesten Thrush Soft Gel Pessary
6. Further information
1. WHAT IS CANESTEN® THRUSH SOFT GEL
PESSARY AND WHAT IS IT USED FOR?
Canesten Thrush Soft Gel Pessary is a single application for the
treatment
of vaginal thrush. It is inserted into the vagina for treatment at the
site of
infection.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR
DOCTOR AS HAVING VAGINAL THRUSH.
The active substance in Canesten Thrush Soft Gel Pessary 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
SOFT GEL PESSARY
DO NOT USE CANESTEN® THRUSH SOFT GEL PESSARY:
•
If you are allergic (hypersensitive) to clotrimazole or any of the
other
ingredients of Canesten Thrush Soft Gel Pessary (_see Section 6.
Further _
_Information_).
BEFORE USING CANESTEN® THRUSH SOFT GEL PESSARY, 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

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Canesten Thrush Soft Gel Pessary 500mg vaginal capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 500mg.
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Vaginal capsule, soft
Yellow teardrop-shaped soft capsule
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Canesten Soft Gel Pessary is indicated for the treatment of candidal
vaginitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
One 500mg soft gel pessary should be inserted 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. A second treatment may be
carried out if
necessary.
Generally:
Treatment during the menstrual period should not be performed 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.
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
Hypersensitivity to clotrimazole or any other ingredient in this
medicine.
Page 2 of 5
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 Soft Gel Pessaries, medical advice must be
sought if any of the
following are applicable:
- more than two infections of candidal vaginitis in the last 6 months.
- previous history of 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
products.
Canesten Soft Gel Pessaries should not be used if the pati