Canesten 100mg Pessary

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 100 mg

Pharmaceutical form:

PESSARY

Composition:

CLOTRIMAZOLE 100 mg

Prescription type:

OTC

Therapeutic area:

GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS

Authorization status:

Withdrawn

Authorization date:

2006-03-09

Patient Information leaflet

PMR 86102714 (69/00-C) Pantone: 485, Cool Gray 11
0
100MG PESSARY
Clotrimazole
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 100mg 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 100mg Pessary and what is it used for?
2.
Before you use Canesten 100mg Pessary
3.
How to use Canesten 100mg Pessary
4.
Possible side effects
5.
How to store Canesten 100mg Pessary
6.
Further information
1.
WHAT IS CANESTEN® 100MG PESSARY
AND WHAT IS IT USED FOR?
Canesten 100mg Pessary is indicated 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 100mg 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® 100MG
PESSARY
DO NOT USE CANESTEN® 100MG PESSARY:
•
You are allergic (hypersensitive) to clotrimazole or any of the other
ingredients of Canesten 100mg Pessary (_see Section 6. Further_
_Information_).
•
During your period as it may be less effective.
BEFORE USING CANESTEN® 100MG 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 to C

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Canesten 100mg Pessary.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 100mg.
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Pessary
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Canesten 100mg Pessaries are recommended for the treatment of candidal
vaginitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The pessaries should be inserted into the vagina, as high as possible,
using the applicator
provided. This is best achieved when lying back with legs bent up.
Adults:
Two pessaries should be inserted daily (preferably at night) for three
consecutive days.
Alternatively, one pessary may be inserted daily for six days,
preferably at night. A
second treatment may be carried out if necessary.
There is no separate dosage schedule for the elderly.
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 into the vagina
at bedtime.
Generally:
treatment during the menstrual period should not be performed 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.
2
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
CONTRA-INDICATIONS
Hypersensitivity to clotrimazole or any other ingredient in this
medicine.
4.4
SPECIAL WARNINGS AND SPECIAL 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 100mg Pessaries, medical advice must be sought
if any of the
fo