Canesten 500mg pessaries

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clotrimazole

Available from:

Bayer Plc

ATC code:

G01AF02

INN (International Name):

Clotrimazole

Dosage:

500mg

Pharmaceutical form:

Pessary

Administration route:

Vaginal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07020200; GTIN: 5010605620010

Patient Information leaflet

PMR 86114984 (O8/00-C) Pantone: 485, Cool Gray 11
86114984
0
500MG PESSARY
Clotrimazole
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not give it to
anyone else under any circumstances.
•
If you have any unusual effects after using this product, tell
your doctor.
IN THIS LEAFLET
1.
What is Canesten 500mg Pessary and what is it used for?
2.
Before you use Canesten 500mg Pessary
3.
How to use Canesten 500mg Pessary
4.
Possible side effects
5.
How to store Canesten 500mg Pessary
6.
Further information
1.
WHAT IS CANESTEN® 500MG PESSARY
AND WHAT IS IT USED FOR?
Canesten 500mg Pessary is a full course of treatment for vaginal
thrush (candidiasis). It is inserted into the vagina for treatment at
the site of infection.
The active substance in Canesten 500mg 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® 500MG
PESSARY
DO NOT USE CANESTEN® 500MG PESSARY:
•
If you are allergic (hypersensitive) to clotrimazole or any of the
other ingredients of Canesten 500mg Pessary_ (see Section 6._
_Further Information)_.
•
During your period as it may be less effective.
SPECIAL PRECAUTIONS:
As with other pessaries, this product may reduce the effectiveness
of rubber contraceptives, such as condoms or diaphragms.
Consequently, you should use alternative precautions for at least
five days after using this product.
Do not use tampons, intravaginal douches, spermicides or other
vaginal products while using this product.
Avoid vaginal intercourse while you have thrush and during use of
this product because your partner could become infected.
USING OTHER MEDICINES:
Please tell your doctor or pharmacist if you are taking or have
recently
taken any other medicines, including

Summary of Product characteristics

OBJECT 1
CANESTEN 500MG PESSARY
Summary of Product Characteristics Updated 16-Jan-2018 | Bayer plc
1. Name of the medicinal product
Canesten 500mg Pessary
2. Qualitative and quantitative composition
Clotrimazole 500mg.
For excipients, see 6.1.
3. Pharmaceutical form
Pessary.
White convex pessary.
4. Clinical particulars
4.1 Therapeutic indications
Canesten 500mg Pessary is recommended for the treatment of candidal
vaginitis.
4.2 Posology and method of administration
The pessary should be inserted into the vagina, as high as possible,
using the applicator provided.
Adults:
One 500mg pessary should be inserted 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. A second treatment may be carried out if necessary.
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.
Vaginal intercourse should be avoided in case of vaginal infection and
while using this product because
the partner could become infected.
Children: As the product is used with an applicator, paediatric usage
is not recommended.
4.3 Contraindications
Hypersensitivity to clotrimazole or any ingredient in this medicine.
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 Pessaries, medical advice must be s