Canesten 500 mg Pessary
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
05-12-2022
Summary of Product characteristics
(SPC)
05-12-2022
Active ingredient:
Clotrimazole
Available from:
Bayer Limited
ATC code:
G01AF; G01AF02
INN (International Name):
Clotrimazole
Dosage:
500 milligram(s)
Pharmaceutical form:
Pessary
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Imidazole derivatives; clotrimazole
Authorization status:
Marketed
Authorization date:
1983-03-14
Patient Information leaflet
BCH22024
PACKAGE LEAFLET: INFORMATION FOR THE USER
CANESTEN® 500MG PESSARY
clotrimazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your pharmacist has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See Section 4.
•
You must contact a doctor if your symptoms worsen or do not improve in
7 days.
WHAT IS IN THIS LEAFLET
1. What is Canesten 500mg Pessary and what is it used for
2. What you need to know 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. Contents of the pack and other information
1. WHAT IS CANESTEN® 500MG PESSARY AND WHAT IS IT USED FOR
Canesten 500mg 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 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. WHAT YOU NEED TO KNOW 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 (listed in section 6).
•
During your period as it may be less effective.
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist before using
CANESTEN® 500MG PESSARY
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
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Summary of Product characteristics
Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten 500 mg Pessary
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pessary contains 500mg Clotrimazole.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Pessary.
White, convex pessary marked ‘Bayer’ on one side and ‘MU’ on
the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Canesten Pessaries are recommended for the treatment of candidal
vaginitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Canesten Pessary should be inserted intravaginally, as high as
possible, using the applicator supplied.
Adults and children of 12 years of age and over:
Insert one pessary daily, preferably at night before going to bed.
If symptoms persist for more than 7 days the patient may have a
medical condition that requires treatment by a doctor.
The treatment can be repeated if necessary, however, recurrent
infections may indicate an underlying medical cause. Patient
should seek medical advice if symptoms return within 2 months.
If the labia and adjacent areas are simultaneously infected, local
treatment with an external cream should also be given, in
addition to the intravaginal treatment (combination treatment).
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.
Children under 12 years of age:
As this product is administered with a vaginal applicator, paediatric
usage is not recommended.
To insert the pessary:
1.
Pull out plunger until it stops. Place the pessary into the
applicator.
2.
Carefully insert the applicator containing the pessary as deeply as is
comfortable into the vagina. (This is best done
with the patient lying on her back with th
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