Canesten 500 mg Pessary.

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Clotrimazole

Verfügbar ab:

PCO Manufacturing Ltd.

ATC-Code:

G01AF02

INN (Internationale Bezeichnung):

Clotrimazole

Dosierung:

500 milligram(s)

Darreichungsform:

Pessary

Verschreibungstyp:

Product not subject to medical prescription

Therapiebereich:

clotrimazole

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2006-03-03

Gebrauchsinformation

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
CANESTEN
®
500 MG PESSARY
CLOTRIMAZOLE
R
EAD 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 500 mg Pessary and what is it used for
2.
What you need to know before you use Canesten 500 mg
Pessary
3.
How to use Canesten 500 mg Pessary
4.
Possible side effects
5.
How to store Canesten 500 mg Pessary
6.
Contents of the pack and other information
1.
WHAT IS CANESTEN 500 MG PESSARY AND WHAT IS
IT USED FOR
Canesten 500 mg Pessary is a single application for the
treatment of vaginal thrush. It is inserted into the vagina for the
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 500 mg 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 500 MG PESSARY
DO NOT USE CANESTEN 500 MG PESSARY:
•
If you are allergic (hypersensitive) to clotrimazole or any of
the other ingredients of Canesten 500 mg 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®
500 MG 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 mont

Fachinformation

Health Products Regulatory Authority
13 April 2022
CRN00CVKD
Page 1 of 2
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.
_Product imported from the UK and Greece:_
White, convex pessary marked 'BAYER' on one side and 'MU' on the
other.
4 CLINICAL PARTICULARS
As per PA1410/039/009
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/039/009
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Microcrystalline cellulose
Lactic acid
Maize starch
Crospovidone
Calcium lactate pentahydrate
Magnesium stearate
Silica, colloidal anhydrous
Hypromellose
Product sourced from Greece also contain purified water.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
Each pessary is packed into a foil blister. The foil blister is
enclosed in an over-labelled outer cardboard carton with a
disposable applicator and patient information leaflet.
Health Products Regulatory Authority
13 April 2022
CRN00CVKD
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the environment.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/048/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 03 March 2006
Last updated: February 2021
10 DATE