Canesten Combi Pessary & Cream

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Clotrimazole

Boleh didapati daripada:

PCO Manufacturing Ltd.

Kod ATC:

G01AF; G01AF02

INN (Nama Antarabangsa):

Clotrimazole

Dos:

500mg + 2 percent weight/weight

Borang farmaseutikal:

Pessaries and Cream

Jenis preskripsi:

Product not subject to medical prescription

Kawasan terapeutik:

Imidazole derivatives; clotrimazole

Status kebenaran:

Authorised

Tarikh kebenaran:

2009-06-25

Risalah maklumat

_ _
_ _
PATIENT INFORMATION LEAFLET
CANESTEN
® COMBI
PESSARY AND CREAM
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 Combi Pessary & Cream 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 Combi and what is it used for?
2.
Before you use Canesten Combi
3.
How to use Canesten Combi
4.
Possible side effects
5.
How to store Canesten Combi
6.
Further information
1.
WHAT IS CANESTEN COMBI AND WHAT IS IT USED FOR?
Canesten Combi Pessary & Cream is a complete treatment for
vaginal thrush because it treats both the internal cause and
external symptoms.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY
DIAGNOSED BY YOUR DOCTOR AS HAVING VAGINAL THRUSH.
The active substance in Canesten Combi Pessary & Cream 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.
Some women suffer from recurrent attacks of thrush. To reduce
the frequency of these attacks, the sexual partner’s penis can be
treated with this cream to prevent reinfection, even if they have
no symptoms of thrush.
2.
BEFORE YOU USE CANESTEN COMBI
DO NOT USE CANESTEN COMBI PESSARY & CREAM:

If you are allergic (hypersensitive) to clotrimazole or any of
the other ingredients of Canesten Combi Pessary & Cream
(see Section 6. Further Information)

During your period as it may be less effective.
BEFORE USING CANESTEN COMBI PESSARY & CREAM, 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

Ciri produk

Health Products Regulatory Authority
10 November 2020
CRN00C0YR
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten Combi Pessary & Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The pessary contains clotrimazole 500 mg.
Each gram of cream contains 20 mg of clotrimazole (equivalent to 2%
w/w)
Excipient(s) with known effect: Cetostearyl alcohol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pessary and vaginal cream
_Product imported from_ UK:
White, convex pessary marked ‘Bayer’ on one side and ‘MU’ on
the other side.
A white oil-in-water type cream
4 CLINICAL PARTICULARS
As per PA1410/039/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/039/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Pessary:
Lactose monohydrate
Microcrystalline cellulose
Lactic acid
Maize starch
Crospovidone
Calcium lactate pentahydrate
Magnesium stearate
Silica, colloidal anhydrous
Hypromellose
Cream:
Sorbitan stearate
Cetyl Palmitate
Cetostearyl alcohol
Octyldodecanol
Benzyl alcohol
Purified Water
6.2 INCOMPATIBILITIES
Health Products Regulatory Authority
10 November 2020
CRN00C0YR
Page 2 of 2
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 blister consisting of 25 micrometers
PA/45 micrometers soft aluminium/ 60 micrometers PVC
and 20 micrometers hard aluminium/7g/m2 heat seal lacquer. The cream
is supplied in overlabelled aluminium tubes. Both
components are enclosed in an overlabelled cardboard carton.
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