Canesten 10 mg/g Cream

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Clotrimazole

থেকে পাওয়া:

PCO Manufacturing Ltd.

এটিসি কোড:

D01AC; D01AC01

INN (International Name):

Clotrimazole

ডোজ:

10 milligram(s)/gram

ফার্মাসিউটিকাল ফর্ম:

Cream

প্রেসক্রিপশন টাইপ:

Product not subject to medical prescription

Therapeutic area:

Imidazole and triazole derivatives; clotrimazole

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2000-04-14

তথ্য লিফলেট

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PATIENT LEAFLET: INFORMATION FOR THE USER
CANESTEN
®
10 MG/G CREAM
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.
WHAT IS IN THIS LEAFLET
1.
What is Canesten Cream and what is it used for
2.
What you need to know before you use Canesten Cream
3.
How to use Canesten Cream
4.
Possible side effects
5.
How to store Canesten Cream
6.
Contents of the pack and other information
1.
WHAT IS CANESTEN CREAM AND WHAT IT IS USED FOR
Canesten Cream is used to treat fungal skin infections such as
ringworm, athlete’s foot, fungal nappy rash and fungal sweat rash.
It is also used to relieve irritation of the vulva (external thrush)
or
the end of the penis, which may be associated with thrush.
IF YOU ARE UNSURE WHETHER YOU (OR YOUR BABY IF TREATING NAPPY
RASH) HAVE ONE OF THESE FUNGAL SKIN INFECTIONS, SEEK THE
ADVICE OF YOUR DOCTOR OR PHARMACIST.
The active substance in Canesten Cream is clotrimazole.
Clotrimazole belongs to a group of medicines called imidazoles
and is an antifungal agent which fights the cause of fungal skin
infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CANESTEN CREAM
DO NOT USE CANESTEN CREAM
If you (or your baby if treating nappy rash) are allergic
(hypersensitive) to clotrimazole or any of the other ingredients
including cetostearyl alcohol or benzyl alcohol, of Canesten
Cream (listed in section 6).
CANESTEN CREAM CONTAINS CETOSTEARYL ALCOHOL AND BENZYL
ALCOHOL.
This product contains cetostearyl alcohol which may cause local
skin irritation (e.g. rash, itching o

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
23 August 2022
CRN00D05N
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten 10 mg/g Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 10 mg clotrimazole equivalent to 1% w/w.
Excipient(s) with known effect: cetostearyl alcohol and benzyl
alcohol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
_Product imported from Greece and Portugal_
A white oil-in water type cream.
4 CLINICAL PARTICULARS
As per PA1410/039/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/039/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sorbitan Stearate
Polysorbate 60
Cetyl Palmitate
Cetostearyl alcohol
2-Octyldodecanol
Benzyl alcohol
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date on the
container and outer package of the product in 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
Aluminium tubes with screw on caps containing 20 g of cream. Each tube
is contained within a cardboard carton.
Health Products Regulatory Authority
23 August 2022
CRN00D05N
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/048/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14 April 2000
Date of last renewal: 14 April 2010
10 DATE OF REVISION OF THE TEXT
August 2022