Canesten Cream 1% w/w

Country: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

সক্রিয় উপাদান:

CLOTRIMAZOLE

থেকে পাওয়া:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

এটিসি কোড:

D01AC01

INN (International Name):

CLOTRIMAZOLE 1 % (W/W)

ফার্মাসিউটিকাল ফর্ম:

CREAM

রচনা:

CLOTRIMAZOLE 1 % (W/W)

প্রেসক্রিপশন টাইপ:

OTC

Therapeutic area:

ANTIFUNGALS FOR DERMATOLOGICAL USE

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2006-03-09

তথ্য লিফলেট

BCH22024
PATIENT LEAFLET: INFORMATION FOR THE USER
CANESTEN® CREAM
Clotrimazole 1% w/w
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 IS IT 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
or

পণ্য বৈশিষ্ট্য

BCH22024
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Canesten Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 10mg Clotrimazole equivalent to 1% w/w.
Excipients with known effect:
Cetostearyl alcohol 100mg in each gram of cream
Benzyl alcohol 20mg in each gram of cream
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
A white oil-in-water type cream.
4.
CLINICAL PARTICULARS
4.1
Therapeutic Indications
A
broad
spectrum
antifungal
for
use
in
the
topical
treatment
of
infections
due
to
superficial
dermatophytes, Candida species and other fungi sensitive to the
anti-infective: Staphylococcus and
Bacteroides. The drug has no effect on Lactobacilli.
4.2
Posology and method of administration
Canesten Cream should be applied to the affected area 2 or 3 times
daily. To prevent relapse, treatment
should be continued for at least two weeks after the disappearance of
all signs of infection.
Patients should notify their physician if there is no improvement
after 4 weeks of treatment.
4.3
Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
Special warnings and precautions for use
All possibly infected areas should be treated at the same time.
This
product
contains cetostearyl
alcohol,
which may
cause local
skin reactions (e.g. contact
dermatitis). The product also contains benzyl alcohol which may cause
allergic reactions and mild
local irritation.
Avoid contact with eyes and do not swallow.
4.5
Interactions with other medicinal products and other forms of
interaction
BCH22024
Laboratory tests have suggested that, when used together, this product
may cause damage to latex
contraceptives. Consequently the effectiveness of such contraceptives
may be reduced. Patients
should be advised to use alternative precautions for at least five
days after using this product.
4.6
Fertility, pregnancy and lactation
Pregnancy:
There are limited data available from the use of clotrimazole in
pregnant wo