Canesten Cream

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Clotrimazole

제공처:

Bayer Limited

ATC 코드:

D01AC; D01AC01

INN (International Name):

Clotrimazole

복용량:

1 percent weight/weight

약제 형태:

Cream

처방전 유형:

Product not subject to medical prescription

치료 영역:

Imidazole and triazole derivatives; clotrimazole

승인 상태:

Marketed

승인 날짜:

1977-04-01

환자 정보 전단

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

제품 특성 요약

Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 1 of 5
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 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
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:
Health Products Regul