Canesten Hydrocortisone Athlete’s Foot 1%, 1% w/w Cream

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

CLOTRIMAZOLE, HYDROCORTISONE

Tillgänglig från:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

ATC-kod:

D01AC20

INN (International namn):

CLOTRIMAZOLE 10 mg/g HYDROCORTISONE 10 mg/g

Läkemedelsform:

CREAM

Sammansättning:

CLOTRIMAZOLE 10 mg/g HYDROCORTISONE 10 mg/g

Receptbelagda typ:

OTC

Terapiområde:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Bemyndigande status:

Withdrawn

Tillstånd datum:

2014-01-17

Bipacksedel

Pack Type:
Pack Size:
Action:
Date:
Country:
Finished Goods Code:
Synaps Request Code:
Component Code:
Pharmacode No/NE:
PIL 148 x 210 (P041)
Leaflet
UK
Cutter
Guides
Technical & Non Printing Items
15 g
BAY352422
Main Text (body copy):
Height (based on lower case x):
7 pt
1.3 mm
FONT SIZE PANEL
12/12/18
TL021765
8080975-04
80179936
B
TR1482807
010001101(652)
1
LTH
Process Black
2
LTH
PANTONE 200 C
Colours
_HYDROCORTISONE_
Clotrimazole
Hydrocortisone acetate
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 Hydrocortisone 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 after 7 days.
•
If you have any unusual effects after using this product,
tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What is Canesten Hydrocortisone and what is it
used for?
2.
Before you use Canesten Hydrocortisone
3.
How to use Canesten Hydrocortisone
4.
Possible side effects
5.
How to store Canesten Hydrocortisone
6.
Further information
1.
WHAT IS CANESTEN
®
HYDROCORTISONE AND WHAT IS IT
USED FOR?
Canesten Hydrocortisone is used to treat athlete’s foot and
fungal sweat rash when there are additional symptoms of
inflammation (such as swelling, redness and itching).
Canesten Hydrocortisone treats the fungal skin infection
and reduces the swelling and itching caused by it.
IF YOU ARE UNSURE WHETHER YOU HAVE ONE OF THESE FUNGAL SKIN
INFECTIONS, SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
The active substances in Canesten Hydrocortisone are
clotrimazole and hydrocortisone acetate. Clotrimazole
belongs to a group of medicines called imidazoles, which
destroy the fungi and some bacteria that cause skin
infections. Hydrocortisone acetate is a mild steroid which
reduces swelling, redness and itching associated with
inflammation of the s

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINALPRODUCT
Canesten Hydrocortisone
Canesten Hydrocortisone Athlete’s Foot 1%, 1% w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 10mg clotrimazole and 11.2mg
hydrocortisone acetate
(equivalent to 10mg hydrocortisone).
Excipient with known effect: Cetostearyl alcohol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
White cream
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Canesten Hydrocortisone is indicated for the treatment of the
following skin infections
where co-existing symptoms of inflammation, e.g. itching, require
rapid relief:
(i)
Athlete’s foot.
(ii)
Candidal intertrigo.
4.2
Posology and method of administration
Posology:
Adults, elderly and children aged 10 years and over:
Canesten Hydrocortisone should be thinly and evenly applied to the
affected area
twice daily and rubbed in gently. The maximum period of treatment is
seven days.
A total daily dose of 10 mg cream per kg body weight should not be
exceeded. For an
adult weighing 50 kg the maximum daily dose is 500 mg cream which
equals
approximately 2 cm of cream to be divided into 2 applications per day.
Treatment duration:
If the acute symptoms have subsided after about 7 days but treatment
is still required,
this may be carried out with the corticoid-free preparation intended
for this purpose.
4.3
Contraindications
Canesten Hydrocortisone is contra-indicated in the following cases:
□
Hypersensitivity to the active substances or to any of the excipients
listed in section
6.1
□
Use on broken skin.
□
Use on large areas of skin.
□
Use for periods of longer than sevendays.
□
To treat cold sores or acne.
□
Use on the face, eyes, mouth ormucous membranes.
□
Children under 10 years of age, unless prescribed by a doctor.
□
Pregnancy and lactation, unless prescribed by adoctor.
□
Use on the ano-genital area, unless prescribed by a doctor.
□
To treat ringworm, unless prescribed by a doctor.
□
To treat secondarily i