Canesten HC CreamClotrimazole 1.0%w/wHydrocortisone 1.0%w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clotrimazole; Hydrocortisone

Available from:

IMED Healthcare Ltd.

ATC code:

D01AC; D01AC01

INN (International Name):

Clotrimazole; Hydrocortisone

Dosage:

1.0 / 1.0 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Imidazole and triazole derivatives; clotrimazole

Authorization status:

Authorised

Authorization date:

2011-09-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION
FOR THE USER
CANESTEN HC CREAM
CLOTRIMAZOLE 1.0% W/W
HYDROCORTISONE 1.0% W/W
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to
anyone
else under any circumstances.
• If you have any unusual effects after using this product, tell
your doctor.
IN THIS LEAFLET
1. What is Canesten HC Cream and what is it used for?
2. Before you use Canesten HC Cream
3. How to use Canesten HC Cream
4. Possible side effects
5. How to store Canesten HC Cream
6. Further information
1. WHAT IS CANESTEN® HC CREAM AND
WHAT IS IT USED FOR?
Canesten HC Cream is used to treat fungal skin infections when there
are additional symptoms of inflammation (such as swelling, redness and
itching). Canesten HC treats the fungal skin infection and reduces the
swelling and itching caused by it.
Canesten HC Cream is used for the treatment of infection and
irritation
of the vulva or end of the penis (glans) caused by thrush. It is also
used
to treat nappy rash and fungal infection of the breast fold
(intertrigo), as
well as infections such as ringworm and athlete’s foot.
The active substances in Canesten HC Cream are clotrimazole and
hydrocortisone. Clotrimazole belongs to a group of medicines called
imidazoles, which destroy the fungi and some bacteria that cause skin
infections. Hydrocortisone is a mild steroid which reduces swelling,
redness and itching associated with inflammation of the skin.
2. BEFORE YOU USE CANESTEN® HC CREAM
DO NOT USE CANESTEN® HC CREAM:
• If you (or your baby if treating nappy rash) are allergic
(hypersensitive)
to clotrimazole, hydrocortisone or any of the other ingredients of
Canesten HC Cream.
• On areas of broken skin.
• On large areas of skin (more than 5–10% of body surface).
• For longer than 7 days.
• To treat cold sores or acne.
• On your face, eyes, mout

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten HC Cream
Clotrimazole 1.0%w/w
Hydrocortisone 1.0%w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The cream contains 1% w/w of clotrimazole and 1% w/w of
hydrocortisone.
Also contains cetostearyl alcohol.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cream
_Product imported from the UK_
A white to pale-yellow cream.
4 CLINICAL PARTICULARS
As per PA1410/040/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/040/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Benzyl alcohol
Cetostearyl alcohol
Medium chain triglycerides
Triceteareth-4 phosphate
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer carton of the product on the
market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Store in the original carton.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium tube with internal lacquer coating and HDPE screw-on cap in
an over-labelled cardboard carton.
Pack size: 30 g
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
No special requirements.
7 PARALLEL PRODUCT AUTHORISA