Canesten HC CreamClotrimazole 1.0% w/w Hydrocortisone 1.0% w/w
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
05-12-2022
Summary of Product characteristics
(SPC)
05-12-2022
Active ingredient:
Clotrimazole; Hydrocortisone
Available from:
Bayer Limited
ATC code:
D01AC; D01AC20
INN (International Name):
Clotrimazole; Hydrocortisone
Dosage:
1 %w/w/1 percent weight/weight
Pharmaceutical form:
Cream
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Imidazole and triazole derivatives; combinations
Authorization status:
Marketed
Authorization date:
1984-08-15
Patient Information leaflet
BCH22024
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist, or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
1. What is Canesten HC Cream and what is it used for?
2. What you need to know 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. Contents of the pack and other 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. WHAT YOU NEED TO KNOW 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 ing
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten HC CreamClotrimazole 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 10% w/w cetostearyl alcohol.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cream
A white to pale yellow cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Canesten HC Cream is a combination of an antifungal and a
corticosteroid, both absorbable through broken skin. It is indicated
for the topical treatment of skin infections due to superficial
dermatophytes, yeasts, moulds and other fungi sensitive to
clotrimazole where co-existing symptoms of inflammation, e.g. itching,
require rapid relief.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Canesten HC Cream should be thinly and evenly applied to the affected
area twice daily and rubbed in gently.
Treatment should be continued for no more than 7 days.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
The following contra-indications apply to the hydrocortisone
component: specific bacterial skin diseases (syphilis, tuberculosis),
chicken pox, vaccination reactions, perioral dermatitis, viral skin
diseases (e.g. herpes simplex, rosacea, shingles), use on broken
skin, acne.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
All possibly infected areas should be treated at the same time.
Because of its corticosteroid content, Canesten HC should not be
applied:
To larger areas (more than 10% of the body surface).
In long term continuous therapy.
Under occlusive dressing, particularly in infants and children,
because of the possibility of adrenocortical
suppression.
This product contains cetostearyl alcohol, which may cause local skin
reaction (e.g contact dermatitis).
Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 2 of 6
VISUAL DIST
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