Canesten HC cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone acetate; Clotrimazole

Available from:

Bayer Plc

ATC code:

D01AC20

INN (International Name):

Hydrocortisone acetate; Clotrimazole

Dosage:

10mg/1gram ; 10mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000; GTIN: 5010605054310

Patient Information leaflet

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 or pharmacist.
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 Cream 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 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 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, including cetostearyl alcohol or
benzyl alcohol, 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 any untreated bacterial skin infection,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Canesten HC Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 10mg clotrimazole and 11.2mg
hydrocortisone acetate
(equivalent to 10mg hydrocortisone).
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
White cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Canesten HC is indicated for the treatment of the following skin
infections
where co-existing symptoms of inflammation, e.g. itching, require
rapid relief:
a)
All dermatomycoses due to dermatophytes (e.g. Trichophyton species),
moulds and other fungi.
b)
All dermatomycoses due to yeasts (Candida species).
c)
Skin diseases showing secondary infection with these fungi.
d)
The treatment of nappy rash where infection due to Candida albicans is
present. Candidal vulvitis, candidal balanitis and candidal
intertrigo.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Canesten HC Cream should be thinly and evenly applied to the affected
area
twice daily and rubbed in gently. Treatment should be for a maximum of
7
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.
There is no separate dosage schedule for the elderly or the young.
However,
long-term therapy to extensive areas of skin should be avoided
particularly in
infants and children.
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
-
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
-
Use on broken skin
-
Diseases affecting the skin (e.g. acne, rosacea, perioral dermatitis,
lues,
t