Canesten HC Cream; Clotrimazole 1.0% w/w; Hydrocortisone 1% w/w

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

CLOTRIMAZOLE, HYDROCORTISONE

Fáanlegur frá:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

ATC númer:

D01AC20

INN (Alþjóðlegt nafn):

CLOTRIMAZOLE 1 % (W/W) HYDROCORTISONE 1 % (W/W)

Lyfjaform:

CREAM

Samsetning:

CLOTRIMAZOLE 1 % (W/W) HYDROCORTISONE 1 % (W/W)

Gerð lyfseðils:

POM

Lækningarsvæði:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Leyfisstaða:

Authorised

Leyfisdagur:

2013-12-17

Upplýsingar fylgiseðill

BCH22024
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 BEFORE YOU START USING THIS
MEDICINE 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. 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 ingredients of Canesten HC Cream.
•
On areas of broken skin.
•
On large areas of skin (more than 5–10% of body surface).
•
For longer th

Vara einkenni

BCH22024
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 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 large areas (more than 10% of the body surface).
BCH22024

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
reactions
(e.g.
contact
dermatitis).
Visual disturbance:
Visual disturbance may be reported with systemic and topical
corticosteroid use. If a patient presents
with symptoms su