FUCICORT CREAM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BETAMETHASONE AS VALERATE; FUSIDIC ACID

Available from:

DEXCEL LTD, ISRAEL

ATC code:

D07CC01

Pharmaceutical form:

CREAM

Composition:

FUSIDIC ACID 2 %; BETAMETHASONE AS VALERATE 0.1 %

Administration route:

DERMAL

Prescription type:

Required

Manufactured by:

LEO LABORATORIES LTD., IRELAND

Therapeutic group:

BETAMETHASONE AND ANTIBIOTICS

Therapeutic area:

BETAMETHASONE AND ANTIBIOTICS

Therapeutic indications:

Treatment of eczematous dermatoses when secondary bacterial infection is confirmed.

Authorization date:

2022-03-31

Patient Information leaflet

Composition: FUCICORT CREAM contains Fusidic acid 2% and Betamethasone
)as
valerate( 0.1%.
Inactive ingredients and allergens - see section 6 “Additional
information” and section 2
“Important information about some of the ingredients of the
medicine”.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE
MEDICINE. This leaflet
contains concise information about the medicine. If you have any
further questions, refer
to the doctor or to the pharmacist.
This medicine has been prescribed for your treatment. Do not pass it
on to others. It may
harm them, even if you think that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
For treating skin infections of various types, such as eczema, which
have secondary
bacterial infection.
MEDICAL ACTIVITY:
FUCICORT CREAM contains two different active ingredients: Fusidic acid
which is a type of
antibiotic and Betamethasone valerate, which is a type of
corticosteroid )steroid(. These
two active ingredients work at the same time in different ways.
FUCICORT CREAM works by:
• The antibiotic killing germs )bacteria( that cause infections.
• The corticosteroid reducing any swelling, redness or itchiness of
your skin.
THERAPEUTIC GROUP: Combination of corticosteroids )steroid( with
antibiotics.
2. BEFORE USING THE MEDICINE
Do not use the medicine:
•
If you are sensitive )allergic( to the active ingredients )Fusidic
acid or Betamethasone
valerate( or any of the other ingredients in this medicine )see
Section 6(
•
To treat a skin condition caused by a fungus )such as athlete’s
foot(.
•
To treat a skin condition caused by a virus )such as cold sores
)herpes( or
chickenpox(.
•
To treat skin conditions caused by bacteria only )such as boils or
spots(.
•
To treat skin conditions caused by tuberculosis or syphilis.
•
To treat a skin condition called perioral dermatitis. This is a red
spotty rash around
the mouth or the chin.
•
To treat a skin condition called rosacea. This is redness and
inflammation over the
nose and the cheeks. As

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Fucicort cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Fucicort cream contains Fusidic acid 2% and Betamethasone (as
valerate) 0.1%.
Excipients with known effect:
Cetostearyl alcohol and Chlorocresol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream.
A white cream.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of eczematous dermatoses when secondary bacterial infection
is confirmed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
A small quantity should be applied to the affected area twice daily
until a satisfactory
response is obtained. A single treatment course should not normally
exceed 2 weeks. In the
more resistant lesions the effect of Fucicort cream can be enhanced by
occlusion with
polythene film. Overnight occlusion is usually adequate.
METHOD OF ADMINISTRATION
Cutaneous use.
4.3 CONTRAINDICATIONS
Hypersensitivity to fusidic acid/sodium fusidate, betamethasone
valerate or to any of the
excipients listed in section 6.1.
Due to the content of
corticosteroid
, Fucicort is contraindicated in the following conditions:
Systemic fungal infections.
Primary skin infections caused by fungi, virus or bacteria, either
untreated or uncontrolled by
appropriate treatment (see section 4.4).
Skin manifestations in relation to tuberculosis or syphilis, either
untreated or uncontrolled by
appropriate therapy.
Perioral dermatitis and rosacea.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Long-term continuous topical therapy with Fucicort should be avoided.
Depending on the application site, possible systemic absorption of
betamethasone valerate
should always be considered during treatment with Fucicort.
Due to the content of corticosteroid, Fucicort should be used with
care near the eyes. Avoid
getting Fucicort into the eyes (see section 4.8).
Visual disturbance may be reported with systemic and topical
corticosteroid use. If a patient
presents with symptoms such as blurred vision or other visual
disturba