Fucicort 20mg/g + 1mg/g Cream

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BETAMETHASONE, FUSIDIC ACID

Available from:

NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta

ATC code:

D07CC01

INN (International Name):

BETAMETHASONE 1 mg/g FUSIDIC ACID 20 mg/g

Pharmaceutical form:

CREAM

Composition:

BETAMETHASONE 1 mg/g FUSIDIC ACID 20 mg/g

Prescription type:

POM

Therapeutic area:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Product summary:

Licence number in the source country: Bulgaria - 20000217

Authorization status:

Authorised

Authorization date:

2014-05-21

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
FUCICORT® 20 MG/G + 1 MG/G CREAM
FUSIDIC ACID/BETAMETHASONE
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 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 OR PHARMACIST.
THIS INCLUDES
ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET.
• IN THIS LEAFLET FUCICORT® CREAM WILL BE CALLED FUCICORT®
WHAT IS IN THIS LEAFLET:
1. WHAT FUCICORT® IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FUCICORT®
3. HOW TO USE FUCICORT®
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE FUCICORT®
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT FUCICORT® IS AND WHAT IT IS USED FOR
Fucicort® contains two different types of medicine. One medicine is
called fusidic acid. It is a type of antibiotic. The other medicine is
called betamethasone valerate. It is a type of corticosteroid
(steroid).
The two medicines work at the same time in different ways.
Fucicort® works by:
• The antibiotic killing germs (bacteria) that cause infections.
• The corticosteroid reducing any swelling, redness or itchiness of
your skin.
Fucicort is used to treat:
• Conditions where the skin is inflamed (eczema or dermatitis) and
infected, or might
become infected, by germs (bacteria).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FUCICORT®
�
DO NOT USE FUCICORT®
• If you are allergic (hypersensitive) to fusidic acid/sodium
fusidate
or betamethasone valerate or any of the other ingredients of this
medicine (listed in
section 6).
• To treat infections caused by a fungus, such as athlete’s foot
or ringworm.
• To treat a skin condition caused by a virus, such as cold sores
orchicken pox.
• To treat skin conditions caused only by bact

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
Fucicort 20 mg/g + 1 mg/g cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Fusidic acid 20 mg/g and betamethasone 1 mg/g (as betamethasone
valerate).
Excipients with known effect
Cetostearyl
alcohol
72
mg/g
Chlorocresol 1 mg/g
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream
A white cream.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Use in inflammatory dermatoses where bacterial infection is present or
likely to occur.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Apply a small quantity to the affected area twice daily until a
satisfactory response is obtained. A single
treatment course should not normally exceed 2 weeks.
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, 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
®
in to 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 disturbances, the
patient should be considered for referral to
an ophthalmologist for evaluation of possible causes which may include
cataract, glaucoma or rare
diseases such as central serous chorioretinopathy (CSCR) which