Fucidin H 20mg/g + 10mg/g Cream

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FUSIDIC ACID, HYDROCORTISONE ACETATE

Available from:

LEO Laboratories Limited 285 Cashel Road, Dublin 12, Ireland

ATC code:

D07CA01

INN (International Name):

FUSIDIC ACID 20 mg/g HYDROCORTISONE ACETATE 10 mg/g

Pharmaceutical form:

CREAM

Composition:

FUSIDIC ACID 20 mg/g HYDROCORTISONE ACETATE 10 mg/g

Prescription type:

POM

Therapeutic area:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2005-08-01

Patient Information leaflet

BATCH RELEASE SITE ITALY
PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIDIN
® H 20 MG/G + 10 MG/G CREAM
Fusidic acid/hydrocortisone acetate
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.
WHAT IS IN THIS LEAFLET
1.
WHAT FUCIDIN
® H CREAM IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FUCIDIN
® H CREAM
3.
HOW TO USE FUCIDIN
® H CREAM
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE FUCIDIN
® H CREAM
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT FUCIDIN® H CREAM IS AND WHAT IT IS USED FOR
Fucidin
®
H cream contains two different types of medicine. One medicine is
called fusidic acid. It is a type
of antibiotic. The other medicine is called hydrocortisone acetate. It
is a type of corticosteroid (steroid). The
two medicines work at the same time in different ways.
Fucidin
®
H cream works by:
The antibiotic killing germs (bacteria) that causes infections.
The corticosteroid reducing any swelling, redness or itchiness of your
skin.
It 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 FUCIDIN® H CREAM
DO NOT USE FUCIDIN
® H CREAM:
If you are allergic (hypersensitive) to fusidic acid/sodium fusidate
or hydrocortisone acetate or any other
ingredients of this medicine (listed in section 6).
AS THIS MEDICINE CONTAINS A STEROID DO NOT USE
•
To treat skin conditions caused by a fungus, such as athlete’s foot
or ringworm
•
To treat skin conditions caused by a virus, such as cold sor

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Fucidin
®
H 20 mg/g + 10 mg/g Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains fusidic acid, anhydrous (as hemihydrate) 20 mg and
hydrocortisone
acetate 10 mg.
Excipients with known effect
Butylhydroxyanisole (E320) 0.04 mg
Cetyl alcohol 111 mg
potassium sorbate 2.7 mg
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Cream.
A white, homogeneous 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, hydrocortisone
acetate or to any of the
excipients listed in section 6.1.
Due to the content of corticosteroid, Fucidin® H is contraindicated
in the following
conditions:
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
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therapy.
Perioral dermatitis and rosacea.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Long-term continuous topical therapy with Fucidin® H should be
avoided. Atrophic changes
may occur on the face and to a lesser degree in other parts of the
body, after prolonged
treatment with topical steroids.
Depending on the application site, possible systemic absorption of
hydrocortisone acetate
should always be considered during treatment with Fucidin® H.
Due to the content of corticosteroid, Fucidin® H should be used with
care near the eyes.
Avoid getting Fucidin® H into the eyes (see section 4.8).
Raised
intra-ocular
pressure
and
glaucoma
can
also
be
caused
by
topical
use
of
corticosteroids on the face, particularly with prolonged use near