Fucidin 20mg/g Cream,

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FUSIDIC ACID

Available from:

LEO Laboratories Limited 285 Cashel Road, Dublin 12, Ireland

ATC code:

D06AX01

INN (International Name):

FUSIDIC ACID 20 mg

Pharmaceutical form:

CREAM

Composition:

FUSIDIC ACID 20 mg

Prescription type:

POM

Therapeutic area:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Authorization status:

Authorised

Authorization date:

2005-08-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIDIN
® 20 MG/G CREAM
fusidic acid
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT FUCIDIN
® CREAM IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FUCIDIN
®
CREAM
3.
HOW TO USE FUCIDIN
® CREAM
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE FUCIDIN
® CREAM
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT FUCIDIN
® CREAM IS AND WHAT IT IS USED FOR
Fucidin cream belongs to a group of medicines called antibiotics. The
antibiotic in this product is
called fusidic acid.
Fucidin cream works by killing germs (bacteria) that cause infections.
It is used to treat skin infections such as those caused by bacteria
called
_Staphylococcus aureus._
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FUCIDIN
® CREAM
DO NOT USE FUCIDIN CREAM:
• If you are allergic to fusidic acid or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE USING FUCIDIN CREAM
•
Do not use Fucidin
cream for a long time as the germs (bacteria) may no longer be killed
by
the antibiotic.
•
Avoid getting the cream in your eyes (e.g., accidentally from your
hands or by using it too
close to your eyes) as it could irritate (sting) them.
OTHER MEDICINES AND FUCIDIN CREAM
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think you may be pregnant or
are

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
Fucidin 20 mg/g Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 20 mg fusidic acid.
Excipients with known effect:
Contains butylhydroxyanisole (E320) 0.04 mg/g, potassium sorbate 2.7
mg/g and cetyl alcohol 111
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
In the topical treatment of infections due to micro-organisms
sensitive to this anti-infective, in
particular _Staphylococcus aureus_.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Apply three to four times daily or as required.
Less frequent application may be adequate for covered lesions.
Method of administration
Cutaneous use
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bacterial resistance among _Staphylococcus aureus _ has been reported
to occur with the use of
topical Fucidin. As with all antibiotics, extended or recurrent use of
fusidic acid may increase the
risk of developing antibiotic resistance.
Fucidin
cream contains butylhydroxyanisole, potassium sorbate and cetyl
alcohol. These
excipients may cause local skin reactions (e.g. contact dermatitis).
Butylhydroxyanisole may also
cause irritation to the eyes and mucous membranes. Fucidin
cream should therefore be used with
care when applied in the proximity of the eyes.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction studies have been performed. Interactions with
systemically administered medicinal
products are considered minimal as the systemic absorption of topical
Fucidin is negligible.
4.6 FERTILITY, PREGNANCY AND LACTATION
Fertility
There are no clinical studies with topical Fucidin regarding
fertility. No effects in women of
childbearing potential are anticipated, since systemic exposure
following topically-applied fusidic
acid/sodium fusidate is negligible.
Pregnancy
No e