Fucidin 20 mg/g ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium fusidate

Available from:

Leo Laboratories Limited

ATC code:

D06AX; D06AX01

INN (International Name):

Sodium fusidate

Dosage:

20 milligram(s)/gram

Pharmaceutical form:

Ointment

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antibiotics for topical use; fusidic acid

Authorization status:

Marketed

Authorization date:

1977-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIDIN
® 20 MG/G OINTMENT
sodium fusidate
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
® OINTMENT IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FUCIDIN
® OINTMENT
3.
HOW TO USE FUCIDIN
® OINTMENT
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE FUCIDIN
® OINTMENT
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT FUCIDIN
® OINTMENT IS AND WHAT IT IS USED FOR
Fucidin ointment belongs to a group of medicines called antibiotics.
The antibiotic in this product
is called sodium fusidate.
Fucidin ointment 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
® OINTMENT
DO NOT USE FUCIDIN OINTMENT:
• If you are allergic to sodium fusidate 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 OINTMENT
•
Do not use Fucidin
ointment for a long time
as the germs (bacteria) may no longer be killed by
the antibiotic.
•
Avoid getting the ointment 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 OINTMENT
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fucidin 20 mg/g ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 20 mg sodium fusidate.
Excipients with known effect: Contains cetyl alcohol 4 mg/g, wool fat
(lanolin) 46 mg/g and butylhydroxytoluene
(E321).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
Translucent, yellowish to white ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fucidin 20 mg/g ointment is indicated in the topical treatment of
infections due to micro
-
organisms sensitive to this
anti-infective such as_ Staphylococcus aureus_.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and Paediatric Population_
Apply three to four times daily 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 ointment contains cetyl alcohol and wool fat (lanolin).
These excipients may cause local skin reactions (e.g.
contact dermatitis). Fucidin ointment contains butylhydroxytoluene
(E321) which may cause local skin reactions (e.g.
contact dermatitis), or irritation to the eyes and mucous membranes.
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