Fucidin 20mg/g Ointment,

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

FUSIDATE SODIUM

Beszerezhető a:

LEO Laboratories Limited 285 Cashel Road, Dublin 12, Ireland

ATC-kód:

D06AX01

INN (nemzetközi neve):

FUSIDATE SODIUM 20 mg/g

Gyógyszerészeti forma:

OINTMENT

Összetétel:

FUSIDATE SODIUM 20 mg/g

Recept típusa:

POM

Terápiás terület:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Engedélyezési státusz:

Authorised

Engedély dátuma:

2005-08-01

Betegtájékoztató

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

Termékjellemzők

1.
NAME OF THE MEDICINAL PRODUCT
Fucidin® Ointment, 20 mg/g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium fusidate 20 mg/g
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Ointment.
Translucent yellowish to white ointment.
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
Adults and children:
Uncovered lesions: apply gently three to four times daily as
required. Covered lesions: less frequent applications may be
adequate.
4.3
Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
Special Warning 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.
When Fucidin® Ointment is used on the face; care should be taken to
avoid contact with the
eyes as the sodium salt of fusidic acid may cause conjunctival
irritation.
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