Fucidin Ointment, 20mg/g

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

FUSIDATE SODIUM

Dostopno od:

LEO Pharma A/S

Koda artikla:

D06AX01

INN (mednarodno ime):

FUSIDATE SODIUM

Farmacevtska oblika:

OINTMENT

Sestava:

FUSIDATE SODIUM 20 mg/g

Tip zastaranja:

POM

Terapevtsko območje:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Status dovoljenje:

Authorised

Datum dovoljenje:

2005-08-01

Navodilo za uporabo

Page 1 of 4
PACKAGE INSERT LEAFLET
FUCIDIN® OINTMENT
_In this leaflet:_
1. What Fucidin® ointment is and what it is used for
2. Before you use Fucidin® ointment
3. How to use Fucidin® ointment
4. Possible side effects
5. How to store Fucidin® ointment
FUCIDIN® OINTMENT
Active substance: Sodium fusidate 20 mg/g
Other ingredients: Cetyl alcohol, wool fat, liquid paraffin and white
soft paraffin.
PRESENTATION AND CONTENTS
Tubes containing 15 g of ointment
MARKETING AUTHORISATION HOLDER
LEO Pharmaceutical Products
Industriparken 55, DK-2750 Ballerup, Denmark
MANUFACTURER
LEO Laboratories Ltd.
285 Cashel Road, IRL-Dublin 12, Ireland
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. BEFORE YOU USE FUCIDIN® OINTMENT
FUCIDIN® OINTMENT MUST NOT BE USED

if you are allergic to sodium fusidate or any of the other ingredients
of this medicine.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING FUCIDIN® OINTMENT

Do not use Fucidin® for a long time as the germs (bacteria) may no
longer be killed by the
antibiotic.
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Page 2 of 4

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.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant or think you might be pregnant; Fucidin® ointment
may be used during
pregnancy.

If you are breast-feeding; Fucidin® ointment may be used by women who
are breast-feeding
but the ointment should not be applied to the breast.
DRIVING AND USING MACHINES
This medicine should not

Lastnosti izdelka

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