Fucidin 20mg/g Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fusidic acid

Available from:

Imbat Limited

ATC code:

D06AX; D06AX01

INN (International Name):

Fusidic acid

Dosage:

20 milligram(s)/gram

Pharmaceutical form:

Cream

Prescription type:

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

Therapeutic area:

Other antibiotics for topical use; fusidic acid

Authorization status:

Authorised

Authorization date:

2009-03-27

Patient Information leaflet

_Page 1 of 2 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIDIN
® 20MG/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 or
pharmacist.

This cream 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 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 medicines (listed in section 6).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING
FUCIDIN
CREAM

Do not use Fucidin 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 planning to have a baby, ask your doctor or p

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fucidin 20mg/g Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 20mg fusidic acid.
Excipients: cetyl alcohol, potassium sorbate, butylhydroxyanisole
(E320)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
Product imported from the United Kingdom.
A white, homogenous 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
Apply three to four times daily or as required.
Less frequent application may be adequate for covered lesions.
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.
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