Fucidin 20mg/g Cream

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Fusidic acid

Հասանելի է:

PCO Manufacturing Ltd.

ATC կոդը:

D06AX; D06AX01

INN (Միջազգային անվանումը):

Fusidic acid

Դոզան:

20 milligram(s)/gram

Դեղագործական ձեւ:

Cream

Ռեկվիզորի տեսակը:

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

Թերապեւտիկ տարածք:

Other antibiotics for topical use; fusidic acid

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2007-04-13

Տեղեկատվական թերթիկ

_ _
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,
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
®
for a long time as the germs
(bacteria) may no longer be killed by the antibiotic.

Avoid getting the cream into 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

Ապրանքի հատկությունները

Health Products Regulatory Authority
30 August 2022
CRN00D4NV
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fucidin 20mg/g Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 20 mg fusidic acid.
Excipients with known effect: contains cetyl alcohol, potassium
sorbate, butylhydroxyanisole (E320).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
_Product imported from Greece:_
A white, homogeneous cream
4 CLINICAL PARTICULARS
As per PA0046/004/012
5 PHARMACOLOGICAL PROPERTIES
As per PA0046/004/012
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Butylhydroxyanisole (E320)
Cetyl alcohol
Glycerol
Liquid paraffin
Polysorbate 60
Potassium sorbate
Purified water
White soft paraffin
all-rac-α-tocopherol and hydrochloric acid for pH adjustment
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
After first opening: 28 days.
Health Products Regulatory Authority
30 August 2022
CRN00D4NV
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC.
6.5 NATURE AND CONTENTS OF CONTAINER
Internally lacquered aluminium tube, sealed with an aluminium membrane
and fitted with a white polyethylene screw cap.
Contents: 15 g and 30 g.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
Any unused product or waste material should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/197/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 13April 2007
Date of last renewal: 13 April 2012
10 DATE OF REVISION OF THE TEXT
August 2022