Fucidin 20 mg/g Cream

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Fusidic acid

から入手可能:

IMED Healthcare Ltd.

ATCコード:

D06AX; D06AX01

INN（国際名）:

Fusidic acid

投薬量:

20 milligram(s)/gram

医薬品形態:

Cream

処方タイプ:

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

治療領域:

Other antibiotics for topical use; fusidic acid

認証ステータス:

Authorised

承認日:

2013-10-18

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIDIN® 20 MG/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 cream 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

製品の特徴

Health Products Regulatory Authority
05 October 2021
CRN00CLVN
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fucidin 20 mg/g Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 20mg fusidic acid.
Excipients: Contains Butylhydroxyanisole (E320), Potassium Sorbate and
cetyl alcohol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
_Product imported from Greece_
A white 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
Hydrochloric acid
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
tube and outer carton of the product on the market in the
country of origin.
After first opening: 28 days
Health Products Regulatory Authority
05 October 2021
CRN00CLVN
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
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: 30 g cream.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
Any unused product or waste material should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/083/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 18th October 2013
10 DATE OF REVISION OF THE TEXT
October 2021