Fucibet 20 mg/g + 1 mg/g cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betamethasone (as betamethasone valerate); Fusidic acid

Available from:

PCO Manufacturing Ltd.

ATC code:

D07CC; D07CC01

INN (International Name):

Betamethasone (as betamethasone valerate); Fusidic acid

Dosage:

20 mg/g + 1 milligram(s)/gram

Pharmaceutical form:

Cream

Prescription type:

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

Therapeutic area:

Corticosteroids, potent, combinations with antibiotics; betamethasone and antibiotics

Authorization status:

Authorised

Authorization date:

2009-08-14

Patient Information leaflet

_ _
_ _
_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIBET
®
20 MG/G + 1 MG/G CREAM
fusidic acid/betamethasone
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 medicine has been prescribed for you. 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.
–
In this leaflet Fucibet
®
cream will be called Fucibet
®
.
WHAT IS IN THIS LEAFLET:
1.
What Fucibet
®
is and what it is used for
2.
What you need to know before you use Fucibet
®
3.
How to use Fucibet
®
4.
Possible side effects
5.
How to store Fucibet
®
6.
Contents of the pack and other information
1.
WHAT FUCIBET
® IS AND WHAT IT IS USED FOR
Fucibet
®
contains two different types of medicine. One medicine is
called fusidic acid. It is a type of antibiotic. The other medicine is
called betamethasone valerate. It is a type of corticosteroid
(steroid). The two medicines work at the same time in different
ways.
Fucibet
®
works by:

The antibiotic killing germs (bacteria) that cause infections.

The corticosteroid reducing any swelling, redness or itchiness
of your skin.
Fucibet
®
is used to treat:

Conditions where the skin is inflamed (eczema or dermatitis)
and infected, or might become infected, by germs (bacteria).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FUCIBET
®
DO NOT USE FUCIBET
®

If you are allergic (hypersensitive) to fusidic acid/sodium
fusidate or betamethasone valerate or any of the other
ingredients of this medicine (listed in section 6).

To treat infections caused by a fungus, such as athlete's foot or
ringworm

To treat a skin condition caused by a virus, such as cold sores
or chicken pox

To treat skin conditions caused only

Summary of Product characteristics

Health Products Regulatory Authority
30 July 2019
CRN00922F
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fucibet 20 mg/g + 1 mg/g cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fusidic acid 20 mg/g and betamethasone 1 mg/g (as betamethasone
valerate).
Excipients with known effect: contains cetostearyl alcohol and
chlorocresol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
_Product imported from United Kingdom:_
A white to off-white homogenous cream.
4 CLINICAL PARTICULARS
As per PA0046/040/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0046/040/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Macrogol cetostearyl ether
Cetostearyl alcohol
Chlorocresol
Liquid paraffin
Sodium dihydrogen phosphate
White soft paraffin
Purified water
Sodium hydroxide
all-rac-α-tocopherol
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
No special precautions for use.
Store below 30°C
6.5 NATURE AND CONTENTS OF CONTAINER
Health Products Regulatory Authority
30 July 2019
CRN00922F
Page 2 of 2
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 AND OTHER HANDLING
Any unused medicinal 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
PPA0465/231/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14
th
August 2009
Last updated: January 2014
Last updated: August 2015
10 DATE OF REVISION OF THE TEXT
July 2019