Fucibet 20 mg/g + 1 mg/g cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fusidic acid; Betamethasone valerate

Available from:

IMED Healthcare Ltd.

ATC code:

D07CC; D07CC01

INN (International Name):

Fusidic acid; Betamethasone valerate

Dosage:

20 + 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:

2013-10-18

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 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.

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).

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 by bacteria, su

Summary of Product characteristics

Health Products Regulatory Authority
29 April 2021
CRN00C9P2
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: contains cetostearyl alcohol and chlorocresol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
_Product imported from the UK:_
A white cream.
4 CLINICAL PARTICULARS
AS PER PA 046/040/001
5 PHARMACOLOGICAL PROPERTIES
AS PER PA 046/040/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Macrogol Cetostearyl Ether
Cetostearyl alcohol
Chlorocresol
Liquid paraffin
Sodium dihydrogen phosphate
White soft paraffin
Sodium hydroxide (for pH adjustment)
all-_rac_-a-tocopherol
Purified water
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 carton of the product on the market in
the country of origin.
After first opening of container: 3 months
Health Products Regulatory Authority
29 April 2021
CRN00C9P2
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium tubes fitted with a white polyethylene screw cap.
Contents: 30g 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
Any unused medicinal 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
PPA1463/082/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 18
th
October 2013
10 DATE OF REVISION OF THE TEXT
April 2021