Fucibet 20 mg/g + 1 mg/g cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betamethasone; Fusidic acid

Available from:

Primecrown 2010 Limited

ATC code:

D07CC; D07CC01

INN (International Name):

Betamethasone; Fusidic acid

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:

2014-12-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIBET
® 20 MG/G + 1 MG/G CREAM
fusidic acid/betamethasone
xxx000/1
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
®
µ
DO NOT USE FUCIBET
®
•
If you are allergic (hypersensitive) to fusidic acid/sodium fusidate
or
betamethasone valerate or any other ingredients of this medicine
(listed in section 6).
•
To treat a skin infection 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, such as boils or
spots.
•
To treat skin conditions caused by tuberculosis (TB).
•
To treat a condition called perioral dermatitis. This is a red spotty
rash
around your mouth or chin.
•
To
treat
a
skin
condition
called
rosacea.
This
is
redness
and
inflammation over your nose and cheeks. Ask your doctor if you are
unsure.
!
WARNING AND PRECAUTIONS
TAKE SPECIAL CARE WITH FUCIBET
®
•
Do not use for a long time, continuously (without stopping), as this
medicine contains a steroid. Do not use the cream on yourself or a
child for more than 2 weeks, this is to avoid bacteria becoming

Summary of Product characteristics

Health Products Regulatory Authority
19 November 2019
CRN009GHP
Page 1 of 5
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 a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
_Product imported from the UK._
A white cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Use in inflammatory dermatoses where bacterial infection is present or
likely to occur.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply a small quantity to the affected area twice daily until a
satisfactory response is obtained. A single treatment course
should not normally exceed 2 weeks.
4.3 CONTRAINDICATIONS
Known hypersensitivity to fusidic acid/sodium fusidate, betamethasone
valerate or any of the excipients.
Due to the content of corticosteroid, Fucibet is contraindicated in
the following conditions: skin infections primarily caused by
bacteria, fungi or virus (such as herpes or varicella), skin
manifestations in relation to tuberculosis or syphilis, perioral
dermatitis
and rosacea.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Long-term continuous topical therapy should be avoided, particularly
in infants and children. Adrenal suppression can occur
even without occlusion. Atrophic changes may occur on the face, and to
a lesser degree in other parts of the body, after
prolonged treatment with potent topical steroids. Caution should be
exercised if Fucibet cream is used near the eye. Glaucoma
might result if the preparation enters the eye. Systemic chemotherapy
is required if bacterial infection persists.
Bacterial resistance has been reported to occur with the use of
fusidic acid. As with all antibiotics, extended or recurrent use
may increase the risk of developing antibiotic resistance.
The use of steroid-antibiotic combinations should be limited to 2
weeks as steroids may mask infections o