Fucibet cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betamethasone valerate; Fusidic acid

Available from:

LEO Pharma

ATC code:

D07CC01

INN (International Name):

Betamethasone valerate; Fusidic acid

Dosage:

1mg/1gram ; 20mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000; GTIN: 5702191001044 5702191004519

Patient Information leaflet

Daivonex
®
range - 10 g, 15 g, 30 g, 60 g
Daivobet
®
range - 10 g, 15 g, 30 g, 60 g
Fucidin
®
range - 15 g, 30 g, 60 g
Fucicort
®
range - 15 g, 30 g, 60 g
FRONT OF LEAFLET
Creation Date:
Revision Date:
Sign:
Sign:
Scale:
OMA
24/08/2015
OMA
06/07/2018
Ref. No.:
Size:
Material:
Type:
100%
IIE042-03
610 x 350 mm
Insert
PACKAGING COMPONENT SPECIFICATION
LEO Pharma
Internal Market Access
Industriparken 55
2750 Ballerup
Denmark
610x350_105x28_mF_154_AK2_Rev 4
Folded to 105 x 28 mm
Comments:
IIE042-00 - 13/09/2016 - OMA: New leaflet based on trial 99991530 with
new supplier drawing
IIE042-01 - 06/11/2017 - JUG: Material number Font and size defind and
info added on drawing
IIE042-02 - 16/05/2018 - OMA: Updated with drawing from Essentra
containing new folding pattern
IIE042-03 - 06/07/2018 - OMA: Updated with drawing from Essentra
containing new folding pattern and i-mark position
Revision info:
Used for:
Only to be used together with CIE093 37 x 32 x 120 mm, CIE094 44 x 32
x 140 mm, CIE095 47 x 38 x 160 mm and LINE 8 TUBE
AND PACKRAT CARTON CIE110 + CIE120 + CIE0130 + CIE140
610 mm
350 mm
IIE042-03 - 610 x 350 mm - page 1 of 2
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.
• In this leaflet Fucibet
®
cream will be called Fucibet®. PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIBET® CREAM
FUSIDIC ACID AND BETAMETHASONE VALERATE
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fucibet
®
Cream.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fucibet
®
Cream contains Fusidic acid Ph.Eur.2% and Betamethasone 0.1% (as
the valerate ester Ph.Eur)
Excipients with known effect:
Cetostearyl alcohol contains 72mg.
Chlorocresol contains 1mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
A white cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fucibet cream is indicated for the treatment of eczematous dermatoses
including atopic eczema, infantile eczema, discoid eczema, stasis
eczema,
contact eczema and seborrhoeic eczema when secondary bacterial
infection is
confirmed or suspected.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
A small quantity should be applied to the affected area twice daily
until a
satisfactory response is obtained. A single treatment course should
not
normally exceed 2 weeks.
In the more resistant lesions the effect of Fucibet
®
cream can be enhanced by
occlusion with polythene film. Overnight occlusion is usually
adequate.
Method of administration
Cutaneous use
4.3
CONTRAINDICATIONS
Hypersensitivity to fusidic acid/sodium fusidate, betamethasone
valerate or to
any of the excipients listed in section 6.1.
Due to the content of corticosteroid, Fucibet is contraindicated in
the following
conditions:
Systemic fungal infections.
Primary skin infections caused by fungi, virus or bacteria, either
untreated or
uncontrolled by appropriate treatment (see section 4.4).
Skin manifestations in relation to tuberculosis or syphilis, either
untreated or
uncontrolled by appropriate therapy.
Perioral dermatitis and rosacea.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Long-term continuous topical therapy with Fucibet should be avoided.
Depending on the application site, possible systemic absorption of
betamethasone
valerate should always be considered during treatment with Fucibet.
Due to the content of corticosteroid, Fucibet should be used with care
near the eyes.
Avoid getting F