Fucibet cream

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Betamethasone valerate; Fusidic acid

Verfügbar ab:

Mawdsley-Brooks & Company Ltd

ATC-Code:

D07CC01

INN (Internationale Bezeichnung):

Betamethasone valerate; Fusidic acid

Dosierung:

1mg/1gram ; 20mg/1gram

Darreichungsform:

Cutaneous cream

Verabreichungsweg:

Cutaneous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 13040000

Gebrauchsinformation

No text or graphics
No text or graphics
5 mm
420 mm
297 mm
28 mm
28 mm
28 mm
28 mm
105 mm
IIE040-00 - 420 x 297 mm - Folded 105 x 28 mm - Page 1 of 2
Only to be used together with CIE140 47 x 38 x 160 mm, CIE130 44 x 32
x 144 mm CIE120 37 x 32 x 110 mm and CIE110 37 x 32 x 123 mm,
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:
JUG
29/06/2018
Ref. No.:
Size:
Material:
Type:
100%
IIE040-00
420 x 297 mm
Insert
PACKAGING COMPONENT SPECIFICATION
LEO Pharma
Internal Market Access
Industriparken 55
2750 Ballerup
Denmark
Essentra / Media Wolfen - AK3
Folded to 105 x 28 mm
Comments:
IIE040-00 - 29/06/2018 - JUG: New leaflet based on trial 991852 with
new supplier drawing
Revision info:
Used for:
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 store Fucibet
®
6. Contents of the pack and other information
1. WHAT FUCIBET
® IS AND WHAT IT IS USED FOR
Fucibet contains 2 different types of medicine. One medicine
is called fusidic acid. It is a type of antibiotic. The other
medicine is called betamethason

Fachinformation

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