Fucibet 20 mg/g + 1 mg/g cream

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Betamethasone; Fusidic acid

Dostupné s:

Leo Laboratories Limited

ATC kód:

D07CC; D07CC01

INN (Mezinárodní Name):

Betamethasone; Fusidic acid

Dávkování:

20 + 1 milligram(s)/gram

Léková forma:

Cream

Druh předpisu:

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

Terapeutické oblasti:

Corticosteroids, potent, combinations with antibiotics; betamethasone and antibiotics

Stav Autorizace:

Marketed

Datum autorizace:

1984-05-23

Informace pro uživatele

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

Charakteristika produktu

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
Cetostearyl alcohol 72 mg/g
Chlorocresol 1 mg/g
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
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
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, 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
®
.
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