Eczibet 20 mg/g + 1 mg/g cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betamethasone; Fusidic acid

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

D07CC; D07CC01

INN (International Name):

Betamethasone; Fusidic acid

Dosage:

20 mg/g+ 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:

Not marketed

Authorization date:

2015-06-19

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ECZIBET 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. See section 4.

In this leaflet Eczibet 20 mg/g + 1 mg/g
cream will be called Eczibet.
WHAT IS IN THIS LEAFLET:
1.
What Eczibet is and what it is used for
2.
What you need to know before you use Eczibet
3.
How to use Eczibet
4.
Possible side effects
5.
How to store Eczibet
6.
Contents of the pack and other information
1.
WHAT ECZIBET IS AND WHAT IT IS USED FOR
Eczibet contains two different types of medicine. One medicine is
called fusidic acid. It is a type of
antibiotic.
The other medicine is called betamethasone. It is a type of
corticosteroid (steroid). These two medicines
work at the same time in different ways.
Eczibet works by:

The antibiotic killing germs (bacteria) that cause infections.

The corticosteroid reducing any swelling, redness or itchiness of your
skin.
Eczibet is used to treat:

Conditions where the skin is inflamed (eczema or dermatitis) and also
infected by germs (bacteria).
If there is no improvement after 7 days you should stop using the
cream and go back to your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ECZIBET
DO NOT USE ECZIBET

If you are allergic to fusidic acid or betamethasone or any of the
other ingredients in this medicine
(listed in Section 6).

To treat infected dermatitis in infants under one year of age.

To treat acne vulgaris.

To treat a skin condition called acne rosacea. This is redness and
inf

Summary of Product characteristics

Health Products Regulatory Authority
06 December 2021
CRN00CLSD
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eczibet 20 mg/g + 1 mg/g cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g cream contains 20 mg fusidic acid and 1 mg betamethasone
corresponding to 1,214 mg betamethasone valerate.
Excipients with known effect: Contains cetostearyl alcohol 72 mg/g and
chlorocresol 1 mg/g.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
White to off white, smooth, homogeneous cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eczibet 20 mg/g + 1 mg/g cream is indicated for the treatment of
eczematous dermatoses in adults and children over 1 year of
age including atopic eczema, discoid eczema, stasis eczema, contact
eczema and seborrhoeic eczema when secondary
bacterial infection is confirmed or suspected.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
A single treatment course should not normally exceed 2 weeks.
Method of administration
For cutaneous use
A small quantity should be applied to the affected area twice daily
until a satisfactory response is obtained.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Due to the content of corticosteroid, fusidic acid/betamethasone cream
is contraindicated in the following conditions:

Infants under one year of age with infected dermatitis.

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.

Acne vulgaris.

Perioral dermatitis and acne rosacea.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Systemic absorption
Health Products Regulatory Authority
06 December 2021
CRN00CLSD
Page 2 of 6
Long-term