Fucibet Lipid 20mg/g + 1mg/g cream

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Fusidic acid; Betamethasone

Доступна з:

IMED Healthcare Ltd.

Код атс:

D07CC; D07CC01

ІПН (Міжнародна Ім'я):

Fusidic acid; Betamethasone

Фармацевтична форма:

Cream

Терапевтична области:

Corticosteroids, potent, combinations with antibiotics; betamethasone and antibiotics

Дата Авторизація:

2023-02-03

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIBET
®
LIPID 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
®
lipid 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).
•
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 caus

Характеристики продукта

Health Products Regulatory Authority
03 February 2023
CRN00D5DD
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fucibet Lipid 20mg/g + 1mg/g cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fusidic acid 20 mg/g and betamethasone 1 mg/g (as betamethasone
valerate)
Excipients with known effect:
Contains cetostearyl alcohol, methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216) and potassium sorbate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
Product imported from _Greece_
White cream
4 CLINICAL PARTICULARS
As per PA0046/040/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0046/040/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Steareth-21
Cetostearyl alcohol
Paraffin, white soft
Paraffin, liquid
Hypromellose
Citric acid, monohydrate
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Potassium sorbate
all-rac-α-tocopherol
Water, purified
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Discard any remaining cream 3 months after first opening.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Health Products Regulatory Authority
03 February 2023
CRN00D5DD
Page 2 of 2
Do not store above 25°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium tube with white screw cap
Pack size: 30 g
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd,
Unit 625 Kilshane Avenue,
Northwest Business Park,
Ballycoolin,
Dublin 15,
Ireland.
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/197/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 3
rd
February 2023
10 DATE OF REVISION OF THE TEXT