Fucidin Cream, 20mg/g

Страна: Мальта

мова: англійська

Джерело: Malta Medicines Authority

Активний інгредієнт:

FUSIDIC ACID

Доступна з:

LEO Pharma A/S

Код атс:

D06AX01

ІПН (Міжнародна Ім'я):

FUSIDIC ACID

Фармацевтична форма:

CREAM

Склад:

FUSIDIC ACID

Тип рецепту:

POM

Терапевтична области:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Статус Авторизація:

Authorised

Дата Авторизація:

2005-08-01

інформаційний буклет

145 mm
280 mm
80 mm
Item-numbe
See details b
000000-00
PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIDIN
®
20 MG/G CREAM
fusidic acid
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 cream 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.
WHAT IS IN THIS LEAFLET:
1. What Fucidin
®
cream is and what it is
used for
2. What you need to know before you
use Fucidin
®
cream
3. How to use Fucidin
®
cream
4. Possible side effects
5. How to store Fucidin
®
cream
6. Contents of the pack and other
information
1. WHAT FUCIDIN
®
CREAM IS AND
WHAT IT IS USED FOR
Fucidin
®
cream belongs to a group of
medicines called antibiotics. The antibi-
otic in this product is called fusidic acid.
Fucidin
®
cream works by killing germs
(bacteria) that cause infections.
It is used to treat skin infections such as
those caused by bacteria called
Staphylococcus aureus
.
2. WHAT YOU NEED TO KNOW
BEFORE YOU USE FUCIDIN
®
CREAM
✖
DO NOT USE FUCIDIN
®
CREAM:
• If you are allergic to fusidic acid or any
of the other ingredients of this
medicines (listed in section 6).
!
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST
BEFORE USING FUCIDIN
®
CREAM
• Do not use Fucidin
®
for a long time as
the germs (bacteria) may no longer be
killed by the antibiotic.
• Avoid getting the cream in your eyes
(e.g. accidentally from your hands or
by using it too close to your eyes) as it
could irritate (sting) them.
!
OTHER MEDICINES AND FUCIDIN
®
CREAM
Tell your doctor or pharmacist if you are
taking, have recently taken or might
take any other medicines.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feed

Характеристики продукта

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Fucidin® Cream, 20 mg/g
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Fusidic acid 20 mg/g
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Cream.
White water-miscible cream.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
In the topical treatment of infections due to micro-organisms
sensitive to this anti-infective, in
particular _Staphylococcus aureus_.
4.2 Posology and Method of Administration
Adults and children:
Uncovered lesions: apply gently three to four times daily or as
required.
Covered lesions: less frequent applications may be adequate.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 Special Warning and Precautions for Use
Bacterial resistance among _Staphylococcus aureus_ has been reported
to occur with the use of
topical Fucidin®. As with all antibiotics, extended or recurrent use
of fusidic acid may increase
the risk of developing antibiotic resistance.
Fucidin® Cream contains butylhydroxyanisole, potassium sorbate and
cetyl alcohol. These
excipients may cause local skin reactions (e.g. contact dermatitis).
Butylhydroxyanisole may also
cause irritation to the eyes and mucous membranes. Fucidin® Cream
should therefore be used
with care when applied in the proximity of the eyes.
4.5 Interaction with Other Medicinal Products and Other Forms of
Interaction
No interaction studies have been performed. Interactions with
systemically administered
v
00574071
1.0
Page 2 of 5
medicinal products are considered minimal as the systemic absorption
of topical Fucidin® is
negligible.
4.6 Fertility, Pregnancy and Lactation
Fertility
There are no clinical studies with topical Fucidin® regarding
fertility. No effects in
women of childbearing potential are anticipated, since systemic
exposure following
topically applied fusidic acid/sodium fusidate is negligible.
Pregnancy
No effects during pregnancy are anticipated, since systemic exposure
to topically applied
fu