Finovare 20 mg/g Cream

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Fusidic acid

Доступна з:

Citrine Healthcare Limited

Код атс:

D06AX01

ІПН (Міжнародна Ім'я):

Fusidic acid

Фармацевтична форма:

Cream

Терапевтична области:

fusidic acid

Статус Авторизація:

Marketed

Дата Авторизація:

2023-03-31

інформаційний буклет

1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
Fucitrine 20 mg/g Cream
________________________________________________________________________________________________
PACKAGE LEAFLET
1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
Fucitrine 20 mg/g Cream
________________________________________________________________________________________________
PACKAGE LEAFLET: INFORMATION FOR THE USER
FINOVARE 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, 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.
WHAT IS IN THIS LEAFLET
:
1.
What Finovare Cream is and what it is used for
2.
What you need to know before you use Finovare Cream
3.
How to use Finovare Cream
4.
Possible side effects
5.
How to store Finovare Cream
6.
Contents of the pack and other information
1.
WHAT FINOVARE CREAM IS AND WHAT IT IS USED FOR
Finovare Cream belongs to a group of medicines called antibiotics. The
antibiotic in this product is called
fusidic acid. Finovare 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.
This cream is particularly useful to treat a condition called
impetigo, which causes itchy red sores and
blisters on the skin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FINOVARE CREAM
DO NOT USE FINOVARE CREAM
If you are allergic (hypersensitive) to fusidic acid or any of the
other ingredients of this medicine (listed in
Section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Finovare Cream.
-
Do not use Finovare Cream for a long t

Характеристики продукта

Health Products Regulatory Authority
31 March 2023
CRN00CCXZ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Finovare 20 mg/g Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 20 mg fusidic acid.
Excipient(s) with known effect
Contains cetyl alcohol 111 mg/g, butylhydroxyanisole 0.04 mg/g and
potassium sorbate 2.7 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
Topical antibiotic treatment of infections, including impetigo, caused
by sensitive micro-organisms, in particular _Staphylococcus_
_aureus_.
Official (local) guidance regarding the correct use of antibacterial
agents should be considered.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Apply three times daily or as required.
Less frequent application may be adequate for skin covered by a
sterile dressing.
Method of administration
Cutaneous use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bacterial resistance among _Staphylococcus aureus _has been reported
to occur with the use of topical fusidic acid. As with all
antibiotics, extended or recurrent use of fusidic acid may increase
the risk of developing antibiotic resistance.
Finovare cream contains cetyl alcohol, butylhydroxyanisole and
potassium sorbate which may cause local skin reactions such as
contact dermatitis. Butylhydroxyanisole may also cause irritation to
the eyes and mucous membranes. If used on the face, care
should be taken to avoid contact with the eyes.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Health Products Regulatory Authority
31 March 2023
CRN00CCXZ
Page 2 of 4
No interaction studies have been performed. There are no known
interactions with other topical or systemic drugs. Systemic
absorption of topical fusidic acid is negligible, consequently
likelihood of interactions is cons