FUCIDIN H CREAM

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

FUSIDIC ACID; HYDROCORTISONE ACETATE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

FUSIDIC ACID; HYDROCORTISONE ACETATE

Unit dalam pakej:

mcg/mL

Dikeluarkan oleh:

LEO Laboratories Ltd

Risalah maklumat

FUCIDIN
® H CREAM
Fusidic acid / Hydrocortisone acetate (20mg/g / 10 mg/g)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Fucidin
®
H Cream is used
for
2.
How Fucidin
®
H Cream works
3.
Before you use Fucidin
®
H Cream
4.
How to use Fucidin
®
H Cream
5.
While you are using Fucidin
®
H
Cream
6.
Side effects
7.
Storage and disposal of Fucidin
®
H Cream
8.
Product description
9.
Manufacturer
and
product
registration holder
10.
Date of revision
WHAT FUCIDIN
® H CREAM IS USED FOR
It is used for the topical treatment of
infected
atopic
dermatitis
(commonly
known
as
eczema,
a
skin
disease
accompanied
by
inflammation
reddening,
exudation
or
scabs
and
itching, frequently of an allergic origin).
You must talk to a doctor if you do not
feel better or if you feel worse.
HOW FUCIDIN
® H CREAM WORKS
Fucidin
®
H
Cream
combines
the
antibacterial
action
of
Fusidic
acid
(antibiotic)
with
the
anti-inflammatory
effect
of
hydrocortisone
acetate
(corticoid).
BEFORE YOU USE FUCIDIN
® H CREAM
-
_When you must not use it_
Do not use Fucidin
®
H Cream
■
If your intention is to treat skin
conditions
caused
by
tuberculosis
■
If
you
are
allergic
to
fusidic
acid, hydrocortisone acetate or
any of the other ingredients of
Fucidin
®
H Cream.
■
If
you
have
a
skin
infection
primarily
caused
by
bacteria,
fungi or virus (such as herpes or
varicella).
■
If you have skin inflammation
around the mouth.
■
If
you
have
rosacea
(severe
flushing of the skin on the face).
_Pregnancy and breast-feeding _
If
you
are
pregnant
or
breast-feeding,
think
you
may
be
pregnant
or
are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine.
Use
during
pregnancy
and
lactation
should be evaluated and decided upon by
a doctor.
Fucidin
®
H Cream should be used with
caution during pregnancy.
-
There is inadequate evidence of safety
in human pregnancy. Safety in mothers
has
not
been
established.
Topical
corticosteroids should not be applied to
the breast prior to nursing.
-
_Be

Ciri produk

145 mm
280 mm
80 mm
Item-number: font: OCR-B, 8 pt.,
kerning +10.,
rotate 90%
000000-00
Fucidin
®
Hcream
Composition
Active ingredients:
Fusidic acid 20 mg/g, Hydrocortisone acetate 10 mg/g.
Inactive ingredients:
Butylated hydroxyanisole, Cetyl alcohol, Glycerol 85%, Liquid paraffin, Polysorbate, Potassium
sorbate, White soft paraffin, all-rac-α-tocopherol, Hydrochloric acid, Purified water.
Pack Sizes: 5g and 15g. Not all pack sizes are marketed.
Pharmacology
Pharmacodynamics:
Fucidin
®H Cream combines the potent antibacterial action of fusidic acid with the anti-inflammatory
effect of hydro cortisone acetate.
When applied topically, Fucidin
®H is effective against staphylococci, streptococci, corynebacteria,
Neisseria and certain Clostrida and Bacteroides.
Pharmacokinetics:
A study in rabbits has shown that the systemic absorption of Fucidin
®cream is negligble.
Properties
Fucidin
®H Cream combines the antibacterial action of fusidic acid with the anti-inflammatory
effect of hydro cortisone acetate.
Indications
Fucidin
®H Cream is indicated for the treatment of dermatitis, including atopic dermatitis and
contact dermatitis, where an infection with bacteria sensitive to fusidic acid is suspected or
confirmed.
Because of its hydrocortisone content, Fucidin
®H Cream is particularly appropriate in cases
where a milder corticosteroid is indicated, including milder inflammatory dermatoses - on the face
and on children’s skin.
Fucidin
®H Cream is cosmetically acceptable for use on the face and hands and convenient for use
in the groin area and armpits.
Dosage
Fucidin
®H cream should be applied 2-3 times daily on uncovered lesions. For covered lesions,
less frequent application may be adequate.
Contraindications
Hypersensitivity to fusidic acid/sodium fusidate, hydrocortisone acetate or to any of the excipients
listed above (see Composition).
Due to the content of corticosteroid, Fucidin
®H is contraindicated in the following conditions:
Primary skin infections caused by fungi, virus or bacteria, either un