Fucicort

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Betamethasone valerate 0.1%{relative} (expressed as betamethasone);  ; Fusidic acid 2%{relative} (hemihydrate, expressed as anhydrous fusidic acid);  

Sẵn có từ:

LEO Pharma Limited

INN (Tên quốc tế):

Betamethasone valerate 0.1% w/w (expressed as betamethasone)

Dạng dược phẩm:

Topical cream

Thành phần:

Active: Betamethasone valerate 0.1%{relative} (expressed as betamethasone)   Fusidic acid 2%{relative} (hemihydrate, expressed as anhydrous fusidic acid)   Excipient: Cetomacrogol 1000 Cetostearyl alcohol Chlorocresol Liquid paraffin Monobasic sodium phosphate dihydrate Purified water Sodium hydroxide White soft paraffin

Các đơn vị trong gói:

Tube, 1x15g, 15 g

Lớp học:

Prescription

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

Crystal Pharma SA

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Tube, - 15 g - 36 months from date of manufacture stored at or below 30°C

Ngày ủy quyền:

1986-07-31

Tờ rơi thông tin

New Zealand Consumer Medicine Information
FUCICORT
®
FUSIDIC ACID AND BETAMETHASONE VALERATE
Cream containing 20 mg fusidic acid and 1 g betamethazone valerate.
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Fucicort
®
.
This leaflet answers some common questions about Fucicort
®
. It does not contain
all the available information. It does not take the place of talking
to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you
using
Fucicort
®
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT FUCICORT
® IS USED FOR
Fucicort
®
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). These two medicines work at
the same time in
different ways.
Fucicort
®
works by:
•
The antibiotic killing germs (bacteria) that cause infections.
•
The corticosteroid reducing any swelling, redness or itchiness of your
skin.
Fucicort
®
is used to treat:
•
Conditions where the skin is inflamed (eczema or dermatitis) and also
infected
by germs (bacteria).
Your doctor may have prescribed Fucicort
®
for another reason.
Ask your doctor if you have any questions about why Fucicort
®
has been
prescribed for you.
BEFORE YOU USE FUCICORT
®
_WHEN YOU MUST NOT USE IT_
Do not use Fucicort
®
if:
•
You are allergic (hypersensitive) to fusidic acid, betamethasone
valerate or
any of the other ingredients in your medicine (see Product Description
at
the end of this leaflet for a list of ingredients).
•
You have a skin condition called acne rosacea. This is redness and
inflammation over your nose and cheeks. Ask your doctor if you are
unsure.
•
You have a skin condition called perioral dermatitis. This is a red
spotty rash
around your mouth or

Đặc tính sản phẩm

NEW ZEALAND DATA SHEET
1
FUCICORT® Cream
Fucicort® fusidic acid 20 mg/g and betamethasone 1 mg/g (as valerate)
cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains active ingredients fusidic acid 20mg and
betamethasone (as
valerate) 1mg.
Excipients of known effect: cetostearyl alcohol 72 mg/g and
chlorocresol 1 mg/g.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Fucicort® is a white cream containing fusidic acid and betamethasone
valerate in a
water miscible base.
4
CLINICAL PARTICULARS
4.1 Therapeutic indications
Fucicort® is indicated in inflammatory dermatoses where bacterial
infection is present or
likely to occur. Inflammatory dermatoses include atopic eczema,
discoid eczema,
seborrheic dermatitis, contact dermatitis, lichen simplex chronicus,
psoriasis, discoid lupus
erythematosus.
4.2 Dosage and method of administration
Uncovered lesions:
A small quantity should be applied to the affected area twice daily
until a satisfactory
response is obtained. A single treatment course should not normally
exceed 2
weeks.
Covered lesions:
In the more resistant lesions the effect of Fucicort® cream can be
enhanced by occlusion
with polyethylene film. Overnight occlusion is usually adequate.
4.3 Contraindications
−
Hypersensitivity to fusidic acid/sodium fusidate, betamethasone
valerate or to any of
the excipients (see section 6.1).
−
Primary skin infections caused by fungi, virus or bacteria, either
untreated or
uncontrolled by appropriate treatment (see section 4.4)
−
Systemic fungal infection.
−
Skin manifestations in relation to tuberculosis, either untreated or
uncontrolled by appropriate therapy.
eDoc-000781317 - Version
7. 0
−
Perioral dermatitis and rosacea.
−
Ulcerative conditions.
−
The use of fluorinated steroids is contraindicated on the face.
4.4 Special warnings and special precautions for use
Long-term continuous topical therapy with Fucicort® should be
avoided.
Although rare, hypersensitivity reactions to fusidic acid have been
reported.