Advantan
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
30-11-2020
Summary of Product characteristics
(SPC)
24-11-2020
Active ingredient:
Methylprednisolone aceponate 0.1%{relative}
Available from:
LEO Pharma Limited
INN (International Name):
Methylprednisolone aceponate 0.1% w/w
Dosage:
0.1 %
Pharmaceutical form:
Topical ointment
Composition:
Active: Methylprednisolone aceponate 0.1%{relative} Excipient: Dehymuls E Liquid paraffin Purified water White beeswax White soft paraffin
Units in package:
Tube, aluminium, physician's sample, 5 g
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Bayer AG
Therapeutic indications:
Atopic dermatitis (endogenous eczema, neurodermatitis), contact eczema, degenerative, dyshidrotic, vulgar eczema, eczema in children.
Product summary:
Package - Contents - Shelf Life: Tube, aluminium, physician's sample - 5 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 15 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 30 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 50 g - 36 months from date of manufacture stored at or below 25°C
Authorization date:
1992-03-26
Patient Information leaflet
ADVANTAN
®
Consumer Medicine Information
Page 1 of 6
CONSUMER MEDICINE INFORMATION
ADVANTAN
®
1g cream or ointment contains 1 mg methylprednisolone aceponate.
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using ADVANTAN
®
. It will
advise you about how to use ADVANTAN
®
properly and when to tell your
doctor about health-related conditions. If you have any questions or
need
more advice, ask your doctor, professional health care provider or
pharmacist.
This preparation has been prescribed for you personally and you should
not
pass it on to others. It may harm them.
WHAT IS ADVANTAN USED FOR AND HOW DOES IT WORK
ADVANTAN
®
is an anti-inflammatory medicine (a corticosteroid) to be used
on the skin. ADVANTAN
®
suppresses inflammatory and allergic skin
reactions and thus relaxes symptoms originating from the skin problem
like
redness (erythema), thickening of the skin, coarseness of the skin
surface,
fluid build-up (oedema), itchiness, and other complaints (burning
sensation or
pain).
ADVANTAN
®
is used for the treatment of atopic dermatitis (endogenous
eczema, neurodermatitis), eczema in children, contact eczema, or
degenerative, dyshidrotic, or vulgar eczema.
ADVANTAN
®
is available in two different formulations which have a different
therapeutic effect which are listed below.
•
ADVANTAN
®
cream
ADVANTAN
®
cream has a high water and low fat content. ADVANTAN
®
cream is particularly suitable for acute and so-called weeping stages
of
eczema, for very greasy skin and for use on exposed or hairy parts of
the
body.
•
ADVANTAN
®
ointment
In certain skin ailments where the skin is neither very dry nor in a
weeping
state (that is, producing fluid), treatment requires a foundation with
balanced
proportions of fat and water. ADVANTAN
®
ointment makes the skin slightly
greasy without retaining warmth and fluid. Of the two formulations,
ADVANTAN
®
ointment has the widest field of use.
ADVANTAN
®
Consumer Medicine Information
Page 2 of 6
BEFORE YOU USE ADVANTAN
®
Do not use ADVANT
Read the complete document
Summary of Product characteristics
NEW ZEALAND DATA SHEET
Page 1 of 8
1 ADVANTAN®
Cream: ADVANTAN® methylprednisolone aceponate 0.1% cream
Ointment: ADVANTAN® methylprednisolone aceponate 0.1% ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g cream or ointment contains 1 mg (0.1%) methylprednisolone
aceponate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Topical cream.
Topical ointment.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Atopic dermatitis (endogenous eczema, neurodermatitis), contact
eczema, degenerative,
dyshidrotic, vulgar eczema, eczema in children.
4.2
Dose and method of administration
ADVANTAN® is for EXTERNAL TOPICAL USE ONLY and NOT FOR OPTHALMIC USE.
In general, the ADVANTAN® formulation appropriate to the skin
condition is applied thinly once per
day to the diseased areas of skin.
In general, the duration of use should not exceed 12 weeks in adults
and 4 weeks in children.
4.3
Contraindications
ADVANTAN® is contraindicated in most viral diseases (e.g. vaccinia,
varicella/herpes zoster) and
when tuberculous or syphilitic processes and post-vaccination skin
reactions are present in the area
to be treated. If rosacea, acne vulgaris, ulcera, atrophic skin
diseases, or perioral dermatitis are
present, ADVANTAN® must not be applied to the face.
Hypersensitivity to the active substance or to any of the excipients
listed in 6.1.
4.4
Special warnings and precautions for use
Care must be taken when using ADVANTAN® to avoid contact with the
eyes, deep open wounds and
mucosae.
Additional specific therapy is required in bacterially infected skin
diseases and/or in fungal
infections. Any spread of infection may require withdrawal of topical
corticosteroid therapy.
If the skin dries out excessively under protracted use of ADVANTAN®
Cream, a switch should be
made to ADVANTAN® ointment, a formulation which has a higher fat
content.
If signs of hypersensitivity develop, ADVANTAN® should be
discontinued and appropriate treatment
instituted.
eDoc-000782917 - Version
6. 0
NEW ZEALAND DATA SHEET
Page 2
Read the complete document
