Advantan 0.1% w/w Fatty Ointment
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
27-07-2019
Summary of Product characteristics
(SPC)
11-06-2019
Active ingredient:
Methylprednisolone aceponate
Available from:
Bayer Limited
ATC code:
D07AC14
INN (International Name):
Methylprednisolone aceponate
Dosage:
0.1%w/w percent weight/weight
Pharmaceutical form:
Ointment
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
methylprednisolone aceponate
Authorization status:
Not marketed
Authorization date:
1998-04-03
Patient Information leaflet
15660
Package leaflet: Information for the patient
ADVANTAN Cream 0.1% w/w
ADVANTAN Ointment 0.1% w/w
ADVANTAN Fatty Ointment 0.1% w/w
Methylprednisolone aceponate (MPA)
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 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. This includes any
possible side effects not
listed in this leaflet. See section 4.
-
WHAT IS IN THIS LEAFLET
-
-
1.
What Advantan is and what it is used for
-
2.
What you need to know before you use Advantan
-
3.
How to use Advantan
-
4.
Possible side effects
-
5.
How to store Advantan
-
6.
Contents of the pack and other information
1. WHAT ADVANTAN IS AND WHAT IT IS USED FOR
Advantan is an anti-inflammatory medicine (a corticosteroid) which is
intended to be used on the
skin.
Advantan reduces the inflammation and allergic reaction of the skin.
Therefore it lessens
redness (erythema), fluid build-up (oedema) and fluid oozing from the
inflamed skin. It also
relieves the itchiness, burning sensation or pain you may feel.
Advantan is used for the treatment of skin conditions which are
sensitive to corticosteroids.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ADVANTAN
DO NOT USE ADVANTAN
• if you are allergic (hypersensitive) to the active substance
methylprednisolone aceponate
(MPA) or to any of the other ingredients of Advantan (see also section
6. Contents of the pack
and other information)
• if pre-existing eczema or rash has become infected
15660
on skin areas affected by a skin inflammation that is red/rosy in
colour (rosacea), ulcers,
inflamed diseases of the sebaceous glands (acne vulgaris) or skin
folds, groin or under the
arm pits (intertrigo acne), or skin diseases accompanied by a thinning
of the
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
10 June 2019
CRN00927H
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Advantan 0.1% w/w Fatty Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g Advantan fatty ointment contains 1 mg (0.1%) methylprednisolone
aceponate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
White to yellowish translucent fatty ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of corticosteroid sensitive dermatoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
If the skin dries out excessively under protracted use of Advantan
Cream, a switch should be made to one of the formulations
with a higher fat content (Advantan Ointment or Advantan Fatty
Ointment).
PEDIATRIC POPULATION
Dose adjustments are not required when Advantan ointment and Advantan
fatty ointment are administered to infants, children,
and adolescents. In general, the duration of use should not exceed 4
weeks in children.
The safety of Advantan Cream in infants below the age of 4 months has
not been established.
4.3 CONTRAINDICATIONS
Known hypersensitivity to the active ingredients or any of its
excipients
Primary bacterial, viral and fungal diseases of the skin and
secondarily infected eczemas or intertrigo acne, perioral dermatitis,
rosacea atrophic skin diseases and vaccination skin reactions in the
area to be treated and, in general, should not be used on
weeping surfaces.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Glucocorticoids must only be used at as low a dose as possible,
especially in children, and only for as long as is absolutely
necessary to achieve and maintain the desired therapeutic effect.
Appropriate antimicrobial therapy should be used whenever treating
inflammatory lesions which have become infected. Any
spread of infection re
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