Advantan cream

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

METHYLPREDNISOLONE ACEPONATE

Available from:

Bayer S.p.a.

ATC code:

D07AC14

INN (International Name):

METHYLPREDNISOLONE ACEPONATE

Pharmaceutical form:

CREAM

Composition:

METHYLPREDNISOLONE ACEPONATE 1 milligram(s)/gram

Prescription type:

POM

Therapeutic area:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2007-02-13

Patient Information leaflet

Page 1 of 5
Package leaflet: Information for the patient
ADVANTAN 0.1% CREAM
METHYLPREDNISOLONE ACEPONATE
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 or pharmacist. 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 contains methylprednisolone aceponate, a potent
corticosteroid.
Advantan is used for the treatment of eczema (non contagious,
inflammatory dermatitis, that
affect the skin surface) such as:

constitutional eczema (atopical dermatitis, neurodermatitis),

eczema vulgaris,

allergic and irritative contact dermatitis,

dyshidrotic eczema,

eczema in children
Given its high water content, the formulation of Advantan cream allows
exudates
(inflammatory liquids) to flow, and is therefore particularly suitable
for treatment of secreting
forms of eczema in the acute phase in areas of skin subject to
maceration, exposed and
covered with body hair.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ADVANTAN
_ _
DO NOT USE ADVANTAN
-
if you are allergic to the active substance or any of the other
ingredients of this medicine
(listed in section 6).
-
if the area to be treated is affected by tuberculosis or syphilis;
-
if the subject has viral infections (e.g. chicken pox or shingles);
-
if the subject has skin conditions accompanied by bacterial or fungal
infections;
-
if the subject has rosacea (redne

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Advantan 0.1% cream
Advantan 0.1% ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Advantan 0.1% cream
1 g of cream contains: methylprednisolone aceponate 1 mg (0.1%).
Excipients with known effects:
cetostearylic alcohol and butylhydroxytoluene.
Advantan 0.1% ointment
1 g of ointment contains: methylprednisolone aceponate 1 mg (0.1%).
For the complete list of excipients, see paragraph 6.1.
3.
PHARMACEUTICAL FORM
Cream (oil in water emulsion, opaque white to yellowish coloured
cream).
Ointment (water in oil emulsion, opaque white to yellowish coloured
ointment).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Advantan cream and ointment
Constitutional eczema (atopical dermatitis, neurodermatitis); eczema
vulgaris; allergic and
irritative contact dermatitis; dyshidrotic eczema; eczema in children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Unless otherwise prescribed by a doctor, Advantan, in the form best
suited to the skin
characteristics, must be applied topically to the affected area of
skin in a thin layer, with
gentle massage, once a day. Advantan cutaneous solution must be
applied drop by drop,
always once a day, on the areas of skin affected by the disorder, and
gently massaged in.
Page 2 of 12
Advantan is available in four pharmaceutical forms: cream, ointment,
fatty ointment and
cutaneous solution.
Given its high water content, the formulation of Advantan cream (1 g
of Advantan cream
contains 1 mg of methylprednisolone aceponate) allows exudates to
flow, and is therefore
particularly suitable for treatment of secreting forms of eczema in
the acute phase in areas of
skin subject to maceration, exposed and covered with body hair. If
application of Advantan
cream for prolonged periods of time should induce excessive skin
dryness, a formulation
with a higher fat content (Advantan ointment or fatty ointment) must
be used instead.
The formulation of Advantan ointment (1 g of Advantan ointment
contains 1 mg of
methylprednisolo