Advantan cream 0.1% w/w

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Methylprednisolone aceponate

Предлага се от:

Bayer Limited

АТС код:

D07AC14

INN (Международно Name):

Methylprednisolone aceponate

дозиране:

0.1%w/w percent weight/weight

Лекарствена форма:

Cream

Вид предписание :

Product subject to prescription which may be renewed (B)

Терапевтична област:

methylprednisolone aceponate

Статус Оторизация:

Not marketed

Дата Оторизация:

1998-04-03

Листовка

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

Данни за продукта

Health Products Regulatory Authority
16 April 2019
CRN008LLS
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Advantan cream 0.1% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g Advantan cream contains 1 mg (0.1%) methylprednisolone aceponate.
Excipients: Also contains Cetostearyl Alcohol and Butylhydroxytoluene
(E321)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
Oil in water emulsion, white to yellowish opaque cream.
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 cream is administered
to children aged 3 years or older 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 h