Advantan

Main information

  • Trade name:
  • Advantan 0.1 % Topical cream
  • Dosage:
  • 0.1 %
  • Pharmaceutical form:
  • Topical cream
  • Units in package:
  • Tube, aluminium, 5g physician's sample, 5 g
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Bayer AG

Documents

Localization

  • Available in:
  • Advantan 0.1 % Topical cream
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Atopic dermatitis (endogenous eczema, neurodermatitis), contact eczema, degenerative, dyshidrotic, vulgar eczema, eczema in children.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 6260
  • Authorization date:
  • 26-03-1992
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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 ADVANTAN

if you have any of the conditions listed below. If any

of these apply to you, tell your doctor before starting to use ADVANTAN

When you must not use it

Do not use ADVANTAN

if you have an allergy to:

any medicine containing methylprednisolone aceponate.

any of the ingredients listed at the end of this leaflet.

any other similar medicine, that is topical corticosteroids.

Some of the symptoms of an allergic reaction may include shortness of

breath, wheezing or difficulty breathing; swelling of the face lips,

tongue or other parts of the body; rash, itching or ‘hives’ on the skin.

Do not use ADVANTAN

you have infection due to:

– tuberculosis (TB) or syphilis

– a virus such as chicken-pox or shingles

– a skin reaction following a vaccination.

Do not use ADVANTAN

if have:

– acne

– rosacea

– ulcera

– atrophic skin disease or

– perioral dermatitis (redness and irritation around the mouth)

If any of these above conditions appear for the first time while using

ADVANTAN

, stop using it at once and consult your doctor.

What else you should know

Prolonged use (longer than 4 weeks) should be avoided (see the side effects

section of this leaflet).

If your doctor diagnoses that your skin disease is accompanied by bacterial or

fungal infections, additional specific therapy is required. Any spread of

infection may require withdrawal of topical corticosteroid therapy.

If your skin dries out excessively under use of ADVANTAN

cream, a switch

should be made ADVANTAN

ointment, the formulation with a higher fat

content.

ADVANTAN

Consumer Medicine Information

Page 3 of 6

If you apply ADVANTAN

to the face, it should not be allowed to come into

contact with your eyes.

Do not put ADVANTAN

in your mouth or allow the product to come in

contact with deep open wounds or mucous membranes.

If you have already suffered a previous case of glaucoma, be sure to inform

your doctor. As known from systemic corticosteroids, glaucoma may also

develop from using corticosteroids (for example, after large-dosed or

extensive application over a prolonged period, air-tight or water-tight dressing

techniques, or application to the skin around the eyes).

No impairment of adrenal gland function has been observed either in adults

or in children on large-area (40 - 60% of the skin surface) or even air-tight or

water-tight dressing treatment when ADVANTAN, has been used for 12

weeks in adults and 4 weeks in children. Nevertheless, the duration of use

should be kept as brief as possible on the treatment of large areas.

ADVANTAN

®

and other medicines

Please inform your doctor or pharmacist if you are using or have recently

used any other medicines, even those for which you needed no prescription.

ADVANTAN

®

and pregnancy

If you are pregnant, your doctor will want to consider this before prescribing

the use of ADVANTAN

, so please mention that you are or could be

pregnant. As a general rule, topical preparations containing corticosteroids

should not be applied during the first three months of pregnancy. In particular,

large-area or prolonged use of air-tight or water-tight dressing should be

avoided. If you suspect that you are pregnant while you are already using

ADVANTAN

, you should consult your doctor as soon as possible.

ADVANTAN

®

and breast-feeding

If you are breast-feeding a baby or small child, you should not apply

ADVANTAN

to the breasts. Treating large areas, prolonged use or air-tight

or water-tight dressings should be avoided.

Your doctor will want to consider the fact that you are breast-feeding before

prescribing the use of ADVANTAN

, so please mention this. In particular,

large-area or prolonged use must be avoided.

How to use ADVANTAN

®

properly

Your doctor will decide which ADVANTAN

formulation (cream, ointment) is

best suited for you. Unless otherwise prescribed by the doctor, you should

apply ADVANTAN

thinly once per day to the affected areas of skin.

ADVANTAN

Consumer Medicine Information

Page 4 of 6

In general, the duration of use should not exceed 12 weeks in adults and 4

weeks in children.

If you have the impression that the effect of ADVANTAN

is too strong or too

weak, talk to your doctor or pharmacist.

Overdosage

No risk is to be expected from a one-time overdose (that is, when applied

once to a large skin area) or from accidental swallowing.

Telephone your doctor or the Poisons Information Centre (in New

Zealand, National Poison Centre, telephone 0800 POISON or 0800 764

766) for advice, or go to Accident and Emergency at the nearest hospital

if you think that you or someone else may have used too much or

swallowed some of this medicine. Do this even if there are no signs of

discomfort or poisoning.

Side effects

Tell your doctor if you notice any unwanted effect, especially if severe or

persistent, or if there is a change in your health that you think might be

caused by ADVANTAN

Like all medicines, ADVANTAN

can have side effects.

Sometimes they are serious, most of the time they are not. You may need

medical treatment if you get some of the adverse effects. Ask your doctor or

pharmacist to answer any questions you may have.

The most common side effects are:

itching

burning

The following list includes side effects that are rare:

skin infection at the site of application

swelling at the site of application

application site irritation

redness

bacterial skin infection

cracks on the skin

fungal skin infection

thinning of the skin

the appearance of fine blood vessels on the skin surface

stretch marks

acne

infection of hair follicles at the application site

ADVANTAN

Consumer Medicine Information

Page 5 of 6

excessive unwanted hair growth

skin discolouration

allergic skin reactions to any of the ingredients of the formulations.

If you notice any side effects not mentioned in this leaflet or if the original

symptoms of your skin ailment should re-occur, please inform your doctor or

pharmacist.

Other side effects not listed above may also occur in some patients. Tell your

doctor if you notice any other effects.

Do not be alarmed by this list of possible side effects. You may not

experience any of them.

Storage

Do not use after the expiry date stated on the package.

ADVANTAN

cream / ointment: Do not store above 25°C.

Store all drugs properly and keep them out of reach of children.

Further information

Pack size: Tubes contain 15g ADVANTAN

, cream or ointment.

ADVANTAN

contains:

active substance

Methylprednisolone aceponate

other substances

Cream

decyl oleate, glycerol monosteartae 40-55%, cetostearyl alcohol, hard fat,

caprylic-capric-stearic acid triglceride (Softisan 378) polyoxyl-40-sterate,

glycerol 85%, disodium edetate, benzyl alcohol, butyl hydroxytouene, purified

water

Ointment

white soft paraffin, liquid paraffin, white beeswax, Dehymulus E, purified

water

If you have any further questions please consult your doctor or

pharmacist.

ADVANTAN

Consumer Medicine Information

Page 6 of 6

Sponsor

Seqirus (NZ) Ltd

PO Box 62 590

Greenlane

Auckland 1546

New Zealand.

Telephone: 09 579 8105

Date of preparation of this information

February 2017

29-8-2018

Cortacare (Ecuphar NV)

Cortacare (Ecuphar NV)

Cortacare (Active substance: Hydrocortisone aceponate) - Centralised - Authorisation - Commission Decision (2018)5781 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4689

Europe -DG Health and Food Safety