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ADVANTAN OINTMENT 0.1% 15G




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Product Description

ADVANTAN OINTMENT 0.1% 15G

ADVANTAN(R)

OINTMENT, FATTY OINTMENT, CREAM & LOTION

Methylprednisolone aceponate (meth'il -predd -niz-oh -lone ass-epp -on -eight)

CONSUMER MEDICINE INFORMATION

What is in this leaflet?

Please read this leaflet carefully

before you start your treatment.

Keep this leaflet.

You may want to read it again.

This leaflet answers some common

questions about using Advantan(R).

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using Advantan(R)

against the benefits it is expected to

have for you.

If you have any concerns about

using Advantan(R), talk to your

doctor or pharmacist.

What Advantan(R) is

used for

The active ingredient in Advantan(R)

belongs to the group of medicines

called corticosteroids. The

corticosteroid in Advantan(R) is

suitable to put on the skin. It is

therefore called a topical

corticosteroid, which is sometimes

shortened to topical steroid.

When Advantan(R) is put on the

skin, it relieves the redness, swelling,

itching and irritation of the skin in

eczema and psoriasis.

Advantan(R) preparations are

available only with a doctor's

prescription.

Advantan(R) is made up as four

different preparations. Each has a

distinct look and feel. They are:

* ointment,

* fatty ointment,

* cream and

* lotion.

The most solid is the fatty ointment;

the most runny is the lotion. The

ointment and cream are in-between in

thickness.

Each preparation is especially

suitable in consistency for a

particular area of skin or skin

condition needing treatment. Your

doctor will prescribe the preparation

most suitable for you.

The Advantan(R) preparations are

medicines and should only be used

on skin affected by the conditions

described below.

All four Advantan(R) preparations

treat eczema.

Advantan(R) ointment, fatty

ointment and cream (but NOT lotion)

also treat psoriasis.

Eczema is a skin condition with

redness, swelling, oozing of fluid,

crusting and later scaling. It is often

very itchy.

Psoriasis is a skin disorder with

raised, rough, reddened areas covered

with dry, fine, silvery scales.

Your doctor may have prescribed

Advantan(R) for another reason.

Discuss this with him/her.

Advantan(R) is not addictive. It is

not expected to affect your ability to

drive a car or operate machinery.

Before you use

Advantan(R)

When you must not use

Advantan(R)

Do not use Advantan(R) if you

have an allergy to:

* any medicine containing

methylprednisolone aceponate

* any of the ingredients listed at the

end of this leaflet (see Product

description).

* 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(R) if in the

area of skin you are treating:

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(R) if you

have acne, rosacea or perioral

dermatitis.

Your doctor will identify these

conditions for you.

Do not use Advantan(R)

* after the expiry date printed on

the pack OR

* if the packaging is torn, doesn't

look quite right or shows signs

of tampering.

ADVANTAN(R) 2

If the Advantan(R) packaging is

damaged or it is past the expiry date,

return it to your pharmacist for

disposal.

If you have not told your doctor

about any of the above, tell

him/her before you start using

Advantan(R).

If you are not sure whether you

should start using this medicine,

talk to your doctor.

Before you start to use it

Tell your doctor if you have a

known allergy to Advantan(R) or

any ingredients listed at the end of

this leaflet.

Tell your doctor if you

* are pregnant or plan to become

pregnant

* are breast-feeding

* plan to breastfeed.

Your doctor can discuss with you the

risks and benefits of using

Advantan(R).

Advantan(R) should be used only

on the skin. Avoid getting

Advantan(R) in your eyes. Do not

put Advantan(R) in your mouth.

Do not swallow Advantan(R).

Taking other medicines

Tell your doctor or pharmacist if

you are on any other medicines,

including any that you buy without

a prescription from your

pharmacy, supermarket or health

food shop.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while using

Advantan(R).

How to use

Advantan(R)

Follow carefully all directions

given to you by your doctor or

pharmacist.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions in this leaflet, ask your

doctor or pharmacist for help.

How to use Advantan(R)

preparations

Advantan(R) ointment, fatty

ointment and cream

Apply thinly to the affected area of

skin.

Advantan(R) lotion

Apply thinly to the affected area of

skin and gently rub in.

When to use it

Treatment of eczema

Use Advantan(R) once a day to treat

the affected skin.

Treatment of psoriasis

Use Advantan(R) ointment, fatty

ointment or cream once or twice a

day on the patches of psoriasis.

How long to use it

Usually, treatment with Advantan(R)

is for up to 12 (twelve) weeks in

adults and 4 (four) weeks in children.

Treatment with Advantan(R) should

be for the shortest possible time

period, and minimised to only on

affected area. This is particularly

important when using Advantan

under bandages.

This is particularly important when

treating large areas, and in children.

Excessive application of topical

corticosteroids to large areas of the

body for prolonged periods of time

can increase the risk of side effects.

Discuss this with your doctor.

If you forget to use it

If you forget to use Advantan(R), use

it as soon as you remember. Then go

on as before.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to use your medicine, ask your

doctor or pharmacist for some

hints.

If you use too much or use it

other than directed

(Overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26 in Australia)

for advice, or go to the Emergency

Department at the nearest hospital,

if you think that you or anyone else

may have used too much or

swallowed some of this medicine.

Do this even if there are no signs of

discomfort or poisoning.

If you use too much Advantan(R) or

use it for a long time, you may notice

the following in the treated area:

* your skin becomes thinner

* pink/purple stretch marks appear

* a network of tiny blood vessels

appears.

Stop using Advantan(R) if you have

these symptoms and tell your doctor.

These symptoms usually disappear

about two weeks after you stop using

Advantan(R).

While you are using

Advantan(R)

Things you must do

Stop using Advantan(R) if you

develop a skin allergy.

Tell your doctor if your skin

becomes very dry when you use

Advantan(R) cream or lotion. Your

doctor may prescribe Advantan(R)

ointment or fatty ointment instead.

If your eczema or psoriasis is

infected, you must

* use specific anti-infection

treatments prescribed by your

doctor

* Stop using Advantan(R) if the

infection spreads.

ADVANTAN(R) 3

If you are going to start any new

medicine, tell your doctor and

pharmacist that you are using

Advantan(R).

If you become pregnant while

using Advantan(R), tell your

doctor immediately.

Things you must not do

Do not use Advantan(R) to treat

any other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

See also the section with the heading

Before you use Advantan(R).

Side effects

As with all medicines, Advantan(R)

can cause some side effects. Side

effects not listed in this leaflet may

occur in some patients.

Do not be alarmed by the following

list of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may have.

Tell your doctor or pharmacist:

* if you have any unpleasant

effects while you are using

Advantan(R)

or

* if you notice any of the following

and they worry you:

- itching

- burning

- redness.

The above list includes the more

common side effects.

The following list includes side

effects that are rare:

- thinning of the skin

- the appearance of fine blood

vessels on the skin surface

- stretch marks

- acne

- infection of hair follicles

- excessive unwanted hair growth

- redness and irritation around the

mouth (perioral dermatitis)

- skin discolouration

- allergic skin reactions.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people.

After using

Advantan(R)

Keep Advantan(R) in its pack until

required.

Storage

Keep your Advantan(R) ointment

or cream in a cool dry place where

the temperature stays below 25

degrees C.

Keep your Advantan(R) fatty

ointment or lotion in a cool dry

place where the temperature stays

below 30 degrees C.

Do not store Advantan(R) or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy some

medicines.

Keep Advantan(R) where children

cannot reach it.

A locked cupboard at least

one-and-a-half metres above the

ground is a good place to store

medicines.

Do not use Advantan(R) after the

expiry date on the pack.

Disposal

If your doctor tells you to stop

using Advantan(R) or the expiry

date has passed, ask your

pharmacist what to do with any

Advantan(R) that is left over.

Product description

What Advantan(R)

formulations look like

Advantan(R) ointment is a white to

yellowish, opaque ointment, with a

firm consistency.

Advantan(R) fatty ointment is a

white to yellowish, semi-clear

ointment, which is greasier than

Advantan(R) ointment.

Advantan(R) cream is a white cream,

lighter in consistency than the

ointments, and less greasy.

Advantan(R) lotion is a white lotion,

more fluid than the cream.

Ingredients

Advantan(R) ointment contains 1 mg

of methylprednisolone aceponate per

gram of ointment as the active

ingredient. It also contains

* white beeswax

* heavy liquid paraffin

* white soft paraffin

* Dehymuls E

* water.

Advantan(R) fatty ointment contains

1 mg of methylprednisolone

aceponate per gram of fatty ointment

as the active ingredient. It also

contains

* heavy liquid paraffin

* white soft paraffin

* microcrystalline wax

* hydrogenated castor oil.

Advantan(R) cream contains 1 mg of

methylprednisolone aceponate per

gram of cream as the active

ingredient. It also contains

* decyl oleate

* glyceryl monostearate

* cetostearyl alcohol

* hard fat

* Softisan 378

* PEG-40 stearate

* glyceryl 85%

* butylated hydroxytoluene

* benzyl alcohol

ADVANTAN(R) 4

* disodium edetate

* water.

Advantan(R) lotion contains 1 mg of

methylprednisolone aceponate per

gram of lotion as the active

ingredient. It also contains

* medium chain trigylcerides

* caprylic/capric/stearic

triglycerides

* steareth-2

* steareth-21

* benzyl alcohol

* disodium edetate

* glycerol

* water.

Advantan(R) does not contain

lactose, sucrose, gluten, tartrazine or

any other azo dyes.

The Australian Registration Numbers

are

Advantan(R) ointment AUST R

49381

Advantan(R) fatty ointment: AUST

R 49382

Advantan(R) cream: AUST R 49380

Advantan(R) lotion: AUST R 80272

This is not all the information

available on Advantan(R). If you

have any more questions or are

unsure about anything, ask your

doctor or pharmacist.

Sponsor

Advantan(R) is sponsored in

Australia by:

CSL Limited

ABN 99 051 588 348

45 Poplar Road

Parkville 3052

Victoria

Australia

This leaflet was prepared in February

2008

 
 
 
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