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ADVANTAN(R)

OINTMENT, FATTY OINTMENT, CREAM & LOTION
Methylprednisolone aceponate (meth`il -predd -niz-oh -lone ass-epp -on -eight)
CONSUMER MEDICINE INFORMATION

Buy ADVANTAN CRM 0.1% 15G 1.

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. 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 against the benefits it is expected to have for you.

If you have any concerns about using Advantan, talk to your doctor or pharmacist.

What Advantan is used for

The active ingredient in Advantan belongs to the group of medicines called corticosteroids. The corticosteroid in Advantan is suitable to put on the skin. It is therefore called a topical corticosteroid, which is sometimes shortened to topical steroid.

When Advantan is put on the skin, it relieves the redness, swelling, itching and irritation of the skin in eczema and psoriasis.

Advantan preparations are available only with a doctor`s prescription.

Advantan 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 preparations are medicines and should only be used on skin affected by the conditions described below.

All four Advantan preparations treat eczema.

Advantan 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 for another reason. Discuss this with him/her.

Advantan is not addictive. It is not expected to affect your ability to drive a car or operate machinery.

Before you use Advantan

When you must not use Advantan

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 (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 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 if you have acne, rosacea or perioral dermatitis.
Your doctor will identify these conditions for you.
Do not use Advantan
after the expiry date printed on the pack OR
if the packaging is torn, doesn`t look quite right or shows signs of tampering.

If the Advantan 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.

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 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.

Advantan should be used only on the skin. Avoid getting Advantan in your eyes. Do not put Advantan in your mouth. Do not swallow Advantan.

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.

How to use Advantan

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 preparations

Advantan ointment, fatty ointment and cream

Apply thinly to the affected area of skin.

Advantan lotion

Apply thinly to the affected area of skin and gently rub in.

When to use it

Treatment of eczema

Use Advantan once a day to treat the affected skin.

Treatment of psoriasis

Use Advantan ointment, fatty ointment or cream once or twice a day on the patches of psoriasis.

How long to use it

Usually, treatment with Advantan is for up to 12 (twelve) weeks in adults and 4 (four) weeks in children.

Treatment with Advantan should be for the shortest possible time period.

This is particularly important when treating large areas, and in children.

Discuss this with your doctor.

If you forget to use it

If you forget to use Advantan, 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 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 if you have these symptoms and tell your doctor.

These symptoms usually disappear about two weeks after you stop using Advantan.

While you are using Advantan

Things you must do

Stop using Advantan if you develop a skin allergy.

Tell your doctor if your skin becomes very dry when you use Advantan cream or lotion. Your doctor may prescribe Advantan 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 if the infection spreads.

If you are going to start any new medicine, tell your doctor and pharmacist that you are using Advantan.

If you become pregnant while using Advantan, tell your doctor immediately.

Things you must not do

Do not use Advantan 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.

Side effects

As with all medicines, Advantan 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

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)
-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

Keep Advantan in its pack until required.

Storage

Keep your Advantan ointment or cream in a cool dry place where the temperature stays below 25 degrees C.

Keep your Advantan fatty ointment or lotion in a cool dry place where the temperature stays below 30 degrees C.

Do not store Advantan 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 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 after the expiry date on the pack.

Disposal

If your doctor tells you to stop using Advantan or the expiry date has passed, ask your pharmacist what to do with any Advantan that is left over.

Product description

What Advantan formulations look like

Advantan ointment is a white to yellowish, opaque ointment, with a firm consistency.

Advantan fatty ointment is a white to yellowish, semi-clear ointment, which is greasier than Advantan ointment.

Advantan cream is a white cream, lighter in consistency than the ointments, and less greasy.

Advantan lotion is a white lotion, more fluid than the cream.

Ingredients

Advantan 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 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 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
disodium edetate
water

Advantan 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 does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

The Australian Registration Numbers are:

Advantan ointment AUST R 49381

Advantan fatty ointment: AUST R 49382

Advantan cream: AUST R 49380

Advantan lotion: AUST R 80272

This is not all the information available on Advantan. If you have any more questions or are unsure about anything, ask your doctor or pharmacist.

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Advantan 0.1% Cream 15g