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BETNOVATE™

CREAM, OINTMENT and SCALP APPLICATION
Betamethasone valerate (Bay-ta-METH-a-sone val-AIR-rate)


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about BETNOVATE.

It does not contain all the available information about BETNOVATE.

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 BETNOVATE against the benefits this medicine is expected to have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What is BETNOVATE

The name of your medicine is BETNOVATE.

BETNOVATE contains an active ingredient called betamethasone valerate.

Betamethasone valerate is a type of cortisone and belongs to the group of medicines called the corticosteroids.

BETNOVATE is available as a cream, an ointment and as a scalp application.

What BETNOVATE is used for

BETNOVATE is a topical corticosteroid, which is applied to the body surface (skin).

BETNOVATE is used to help relieve the redness, swelling, itching and discomfort of various skin problems such as:

  • eczema
  • other types of dermatitis

Your doctor knows which skin conditions BETNOVATE is helpful for.

Ask your doctor or pharmacist if you have any questions about why BETNOVATE has been prescribed for you.

BETNOVATE cream, ointment and scalp application is only available with a doctor's prescription.

Before you use BETNOVATE

When you must not use it

Do not use BETNOVATE if you have ever had an allergic reaction to:

  • betamethasone valerate or any other corticosteroid
  • any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction to BETNOVATE may include red, itchy skin rashes or a lumpy rash ("hives").

It may also include some or all of the following: wheezing, swelling of the lips/mouth, difficulty in breathing, hay fever or fainting.

Do not use: If you are pregnant or intend to become pregnant or breast feeding

Your doctor will discuss the risks and benefits of using BETNOVATE during pregnancy and breast feeding

Do not use BETNOVATE if you suffer from the following medical conditions:

  • acne rosacea or vulgaris
  • inflammation around the mouth
  • a viral skin infection (e.g. chickenpox, cold sores, shingles, warts)
  • a bacterial skin infection (e.g. impetigo, boils, cellulitus)
  • a fungal skin infection (e.g. tinea, ringworm, thrush)
  • skin conditions with ulcers e.g. leg ulcers
  • tuberculosis of the skin
  • anal or genital itching

If you are not sure whether you suffer from any of the above medical conditions, ask your doctor before you start using BETNOVATE.

BETNOVATE should not be used if you suffer from poor circulation of blood in the skin region, as it may result in skin ulcers.

Occlusive dressings should not be used if you have a skin infection.

BETNOVATE should not be used in children under the age of 1 year, unless advised by your doctor.

Do not use BETNOVATE after the expiry date (EXP.) printed on the pack.

If you use it after the expiry date has passed, it may have no effect at all, or worse, it may give an entirely unexpected effect.

Do not use BETNOVATE if the packaging shows signs of tampering or if the seal on the tube is broken, or if the product does not look quite right.

If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to use it

You must tell your doctor if:

  • You are allergic to any other medicines, foods, dyes or preservatives.
  • You have any other health problems, especially if you have an infection
  • You are pregnant or intend to become pregnant
  • You are breast-feeding or intend to breastfeed.

If you have not told your doctor about any of the above, tell them before you start to use BETNOVATE.

Use in Children

BETNOVATE is not recommended for use in children, unless your doctor tells you to do so.

Using other medicines

Tell your doctor or pharmacist if you are using any other creams, ointments or lotions or if you are taking any medicine. This includes medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with BETNOVATE if they are used excessively or for prolonged periods.

Your doctor or pharmacist has a list of medicines that may interfere with BETNOVATE.

If you have not told your doctor about any of the above, tell them before you start using BETNOVATE.

How to use BETNOVATE

Follow your doctor's instructions carefully, as they may differ from the information contained in this leaflet.

How to use it

Before you start using BETNOVATE, wash and dry your hands thoroughly.

Betnovate Cream and Ointment:

Gently rub a small amount of BETNOVATE on the affected area as directed by your doctor.

After applying the ointment or cream, wash and dry your hands thoroughly, unless it is being used for treating your hands.

Betnovate Scalp Application:

Unscrew the cap on the bottle to expose the nozzle. Apply the nozzle directly onto the scalp. Squeeze the bottle gently.

After applying the scalp application, wash and dry your hands thoroughly.

It is important that BETNOVATE scalp application is only used on the affected areas of your scalp.

Occlusive dressings are NOT recommended, unless advised by your doctor.

It is important to use BETNOVATE exactly as your doctor or pharmacist has told you to.

Do not use BETNOVATE just before having a bath, shower or going swimming.

If you do, you may reduce the effectiveness of BETNOVATE.

Do not apply BETNOVATE to your face unless specifically advised by your doctor.

If your doctor has told you to use it on your face, do not let BETNOVATE get into your eyes.

If you accidentally get some BETNOVATE in your eyes, wash them thoroughly with running water for at least ten minutes.

If you use BETNOVATE less than you should, it may not work as well and your skin problem may not improve.

However if you use BETNOVATE more often than you should, it may not improve your skin problem any faster and may cause or increase side effects.

How long to use it

Your doctor will tell you how long to use BETNOVATE.

Your doctor may tell you to reduce the number of applications as the skin disorder subsides.

If you use BETNOVATE for a long time, the chance of side effects occurring is increased.

If you forget to use it

If you forget to use BETNOVATE, use it as soon as you remember and then go back to your normal times for applying BETNOVATE.

Do not try to make up for the amount that you missed by using more than you would normally use.

If you swallow it

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to the accident and emergency centre at your nearest hospital, if anyone swallows BETNOVATE. Do this even if there are no signs of discomfort or poisoning. Urgent medical attention may be needed.

Keep telephone numbers for these places handy.

While you are using BETNOVATE

Things you must do

Immediately discontinue using BETNOVATE if an irritation or sensitisation occurs.

Tell any doctors and pharmacists who are treating you that you are using BETNOVATE.

Tell your doctor if you become pregnant while using BETNOVATE.

Tell your doctor if you feel BETNOVATE is not helping your condition or if your skin condition worsens or seems infected.

Tell your doctor if, for any reason, you have not used BETNOVATE exactly as prescribed.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Things you must not do

Do not use BETNOVATE under occlusive dressings (airtight covering) or on large areas of skin unless your doctor tells you to.

Do not use BETNOVATE in or near the eyes.

Do not stop using BETNOVATE or change the amount, area or method of application, without first checking with your doctor.

Do not give BETNOVATE to anyone else even if his or her symptoms seem similar to yours.

Do not use plastic pants or tight-fitting nappies if BETNOVATE is to be used on the nappy area of young children.

Do not use BETNOVATE to treat any other conditions unless your doctor tells you to do so.

Your doctor has prescribed BETNOVATE especially for you and your condition.

If you use it for another condition, it may not work at all or make the condition worse.

Things to be careful of

Do not use large amounts of BETNOVATE for a long period of time.

If you use large amounts for a long time, the chance of systemic absorption through the skin and the chance of side effects may increase.

Only use BETNOVATE on skin areas that rub together such as under the arm or in the groin area if your doctor tells you to.

Only use BETNOVATE on the face if your doctor tells you to. If improvement does not occur within one week, tell your doctor immediately.

Children and adolescents should be followed closely by the doctor, since this medicine is absorbed through the skin and can affect growth or cause other unwanted side effects.

Ask your doctor or pharmacist if you are concerned about the length of time you have been using BETNOVATE.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using BETNOVATE.

BETNOVATE helps most people with skin problems but it may have some unwanted side effects in some people.

If side effects occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

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

The most commonly reported side effect is local irritation which includes:

  • itching
  • burning
  • dryness
  • redness

Mild temporary stinging/tingling may be expected when BETNOVATE scalp application is applied to the scalp.

Tell your doctor or pharmacist immediately if you notice any of the following at the application site:

  • thinning of the skin with easy bruising
  • rash around the mouth area
  • stretch marks or streaks on the skin
  • infection of the hair roots
  • change in skin colour
  • increased hair growth
  • heat rash
  • acne

Side effects are more frequent if BETNOVATE is used under dressings that are close-fitting, and keep out the air.

Long periods of treatment under close-fitting dressings, may cause thinning of the skin.

If large areas of the skin are treated, especially for a long time and under tight dressings, some steroid may be absorbed into the body. This may cause various effects including:

  • stomach ulcers
  • high blood pressure
  • delayed wound healing
  • increased chance of infection
  • excessive growth of facial and body hair
  • acne
  • increased body fluid
  • muscle weakness

If you have any questions about any of these effects, you should speak to your doctor immediately.

If you think you are having an allergic reaction to BETNOVATE, tell your doctor immediately or go to the accident and emergency centre at your nearest hospital. Symptoms may include:

  • wheezing
  • swelling of the eyelids, face, lips and mouth
  • lumpy rash ("hives")
  • tightness in the chest
  • fainting

This is not a complete list of all possible side effects. BETNOVATE may cause other side effects.

Check with your doctor as soon as possible if you have any problems while using BETNOVATE, even if you do not think the problems are connected with this medicine or are not listed in this leaflet.

After using BETNOVATE

Storage

Keep your BETNOVATE in its pack, until it is time to use it.

Keep BETNOVATE where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep BETNOVATE in a cool dry place where the temperature stays below 25 °C.

Keep BETNOVATE scalp application away from any fire or open flames, as the solution is flammable and may catch fire.

Do not leave BETNOVATE in the car or on windowsills.

Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop using BETNOVATE or it has passed its expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

BETNOVATE cream is a soft, white cream with a faint odour of chlorocresol. It is available in the following strengths:

  • Betnovate cream (0.1%), 30 g tube
  • Betnovate 1/2 cream (0.05 %), 15 g and 30 g tubes
  • Betnovate 1/5 cream (0.02%), 100 g tube

BETNOVATE ointment is a greyish-white, smooth ointment. It is available in the following strengths:

  • Betnovate ointment (0.1%), 30 g tube
  • Betnovate 1/2 ointment (0.05 %), 15 g tube

BETNOVATE scalp application is a colourless, hazy and slightly viscous liquid, available in the following strength:

  • Betnovate scalp application (0.1%),
30 g plastic bottle

Ingredients

Betamethasone valerate is the active ingredient in BETNOVATE cream, ointment and scalp application.

List of inactive ingredients

Betnovate Cream

  • Paraffin-soft white
  • Paraffin-liquid
  • Chlorocresol (preservative)
  • Cetostearyl alcohol
  • Cetomacrogol 1000
  • Sodium phosphate-monobasic
  • water-purified

BETNOVATE cream contains a preservative.

Betnovate Ointment

  • Paraffin - soft white
  • Paraffin - liquid

BETNOVATE ointment is preservative free.

Betnovate Scalp Application

  • Sodium hydroxide
  • Isopropyl alcohol
  • Carbomer
  • Water-purified

BETNOVATE cream, ointment and scalp application does not contain any colouring agents, lanolin or parabens.

The Australian Product Registration numbers are:

  • BETNOVATE cream
AUST R 12492
  • BETNOVATE ointment
AUST R 57335
  • BETNOVATE 1/2 ointment
AUST R 57336
  • BETNOVATE 1/2 cream
AUST R 12488
  • BETNOVATE 1/5 cream
AUST R 12491
  • BETNOVATE scalp application
AUST R 12494

Sponsor or Supplier

Sigma Pharmaceuticals Pty Ltd
96 Merrindale Drive
Croydon Victoria 3136
Australia

Phone: (03) 9839 2800

This leaflet was prepared in April 2001 and updated May 2003, April 2004 and May 2004, May 2005.

Published by MIMS/myDr August 2005

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