CORTIVAL™
CREAM AND OINTMENT

Betamethasone valerate (Bay-ta-METH-a-sone val-AIR-rate)

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Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about CORTIVAL.

It does not contain all the available information about CORTIVAL.

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 CORTIVAL 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 CORTIVAL

The name of your medicine is CORTIVAL.

CORTIVAL contains an active ingredient called betamethasone valerate.

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

CORTIVAL is available as a cream and as an ointment.

What CORTIVAL is used for

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

CORTIVAL 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 CORTIVAL is helpful for.

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

CORTIVAL cream and ointment is only available with a doctor's prescription.

Before you use CORTIVAL

When you must not use it

Do not use CORTIVAL 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 CORTIVAL 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 CORTIVAL during pregnancy and breast feeding.

Do not use CORTIVAL 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 CORTIVAL.

CORTIVAL 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.

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

Do not use CORTIVAL 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 CORTIVAL 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 CORTIVAL.

Use in Children

CORTIVAL 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 CORTIVAL if they are used excessively or for prolonged periods.

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

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

How to use CORTIVAL

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 CORTIVAL, wash and dry your hands thoroughly.

Gently rub a small amount of CORTIVAL 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.

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

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

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

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

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

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

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

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

However if you use CORTIVAL 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 CORTIVAL.

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

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

If you forget to use it

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

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 CORTIVAL. 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 CORTIVAL

Things you must do

Immediately discontinue using CORTIVAL if an irritation or sensitisation occurs.

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

Tell your doctor if you become pregnant while using CORTIVAL.

Tell your doctor if you feel CORTIVAL 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 CORTIVAL 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 CORTIVAL under occlusive dressings (airtight covering) or on large areas of skin unless your doctor tells you to.

Do not use CORTIVAL in or near the eyes.

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

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

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

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

Your doctor has prescribed CORTIVAL 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 CORTIVAL 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 CORTIVAL on skin areas that rub together such as under the arm or in the groin area if your doctor tells you to.

Only use CORTIVAL 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 CORTIVAL.

Side effects

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

CORTIVAL 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

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 CORTIVAL 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 CORTIVAL, 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. CORTIVAL may cause other side effects.

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

After using CORTIVAL

Storage

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

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

Do not leave CORTIVAL in the car or on windowsills.

Heat and dampness can destroy some medicines.

Disposal

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

Product description

What it looks like

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

• CORTIVAL 1/2 cream and ointment (0.05 %), 15 g tube
• CORTIVAL 1/5 cream (0.02%), 100 g tube

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

• CORTIVAL 1/2 ointment (0.05 %), 15 g tube

Ingredients

Betamethasone valerate is the active ingredient in CORTIVAL cream and ointment.

List of inactive ingredients

CORTIVAL Cream

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

CORTIVAL cream contains a preservative.

CORTIVAL Ointment

• Paraffin - soft white
• Paraffin - liquid

CORTIVAL ointment is preservative free.

CORTIVAL cream and ointment does not contain any colouring agents, lanolin or parabens.

The Australian Product Registration numbers are:

• CORTIVAL 1/2 cream

AUST R 91054

• CORTIVAL 1/5 cream

AUST R 91053

• CORTIVAL 1/2 ointment

AUST R 91055

Sponsor or Supplier

Fawns & McAllan Pty Ltd
(a member of Sigma group of companies)
96 Merrindale Drive, Croydon, Victoria 3136
Australia

Phone: (03) 9839 2800

This leaflet was prepared in June 2002 and updated May 2003 and May 2005.

Published by MIMS/myDr August 2005

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