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AUDAVATE RD 0.025% W/W OINTMENT

Active substance(s): BETAMETHASONE VALERATE

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Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

PATIENT INFORMATION LEAFLET

Audavate™ RD 0.025% w/w Cream &
Audavate™ RD 0.025% w/w Ointment

5. How to store Audavate RD

(Betamethasone Valerate)

Keep this medicine out of the sight and reach of children.

Read all of this leaflet carefully before you start using this medicine because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness
are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.

Do not store above 30 °C.
Once opened, do not use this medicine for more than 3 months.
Do not use this medicine after the expiry date which is stated on the tube or carton. The expiry date refers
to the last day of that month.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

What is in this leaflet:
1. What is Audavate RD and what is it used for?
2. What you need to know before you use Audavate RD
3. How to use Audavate RD
4. Possible side effects
5. How to store Audavate RD
6. Contents of the pack and other information

6. Contents of the pack and other information
What Audavate RD contains:
The active ingredient is betamethasone valerate.
Each 1g contains 0.25mg of betamethasone (0.025% w/w) as betamethasone valerate.

1. What is Audavate RD and what is it used for?

The other ingredients are:
•C
 ream: Macrogol cetostearyl ether 20, cetostearyl alcohol, chlorocresol, disodium hydrogen phosphate dodecahydrate, citric
acid monohydrate, liquid paraffin, white soft paraffin and purified water.
• Ointment: liquid paraffin and white soft paraffin.

Audavate RD contains a medicine called betamethasone valerate. It belongs to a group of medicines called steroids. It helps to
reduce swelling and irritation.

What Audavate RD looks like and contents of the pack:
Audavate RD Cream is a white or almost white cream.

Audavate RD is used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema,
psoriasis and dermatitis.

Audavate RD Ointment is an opaque ointment.

RD stands for ‘Ready Diluted’. It contains less active ingredient than Audavate 0.1% preparations. It is used:
• For milder skin problems, or
• To keep your skin problem under control after Audavate 0.1% has improved it.

Within each carton is a tube with a plastic screw cap, which contains 100g of cream or ointment.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd., Mckenzie House, Bury Street, Ruislip, Middlesex HA4 7TL, UK

2. What you need to know before you use Audavate RD

Manufacturer:
Tiofarma B.V., Benjamin Franklinstraat 5-10, 3261 LW Oud-Beijerland, The Netherlands

Do not use Audavate RD:
• if you are allergic to betamethasone valerate or any of the other ingredients of this medicine (listed in Section 6)
• on a child under 1 years old
• to treat any of the following skin problems, it could make them worse:
• acne
• severe flushing of skin on and around your nose (rosacea)
• spotty red rash around your mouth (perioral dermatitis)
• circular to oval red plaques found over the body and the scalp (plaque psoriasis)
• itching around your back passage or private parts - unless your doctor has told you to do so
• itchy skin which is not inflamed
• viral infections, such as cold sores, herpes or chicken pox
• fungal infections, such as ringworm, athletes foot or thrush
• skin blisters or sores that are caused by bacterial infections, such as impetigo.

More Information
If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you. Other sources of
information are:
• National Eczema Society, Hill House, Highgate Hill, London N19 5NA
• The Psoriasis Association, 2 Queensbridge, Northampton, NN4 7BF
• You may also be able to find out more from books in public libraries.
This leaflet was last revised in September 2017

For information in large print, on tape, on CD or in Braille,
phone 01271 385257.

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using
Audavate RD.
Warnings and precautions
Talk to your doctor or pharmacist before using Audavate RD if:
• you have previously had an allergic reaction with another steroid
• you are applying the cream or ointment under an airtight dressing, including a child’s nappy. These dressings make it easier for
the active ingredient to pass through the skin. It is possible to accidentally end up using too much.
• you have psoriasis, your doctor will want to see you more often.
• using for a chronic leg ulcer as you may be at increased risk of local allergic reaction or infection.
• you are applying to a large surface area
• you are applying the ointment on broken skin or within the skin folds.
continued on the other side

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Revised By:

S.Anson
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26/09/17
C.Grant

Dimensions:
297 x 218
Min Body Text Size: 8pt
Supplier:
Tiofarma

Colours

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Technical
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Date sent:
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Date received: 30.05.17

6.

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For a child:
• Do not use it on children under 1 years of age.
• The smaller the child the less you will need to use.
• A child of 4 years needs about a third of the adult amount.
•A
 course of treatment for a child should not normally last more than 5 days - unless your doctor has told you to use it for longer.

• y ou are applying near eyes or on eyelids, as cataracts or glaucoma may result if the ointment repeatedly enters the eye.
• y ou are applying to thin skin such as the face or on children as their skin is thinner than adults and as a result may absorb
larger amounts
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.
Contact your doctor if you experience blurred vision or other visual disturbances.
Dressing or bandages should not be used on children or on the face where the ointment is applied. Use on children or on the
face should be limited to 5 days
Other medicines and Audavate RD
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, especially if you are taking
ritonavir and itraconazole medications.
Pregnancy and breast feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist
for advice before using this medicine.

If you have psoriasis
If you have thick patches of psoriasis on your elbows or knees, your doctor may suggest applying the cream or ointment under
an airtight dressing. It will only be at night to help the cream or ointment to start working. After a short period of time you will then
apply the cream or ointment as normal.
If you apply Audavate RD to your face
You should only apply the cream or ointment to your face if your doctor tells you to. It should not be used for more than 5 days,
as the skin on your face thins easily. Do not let the cream or ointment get into your eyes. If it does, wash it out with plenty of
water.
If you use more Audavate RD than you should
If, by mistake on a few occasions you use more than you should, do not worry. If you apply a lot or if a lot is accidentally
swallowed, it could make you ill. Talk to your doctor or go to hospital as soon as possible.

Audavate RD Cream contains cetostearyl alcohol and chlorocresol
These may cause local skin reactions (e.g. contact dermatitis) and allergic reactions.

If you forget to use Audavate RD
If you forget to apply your cream or ointment, apply it as soon as you remember. If it is close to the time you are next meant to
apply it, wait until this time.

3. How to use Audavate RD
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not
sure.

If you stop using Audavate RD
If you use Audavate RD regularly make sure you talk to your doctor before you stop using it.

Using this medicine
• You usually apply Audavate RD 1 to 3 times a day. This may be reduced as your skin begins to get better, or stopped when it is
better.
• This cream or ointment is for use on your skin only.
• Do not use more than the amount prescribed for you.
•D
 o not use on large areas of the body for a long time (such as every day for many weeks or months), unless your doctor tells
you to.
• The germs that cause infections like warm and moist conditions under bandages or dressings, so always clean the skin before
a fresh dressing is put on.
• If you are applying the cream or ointment on someone else make sure you wash your hands after use or wear disposable
plastic gloves.
• If your skin problem does not improve in 2 to 4 weeks, talk to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Guidance on how to apply the cream or ointment
1. Wash your hands.
2.Gently rub the correct amount of cream or ointment into the skin until it has all disappeared. You can measure how much
Audavate RD to use with your fingertip.

Other side effects you may notice when using Audavate RD include:
Common (may affect up to 1 in 10 people)
• A feeling of burning, pain, irritation or itching where the cream or ointment is applied.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Audavate RD and tell your doctor as soon as possible if:
• you develop a generalized rash on your skin
• y ou find that your skin problem gets worse or become swollen during treatment. You may be allergic to the cream or ointment,
have an infection or need other treatment.
• y ou have psoriasis you may get raised bumps with pus under the skin. This can happen very rarely during or after treatment
and is known as pustular psoriasis.

Very Rare (may affect up to 1 in 10,000 people)
• An increased risk of infection
• An allergic skin reaction where the cream or ointment is applied
• Rash, itchy bumpy skin or redness of the skin
• Thinning and dryness of your skin and it may also damage or wrinkle more easily
• Stretch marks may develop.
• Veins under the surface of your skin may become more noticeable.
• Increased hair growth or reduction in hair growth or hair loss and changes in skin colour.
• Thinning of your skin that may also damage more easily.
•W
 eight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and children.
• Bones can become thin, weak and break easily
• Cloudy lens in the eye (cataract) or increased pressure in eye (glaucoma)
• Increased blood sugar levels or sugar in the urine
• High blood pressure
• Slow growth in children

This picture shows one fingertip unit.

3.Unless you are meant to apply the cream or ointment to your hands as a part of the treatment, wash them again after using
thecream or ointment.
For an adult:
You should find that:
• two fingertips of cream or ointment will cover both hands or one foot
• three fingertips of cream or ointment will cover one arm
• six fingertips of cream or ointment will cover one leg
• fourteen fingertips of cream or ointment will cover the front and back of the body.

Not known (frequency cannot be estimated from the available data):
• Blurred vision

Do not worry if you find you need a little more or a little less than this. It is only a rough
guide.

continued on the other side

Betamethasone (Audavate) 0.025% Cream & Ointment PIL - UK
approved for print/date

Proof Round

07

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0719

Originator:
Origination Date:
Revision Date:
Revised By:

S.Anson
10.05.17
26/09/17
C.Grant

Dimensions:
297 x 218
Min Body Text Size: 8pt
Supplier:
Tiofarma

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
10.05.17 + 30.05.17
Date received: 30.05.17

6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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Further information

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