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AUDAVATE 0.1% W/W CREAM

Active substance(s): BETAMETHASONE VALERATE / BETAMETHASONE VALERATE

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Not known (frequency cannot be estimated
from the available data)
•b
 lurred vision

What Audavate looks like and contents
of the pack:

If any of the above side effects are troublesome
or last more than a few days or if you notice any
side effects not mentioned in this leaflet, please
inform your doctor or pharmacist.

Within each carton is a tube with a plastic screw
cap, which contains 30g or 100g of cream.

Audavate Cream is a white or almost white
cream.

Marketing authorisation holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. 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

5

More Information
If you have any questions
or are not sure about anything,
ask your doctor or pharmacist
who will advise you.

How to store Audavate
Keep all medicines out of the sight and reach of
children.

Other sources of information are:
•N
 ational Eczema Society,
Hill House,
Highgate Hill,
London
N19 5NA
• The Psoriasis Association,
2 Queensbridge,
Northampton,
NN4 7BF
•Y
 ou may also be able to find out more from
books in public libraries.

Do not store above 30°C.
Once opened, do not use this medicine for
more than 3 months.
Do not use Audavate after the expiry date
which is shown on the tube or carton. The
expiry date refers to the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines that
are no longer required. This will help to protect
the environment.
6

This leaflet was last revised in July 2017

Contents of the pack and other
information

If you would like a
leaflet with larger text,
please contact
01271 385257.

What Audavate contains:

The active ingredient is betamethasone
valerate.

Audavate™ 0.1% w/w Cream
betamethasone valerate

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

By reporting side effects you can help provide
more information on the safety of this
medicine.

Package leaflet: Information for the user

Read all of this leaflet carefully 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. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as yours.
•  If any of the side effects become serious
or if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
•  The full name of this medicine is
AudavateTM 0.1% w/w Cream but
within the leaflet it will be referred to as
Audavate.

2

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

Each 1g contains 1mg of betamethasone (0.1%
w/w) as betamethasone valerate.

What Audavate is and what it is used
for
Audavate contains a medicine called
betamethasone valerate. It belongs to a group
of medicines called steroids. It helps to reduce
swelling and irritation.

The other ingredients are macrogol cetostearyl
ether 20, cetostearyl alcohol, chlorocresol,
sodium dihydrogen phosphate dihydrate,
phosphoric acid, sodium hydroxide, liquid
paraffin, white soft paraffin and purified water.

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

Continued top of next column

Actavis, Barnstaple, EX32 8NS, UK

BBBA0834

What you need to know before you
use Audavate
Do not use Audavate:

• if you are allergic (hypersensitive) to
betamethasone valerate or any of the other
ingredients of Audavate (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.
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.

Take special care with Audavate:

Check with your doctor or pharmacist before
using Audavate if:
• you have previously had an allergic reaction
with another steroid.
• you are applying the cream 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.

Continued top of next column

Continued over page

Batamethasone (Audavate) 0.1% w/w Cream PIL - UK
approved for print/date

Proof Round

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UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0834

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
23.05.17
01.08.17
S.Anson

Dimensions:
297 x 218
Min Body Text Size: 9pt
Supplier:
Tiofarma

Date sent:
24.05.17 + 07.06.17
Date received: 13.06.17

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.
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.

• 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 on broken skin or within the
skin folds.
• you are applying near eyes or on eyelids, as
cataracts or glaucoma may result if the cream
repeatedly enters the eye.
• you 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.

3

How to use Audavate

4

Always use Audavate exactly as your doctor or
pharmacist has told you. You should check with
your doctor or pharmacist if you are not sure.

Like all medicines, Audavate can cause side
effects, although not everybody gets them.

Stop using Audavate and tell your
doctor as soon as possible if:

Using this medicine

• You usually apply Audavate 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 is for use on your skin only.
• Do not use more than the amount prescribed
for you.
• Do 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 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.

Dressing or bandages should not be used on
children or on the face where the cream is
applied. Use on children or on the face should
be limited to 5 days.
If this product comes into contact with
dressings, clothing and bedding the fabric can
be easily ignited with a naked flame. You should
keep away from fire when using this product.
Contact your doctor if you experience blurred
vision or other visual disturbances.

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.

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.

Other side effects you may notice when
using Audavate include:

If you have psoriasis

Common (affects less than 1 in 10 people)
• a feeling of burning, pain, irritation or itching
where the cream is applied.

If you have thick patches of psoriasis on your
elbows or knees, your doctor may suggest
applying the cream under an airtight dressing.
It will only be at night to help the cream to start
working. After a short period of time you will
then apply the cream as normal.

1. Wash your hands.
2. Gently rub the correct amount of cream
into the skin until it has all disappeared. You
can measure how much Audavate to use
with your fingertip. This picture shows one
fingertip unit.

Other medicines and Audavate

• y ou develop a generalised 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, have an infection or
need other treatment
• y ou have psoriasis and you get raised bumps
with pus under the skin. This can happen very
rarely during or after treatment and is known
as pustular psoriasis.

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

Guidance on how to apply the cream

If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using this medicine.

Side effects if you use Audavate for a
long time, or you use a lot each time
you apply it, or you apply it under an
airtight dressing or a nappy:

If you apply Audavate to your face

You should only apply the cream 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 get into
your eyes. If it does, wash it out with plenty of
water.

Very Rare (affects less than 1 in 10,000 people)
• a n increased risk of infection
• a n allergic skin reaction where the cream is
applied
• r ash, itchy bumpy skin or redness of the skin
• t hinning and dryness of your skin and it may
also damage or wrinkle more easily
• s tretch marks may develop
• v eins 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
• t hinning 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
•b
 ones can become thin, weak and break easily
• c loudy lens in the eye (cataract) or increased
pressure in eye (glaucoma)
• increased blood sugar levels or sugar in the
urine
•h
 igh blood pressure
• s low growth in children.

If you use more Audavate than you
should

Pregnancy and breast-feeding

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.

Talk to your doctor or pharmacist before
using this medicine if you are pregnant, might
become pregnant or are breast-feeding.
3. Unless you are meant to apply the cream to
your hands as a part of the treatment, wash
them again after using the cream.

Important information about some of
the ingredients of Audavate

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

If you forget to use Audavate

If you forget to apply your cream, 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.

For an adult:

You should find that:
• two fingertips of cream will cover both hands
or one foot
• three fingertips of cream will cover one arm
• six fingertips of cream will cover one leg
• fourteen fingertips of cream will cover the
front and back of the body.

Continued top of next column

If you stop using Audavate

If you use Audavate regularly make sure you
talk to your doctor before you stop using it.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
Continued top of next column

Continued over page

Possible side effects

Continued over page

Batamethasone (Audavate) 0.1% w/w Cream PIL - UK
approved for print/date

Proof Round

5

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0834

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
23.05.17
01.08.17
S.Anson

Dimensions:
297 x 218
Min Body Text Size: 9pt
Supplier:
Tiofarma

Date sent:
24.05.17 + 07.06.17
Date received: 13.06.17

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.
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.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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