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Package Leaflet: Information for the User

Trimovate® Cream
clobetasone butyrate, calcium
oxytetracycline and nystatin
Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it
• 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 gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1 What Trimovate is and what it is used for
2 Before you use Trimovate
3 How to use Trimovate
4 Possible side effects
5 How to store Trimovate
6 Further information

1 What Trimovate is and what
it is used for
Trimovate contains three different medicines
called clobetasone butyrate, calcium
oxytetracycline and nystatin.
• Clobetasone butyrate belongs to a group of
medicines called steroids. It helps to reduce
swelling and irritation.
• Calcium oxytetracycline and nystatin are
medicines used to fight infections. They fight
certain bacterial and fungal infections of the
Trimovate is used to help reduce the redness
and itchiness of certain skin problems, such as
eczema, nappy rash and dermatitis where
infection may be a problem.

3 How to use Trimovate
Always use Trimovate exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
Using this medicine
• You usually apply Trimovate up to 4 times a
• 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,
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
after 7 days talk to your doctor.
• Do not mix with any other creams or
Guidance on how to apply the cream
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 cream to use
with your fingertip. This picture shows one
fingertip unit.

2 Before you use Trimovate
Do not use Trimovate:
• if you are allergic (hypersensitive) to
clobetasone butyrate, calcium
oxytetracycline or oxytetracycline, nystatin
or any of the other ingredients in Trimovate
(listed in Section 6)
• to treat any of the following skin problems,
it could make them worse:
- acne
- viral infections, such as cold
sores, herpes or chicken pox
- blisters or sores on your face and
hands (impetigo)
- fungal infections, such as
ringworm, athletes foot or thrush.
Do not use if any of the above apply
to you. If you are not sure, talk to
your doctor or pharmacist before
using Trimovate.
Take special care with Trimovate
Check with your doctor or
pharmacist before using your medicine if:
• you are applying the cream under a child’s
nappy or an airtight dressing for more than
7 days. Nappies and airtight dressings make
it easier for the active ingredient to pass
through the skin and it is possible to
accidentally end up using too much cream.
Pregnancy and breast-feeding
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 it.
For an adult
You should find that:
• two fingertips of cream will cover both
hands or a 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 your body.
Do not worry if you find you need a little more
or a little less than this. It is only a rough guide.

5 How to store Trimovate
• Keep out of the reach and sight of children.
• Do not use Trimovate after the expiry date
on the tube end or carton (EXP). The expiry
date refers to the last day of that month.
• Do not store above 25°C.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6 Further information
For a child
• The smaller the child the less you will need
to use.
• An infant between 6 months and 1 year old
needs about a quarter of the adult amount.
• A child of 4 years needs about a third of the
adult amount.
If you apply Trimovate to your face
You should only apply the cream to your face if
your doctor tells you to. The cream should not
be used for too long as the skin on your face
thins easily. Do not let the cream get into
your eyes.
If you use more Trimovate 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 the
hospital as soon as possible.
If you forget to use Trimovate
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
If you stop using Trimovate
If you use Trimovate 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.

4 Possible side effects
Like all medicines, Trimovate can cause side
effects, although not everybody gets them.
Stop using Trimovate and tell your doctor
as soon as possible if:
• you find your skin problem gets worse or
becomes swollen during treatment. You may
be allergic to the cream or need other
Other side effects you may notice when
using Trimovate include:
• redness of your skin (erythema)
• rash including an itchy rash or swellings on
the skin called nettle rash or hives (urticaria)
• itching (pruritus)
• a feeling like your skin is burning
• changes in skin colour
• increased hair growth
• staining of your hair, skin and clothes can
occur. You can protect clothes by covering
the treated area with a cotton bandage or
piece of clean cloth
• thinning of your skin and it damages more
easily. This could happen if you use it over a
long period of time or you use a lot each
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

What Trimovate contains
• The active ingredients are clobetasone
butyrate, calcium oxytetracycline and
nystatin. Each 1 g contains 0.5 mg of
clobetasone butyrate (0.05% w/w), 30 mg
oxytetracycline (3% w/w) as calcium
oxytetracycline and 100,000 units of
• The other ingredients are titanium dioxide,
glyceryl monostearate, cetostearyl alcohol,
soft paraffin white, polyoxyl 40 stearate,
dimeticone 20, glycerol, chlorocresol,
sodium metabisulphite, sodium acid
phosphate, disodium hydrogen phosphate
and purified water.
What Trimovate looks like and contents of
the pack
Within each carton is a tube with a plastic
screw cap, which contains 30 g of yellow
Marketing Authorisation Holder and
Product licence held by GlaxoSmithKline UK,
Stockley Park West, Uxbridge, Middlesex
UB11 1BT.
Manufactured by Glaxo Wellcome Operations,
Barnard Castle, Durham DL12 8DT.
Other formats
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of

0800 198 5000 (UK Only)
Please be ready to give the following
Product name
Trimovate Cream
Reference number
This is a service provided by the Royal National
Institute of Blind People.
More information
This leaflet does not contain all the information
about your medicine. If you have any questions
or are not sure about anything,
ask your doctor or pharmacist who
has the information you need and
will advise you.
A source of information is:
National Eczema Society
Hill House
Highgate Hill
London N19 5NA
You may also be able to find out
more from books in public
Leaflet date: April 2008
Trimovate is a registered
trademark of the GlaxoSmithKline
group of companies
© 2008 GlaxoSmithKline group of companies


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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.