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Package leaflet: Information for the user

Trimovate® Cream
clobetasone 17-butyrate, calcium
oxytetracycline and nystatin
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
• 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 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.
What is in this leaflet
1 What Trimovate is and what it is used for
2 What you need to know before you use
3 How to use Trimovate
4 Possible side effects
5 How to store Trimovate
6 Contents of the pack and other information

1 What Trimovate is and what
it is used for
Trimovate contains three different active
substances called clobetasone butyrate,
calcium oxytetracycline and nystatin.
• Clobetasone butyrate belongs to a group
of medicines called corticosteroids. It
helps to reduce redness, swelling and
irritation of the skin.
• Calcium oxytetracycline (an antibiotic)
and nystatin (an antifungal) are
medicines used to fight infections. They
fight certain bacterial and fungal
infections of the skin.
Trimovate is used in adults, the elderly,
children and infants to help reduce the
redness and itchiness of certain skin
problems, such as eczema, nappy rash and
dermatitis where infection may be a

• If your condition does not improve
after 7 days of treatment, speak to
your doctor.
Other medicines and Trimovate
Some medicines may affect how Trimovate
works or make it more likely that you’ll have
side effects. Examples of these medicines
• ritonavir (used to treat HIV infection)
• itraconazole (used to treat fungal
Tell your doctor or pharmacist if you are
using, have recently used or might use any
other medicines.
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
do use Trimovate when breast-feeding, do
not use it near your nipple to ensure that the
baby does not accidentally get it in their
Trimovate contains cetostearyl alcohol
and chlorocresol
Cetostearyl alcohol may cause local skin
reactions (e.g. contact dermatitis).
Chlorocresol may cause allergic reactions.

GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR

3 How to use Trimovate

Always use Trimovate exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Using this medicine
• You usually apply Trimovate once or
twice a day.
• 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.




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, as it could make them worse:
- acne
- fungal or bacterial infections such as
ringworm, athlete’s foot, thrush, or
- viral infections, such as cold sores,
herpes or chicken pox
- rosacea (a facial skin condition where
the nose, cheeks, chin, forehead or
entire face are unusually red, with or
without tiny visible blood vessels,
bumps (papules) or pus-filled bumps
- itchy skin which is not inflamed
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. Some
bacterial infections may not fully respond to
treatment with Trimovate.
If your infection worsens at any time,
speak to your doctor straight away.
Warnings and precautions
Talk to your doctor or pharmacist before
using Trimovate.
• Check with your doctor or pharmacist if
you are applying the cream under a child’s
nappy or an airtight dressing. 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
• Antibiotics may cause a condition that can
result in severe diarrhoea and stomach
cramps. Although this is unlikely to
happen with antibiotics applied to the
skin, if you develop stomach cramps or
diarrhoea that does not improve or is
severe, stop using Trimovate and contact
your doctor immediately
• Trimovate may cause slight staining of
hair, skin or fabric, but this can be
removed by washing. The application
may be covered with a non-airtight
dressing e.g. cotton bandage or clean
cloth to protect clothing
• Trimovate can cause increased sensitivity
to sunlight. Avoid using sunlamps and
spending a long time in the sun while
using Trimovate and use a sunscreen
product and protective clothing to
prevent sunburn
• Take care when applying Trimovate to
the eyelids to make sure it does not get
into your eye
• If you accidently get Trimovate in your
eyes wash them well with water
• Take care when applying Trimovate to
the face over a long period of time as it
may cause skin thinning
• If you have eczema around a leg ulcer,
using Trimovate may increase the risk of
an allergic reaction or an infection
around the ulcer
• Only use an airtight dressing over this
medicine if your doctor has told you to.
If you are applying Trimovate under an
airtight dressing, including a child’s
nappy, make sure that the skin is
cleansed before a fresh dressing is
applied, to prevent infections
• Trimovate contains chlorocresol which
may cause allergic reactions and
cetostearyl alcohol which may cause local
skin reactions (e.g. contact dermatitis)
• Only use Trimovate for as long as your
doctor recommends

• If you are applying the cream on someone
else make sure you wash your hands after
use or wear disposable plastic gloves.
• Do not dilute or mix with any other
creams or ointments.
Guidance on how to apply the cream
1 Wash your hands.
2 Apply a thin layer to the affected area(s)
and gently rub into the skin until it has
all disappeared. You can measure how
much Trimovate to use with your
fingertip. For children you will need to
use less cream but still use an adult
finger to measure out the fingertip unit.
This picture shows one fingertip unit.

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

Do not worry if you find you need a little
more or less than this. It is only a rough
For a child
Number of fingertip units needed
Face Arm Leg
and and and Front including
neck hand foot
1 1.5
1½ 1½ 2
1½ 2

2 2½ 4½ 3½
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 time.
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 medicine, ask your doctor or pharmacist.

Pharma code Ref. No. 7563

2 What you need to know before
you use Trimovate cream


Page 1 of 2

4 Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
Stop using Trimovate and tell your
doctor immediately if:
• you notice swelling of the face, lips,
tongue or other parts of the body, or you
have difficulty breathing.
• you find your skin condition gets worse
or your skin becomes swollen during
treatment. You may be allergic to the
cream or need other treatment.
Side effects with frequencies that
cannot be estimated from the available
data include:
Use of over a long period of time, or
use under an airtight dressing, may
cause the following symptoms:
• increased weight
• obesity, especially around the centre
of the body
• moon face / rounding of the face
• skin thinning
• changes to the colour of your skin
• increased body hair
Other skin reactions that may occur are:
• allergic reaction at the site of
• sensitivity to sunlight
• itching
• local skin burning, or pain
• redness
• rash or hives
• worsening of condition
• skin infection
The following side effects may also
occur in children:
• delayed weight gain
• slow growth
Side effects that may show up in blood
tests or when your doctor gives you a
medical examination:
• a decrease in the level of the hormone
cortisol in your blood
• increased levels of sugar in your blood
or urine
• high blood pressure
• cloudy lens in the eye (cataract)
• increased pressure in the eye

Other formats
To listen to or request a copy of this leaflet
in Braille, large print or audio please call,
free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following
Product Name:
Trimovate Cream
Reference Number 10949/0040
This is a service provided by the
Royal National Institute of Blind People.
Trimovate is a registered trade mark of the
GSK group of companies
© 2016 GSK group of companies. All rights

GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR



• weakening of the bones through
gradual loss of mineral (osteoporosis) additional tests may be needed after
your medical examination to confirm
if you have this condition
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any side effects
not listed in this leaflet. You can also report
side effects directly via the Yellow Card
Scheme at:
By reporting side effects you can help
provide more information on the safety of
this medicine.

5 How to store Trimovate
• Keep this medicine out of the sight and
reach of children.
• Do not use this medicine after the expiry
date which is stated on the tube end or
carton after EXP. The expiry date refers
to the last day of that month.
• Do not store above 25°C.
• Do not throw away any 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.

6 Contents of the pack and
other information
What Trimovate contains
• The active substances are clobetasone
17-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 nystatin.
• 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 cream.
Marketing Authorisation Holder and
Marketing Authorisation Holder:
Glaxo Wellcome UK Ltd, Stockley Park West,
Uxbridge, Middlesex, UB11 1BT
Glaxo Wellcome Operations, Harmire Road,
Barnard Castle, Co. Durham, DL12 8DT
This leaflet was last revised in
April 2016



Pharma code Ref. No. 7563

Page 2 of 2

Pharma code Ref. No. 7563

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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.