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TRIMOVATE CREAM

Active substance(s): CLOBETASONE BUTYRATE / NYSTATIN / OXYTETRACYCLINE CALCIUM / CLOBETASONE BUTYRATE / NYSTATIN / OXYTETRACYCLINE CALCIUM / CLOBETASONE BUTYRATE / NYSTATIN / OXYTETRACYCLINE CALCIUM

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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 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 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 Trimovate
3 How to use Trimovate
4 Possible side effects
5 How to store Trimovate
6 Contents of the pack and other information

3

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.

10000000147280
GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR

Trimovate

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

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1 What Trimovate is and what it is used for

2 What you need to know before you use
Trimovate cream
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 impetigo
- 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
(pustules))
- 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 accidentally get Trimovate in your eyes wash them well
with water
• If you experience blurred vision or other visual disturbances
• 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
• Only use Trimovate for as long as your doctor recommends
• If your condition does not improve after 7 days of
treatment, speak to your doctor.
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.
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
include:
• ritonavir (used to treat HIV infection)
• itraconazole (used to treat fungal infections)
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 mouth.
Trimovate contains cetostearyl alcohol and chlorocresol
Cetostearyl alcohol may cause local skin reactions (e.g. contact
dermatitis). Chlorocresol may cause allergic reactions.

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.
• 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.

N/A
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1
Do not worry if you find you need a little more or less than this. It
is only a rough guide.
For a child
Number of fingertip units needed
Face
Arm
Leg
Back
Childs age and
and
and
Front
including
neck
hand
foot
buttocks
3-6 months
1
1
1.5
1
1.5
1-2 years


2
2
3
3-5 years

2
3
3

6-10 years
2



5

K

0

0

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.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
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 application
• 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 (glaucoma)
• 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
Another side effect with an unknown frequency is:
• blurred vision
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:
www.mhra.gov.uk/yellowcard. 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.

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8.2pt
Leading: 8.6pt
Horizontal Scale: 100%
Smallest text size: 8.2pt
Microtext: No

Pharma code Ref. No. 370

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
problem.

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.

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Pharma code Ref. No. 370

Pharma code Ref. No. 370
• 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 Manufacturer
Marketing Authorisation Holder:
Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex,
UB11 1BT
Manufacturer:
Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, Co. Durham,
DL12 8DT
This leaflet was last revised in June 2017.
Other formats
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge:

3
10000000147280
GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product Name:
Trimovate Cream
Reference Number
10949/0040
This is a service provided by the Royal National Institute of Blind
People.
Trade marks are owned by or licensed to the GSK group of
companies.

Trimovate
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JMF333

© 2017 GSK group of companies or its licensor.

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K

0

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TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8.2pt
Leading: 8.6pt
Horizontal Scale: 100%
Smallest text size: 8.2pt
Microtext: No

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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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