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FLUTICASONE PROPIONATE 0.05% W/W CREAM

Active substance(s): FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE

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500000/PL1a

Package Leaflet: Information for the User

Cutivate® 0.05% w/w Cream
Fluticasone Propionate 0.05% w/w Cream
fluticasone propionate
The name of your medicine is
Cutivate 0.05% w/w Cream or
Fluticasone Propionate 0.05% w/w
Cream. It will be referred to as
Cutivate throughout the remainder of
this leaflet.
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.
What is in this leaflet:
1 What Cutivate is and what it is used for
2 What you need to know before you
use Cutivate
3 How to use Cutivate
4 Possible side effects
5 How to store Cutivate
6 Contents of the pack and other
information

1 What Cutivate is
and what it is used for
Cutivate contains a medicine called
fluticasone propionate. It belongs to a
group of medicines called steroids. It
helps to reduce swelling and irritation.
Cutivate is used to help reduce the
redness and itchiness of certain skin
problems.
• For adults these skin problems
include eczema, psoriasis,
dermatitis, insect bites or 'prickly
heat'.
• For infants and children it is used for
dermatitis that has not responded to
milder steroid creams or ointments,
following doctors advice.

2 What you need to know
before you use Cutivate

Cutivate cream also contains cetostearyl
alcohol which may cause local skin
reactions (e.g. local dermatitis) and
propylene glycol which may cause local
skin irritation.

3 How to use Cutivate
Always use this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are not
sure.
Using this medicine
• Apply a thin layer of Cutivate up to
2 times a day. This may be reduced
as your skin begins to get better.
• This cream is for use on your skin only.
• 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
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, talk to your doctor.
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 Cutivate 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
the cream.
For an adult

Do not use Cutivate:
• if you are allergic to fluticasone
propionate or any of the other
ingredients of this medicine (listed
in Section 6)
• on an infant under 3 months
• 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)
− itching around your back passage
or private parts
− infected skin (unless the infection is
being treated with an anti-infective
medicine at the same time).
− 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
Cutivate.
Warnings and precautions
Talk to your doctor or pharmacist
before using Cutivate 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 cream.
• you have psoriasis, your doctor will
want to see you more often.
If you are not sure if the above apply to
you, talk to your doctor or pharmacist
before using this medicine.
Other medicines and Cutivate
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, breast-feeding and
fertility
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
taking this medicine.
Cutivate Cream contains imidurea,
cetostearyl alcohol and propylene
glycol
Cutivate cream contains an ingredient
called imidurea. Your body can break
down imidurea in to small amounts of a
chemical called formaldehyde. This
chemical may cause a skin reaction,
including redness and itchiness.

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
and
and and Front including
neck hand foot
buttocks

Child’s
age

3-6
months
1-2
years
3-5
years
6-10
years

1

1



1







2

2

3



2

3

3



2







5

• Do not use it on infants under
3 months of age.
• A doctor will provide expert advice
on treating your child's skin
problem.
• If the child's skin problem does not
improve in 7 to 14 days, talk to your
doctor.
• It should not be used every day for
more than 4 weeks.
If you apply Cutivate 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 Cutivate 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.

Continued overleaf

If you forget to use Cutivate
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 Cutivate
If you use Cutivate 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 Cutivate and tell your
doctor as soon as possible if:
• you find that your skin problem gets
worse or becomes swollen during
treatment. You may be allergic to
the cream, have an infection or
need other treatment.

Manufacturer:
Glaxo Operations UK Limited (trading as
Glaxo Wellcome Operations)
Harmire Road
Barnard Castle
Co. Durham
DL12 8DT
UK
Product Licence Holder
Procured from within the EU. Product
Licence Holder Ginova Ltd, repackager
Ginova UK Ltd, both of St James' House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Cutivate 0.05% w/w Cream
Fluticasone Propionate 0.05% w/w
Cream
PL 18067/0504
POM
This leaflet was last revised on
7th February 2017
Cutivate® is a trademark of Glaxo Group
Ltd

Other side effects you may notice
when using Cutivate include:
Common (may affect up to 1 in
10 people)
• Irritation or itching.
Uncommon (may affect up to 1 in
100 people)
• A feeling of burning where the
cream is applied.
Very rare (may affect up to 1 in
10,000 people)
• If you have psoriasis you may get
raised bumps with pus under the
skin. This can happen during or
after the treatment and is known as
pustular psoriasis.
• An infection may be caused under
airtight dressings or skin folds.
Side effects if you use Cutivate 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:
Very rare (may affect up to 1 in
10,000 people)
• Stretch marks may develop.
• Veins under the surface of your skin
may become more noticeable.
• Increased hair growth and loss of
skin colour.
• Thinning of your skin that may also
damage more easily.
• Weight gain, rounding of the face
and high blood pressure. These are
more likely to happen in infants and
children.
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
By reporting side effects you can help
provide more information on the safety
of this medicine.

5 How to store Cutivate
• Keep out of the sight and reach of
children.
• Do not use this medicine after the
expiry date which is stated on the
tube or carton after Exp. The expiry
date refers to the last day of that
month.
• Do not store above 30°C.
• Do not freeze.
• Do not throwaway medicines via
wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help to protect
the environment.
• If you notice any signs of discolouration
or deterioration of your medicine,
please tell your pharmacist
immediately.

6 Contents of the pack and
other information
What Cutivate contains
• The active ingredient is fluticasone
propionate. Each 1 g of cream
contains 0.5 mg of fluticasone
propionate (0.05% w/w).
• The other ingredients are liquid
paraffin, cetostearyl alcohol,
isopropyl myristate, cetomacrogol 1000,
propylene glycol, imidurea, sodium
phosphate, citric acid monohydrate and
purified water.
What Cutivate looks like and
contents of the pack
Each carton contains a tube with a
plastic screw cap. The tube contains
30 g of white, smooth cream.

500000/PL1a

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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.

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