FLUTICASONE PROPIONATE 0.05% CREAM

Active substance: FLUTICASONE PROPIONATE MICRONISED

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®

Cutivate 0.05% Cream

Ref: 1039/080113/1/F

(fluticasone propionate)
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine.
- 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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Your medicine is called Cutivate 0.05% Cream but
will be referred to as Cutivate cream throughout this
leaflet

In this leaflet:
1
2
3
4
5
6

1

What Cutivate cream is and what it is used
for
Before you use Cutivate cream
How to use Cutivate cream
Possible side effects
How to store Cutivate cream
Further information
What Cutivate cream is and what it is
used for

Cutivate cream contains a medicine called
fluticasone propionate. It belongs to a group of
medicines called steroids. It helps to reduce swelling
and irritation.
Cutivate cream 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

Before you use Cutivate cream

Do not use Cutivate cream:
• if you are allergic (hypersensitive) to fluticasone
propionate or any of the other ingredients of
Cutivate (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 cream.
Take special care with Cutivate cream
Check with your doctor or pharmacist
before using your medicine 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 taking ritonavir and itraconazole
medications.
If you are not sure if the above apply to you, talk
to your doctor or pharmacist before using this
medicine.
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.
Important information about some of the
ingredients of Cutivate cream
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.

3 How to use Cutivate cream
Always use Cutivate cream exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Using this medicine
• Apply a thin layer of Cutivate cream 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

Face and neck:
2 ½ fingertip units.
Back: 7 fingertip units.
Front: 7 fingertip units.
One arm (not including
the hand):
3 fingertip units.
Both sides of one hand:
1 fingertip unit.
One leg (not including
the foot):
6 fingertip units.
One foot:
2 fingertip units.

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

• Weight gain, rounding of the face and high blood
pressure. These are more likely to happen in
infants and children.
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
5




6
• 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 cream 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 cream 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.
If you forget to use Cutivate cream
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 cream
If you use Cutivate cream 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, Cutivate cream can cause side
effects, although not everybody gets them.
Stop using Cutivate cream 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.
Other side effects you may notice when using
Cutivate cream include:
Common (affects less than 1 in 10 people)
• Irritation or itching.
Uncommon (affects less than 1 in 100 people)
• A feeling of burning where the cream is applied.
Very rare (affects less than 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 cream 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 (affects less than 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.

How to store Cutivate cream
Do not store above 30°C.
KEEP THIS MEDICINE OUT OF THE SIGHT
AND REACH OF CHILDREN

Further Information

What Cutivate cream contains
Cutivate Cream contains 0.05% w/w of fluticasone
propionate as the active ingredient. Your cream also
contains the following inactive ingredients:
propylene glycol, liquid paraffin, cetosterryl alcohol,
isopropyl myristate, cetomacrogol 1000, imidurea,
sodium hydrogenphosphate dodecahydrate, citric
acid monohydrate, purified water.
What Cutivate cream looks like and contents of
the pack
Cutivate Cream is a white cream.
Cutivate Cream is available in tubes of 30g
Manufacturer and Licence Holder
Cutivate Cream is manufactured by Glaxo Wellcome
Operations, Harmire Road Barnard Castle, Co
Durham, DL12 8DT, United Kingdom and is
procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit
18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 ORE

POM

PL 15184/1039 Cutivate 0.05% Cream

Cutivate is a registered trademark of the
GlaxoSmithKline Group of companies.
Leaflet revision date: 08/01/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 1039/080113/1/B

®

Fluticasone Propionate 0.05% Cream

Ref: 1039/080113/F

(fluticasone propionate)
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine.
- 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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Your medicine is called Fluticasone Propionate
0.05% Cream but will be referred to as Fluticasone
Propionate cream throughout this leaflet

In this leaflet:
1 What Fluticasone Propionate cream is and
what it is used for
2 Before you use Fluticasone Propionate
cream
3 How to use Fluticasone Propionate cream
4 Possible side effects
5 How to store Fluticasone Propionate
cream
6 Further information

Take special care with Fluticasone Propionate
cream
Check with your doctor or pharmacist before using
your medicine 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 taking ritonavir and itraconazole
medications
If you are not sure if the above apply to you, talk
to your doctor or pharmacist before using this
medicine.
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.
Important information about some of the
ingredients of Fluticasone Propionate cream
Fluticasone Propionate 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.

3
1

What Fluticasone Propionate cream is
and what it is used for

Fluticasone Propionate cream contains a medicine
called fluticasone propionate. It belongs to a group
of medicines called steroids. It helps to reduce
swelling and irritation.
Fluticasone Propionate cream 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

Before you use Fluticasone Propionate
cream

Do not use Fluticasone Propionate cream:
• if you are allergic (hypersensitive) to fluticasone
propionate or any of the other ingredients of
Cutivate (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 Fluticasone.

How to use Fluticasone Propionate
cream

Always use Fluticasone Propionate cream exactly
as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Using this medicine
• Apply a thin layer of Fluticasone Propionate cream
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 Fluticasone 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
Face and neck:
2 ½ fingertip units.
Back: 7 fingertip units.
Front: 7 fingertip units.
One arm (not including
the hand):
3 fingertip units.
Both sides of one hand:
1 fingertip unit.
One leg (not including
the foot):
6 fingertip units.
One foot:
2 fingertip units.

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

Common (affects less than 1 in 10 people)
• Irritation or itching.
Uncommon (affects less than 1 in 100 people)
• A feeling of burning where the cream is applied.
Very rare (affects less than 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 Fluticasone 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 (affects less than 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.
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

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.




6
If you apply Fluticasone Propionate cream 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 Fluticasone Propionate cream
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.
If you forget to use Fluticasone Propionate
cream
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 Fluticasone Propionate cream
If you use Fluticasone 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.

How to store Fluticasone Propionate
cream
Do not store above 30°C.
KEEP THIS MEDICINE OUT OF THE SIGHT
AND REACH OF CHILDREN

Further Information

What Fluticasone Propionate cream contains
Fluticasone Propionate cream contains 0.05% w/w
of fluticasone propionate as the active ingredient.
Your cream also contains the following inactive
ingredients: propylene glycol, liquid paraffin,
cetosterryl alcohol, isopropyl myristate, cetomacrogol 1000, imidurea, sodium hydrogenphosphate
dodecahydrate, citric acid monohydrate, purified
water.
What Fluticasone Propionate cream looks like
and contents of the pack
Fluticasone Propionate cream is a white cream.
Fluticasone Propionate cream is available in tubes
of 30g
Manufacturer and Licence Holder
Fluticasone Propionate cream is manufactured by
Glaxo Wellcome Operations, Harmire Road Barnard
Castle, Co Durham, DL12 8DT, United Kingdom and
is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 ORE

POM
4

Possible side effects

Like all medicines, Fluticasone Propionate cream
can cause side effects, although not everybody gets
them.
Stop using Fluticasone Propionate cream 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.
Other side effects you may notice when using
Fluticasone include:

PL 15184/1039 Fluticasone propionate
cream

Fluticasone is a registered trademark of the
GlaxoSmithKline Group of companies.
Leaflet revision date: 08/01/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 1039/080113/2/B

Expand view ⇕

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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