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CUTIVATE 0.005% W/W OINTMENT

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

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4

10000000147214
Package Leaflet: Information for the User

10000000147214

0.005% w/w Ointment

GSK-GBR-Barnard Castle-UKBAR

fluticasone propionate

United Kingdom-GBR

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
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 ointment 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 ointment.
• y ou are applying the ointment on broken or damaged skin or
within skin folds.
• y ou are applying to a large surface area.
• y ou have psoriasis, your doctor will want to see you more often
• y ou are using for a chronic leg ulcer as you may be at increased
risk of local reaction or infection
• y ou are applying near eyes or on eyelids, as cataracts or
glaucoma may result if the ointment repeatedly enters the eye
• y ou have an infection of the skin as this will need to be treated
• y ou are applying to thin skin such as the face, as Cutivate may
cause skin thinning.
If you are not sure if the above apply to you, talk to your
doctor or pharmacist before using this medicine.
Contact your doctor if you experience blurred vision or other
visual disturbances.
Children
Avoid continuous treatment for a long period of time in
infants and children under 12 years of age, as their skin may
absorb larger amounts.
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 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 Ointment contains propylene glycol
Propylene glycol 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 ointment 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 ointment 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 ointment
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 ointment 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 ointment to your hands
as a part of the treatment, wash them again after using
the ointment.
For an adult

Cutivate
N/A
JMF333

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

K

Number of fingertip units needed
Child’s age

Face
and neck

Arm
and
hand

Leg
and
foot

Front

Back
including
buttocks

3-6 months

1

1



1



1-2 years





2

2

3

3-5 years



2

3

3



6-10 years

2







5

0

0

• 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 ointment to your face if your doctor
tells you to. The ointment should not be used for too long as
the skin on your face thins easily. Do not let the ointment
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.
If you forget to use Cutivate
If you forget to apply your ointment, 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
ointment, have an infection or need other treatment.
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 ointment 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.
• Worsening of condition
• Redness
• Rash or hives
• Stretch marks may develop
• Blood vessels under the surface of your skin may become
more noticeable
• Changes to the colour of your skin
• Increased body hair
• Skin thinning
• Skin wrinkling
• Skin dryness
• Weight gain and rounding of the face
• Obesity
In children, also look out for the following symptoms:
• Delayed weight gain
• Slow growth
Very rare 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
sugar in the 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
Not Known (frequency cannot be estimated from the
available data)
• Blurred vision

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Pharma code Ref. No. 518

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

Page 1 of 2

Pharma code Ref. No. 518

4

Pharma code Ref. No. 518
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 or search for
MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more
information on the safety of this medicine.

10000000147214
GSK-GBR-Barnard Castle-UKBAR

5 How to store Cutivate

United Kingdom-GBR

• 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 or carton after EXP. The expiry date refers to
the last day of that month.
• Do not store above 30°C.
• Do not throw away 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.

Cutivate
N/A
JMF333

6 Contents of the pack and other information
What Cutivate contains
• The active ingredient is fluticasone propionate.
Each 1 g contains 0.05 mg of fluticasone propionate
(0.005% w/w).
• The other ingredients are propylene glycol (see section 2),
sorbitan sesquioleate, microcrystalline wax and liquid
paraffin.
What Cutivate looks like and contents of the pack
Within each carton is a tube with a plastic screw cap, which
contains either 15, 30 or 50 g of ointment. Not all pack sizes
may be marketed.
Marketing Authorisation Holder and Manufacturer
Product licence held by Glaxo Wellcome UK Ltd,
Stockley Park West, Uxbridge,
Middlesex, UB11 1BT
Manufactured by Glaxo Operations UK Ltd (trading as
Glaxo Wellcome Operations), Harmire Road, Barnard Castle,
Durham, DL12 8DT
More Information
If you have any questions or are not sure about anything, ask
your doctor or pharmacist who will advise you. You may be
able to find out more from books in public libraries.

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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 information:
Product name Cutivate 0.005% w/w Ointment
Reference number 10949/0012
This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in August 2017.
Trade marks are owned by or licensed to the
GSK group of companies
© 2017 GSK group of companies or its licensor

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10000000147214

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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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