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Var app 6. Assessed against UK PIL dated March 04. Changes throughout PIL
By keddies at 4:44 pm, 3/22/06

(hydrocortisone 17-butyrate)

Mock up

Patient Information Leaflet
Please read this information leaflet about Locoid
Ointment 0.1% carefully before you start using your
ointment. It contains all the information you should need
to know. If you have any further questions or are not sure
about anything, ask your doctor or pharmacist. Please
keep this leaflet in a safe place, you may wish to refer to
it again.
Your medicine is called Locoid Ointment 0.1%. Each
gram of white, translucent ointment contains 1mg of the
active ingredient hydrocortisone 17-butyrate.
Locoid Ointment 0.1% also contains the following
inactive ingredients:
polyethylene and liquid paraffin.
Locoid Ointment 0.1% is available as a tube containing
30g of the ointment.
Hydrocortisone 17-butyrate belongs to a group of
medicines called corticosteroids, which when made up as
an ointment can be applied topically to the skin. Topical
corticosteroids are ranked as mildly potent, moderately
potent, potent, and very potent. Locoid Ointment 0.1% is
classed as potent.
Topical corticosteroids reduce the inflammation caused
by a variety of skin conditions and so allow it to get
better. They can also affect the cause of the condition,
which can lead to healing of the condition.

PL No: 04423/0251

This product is manufactured by Yamanouchi Europe BV,
Leiderdorp, The Netherlands
Procured from within the EU by, and the Product Licence
holder: Doncaster Pharmaceuticals Group Ltd., 6 Kirk
Sandall Industrial Estate, Doncaster DN3 1QR
What is Locoid Ointment 0.1% used for:
Locoid Ointment 0.1% is used in the treatment of a
variety of skin conditions that respond to topical
corticosteroids. Among these are eczema and dermatitis
(itching) of all types including atopic (childhood) eczema,
photodermatitis (a dermatitis caused by exposure to light)
and dermatitis caused by skin irritants and allergies.
This medicine is also used in the treatment of psoriasis, a
condition resulting in thickening of areas of the skin. It is
important that you follow your doctor s instructions
particularly carefully in psoriasis, and use it only on small
areas on the scalp, hands or feet.
Before you use your medicine:
Make sure it is safe for you to use Locoid Ointment
Do not use Locoid Ointment 0.1% if you have:
ever had an allergy to hydrocortisone or any other
ingredients of the ointment
An untreated viral or fungal infection (such as cold
sores, herpes, chicken pox, ringworm or athlete s
Tubercular or syphilitic lesions

Final Draft
Acne or perioral dermatitis (spotty red rash around
An untreated bacterial infection (impetigo)

Your doctor will know if you have any of these problems.
Topical corticosteroids can be effective in psoriasis in the
short term, but the condition may relapse or significantly
worsen on stopping treatment, and there is a risk of
widespread pustular psoriasis. This is a condition where
the psoriasis spreads and becomes very inflamed. In
order to minimise side effects Locoid Ointment 0.1%
should only be used on small areas of psoriasis (e.g.
scalp, hands and feet). If your doctor has prescribed
Locoid Ointment 0.1% to treat psoriasis, you should let
your doctor review your progress regularly as such
treatment needs careful supervision.
As with corticosteroids application to the face and other
areas where the skin is thin (such as the genital areas)
may damage the skin and should be avoided. Do not use
it in these areas unless your doctor has told you to.
Tell your doctor if you are pregnant, think that you may be
pregnant or trying to become pregnant? There may be a
small risk of harm to your baby if you use any
corticosteroid preparation whilst pregnant, so if your
doctor does prescribe it for you knowing you are
pregnant, you should not use it in large amounts or for a
long time.
If you are breast-feeding tell your doctor and seek their
advice before using Locoid Ointment 0.1%
In infants, Locoid Ointment 0.1% should not normally be
used for more than seven days.
Application of the ointment under dressings or bandages
should only be used on small areas for a limited amount
of time, and only on the advice of your doctor. Bandages
and dressings should not be used on babies or young
You should tell your doctor if you are taking or using any
other medicines whether prescribed for you or bought
without prescription.
If you are not sure what to do, check with your doctor or
How to use your medicine:
Follow the doctor's instructions, and check the directions
on the pharmacy label, which should tell you how much
of the ointment to use in a day. If it does not or you are
not sure about something, ask your doctor or pharmacist.
Locoid Ointment 0.1% is for external use only. Avoid
getting the ointment into your eyes or mouth.
For adults, children and the elderly, apply a small quantity
evenly to the affected area two or three time s daily.
Thickened areas of psoriasis on elbows and knees may
be treated with Locoid Ointment 0.1% under a dressing,
but only if your doctor has told you so. Keep it away from
your eyes.
If your skin problem does not improve you should go
back to your doctor.

Var app 6. Assessed against UK PIL dated March 04. Changes throughout PIL
What to do if you accidentally swallow the medicine
or use too much of it:
If you accidentally swallow some of the ointment tell your
doctor or go to your nearest hospital casualty department
IMMEDIATELY. Take any remaining ointment, the box or
this leaflet with you to show the doctor what you have
If you apply too much ointment simply wipe off the excess
with a clean paper tissue.

If the ointment becomes discoloured or shows any other
signs of deterioration, you should seek the advice of your
pharmacist who will tell you what to do.
This medicine is for YOUR use only. A doctor can only
prescribe it. Never give it to anyone else. It may harm
them even if their symptoms are the same as yours.

If you are not sure what to do, ask your doctor or

This leaflet does not contain the complete information
about your medicine. If you have any questions, or are
not sure about anything, ask your doctor or pharmacist
who has access to additional information.

What to do if you miss a dose:
If you miss an application of the ointment, use it as soon
as you remember. However, if the next application is due
within a few hours, omit the forgotten application, and use
the next application on time.

Further support and information for skin conditions such
as eczema can be gained from
National Eczema Society, Hill House, Highgate Hill,
London N19 5NA, UK

If you are not sure what to do, ask your doctor or

Information centre Tel: 0870 2413604
If dialling from the Republic of Ireland, please dial 0044
870 2413604

After using the medicine:
As with all medicines Locoid Ointment 0.1% can cause
unwanted side effects in some patients.
A small number of people may be hypersensitive
(allergic) to the constituents of the ointment. If your skin
condition seems to get worse, or redness, itching or
irritation occurs, tell your doctor or pharmacist if this
becomes troublesome.
If the ointment is used in moist skin areas (e.g. skin folds)
the skin may become thin and damaged. Tell your doctor
if this happens.
If the ointment is used for a long time other side effects
may occur, particularly if used in areas of moist skin such
as skin folds. If you notice any of the following, tell your
doctor immediately: oily skin, acne, increased facial hair,
thin skin which bruises easily, or reddish lines on the
face, arms, legs or trunk.
Prolonged use may affect the working of the adrenal
gland and your doctor should monitor you for any signs or
symptoms. As with other ointments of this kind, these are
of more importance in infants and children or if bandages
cover the skin.
You should also see your doctor or pharmacist if you
experience any other unusual or unexpected side-effects
not mentioned above during or after using Locoid
Ointment 0.1%. He or she will have more information
about Locoid Ointment 0.1% and will tell you what to do.
Expiry Date:
Do not use after the expiry date printed on the carton or
tube label.
Locoid Ointment 0.1% should be stored at room
temperature (below 25 C)
If your doctor tells you to stop using the ointment, please
take it back to the pharmacist for safe disposal. Only
keep the medicine if your doctor tells you to.

Leaflet revision and issue date (Ref.): 24.01.06
Locoid is a registered trademark of Yamanouchi
Pharma Ltd.

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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.