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LOCOID CREAM

Active substance: HYDROCORTISONE BUTYRATE MICRONISED

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Package leaflet: Information for the user

Locoid® Cream

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Hydrocortisone butyrate 0.1% w/w

Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
•  eep this leaflet. You may need to read it again.
K
•  you have any further questions, ask your doctor, pharmacist or nurse.
If
• 
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.
• f you get any side effects, talk to your doctor, pharmacist or nurse. This includes
I
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.  hat Locoid Cream is and what it is used for
W
2.  hat you need to know before you use Locoid Cream
W
3.  ow to use Locoid Cream
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4.  ossible side effects
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5.  ow to store Locoid Cream
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6.  ontents of the pack and other information
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1. What Locoid Cream is and what it is used for
Locoid Cream contains the active substance hydrocortisone butyrate. This is a
corticosteroid which when made up as a cream is for use on the skin. This is known
as topical application. Topical corticosteroids are ranked as mildly potent,
moderately potent, potent and very potent; Locoid Cream is classed as potent.
Topical corticosteroids are able to 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 its healing.
Locoid Cream is indicated in adults, children and infants. It is used to treat 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 (itching caused by exposure to light) and dermatitis caused by skin
irritants and allergies.
It can also be 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 in psoriasis, and use it only on small areas on the scalp, hands or feet.
The original symptoms may return if you stop using Locoid Cream prematurely.

2. What you need to know before you use Locoid Cream
Do not use Locoid Cream:
•  you are allergic to hydrocortisone butyrate or any of the other ingredients of
if
this medicine (listed in section 6), and see also the end of this section for some
important information on some of the ingredients.
•  your skin disorder is caused by an untreated bacterial, viral (e.g. cold sores,
if
herpes, chicken pox), fungal (e.g. athlete’s foot), yeast or parasitic (e.g.
ringworm) infection. Locoid Cream may worsen or hide these disorders. Your
doctor will check these.
•  you have skin problems associated with syphilis (a sexually transmitted
if
disease) or tuberculosis.
• if the skin around your mouth is inflamed (perioral dermatitis). It might be
the result of previous treatment with corticosteroids.
•  you have pimples or spots (acne).
if
•  you have redness of the facial skin.
if

Warnings and precautions
Talk to your doctor before using Locoid Cream. This is especially important if you
intend to:
•  reat facial skin, thin skin (e.g. skin of your genitals). These areas of your skin are
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particularly sensitive to corticosteroids. You should not apply to your eyes or your
eyelids.
•  se Locoid Cream at skin folds, under an airtight dressing or on large areas of
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your skin. If you are using Locoid Cream under bandages, it should only be on
small areas for a short time, and only on the advice of your doctor. Bandages
and dressings should not be used on babies or children.
•  reat your child (see further information below).
t
•  se it for psoriasis. Topical corticosteroids can be effective in psoriasis in the
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short term. 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 Cream should only be used on small areas of psoriasis
(e.g. scalp, hands and feet). If your doctor has prescribed Locoid Cream to treat
psoriasis, you should let your doctor review your progress regularly as such
treatment needs careful supervision.

Children and adolescents
Long term treatment of children should be avoided where possible. In infants
treatment should be limited if possible to a maximum of seven days.

Other medicines and Locoid Cream
Tell your doctor or pharmacist if you are using, have recently used or might use any
other medicines.
Pregnancy and breast-feeding
You should not use Locoid Cream if you are pregnant or breast-feeding unless
clearly necessary. There may be a small risk of harm to your baby if you use any
corticosteroid cream whilst pregnant, so if your doctor does prescribe it for you
knowing you are pregnant, you should not use it in large amounts for a long time.

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.
Driving and using machines
Locoid Cream is unlikely to affect your ability to drive or use machines.

Locoid Cream contains cetostearyl alcohol, propyl parahydroxybenzoate
(E216) and butyl parahydroxybenzoate (E218)
Locoid Cream contains cetostearyl alcohol that may cause local skin reactions

Locoid
Cream
Great Britain
LFT 118 x 298 mm
LFT_140
VTB 4999
Eq. to: N/A

20.04.2015
kj

Black

(e.g. contact dermatitis) and propyl parahydroxybenzoate (E216) and butyl
parahydroxybenzoate (E218) that may cause allergic reactions (possibly delayed).
3. How to use Locoid Cream
Always use this medicine exactly as your doctor has told you. Check with your
doctor, pharmacist or nurse if you are not sure. If your skin problem does not
improve, you should go back to your doctor.

The recommended dose of Locoid Cream is no more than twice daily. Thickened
areas of psoriasis on elbows and knees may be treated with Locoid Cream under a
dressing, but only if your doctor has told you so.
This medicine is for cutaneous use. Apply a thin layer of Locoid Cream to the
affected skin. Gently massage the cream into the affected area.

On advice of your doctor you may have to apply Locoid Cream under an airtight
dressing in order to obtain a better result.
If you use more Locoid Cream than you should
If you have used too much Locoid Cream the side effects (as described in
Section 4) can occur. Contact your doctor, pharmacist or nurse immediately.
If you forget to use Locoid Cream
Do not use a double dose to make up for a forgotten dose.

If you stop using Locoid Cream
The original symptoms may return if you stop using Locoid Cream prematurely.
If you have any further questions on the use of this product, ask your doctor,
pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.

A small number of people may be hypersensitive (allergic) to the constituents of
Locoid Cream. If your skin condition seems to get worse, the skin becomes red,
itchy or irritated, tell your doctor, pharmacist or nurse if this becomes troublesome.
If Locoid Cream is used in moist skin areas (e.g. skin folds) the skin may become
thin and damaged. Tell your doctor if this happens.

Locoid Cream may cause the following:

Rare side effects (likely to affect more than 1 in 10,000 patients and less
than 1 in 1000 patients)
•  hinning of the skin, redness of the skin, bruising and stretch marks.
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• 
Facial spots, redness of the skin around the mouth.
•  orsening of the skin condition after treatment has stopped.
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• 
Discolouration of skin.
Very rare side effects (likely to affect less than 1 in 10,000 patients)
•  uppression of the release of the stress hormones.
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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 Locoid Cream
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 (EXP).
The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original packaging. Do not refrigerate or
freeze.

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 to protect the environment.
6. Contents of the pack and other information
What Locoid Cream contains
• 
The active substance is hydrocortisone butyrate. Locoid Cream contains
0.1% hydrocortisone butyrate.
•  he other ingredients are cetostearyl alcohol, macrogol 25 cetostearyl ether,
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liquid paraffin, white soft paraffin, propyl parahydroxybenzoate (E216), butyl
parahydroxybenzoate (E218), citric acid (E330), sodium citrate (E331) and
purified water.

What Locoid Cream looks like and contents of the pack
Locoid Cream is a white cream and is supplied in 30 or 100 gram tubes with white
polyethylene screw caps.
Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:
Astellas Pharma Ltd.,
2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, UK.
Manufacturer:
Temmler Italia S.r.l.,
Via Delle Industrie 2, 20061, Carugate (MI), Italy

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
Information Centre Tel: 0870 2413604
This leaflet was last revised in April 2015.

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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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