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LOCOID CREAM

Active substance(s): HYDROCORTISONE BUTYRATE MICRONISED

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Astellas: 147037

Mock-up for registration purpose.

IAT001 (LFT293) Page 1+2, 145x270 mm

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Package leaflet: Information for the user

Locoid® Cream

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.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Locoid Cream is and what it is used for
2. What you need to know before you use Locoid Cream
3. How to use Locoid Cream
4. Possible side effects
5. How to store Locoid Cream
6. Contents of the pack and other information
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:

• if you are allergic to hydrocortisone butyrate or any of the other ingredients of this medicine (listed in
section 6), and see also the end of this section for some important information on some of the ingredients.
• if your skin disorder is caused by an untreated bacterial, viral (e.g. cold sores, 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.
• if you have skin problems associated with syphilis (a sexually transmitted disease) or tuberculosis.
• if the skin around your mouth is inflamed (perioral dermatitis). It might be the result of previous
treatment with corticosteroids.
• if you have pimples or spots (acne).
• if you have redness of the facial skin.

Warnings and precautions

Talk to your doctor before using Locoid Cream. This is especially important if you intend to:
• treat facial skin, thin skin (e.g. skin of your genitals). These areas of your skin are particularly sensitive to
corticosteroids. You should not apply to your eyes or your eyelids.
• use Locoid Cream at skin folds, under an airtight dressing or on large areas of 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.
• treat your child (see further information below).
• use it for psoriasis. Topical corticosteroids can be effective in psoriasis in the 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 (e.g. contact dermatitis)
and propyl parahydroxybenzoate (E216) and butyl parahydroxybenzoate (E218) that may cause allergic
reactions (possibly delayed).

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EBD

Supplier / Place of production

Locoid Cream® 0,1%

02/09/16

Black
Preparation
Strength

Date

16/06/16

7.

INS 145 x 270 mm

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Scale

Get-up

100%

Matrial No
.

GB

Rev. No.

000000

Subject

INS 145 x 270 mm
Colour

XX
Date

Date

Date

Sign.

Sign.

16/06/16
Sign.

Black
Preparation
Strength

Sent by e-mail



Scale

OMA
Supplier / Place of production

Locoid Cream® 0,1%

Temmler

Comments:

Page 2 of 2

Astellas: 147037

Mock-up for registration purpose.

IAT001 (LFT293) Page 1+2, 145x270 mm

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 (may affect up to 1 in 1,000 people)





Thinning of the skin, redness of the skin, bruising and stretch marks.
Facial spots, redness of the skin around the mouth.
Worsening of the skin condition after treatment has stopped.
Discolouration of skin.

Very rare side effects (may affect up to 1 in 10,000 people)
• Suppression of the release of the stress hormones.

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.
• The other ingredients are cetostearyl alcohol, macrogol 25 cetostearyl ether, 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 available in 30 g, 50 g, 100 g or 200 g tubes with white polyethylene
screw caps. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:

LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark

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
11 Murray Street, London, NW1 9RE, UK.
Helpline Tel: 0800 089 1122

This leaflet was last revised in September 2016.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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