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HYDROCORTISONE BUTYRATE 0.1%W/V SCALP LOTION

Active substance(s): HYDROCORTISONE BUTYRATE MICRONISED

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S0844 LEAFLET Locoid 20151221

PACKAGE LEAFLET: INFORMATION FOR USER

LOCOID SCALP LOTION
(hydrocortisone 17-butyrate)
Your medicine is known as Locoid Scalp Lotion but will be referred
to as Locoid throughout the following leaflet.
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 is and what it is used for
2. What you need to know before you use Locoid
3. How to use Locoid
4. Possible side effects
5. How to store Locoid

Warnings and precautions
Talk to your doctor before using Locoid. 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 at skin folds, under an airtight dressing or on large
areas of your skin. If you are using Locoid 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 should only be used on small
areas of psoriasis.
If your doctor has prescribed Locoid 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.

6. Contents of the pack and other information
Other medicines and Locoid
1. WHAT LOCOID IS AND WHAT IT IS USED FOR
Locoid contains the active substance hydrocortisone butyrate. This
is a corticosteroid which when made up as a lotion 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 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 is indicated in adults, children and infants. It is used to treat
a variety of skin conditions such as eczema and dermatitis (itching)
of all types, but it is used in particular in the treatment of psoriasis of
the scalp. This is a condition resulting in thickening of areas of the
scalp. It can also be used for the treatment of seborrhoea capitis, a
condition causing redness and inflammation of the scalp, and
scaling of the scalp with crusted patches, often with severe
dandruff. It is not suitable for treating large areas of psoriasis of the
scalp. You should let your doctor review your progress regularly as
treatment of psoriasis needs careful supervision. The original
symptoms may return if you stop using Locoid prematurely.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LOCOID
Do not use Locoid:


if you are allergic to hydrocortisone butyrate or any of the other
ingredients of this medicine (listed in section 6).



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
may worsen or hide these disorders.
Your doctor will check these.

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 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 lotion 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 is unlikely to affect your ability to drive or use machines.
3. HOW TO USE LOCOID
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 scalp problem does not improve, you should go back to your
doctor.
The recommended dose of Locoid is no more than twice daily. Do
not use Locoid near a naked flame.
This medicine is for cutaneous use. Apply a thin layer of Locoid to
the affected skin. Gently massage the lotion into the affected area.
On advice of your doctor you may have to apply Locoid under an
airtight dressing in order to obtain a better result.



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 forget to use Locoid



if you have redness of the facial skin.

Do not use a double dose to make up for a forgotten dose.



if for treating areas other than the scalp.

If you use more Locoid than you should
If you have used too much Locoid the side effects (as described in
Section 4) can occur. Contact your doctor, pharmacist or nurse
immediately.

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

4. POSSIBLE SIDE EFFECTS

6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

What Locoid contains

A small number of people may be hypersensitive (allergic) to the
constituents of Locoid. 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 is used in moist skin areas (e.g. skin folds) the skin may
become thin and damaged. Tell your doctor if this happens.
Locoid 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.



Locoid contains 0.1%w/v of the active ingredient,
hydrocortisone 17-butyrate.



Locoid also includes the following: isopropyl alcohol, glycerol,
povidone K90, anhydrous citric acid, sodium citrate and purified
water.

What Locoid looks like and contents of the pack
Locoid is clear colourless topical solution and is available in bottles
containing 100ml.
Product Licence holder
Procured from within the EU and repackaged by the PL holder:
S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA0 1DX.

Very rare side effects (may affect up to 1 in 10,000 people)

Manufacturer



This product is manufactured by:

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


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not use after the expiry date printed on the carton or bottle
label.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Astellas Pharma Europe B.V., Hogemaat, 2, 7942 JG, Meppel,
Netherlands.



Temmler Italia S.r.l., Via delle Industrie 2, 20061 Carugate,
Milan, Italy.

POM

PL 19488/0844

Leaflet revision date: 21 December 2015
Locoid is a registered trade mark of Yamanouchi Europe BV,
The Netherlands.
S0844 LEAFLET Locoid 20151221

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

S0844 LEAFLET Hydrocortisone 20151221

PACKAGE LEAFLET: INFORMATION FOR USER

HYDROCORTISONE BUTYRATE 0.1% w/v
SCALP LOTION
Your medicine is known as Hydrocortisone Butyrate 0.1% w/v Scalp
Lotion but will be referred to as Hydrocortisone throughout the
following leaflet.

Warnings and precautions
Talk to your doctor before using Hydrocortisone. 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 Hydrocortisone at skin folds, under an airtight dressing or
on large areas of your skin. If you are using Hydrocortisone
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
minimize side effects Hydrocortisone should only be used on
small areas of psoriasis.
If your doctor has prescribed Hydrocortisone to treat psoriasis,
you should let your doctor review your progress regularly as
such treatment needs careful supervision.

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 Hydrocortisone is and what it is used for
2. What you need to know before you use Hydrocortisone

Children and adolescents

3. How to use Hydrocortisone

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

4. Possible side effects
5. How to store Hydrocortisone
6. Contents of the pack and other information
1. WHAT HYDROCORTISONE IS AND WHAT IT IS USED FOR
Hydrocortisone contains the active substance hydrocortisone
butyrate. This is a corticosteroid which when made up as a lotion 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; Hydrocortisone 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.
Hydrocortisone is indicated in adults, children and infants. It is used
to treat a variety of skin conditions such as eczema and dermatitis
(itching) of all types, but it is used in particular in the treatment of
psoriasis of the scalp. This is a condition resulting in thickening of
areas of the scalp. It can also be used for the treatment of
seborrhoea capitis, a condition causing redness and inflammation
of the scalp, and scaling of the scalp with crusted patches, often
with severe dandruff. It is not suitable for treating large areas of
psoriasis of the scalp. You should let your doctor review your
progress regularly as treatment of psoriasis needs careful
supervision. The original symptoms may return if you stop using
Hydrocortisone prematurely.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
HYDROCORTISONE
Do not use Hydrocortisone:


if you are allergic to hydrocortisone butyrate or any of the other
ingredients of this medicine (listed in section 6).



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.
Hydrocortisone 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.



if for treating areas other than the scalp.

Other medicines and Hydrocortisone
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 Hydrocortisone if you are pregnant or breastfeeding unless clearly necessary. There may be a small risk of
harm to your baby if you use any corticosteroid lotion 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
Hydrocortisone is unlikely to affect your ability to drive or use
machines.
3. HOW TO USE HYDROCORTISONE
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 scalp problem does not improve, you should go back to your
doctor.
The recommended dose of Hydrocortisone is no more than twice
daily. Do not use Hydrocortisone near a naked flame.
This medicine is for cutaneous use. Apply a thin layer of
Hydrocortisone to the affected skin. Gently massage the lotion into
the affected area.
On advice of your doctor you may have to apply Hydrocortisone
under an airtight dressing in order to obtain a better result.
If you use more Hydrocortisone than you should
If you have used too much Hydrocortisone the side effects (as
described in Section 4) can occur. Contact your doctor, pharmacist
or nurse immediately.
If you forget to use Hydrocortisone
Do not use a double dose to make up for a forgotten dose.
If you stop using Hydrocortisone
The original symptoms may return if you stop using Hydrocortisone
prematurely.
If you have any further questions on the use of this product, ask
your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

What Hydrocortisone contains

A small number of people may be hypersensitive (allergic) to the
constituents of Hydrocortisone. 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 Hydrocortisone is used in moist skin areas (e.g. skin folds) the
skin may become thin and damaged. Tell your doctor if this
happens.
Hydrocortisone 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.



Hydrocortisone contains 0.1%w/v of the active ingredient,
hydrocortisone 17-butyrate.



Hydrocortisone also includes the following: isopropyl alcohol,
glycerol, povidone K90, anhydrous citric acid, sodium citrate
and purified water.

What Hydrocortisone looks like and contents of the pack
Hydrocortisone is clear colourless topical solution and is available in
bottles containing 100ml.
Product Licence holder
Procured from within the EU and repackaged by the PL holder:
S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA0 1DX.
Manufacturer

Very rare side effects (may affect up to 1 in 10,000 people)

This product is manufactured by:





Astellas Pharma Europe B.V., Hogemaat, 2, 7942 JG, Meppel,
Netherlands.



Temmler Italia S.r.l., Via delle Industrie 2, 20061 Carugate,
Milan, Italy.

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.

POM

PL 19488/0844

Leaflet revision date: 21 December 2015
S0844 LEAFLET Hydrocortisone 20151221

5. HOW TO STORE HYDROCORTISONE


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not use after the expiry date printed on the carton or bottle
label.

National Eczema Society



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

Helpline Tel: 0800 089 1122



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Further support and information for skin conditions such as eczema
can be gained from:
11 Murray Street, London, NW1 9RE, UK.

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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