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HYDROCORTISONE 0.5% M/M CREAM

Active substance(s): HYDROCORTISONE

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POSITIONAL FOR THE
PHARMA CODE

HYDROCORTISONE 0.5 %,
1 % AND 2.5 % m/m CREAM

• will be applying the cream to your
face. This cream should not be used
for long on the face as it may damage
the facial skin
PACKAGE LEAFLET:
• will be using the cream for the
INFORMATION FOR THE USER
treatment of dermatitis or nappy rash
on children and infants. In this case
Read all of this leaflet carefully before
the courses of treatment should not
you start taking this medicine.
normally exceed 7 days
• Keep this leaflet. You may need to

are
using this cream under occlusive
read it again.
dressing that can considerably
• If you have any further questions, ask
increase the absorption of this cream.
your doctor or pharmacist.
• This medicine has been prescribed for Caution should be taken to keep away
from the eyes.
you. Do not pass it on to others. It
may harm them, even if their
Taking other medicines
symptoms are the same as yours.
• Please tell your doctor or pharmacist
• If you get any side effects, talk to your
if you are taking or have recently
doctor or pharmacist. This includes
taken any other medicines, including
any possible side effects not listed in
medicines obtained without a
this leaflet. See section 4.
prescription.
Important information about some of
IN THIS LEAFLET:
the ingredients of Hydrocortisone Cream
1. What Hydrocortisone Cream is and
• Hydrocortisone Cream contains
what it is used for
Chlorocresol which may cause
2. Before you use Hydrocortisone Cream
allergic reactions.
3. How to use Hydrocortisone Cream
Pregnancy and breast-feeding
4. Possible side effects
• If you are pregnant, planning to
5. How to store Hydrocortisone Cream
become pregnant or are
6. Further information
breast-feeding, ask your doctor for
advice before using this medicine.
WHAT HYDROCORTISONE
Driving and using machines
CREAM IS AND WHAT IT IS
• Hydrocortisone Cream is not
USED FOR
expected to affect your ability to drive
or operate machinery.
Hydrocortisone Cream is a mild topical
(applied to the skin) corticosteroid, or
HOW TO USE
‘steroid’ (not to be confused with
HYDROCORTISONE CREAM
‘anabolic’ or ‘sex’ steroids).
Hydrocortisone Cream is used for
Always use Hydrocortisone Cream
inflamed skin conditions such as
exactly as your doctor has told you. You
eczema, many types of dermatitis and
should check with your doctor or
insect bite reaction.
pharmacist if you are not sure.
Wash your hands before and after
BEFORE YOU USE
applying Hydrocortisone Cream but if
HYDROCORTISONE CREAM
applying to the hands do not wash after
Do NOT use Hydrocortisone Cream if you: application.
• Use the spike in the top of the cap to
• are allergic (hypersensitive) to
make a hole through the seal of the
hydrocortisone or any of the other
tube
ingredients of this medicine
• Apply sufficient cream to thinly cover
• have any other skin infection such as
the affected area and gently rub into
athlete’s foot (tinea paedis),
the skin until it disappears
chickenpox (varicella) or shingles
• If the affected area becomes weepy or
(Herpes zoster), coldsores (Herpes
infected, stop using the cream and
simplex), impetigo, ringworm or
speak to your doctor. You may need to
thrush, infected lesions, ulcerative
start antibiotic treatment, especially if
conditions, red appearance on face,
the infection spreads
peri-oral dermatitis or acne.

You should not normally use
Take special care with Hydrocortisone
Hydrocortisone Cream on the face for
Cream
many weeks or months, unless
Talk to your doctor before you start to
specifically prescribed by your doctor.
use this medicine if you:
The
usual dose is:
• have psoriasis, the condition may
Adults
(including the elderly)
become worse after stopping
• Apply thinly two to three times a day,
long-term treatment
reducing as the skin heals.

1

3

2

Children and Infants
• Apply as for adults but avoid long
term use. Treatment should be limited
to seven days – especially in infants
• The lowest concentration suitable
should be used, 2.5 % should not
normally be used for children or
infants
• Do not use under a nappy or an
airtight dressing (such as a plaster) on
an infant because this will enable too
much active ingredient to pass
through the skin.
If you use more Hydrocortisone Cream
than you should
If you squeeze out too much cream, wipe
off the excess with a paper towel. Do not
use the cream under airtight dressings
(such as plasters) or nappies, as too
much hydrocortisone may be absorbed
and may result in adverse effects upon
adrenal gland function.
If you forget to use Hydrocortisone Cream
If you forget to apply the Hydrocortisone
Cream, apply it as soon as possible and
carry on as before. If it is 3 hours or less
until the next application, then ignore
the missed dose.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Hydrocortisone
Cream can cause side effects, although
not everybody gets them. Most patients
using Hydrocortisone Cream will have
no problems when used in the correct
amount for the prescribed time.
If the following happens, stop using the
cream and tell your doctor immediately
or go to the casualty department at your
nearest hospital:
• an allergic reaction (swelling of the
lips, face or neck leading to severe
difficulty in breathing; skin rash or
hives).
This is a very serious but rare side effect.
You may need urgent medical attention
or hospitalisation.
Other effects which may occur:
• If your condition becomes worse
during treatment you may have an
allergy to one of the ingredients of the
cream or an infection. Stop using the
cream and tell your doctor as soon as
possible
• The skin may become thinner when
used in the nappy areas of children
where conditions are moist
• If Hydrocortisone Cream is used often,
over a large area of skin or for a long
time, especially under dressings,

adverse effects on adrenal gland
function are more likely. These effects
are also more likely in children and
infants
• Prolonged use, especially on sensitive
areas including skin folds, may result
in thinning of the skin, widening of
the blood vessels, stretch marks and
may suppress the functioning of the
adrenal gland.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. 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
HYDROCORTISONE CREAM

Keep out of the reach and sight of
children.
Hydrocortisone Cream should be stored
below 25ºC and not frozen.
Do not use Hydrocortisone Cream after
the expiry date that is stated on the outer
packaging or on the tube. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask
your pharmacist how to dispose of
medicines no longer required. These
measures will help to protect the
environment.

6

FURTHER INFORMATION

What Hydrocortisone Cream contains:
• The active ingredient is
hydrocortisone
• The other ingredients are white soft
paraffin, cetomacrogol emulsifying
wax, liquid paraffin, chlorocresol,
purified water.
What Hydrocortisone Cream looks like
and contents of the pack:
• Hydrocortisone 0.5 %, 1 %, and 2.5 %
Cream is an aqueous cream
• Hydrocortisone 0.5 %, 1 %, and 2.5 %
Cream is available in 15 g tubes.
Hydrocortisone 1 % Cream is also
available in 30 g and 50 g tubes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder and
company responsible for manufacture is
TEVA UK Limited, Eastbourne BN22 9AG.
This leaflet was last revised: June 2015
PL 00289/0753-0755
96918-X

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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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