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HYDROCORTISONE 0.5 % M/M OINTMENT

Active substance(s): HYDROCORTISONE

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V

POSITIONAL FOR THE
DEBRECEN PHARMA CODE

become worse after stopping long-term
treatment
will be applying the ointment to your
face. This ointment should not be used
PACKAGE LEAFLET: INFORMATION
for long on face as it may damage the
FOR THE USER
facial skin
Read all of this leaflet carefully before you • will be using the ointment for the
treatment of dermatitis or nappy rash
start using this medicine.
on children and infants. In this case the
• Keep this leaflet. You may need to read
courses of treatment should not
it again.
normally exceed 7 days
• If you have any further questions, ask

are using this ointment under occlusive
your doctor or pharmacist.
dressing that can considerably increase
• This medicine has been prescribed for
the absorption of this ointment.
you. Do not pass it on to others. It may
harm them, even if their symptoms are Caution should be taken to keep away
from
the eyes.
the same as yours.
• If you get any side effects, talk to your
Taking other medicines
doctor or pharmacist. This includes any • Please tell your doctor or pharmacist if
possible side effects not listed in this
you are taking or have recently taken
leaflet. See section 4.
any other medicines, including
medicines obtained without a
IN THIS LEAFLET:
prescription.
1. What Hydrocortisone Ointment is and Pregnancy and breast-feeding
what it is used for
• If you are pregnant, planning to
2. Before you use Hydrocortisone
become pregnant or are breast-feeding,
Ointment
ask your doctor for advice before taking
3. How to use Hydrocortisone Ointment
this medicine.
4. Possible side effects
Driving and using machines
5. How to store Hydrocortisone Ointment • Hydrocortisone is not expected to affect
6. Further information
your ability to drive or operate
machinery.

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

1

WHAT HYDROCORTISONE
OINTMENT IS AND WHAT IT IS
USED FOR

Hydrocortisone Ointment is a mild topical
(applied to the skin) corticosteroid, or
‘steroid’ (not to be confused with
‘anabolic’ or ‘sex’ steroids).
Hydrocortisone Ointment is used to treat
inflamed skin conditions such as eczema,
dermatitis and contact sensitivity
reactions.



3

HOW TO USE
HYDROCORTISONE OINTMENT

Always use Hydrocortisone Ointment
exactly as your doctor has told you. You
should check with your doctor or
pharmacist if you are not sure.
If no specific instructions have been given
then the following guidelines may be
followed.
• Use the spike in the top of the cap to
make a hole through the seal of the
BEFORE YOU USE
tube
HYDROCORTISONE OINTMENT • Wash your hands before applying the
ointment
DO NOT use Hydrocortisone Ointment if
• Apply using barrier gloves if available.
you:
If these are not available, then wash
• are allergic (hypersensitive) to
hands after applying. If applying to the
hydrocortisone or any of the other
hands do not wash hands after
ingredients of this medicine
application
• have an untreated skin infection such
• Apply a small amount of ointment and
as athlete’s foot (tinea pedis),
smooth over the affected area
chickenpox (varicella) or shingles
• If the affected area becomes ‘weepy’ or
(Herpes zoster), coldsores (Herpes
infected, stop using the ointment and
simplex), impetigo, ringworm or
speak to your doctor. You may need
thrush, infected lesions, ulcerative
antibiotic treatment, especially if the
conditions, red appearance on face,
infection spreads
peri-oral dermatitis or acne.
• You should not normally use
Take special care with Hydrocortisone
Hydrocortisone Ointment on your face
Ointment
for many weeks or months, unless
Talk to your doctor before you start to use
specifically prescribed by your doctor.
this medicine if you:
Caution should be taken to keep away
• have psoriasis, the condition may
from the eyes.

2

The usual dose is:
Adults (including the elderly):
• Apply two to three times a day,
reducing as the skin heals.
Children and Infants:
• Apply as for adults but avoid long term
use. Treatment should be limited to five
to seven days – especially in infants
• The lowest concentration should be
used, 2.5 % is not normally 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 the active
ingredient to pass through the skin.
Follow your doctor’s instructions
carefully if using to treat nappy rash.
If you use more Hydrocortisone Ointment
than you should
If you have squeezed out too much
ointment, wipe off the excess with a paper
towel. Do not use the ointment under
dressings (such as plasters) or nappies
because too much hydrocortisone may be
absorbed and may result in adverse
effects upon adrenal gland function.
If you forget to use Hydrocortisone
Ointment
If you forget to apply the Hydrocortisone
Ointment, 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



If Hydrocortisone Ointment is used
often and 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 OINTMENT

Keep out of the reach and sight of children.
Store the ointment in a cool place.
Do not use Hydrocortisone Ointment after
the expiry date that is stated on the outer
packaging. 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 Ointment contains:
Like all medicines, Hydrocortisone
Ointment can cause side effects, although • The active ingredient is hydrocortisone.
• The other ingredient is white soft
not everybody gets them. Most patients
paraffin.
using Hydrocortisone Ointment will have
What Hydrocortisone Ointment looks like
no problems when used in the correct
and contents of the pack:
amount for the prescribed time.
• Hydrocortisone Ointment is a white
If the following happens, stop using the
translucent ointment.
ointment and tell your doctor immediately
• Hydrocortisone 0.5 %, 1 % and 2.5 %
or go to the casualty department at your
Ointment is available in 15 g tubes and
nearest hospital:
50 g or 200 g jars. Hydrocortisone 1 %
• an allergic reaction (swelling of the lips,
Ointment is also available in 30 g and
face or neck leading to severe difficulty
50 g tubes.
in breathing; skin rash or hives).
Not
all pack sizes may be marketed.
This is a very serious but rare side effect.
Marketing
Authorisation Holder and
You may need urgent medical attention or
Manufacturer
hospitalisation.
The Marketing Authorisation holder and
Other effects which may occur:
company responsible for manufacture is
• If your condition becomes worse
TEVA UK Limited, Eastbourne BN22 9AG.
during treatment you may have an
This leaflet was last revised: May 2015
allergy to one of the ingredients or an
PL 00289/0756-0758
infection. Stop using the ointment 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

96914-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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