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HYDROCORTISONE 1.0 % M/M OINTMENT

Active substance(s): HYDROCORTISONE

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TEVA UK Ref:

Version:

231-30-96914-Y LEA HYDROCORTISONE A/S OINT TUK >DEB

HYDROCORTISONE 0.5 %, 1 %
AND 2.5 % m/m OINTMENT
PACKAGE LEAFLET: INFORMATION
FOR THE USER

Read all of this leaflet carefully before you start
using this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same as
yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:

1. What Hydrocortisone Ointment is and what
it is used for
2. Before you use Hydrocortisone Ointment
3. How to use Hydrocortisone Ointment
4. Possible side effects
5. How to store Hydrocortisone Ointment
6. Further information

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.

2

BEFORE YOU USE
HYDROCORTISONE OINTMENT

DO NOT use Hydrocortisone Ointment if you:
• are allergic (hypersensitive) to
hydrocortisone or any of the other
ingredients of this medicine
• have an untreated skin infection such as
athlete’s foot (tinea pedis), chickenpox
(varicella) or shingles (Herpes zoster),
coldsores (Herpes simplex), impetigo,
ringworm or thrush, infected lesions,
ulcerative conditions, red appearance on
face, peri-oral dermatitis or acne.
Take special care with Hydrocortisone
Ointment
Talk to your doctor before you start to use this
medicine if you:
• have psoriasis, the condition may become
worse after stopping long-term treatment

REG0064856

Version 2.2

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• will be applying the ointment to your face.
This ointment should not be used for long on
face as it may damage the facial skin
• will be using the ointment for the treatment
of dermatitis or nappy rash on children and
infants. In this case the courses of treatment
should not normally exceed 7 days
• are using this ointment under occlusive
dressing that can considerably increase the
absorption of this ointment.
Caution should be taken to keep away from the
eyes.
Taking other medicines
• Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
• If you are pregnant, planning to become
pregnant or are breast-feeding, ask your
doctor for advice before taking this medicine.
Driving and using machines
• Hydrocortisone is not expected to affect your
ability to drive or operate machinery.

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 tube
• Wash your hands before applying the
ointment
• Apply using barrier gloves if available. If
these are not available, then wash hands
after applying. If applying to the hands do not
wash hands after application
• Apply a small amount of ointment and
smooth over the affected area
• If the affected area becomes ‘weepy’ or
infected, stop using the ointment and speak
to your doctor. You may need antibiotic
treatment, especially if the infection spreads
• You should not normally use Hydrocortisone
Ointment on your face for many weeks or
months, unless specifically prescribed by
your doctor. Caution should be taken to keep
away from the eyes.
The usual dose is:
Adults (including the elderly):
• Apply two to three times a day, reducing as
the skin heals.

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14 July 2015

TEVA UK Ref:

Version:

231-30-96914-Y LEA HYDROCORTISONE A/S OINT TUK >DEB

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

Like all medicines, Hydrocortisone Ointment
can cause side effects, although not everybody
gets them. Most patients using Hydrocortisone
Ointment will have no problems when used in
the correct amount for the prescribed time.
If the following happens, stop using the
ointment 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 or an 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

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• 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:
• The active ingredient is hydrocortisone.
• The other ingredient is white soft paraffin.
What Hydrocortisone Ointment looks like and
contents of the pack:
• Hydrocortisone Ointment is a white
translucent ointment.
• Hydrocortisone 0.5 %, 1 % and 2.5 %
Ointment is available in 15 g tubes and 50 g
or 200 g jars. Hydrocortisone 1 % Ointment 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: May 2015
PL 00289/0756-0758

96914-Y

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14 July 2015

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-00289-0756-0757-0787-hydrocortisone-0.5%-1.0%-2.5%-oi
ntment

APPROVALS
Signed by
Jack Barnwell

REG0064856

Meaning of Signature
Regulatory Affairs Approval

Version 2.2

Approved

Server Date
24-Aug-2016 11:06:45 AM

Page 3 of 3

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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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