Skip to Content

HYDROCORTISONE 1.0 % M/M OINTMENT

Active substance(s): HYDROCORTISONE / HYDROCORTISONE / HYDROCORTISONE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

ZINC Ref:

EAS1127a LEA HYDROCORTISONE 0.5, 1 AND 2.5% M/M OINT TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
230 mm
160 mm
N/A
N/A

WHAT IS IN THIS LEAFLET:

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

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.

WHAT YOU NEED TO KNOW 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.
Warnings and precautions
Talk to your doctor or pharmacist before you
start to use this medicine if you:
• have psoriasis; the condition may become
worse after stopping long-term treatment
• 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

Version 1.4

BLACK

Template

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 or pharmacist.
• This medicine has been prescribed for you
only. 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 or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

REG0208376

17 August 2017

PANTONE® GREEN C

PACKAGE LEAFLET: INFORMATION
FOR THE USER

2

3

Colours Used:

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

1

Version:

Approved

• 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.
Contact your doctor if you experience blurred
vision or other visual disturbances.
If this product comes into contact with
dressings, clothing and bedding, the fabric
can be easily ignited with a naked flame. You
should keep away from fire when using this
product.
Other medicines and Hydrocortisone
Ointment
• Tell your doctor or pharmacist if you are
taking, have recently taken, or might take
any other medicines, including medicines
obtained without a prescription.
Pregnancy, breast-feeding and fertility
• 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 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 or pharmacist has told you.
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.

Page 1 of 4

ZINC Ref:

EAS1127a LEA HYDROCORTISONE 0.5, 1 AND 2.5% M/M OINT TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
230 mm
160 mm
N/A
N/A

3

17 August 2017

Colours Used:

BLACK
PANTONE® GREEN C
Template

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 medicine, ask your doctor or
pharmacist.

4

Version:

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:
• The skin may become thinner when used in
the nappy areas of children where
conditions are moist
• 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

• Blurred vision. This side effect has been
reported, but the frequency for it to occur is
not known.
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.
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, or
search for MHRA Yellow Card in the Google
Play or Apple App Store.
By reporting side effects you can help provide
more information on the safety of this
medicine.

5

HOW TO STORE HYDROCORTISONE
OINTMENT

Keep this medicine out of the sight and reach
of children.
Store the ointment in a cool place.
Do not use Hydrocortisone Ointment after the
expiry date which is stated on the carton or on
the tube after EXP. The expiry date refers to
the last day of that month.
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 Hydrocortisone Ointment contains:
• The active substance 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: TEVA UK
Limited, Eastbourne, BN22 9AG England and
company responsible for manufacture: Teva
Pharmaceutical Works Private Limited, Pallagi
Street 13, Debrecen, H 4042, Hungary
This leaflet was last revised: August 2017
PL 00289/0756-0758

EAS1127a

REG0208376

Version 1.4

Approved

Page 2 of 4

Expand Transcript

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.

Hide