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HYDROCORTISONE 0.5% M/M CREAM

Active substance(s): HYDROCORTISONE / HYDROCORTISONE / HYDROCORTISONE

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ZINC Ref:

EAS1116a LEA HYDROCORTISONE 0.5%, 1% and 2.5% 15g, 1% in 30 & 50g CREAM TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
230 mm
160 mm
N/A
N/A

• are using this cream under occlusive dressing that
can considerably increase the absorption of this
cream.

WHAT IS IN THIS LEAFLET:

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

WHAT HYDROCORTISONE CREAM IS AND
WHAT IT IS USED FOR

Hydrocortisone Cream is a mild topical (applied to
the skin) corticosteroid, or ‘steroid’ (not to be
confused with ‘anabolic’ or ‘sex’ steroids).

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 Cream
• 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
using this medicine.
Driving and using machines
• Hydrocortisone Cream is not expected to affect
your ability to drive or operate machinery.
Important information about some of the ingredients
of Hydrocortisone Cream
• Hydrocortisone Cream contains Chlorocresol
which may cause allergic reactions.

3

Hydrocortisone Cream is used for inflamed skin
conditions such as eczema, many types of dermatitis
and insect bite reaction.

WHAT YOU NEED TO KNOW BEFORE YOU
USE HYDROCORTISONE CREAM

Do NOT use Hydrocortisone Cream if you:
• are allergic (hypersensitive) to hydrocortisone or
any of the other ingredients of this medicine
• have any other 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 cream to your face. This cream
should not be used for long on the face as it may
damage the facial skin
• will be using the cream 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

Version 1.4

PANTONE® GREEN C
BLACK

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.

REG0206903

15 August 2017

CUTTER

PACKAGE LEAFLET: INFORMATION
FOR THE USER

2

3

Colours Used:

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

1

Version:

HOW TO USE HYDROCORTISONE CREAM

Always use Hydrocortisone Cream exactly as your
doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Wash your hands before and after applying
Hydrocortisone Cream, but if applying to the hands,
do not wash after application.
• Use the spike in the top of the cap to make a hole
through the seal of the tube
• Apply sufficient cream to thinly cover the affected
area and gently rub into the skin until it disappears
• If the affected area becomes weepy or infected,
stop using the cream and speak to your doctor. You
may need to start antibiotic treatment, especially if
the infection spreads
• You should not normally use Hydrocortisone Cream
on the face for many weeks or months, unless
specifically prescribed by your doctor.
The usual dose is:
Adults (including the elderly)
• Apply thinly 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 seven days –
especially in infants
• The lowest concentration suitable should be used;
2.5 % should not normally be used for children or
infants

Approved

Page 1 of 4

ZINC Ref:

EAS1116a LEA HYDROCORTISONE 0.5%, 1% and 2.5% 15g, 1% in 30 & 50g CREAM TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
230 mm
160 mm
N/A
N/A

3

BLACK
CUTTER

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.

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 CREAM

Keep this medicine out of the sight and reach of
children.
Hydrocortisone Cream should be stored below 25ºC
and not frozen.

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
medicine, ask your doctor or pharmacist.

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:
• 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
• Blurred vision. This side effect has been reported,
but the frequency for it to occur is not known.

Do not use Hydrocortisone Cream 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 Cream contains:
• The active substance is hydrocortisone
• The other ingredients are white soft paraffin,
cetomacrogol emulsifying wax, liquid paraffin,
chlorocresol, and 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
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 00289/0753-0755

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.
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

REG0206903

Version 1.4

15 August 2017
PANTONE® GREEN C

Colours Used:

• 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.

4

Version:

Approved

EAS1116a

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.

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