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HYDROCORTISONE 1% CREAM

Active substance(s): HYDROCORTISONE

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TEVA UK Ref:

231-30-63038-Y LEA ZENOXONE 1% CREAM TUK
ZENOXONE®

Take special care with Zenoxone
Talk to your doctor before you start to use
this medicine if you:
PACKAGE LEAFLET: INFORMATION FOR THE USER
• are going to use it on a child under 10 years
old.
Read all of this leaflet carefully because it
Stop
using this cream and consult a doctor
contains important information for you.
immediately
if you experience any allergic
• This medicine is available without
prescription. However, you still need to use type reactions after using this cream or if
your condition does not improve even after
Zenoxone carefully to get the best results
using this cream.
from it.
Taking other medicines
• Keep this leaflet. You may need to read it
• Please tell your doctor or pharmacist if you
again.
are taking or have recently taken any other
• Ask your pharmacist if you need more
medicines, including medicines obtained
information or advice.
without a prescription.
• You must contact a doctor if your symptoms
worsen or do not improve after 7 days.
Important information about some of the
• If you get any side effects, talk to your
ingredients of Zenoxone
doctor or pharmacist. This includes any
• Zenoxone contains Chlorocresol which may
possible side effects not listed in this
cause allergic reactions.
leaflet. See section 4.
Pregnancy and breast-feeding
IN THIS LEAFLET:
• If you are pregnant, planning to become
pregnant or are breast-feeding, ask your
1. What Zenoxone is and what it is used for
doctor for advice before using this
2. Before you use Zenoxone
medicine.
3. How to use Zenoxone
Driving
and using machines
4. Possible side effects
• Zenoxone is not expected to affect your
5. How to store Zenoxone
ability to drive or operate machinery.
6. Further information
HOW TO USE ZENOXONE
WHAT ZENOXONE IS AND WHAT IT IS

HYDROCORTISONE 1 % CREAM

1

USED FOR

3

If your doctor has prescribed this medicine,
always use Zenoxone exactly as your doctor
Zenoxone is the brand name of your
has told you. Otherwise follow the
medicine. It is sometimes known as
instructions below. If you are not sure how to
Hydrocortisone, which is the name of the
use this medicine talk to your doctor or
active ingredient. This medicine will be
pharmacist.
referred to as Zenoxone throughout this
leaflet.
• Use the spike in the top of the cap to make
a hole through the seal of the tube.
Zenoxone is a mild topical (applied to the
• Wash your hands before and after applying
skin) corticosteroid, or ‘steroid’ (not to be
Zenoxone but if applying to the hands do
confused with ‘anabolic’ or ‘sex’ steroids).
not wash after application.
Zenoxone is used for the relief of mild
• If symptoms persist after 7 days, consult
inflammatory skin disorders including:
your doctor.
• mild to moderate eczema
• irritant contact dermatitis or allergic contact • Adults (including the elderly) and children
over 10 years old
dermatitis
Apply sufficient cream once or twice a day
• insect bite reactions.
to thinly cover the affected area and gently
BEFORE YOU USE ZENOXONE
rub into the skin until it disappears. Use the
2
cream for a maximum period of one week.
DO NOT use Zenoxone if you:
• Children under 10 years
• are allergic (hypersensitive) to
Do not use in children under 10 years
hydrocortisone or any of the other
without speaking to your doctor first.
ingredients of this medicine
If
you
use more Zenoxone than you should
• are going to apply the cream to your face,
If
you
have squeezed out too much cream,
eyes or ano-genital region, or to broken or
wipe off the excess with a paper towel.
infected skin (including cold sores, acne,
If you forget to use Zenoxone
athlete’s foot or chickenpox)
If you forget to apply Zenoxone, apply it as
• are going to apply the cream under
soon as possible and carry on as before. If it
occlusive dressing.

REG0064961

Version 3.2

Approved

Version:

1

30 July 2015

is 4 hours or less to the next application, then
6 FURTHER INFORMATION
ignore the missed dose.
What Zenoxone contains:
If you have any further questions on the use
• The active ingredient is hydrocortisone.
of this product, ask your doctor or
• The other ingredients are white soft
pharmacist.
paraffin, cetomacrogol emulsifying wax,
POSSIBLE SIDE EFFECTS
liquid paraffin, chlorocresol, and purified
4
water.
Like all medicines, Zenoxone can cause side
What Zenoxone looks like and contents of
effects, although not everybody gets them.
the pack:
Most patients using Zenoxone will have no
• Zenoxone is an aqueous cream.
problems when used in the correct amount
• Zenoxone is available in 10 g and 15 g
for the prescribed time.
tubes.
If the following happens, stop using the
Not all pack sizes may be marketed.
cream and tell your doctor immediately or go
Marketing Authorisation Holder and
to the casualty department at your nearest
Manufacturer
hospital:
The Marketing Authorisation holder and
• an allergic reaction (swelling of the lips,
company responsible for manufacture is
face or neck leading to severe difficulty in
TEVA UK Limited, Eastbourne BN22 9AG.
breathing; skin rash or hives).
This is a very serious but rare side effect. You This leaflet was last revised: June 2015
may need urgent medical attention or
PL 00289/0759
hospitalisation.
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 Zenoxone and tell your doctor as
soon as possible.
Use of this cream may cause stretch marks on
skin.
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 ZENOXONE

Keep out of the reach and sight of children.
Store Zenoxone below 25ºC and do not
freeze.
Do not use Zenoxone 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.

63038-Y

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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-00289-0759-hydrocortisone-1%-cream-zenoxone

APPROVALS
Signed by
Jack Barnwell

REG0064961

Meaning of Signature
Regulatory Affairs Approval

Version 3.2

Approved

Server Date
08-Aug-2016 03:39:14 PM

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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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