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ZENOXONE HYDROCORTISONE 1% CREAM

Active substance(s): HYDROCORTISONE

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TEVA UK Ref:

231-30-63038-X LEA ZENOXONE 1% CREAM TUK
Version:

3

3 June 2015

POSITIONAL FOR THE
PHARMA CODE

ZENOXONE®

HYDROCORTISONE 1 %
CREAM

2

• Wash your hands before and after
applying Zenoxone but if applying
to the hands do not wash after
application.
• If symptoms persist after 7 days,
consult your doctor.
• Adults (including the elderly) and
children over 10 years old
Apply sufficient cream once or twice
a day to thinly cover the affected
area and gently rub into the skin
until it disappears. Use the cream
for a maximum period of one week.
• Children under 10 years
Do not use in children under 10 years
without speaking to your doctor first.
If you use more Zenoxone than you
should
If you have squeezed out too much
cream, wipe off the excess with a
paper towel.
If you forget to use Zenoxone
If you forget to apply Zenoxone, apply
it as soon as possible and carry on as
before. If it is 4 hours or less to 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.

BEFORE YOU USE
ZENOXONE

DO NOT use Zenoxone if you:
• are allergic (hypersensitive) to
hydrocortisone or any of the other
ingredients of this medicine
• are going to apply the cream to
Read all of this leaflet carefully
your face, eyes or ano-genital
because it contains important
region, or to broken or infected
information for you.
skin (including cold sores, acne,
• This medicine is available without
athlete’s foot or chickenpox)
prescription. However, you still
need to use Zenoxone carefully to • are going to apply the cream under
occlusive dressing.
get the best results from it.
Take special care with Zenoxone
• Keep this leaflet. You may need to
Talk to your doctor before you start to
read it again.
use this medicine if you:
• Ask your pharmacist if you need
• are going to use it on a child under
more information or advice.
10 years old.
• You must contact a doctor if your
symptoms worsen or do not
Stop using this cream and consult a
improve after 7 days.
doctor immediately if you experience
• If you get any side effects, talk to
any allergic type reactions after using
your doctor or pharmacist. This
this cream or if your condition does not
includes any possible side effects not improve even after using this cream.
listed in this leaflet. See section 4.
Taking other medicines
• Please tell your doctor or
IN THIS LEAFLET:
pharmacist if you are taking or
1. What Zenoxone is and what it is
have recently taken any other
used for
medicines, including medicines
2. Before you use Zenoxone
obtained without a prescription.
3. How to use Zenoxone
Important information about some of
4. Possible side effects
the ingredients of Zenoxone
5. How to store Zenoxone
• Zenoxone contains Chlorocresol
6. Further information
which may cause allergic reactions.
Pregnancy and breast-feeding
WHAT ZENOXONE IS AND
• If you are pregnant, planning to
WHAT IT IS USED FOR
become pregnant or are
Zenoxone is the brand name of your
breast-feeding, ask your doctor for
medicine. It is sometimes known as
advice before using this medicine.
Hydrocortisone, which is the name of Driving and using machines
the active ingredient. This medicine
• Zenoxone is not expected to affect
will be referred to as Zenoxone
your ability to drive or operate
throughout this leaflet.
machinery.
Zenoxone is a mild topical (applied to
HOW TO USE ZENOXONE
the skin) corticosteroid, or ‘steroid’
(not to be confused with ‘anabolic’ or
If your doctor has prescribed this
‘sex’ steroids).
Zenoxone is used for the relief of mild medicine, always use Zenoxone
exactly as your doctor has told you.
inflammatory skin disorders
Otherwise follow the instructions
including:
below. If you are not sure how to use
• mild to moderate eczema
this medicine talk to your doctor or
• irritant contact dermatitis or
pharmacist.
allergic contact dermatitis
• Use the spike in the top of the cap
• insect bite reactions.
to make a hole through the seal of
the tube.
PACKAGE LEAFLET: INFORMATION
FOR THE USER

4

Like all medicines, Zenoxone can
cause side effects, although not
everybody gets them. Most patients
using Zenoxone 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.
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.

1

3

REG0064961

Version 2.5

POSSIBLE SIDE EFFECTS

Approved

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.

6

FURTHER INFORMATION

What Zenoxone contains:
• The active ingredient is
hydrocortisone.
• The other ingredients are white
soft paraffin, cetomacrogol
emulsifying wax, liquid paraffin,
chlorocresol, and purified water.
What Zenoxone looks like and
contents of the pack:
• Zenoxone is an aqueous cream.
• Zenoxone is available in 10 g and
15 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: June 2015
PL 00289/0759
63038-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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