ZENOXONE HYDROCORTISONE 1% CREAM
Active substance(s): HYDROCORTISONE
EAS1138a LEA ZENOXONE 1% CREAM TUK
• are going to apply the cream to your face,
eyes or ano-genital region, or to broken or
infected skin (including cold sores, acne,
PACKAGE LEAFLET: INFORMATION FOR THE USER
athlete’s foot or chickenpox)
• are going to apply the cream under
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
Talk to your doctor or pharmacist before you
Always use this medicine exactly as
start to use this medicine if you:
described in this leaflet or as your doctor or
• are going to use it on a child under 10 years
pharmacist has told you.
• This medicine is available without
prescription. However, you still need to use Stop using this cream and consult a doctor
immediately if you experience any allergic
Zenoxone carefully to get the best results
type reactions after using this cream or if
your condition does not improve even after
• Keep this leaflet. You may need to read it
using this cream.
• Ask your pharmacist if you need more
Contact your doctor if you experience blurred
information or advice.
vision or other visual disturbances.
• If you get any side effects, talk to your
If this product comes into contact with
doctor or pharmacist. This includes any
dressings, clothing and bedding, the fabric
possible side effects not listed in this
can be easily ignited with a naked flame. You
leaflet. See section 4.
should keep away from fire when using this
• You must talk to a doctor if you do not feel product.
better, or if your symptoms worsen or do
Other medicines and Zenoxone
not improve after 7 days.
• Tell your doctor or pharmacist if you are
WHAT IS IN THIS LEAFLET:
taking,have recently taken, or might take
any other medicines, including medicines
1. What Zenoxone is and what it is used for
obtained without a prescription.
2. What you need to know before you use
breast-feeding and fertility
• If you are pregnant or breast-feeding, think
3. How to use Zenoxone
you may be pregnant or are planning to
4. Possible side effects
have a baby, ask your doctor or pharmacist
5. How to store Zenoxone
for advice before using this medicine.
6. Contents of the pack and other information
Driving and using machines
ZENOXONE IS AND WHAT IT IS
• Zenoxone is not expected to affect your
ability to drive or operate machinery.
Important information about some of the
Zenoxone is the brand name of your
ingredients of Zenoxone
medicine. It is sometimes known as
• Zenoxone contains Chlorocresol which may
Hydrocortisone, which is the name of the
cause allergic reactions.
active ingredient. This medicine will be referred
to as Zenoxone throughout this leaflet.
3 HOW TO USE ZENOXONE
Zenoxone is a mild topical (applied to the
skin) corticosteroid, or ‘steroid’ (not to be
Always use Zenoxone exactly as described in
confused with ‘anabolic’ or ‘sex’ steroids).
this leaflet or as your doctor or pharmacist
has told you.
Zenoxone is used for the relief of mild
Otherwise follow the instructions below.
inflammatory skin disorders including:
Check with your doctor or pharmacist if you
• mild to moderate eczema
• irritant contact dermatitis or allergic contact are not sure.
• Use the spike in the top of the cap to make
a hole through the seal of the tube.
• insect bite reactions.
• Wash your hands before and after applying
YOU NEED TO KNOW BEFORE
Zenoxone but if applying to the hands do
YOU USE ZENOXONE
not wash after application.
• If symptoms persist after 7 days, consult
DO NOT use Zenoxone if you:
• are allergic (hypersensitive) to
• Adults (including the elderly) and children
hydrocortisone or any of the other
over 10 years old
ingredients of this medicine
HYDROCORTISONE 1 % CREAM
14 August 2017
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 medicine, ask your doctor or
HOW TO STORE ZENOXONE
Keep this medicine out of the sight and reach
Store Zenoxone below 25ºC and do not
Do not use Zenoxone 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.
CONTENTS OF THE PACK AND OTHER
What Zenoxone contains:
• The active substance is hydrocortisone.
• The other ingredients are white soft
Like all medicines, Zenoxone can cause side
paraffin, cetomacrogol emulsifying wax,
effects, although not everybody gets them.
liquid paraffin, chlorocresol, and purified
Most patients using Zenoxone will have no
problems when used in the correct amount
for the prescribed time.
What Zenoxone looks like and contents of
If the following happens, stop using the
cream and tell your doctor immediately or go • Zenoxone is an aqueous cream.
• Zenoxone is available in 10 g and 15 g
to the casualty department at your nearest
Not all pack sizes may be marketed.
• an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty in
Marketing Authorisation Holder and
breathing; skin rash or hives). This is a very Manufacturer
serious but rare side effect. You may need
Marketing Authorisation holder: TEVA UK
urgent medical attention or hospitalisation. Limited, Eastbourne, BN22 9AG England and
• blurred vision. This side effect has been
company responsible for manufacture: Teva
reported, but the frequency for it to occur is Pharmaceutical Works Private Limited, Pallagi
Street 13, Debrecen, H 4042, Hungary.
If your condition becomes worse during
This leaflet was last revised: August 2017
treatment, you may have an allergy to one of PL 00289/0759
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
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
POSSIBLE SIDE EFFECTS
Page 1 of 3
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
Meaning of Signature
Regulatory Affairs Approval
16-Aug-2017 01:38:08 PM
Page 3 of 3
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.