Zenoxone Hydrocortisone 1% Cream
TEVA UK Ref: 231-30-63038-Y LEA ZENOXONE 1% CREAM TUK <DEB Version: 1 30 July 2015
TEVA UK Ref: 231-30-63038-Y LEA ZENOXONE 1% CREAM TUK <DEB Version: 1 30 July 2015
ZENOXONE®
HYDROCORTISONE 1 % CREAM
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully because it
contains important information for you.
• This medicine is available without prescription. However, you still need to use Zenoxone carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 7 days.
• 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.
IN THIS LEAFLET:
1. What Zenoxone is and what it is used for
2. Before you use Zenoxone
3. How to use Zenoxone
4. Possible side effects
5. How to store Zenoxone
6. Further information
OWHAT ZENOXONE IS AND WHAT IT IS USED FOR
Zenoxone is the brand name of your medicine. It is sometimes known as Hydrocortisone, which is the name of the active ingredient. This medicine will be referred to as Zenoxone throughout this leaflet.
Zenoxone is a mild topical (applied to the skin) corticosteroid, or 'steroid' (not to be confused with 'anabolic' or 'sex' steroids). Zenoxone is used for the relief of mild inflammatory skin disorders including:
• mild to moderate eczema • irritant contact dermatitis or allergic contact dermatitis
• insect bite reactions.
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 your face, eyes or ano-genital region, or to broken or infected skin (including cold sores, acne, athlete's foot or chickenpox)
• are going to apply the cream under occlusive dressing.
Take special care with Zenoxone
Talk to your doctor before you start to use
this medicine if you:
• are going to use it on a child under 10 years old.
Stop using this cream and consult a doctor immediately if you experience any allergic type reactions after using this cream or if your condition does not improve even after using this cream.
Taking other medicines
• Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Important information about some of the ingredients of Zenoxone
• Zenoxone contains Chlorocresol which may cause allergic reactions.
Pregnancy and breast-feeding
• If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before using this medicine.
Driving and using machines
• Zenoxone is not expected to affect your ability to drive or operate machinery.
9 HOW TO USE ZENOXONE
If your doctor has prescribed this medicine, always use Zenoxone exactly as your doctor has told you. Otherwise follow the instructions below. If you are not sure how to use this medicine talk to your doctor or pharmacist.
• Use the spike in the top of the cap to make a hole through the seal of the tube.
• 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.
POSSIBLE SIDE EFFECTS
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.
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.
HOW TO STORE ZENOXONE
Keep out of the reach and sight of children.
Store Zenoxone below 25°C 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.
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-Y
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
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Signed by |
Meaning of Signature |
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Jack Barnwell |
Regulatory Affairs Approval |
08-Aug-2016 03:39:14 PM |
REG0064961 Version 3.2 Approved Page 2 of 2