TEVA UK Ref: 231-30-96914-Y LEA HYDROCORTISONE A/S OINT TUK >DEB Version: 1    14 July 2015

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

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start

using this medicine.

•    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.

Do not pass it on to others. It may harm them, even if their symptoms 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.

IN THIS LEAFLET:

1.    What Hydrocortisone Ointment is and what it is used for

2.    Before you use Hydrocortisone Ointment

3.    How to use Hydrocortisone Ointment

4.    Possible side effects

5.    How to store Hydrocortisone Ointment

6.    Further information

^ WHAT HYDROCORTISONE

OINTMENT IS AND WHAT IT IS USED FOR

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

Hydrocortisone Ointment is used to treat inflamed skin conditions such as eczema, dermatitis and contact sensitivity reactions.

BEFORE YOU USE HYDROCORTISONE OINTMENT

DO NOT use Hydrocortisone Ointment if you:

•    are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of this medicine

•    have an untreated 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.

Take special care with Hydrocortisone

Ointment

Talk to your doctor 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 ointment to your face. This ointment should not be used for long on face as it may damage the facial skin

•    will be using the ointment 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

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

Caution should be taken to keep away from the

eyes.

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.

Pregnancy and breast-feeding

•    If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking this medicine.

Driving and using machines

•    Hydrocortisone is not expected to affect your ability to drive or operate machinery.

©HOW TO USE HYDROCORTISONE OINTMENT

Always use Hydrocortisone Ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

If no specific instructions have been given then the following guidelines may be followed.

•    Use the spike in the top of the cap to make a hole through the seal of the tube

•    Wash your hands before applying the ointment

•    Apply using barrier gloves if available. If these are not available, then wash hands after applying. If applying to the hands do not wash hands after application

•    Apply a small amount of ointment and smooth over the affected area

•    If the affected area becomes 'weepy' or infected, stop using the ointment and speak to your doctor. You may need antibiotic treatment, especially if the infection spreads

•    You should not normally use Hydrocortisone Ointment on your face for many weeks or months, unless specifically prescribed by your doctor. Caution should be taken to keep away from the eyes.

The usual dose is:

Adults (including the elderly):

•    Apply 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 five to seven days - especially in infants

•    The lowest concentration should be used,

2.5 % is not normally used for children or infants

•    Do not use under a nappy or an airtight dressing (such as a plaster) on an infant because this will enable the active ingredient to pass through the skin. Follow your doctor's instructions carefully if using to treat nappy rash.

If you use more Hydrocortisone Ointment than you should

If you have squeezed out too much ointment, wipe off the excess with a paper towel. Do not use the ointment under dressings (such as plasters) or nappies because too much hydrocortisone may be absorbed and may result in adverse effects upon adrenal gland function.

If you forget to use Hydrocortisone Ointment

If you forget to apply the Hydrocortisone Ointment, 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 product, ask your doctor or pharmacist.

^4 POSSIBLE SIDE EFFECTS

Like all medicines, Hydrocortisone Ointment can cause side effects, although not everybody gets them. Most patients using Hydrocortisone Ointment will have no problems when used in the correct amount for the prescribed time.

If the following happens, stop using the ointment 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:

•    If your condition becomes worse during treatment you may have an allergy to one of the ingredients or an infection. Stop using the ointment and tell your doctor as soon as possible

•    The skin may become thinner when used in the nappy areas of children where conditions are moist

•    If Hydrocortisone Ointment is used often and 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.

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 HYDROCORTISONE OINTMENT

Keep out of the reach and sight of children.

Store the ointment in a cool place.

Do not use Hydrocortisone Ointment 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 Hydrocortisone Ointment contains:

•    The active ingredient is hydrocortisone.

•    The other ingredient is white soft paraffin.

What Hydrocortisone Ointment looks like and contents of the pack:

•    Hydrocortisone Ointment is a white translucent ointment.

•    Hydrocortisone 0.5 %, 1 % and 2.5 % Ointment is available in 15 g tubes and 50 g or 200 g jars. Hydrocortisone 1 % Ointment is also available in 30 g and 50 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: May 2015

PL 00289/0756-0758

96914-Y

Teva Pharmaceuticals Europe B.V 1.3.2

mockup-pil-uk-pl-00289-0756-0757-0787-hydrocortisone-0.5%-1.0%-2.5%-oi

ntment

Approvals

Signed by	Meaning of Signature	Server Date
Jack Barnwell	Regulatory Affairs Approval	24-Aug-2016 11:06:45 AM

REG0064856 Version 2.2 Approved Page 3 of 3