PACKAGE LEAFLET: INFORMATION FOR THE USER HYDROCORTISONE CREAM 1%

{Hydrocortisone}

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further guestions, ask your doctor or pharmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others.

It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet:

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

2.    What you need to know before you use Hydrocortisone cream

3.    How to use Hydrocortisone cream

4.    Possible side effects

5.    How to store Hydrocortisone cream

6.    Contents of the pack and other information

1.    WHAT HYDROCORTISONE CREAM IS AND WHAT IT IS USED FOR

Hydrocortisone belongs to a group of medicines called topical corticosteroids. These work by calming the inflammation that occurs during certain skin conditions or reactions. Hydrocortisone cream may be used for treating various skin conditions including:

•    Eczema

•    Dermatitis, including intertrigo (irritation between skin folds)

•    Insect bite reactions

•    Inflammation of the external ear (otitis externa)

•    Prurigo nodularis-a long term skin condition where very itchy lumps appear

•    Neurodermatoses- a long term skin condition where itchy skin becomes thick due to scratching

•    Nappy rash, if infection exists it is being treated with appropriate antibiotics.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROCORTISONE CREAM Do not use Hydrocortisone cream If you:

•    Are allergic (hypersensitive) to hydrocortisone or any of the other ingredients (see section 6)

•    Are suffering from skin conditions caused by infections, which are not being treated with appropriate antibiotics, including impetigo, cold sores, chicken pox, herpes, ringworm, athlete's foot or thrush

•    Have the scabies mite

•    Have rosacea (flushing of the skin on the face) or dermatitis around the mouth area.

Warnings and precautions

Check with your doctor or pharmacist before using if you:

•    Are treating a child as long term use in children is not recommended. Do not use under a nappy or airtight dressing for more than five to seven days

•    Are applying the cream to the face, particularly around the eyes. Do not use the cream for longer than your doctor has advised

•    Have a skin infection. If the condition appears to be getting worse despite using antibiotics prescribed, stop using the cream and contact your doctor

•    Suffer with psoriasis.

Other medicines and Hydrocortisone Cream

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Hydrocortisone cream should be used with caution in pregnant and breast-feeding women. Ask your doctor or pharmacist for advice before taking any medicine.

Hydrocortisone Cream contains Chlorocresol

This may cause allergic reactions.

3.    HOWTO USE HYDROCORTISONE CREAM

Always use Hydrocortisone Cream exactly as your doctor has told you.

For application to the skin.

•    Adults - gently apply a thin layer of cream to the affected area(s) two or three times a day.

•    Children and infants - gently apply a thin layer of cream to the affected area(s) two or three times a day. Avoid using for more than five to seven days at a time.

If you use too much cream

Do not use the cream more often or for longer than your doctor tells you to.

•    Do not use larger guantities than as directed, as this will increase the possibility of side effects.

•    If you accidentally use too much on a few occasions do not worry.

•    If you accidentally swallow some cream, small amounts are not harmful.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should stop immediately: this may include allergic contact dermatitis (rash which may be red, itchy and burning) or worsening of your condition.

Prolonged use of large amounts or treatment of extensive areas can result in features of Cushing's syndrome (symptoms include increased fat on the body, fragile or discoloured skin, weakening of bones, excessive hair growth, changes in periods in women, altered sexual function in men, increased thirst and urination, tiredness, irritability, anxiety or depression). If you experience these symptoms or are worried contact your doctor.

Other side effects:

•    Stretch marks may occur in areas where the skin may rub, for example at the joints and at folds in the skin.

•    Thinning of the skin, changes in skin pigmentation (colour) and hair growth.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.    HOWTO STORE HYDROCORTISONE CREAM

Keep out of the sight and reach of children.

Do not use Hydrocortisone cream after the expiry date stated on the carton. 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 reguired. These measures will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Hydrocortisone cream contains.

The active substance is micronised hydrocortisone.

The other ingredients are cetomacrogol emulsifying wax, chlorocresol, liguid paraffin, macrogol 300, white soft paraffin and purified water. What Hydrocortisone cream looks like and contents of the pack

A collapsible aluminiumtube, with a membrane seal at the nozzle, internal epoxy lacguer, latex endseal band in the crimp seal area and a white plastic cap for reclosure after piercing membrane.

Hydrocortisone cream is provided in 1 5g, 30g and SOg tubes.

Marketing Authorisation Holder and Manufacturer

Co-Pharma Ltd.

Unit 4 Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD18 9SS.

This leaflet was last revised in 06/2015.