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Hydrocortisone Ointment 1%

Document: leaflet MAH GENERIC_PL 13606-0186 change

PATIENT INFORMATION LEAFLET

HYDROCORTISONE OINTMENT 1%

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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

1.    WHAT HYDROCORTISONE OINTMENT 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 ointment 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 the infection is being treated by antibiotics

2.    BEFORE YOU USE HYDROCORTISONE OINTMENT Do not use Hydrocortisone ointment 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    by 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

Take special care with Hydrocortisone ointment

Check with your doctor or pharmacist before using if:

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

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

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

•    You suffer with psoriasis.

Using 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

Hydrocortisone ointment should be used with caution in pregnant and breastfeeding women. Ask your doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients of Hydrocortisone ointment

This medicine contains wool fat which may cause local skin reactions (e.g. contact dermatitis).

150 x 170 mm

3.    HOW TO USE HYDROCORTISONE OINTMENT

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

For application to the skin.

•    Adults - gently apply a thin layer of ointment to the affected area(s) up to four times a day. The time in-between applications should be gradually increased every day as your condition improves. Treatment may then be reduced to two to three times a week or when symptoms recur.

•    Children and infants - gently apply a thin layer of ointment 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 ointment

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

•    Do not use larger quantities 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 ointment, small amounts are not harmful.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Hydrocortisone ointment 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.    HOW TO STORE HYDROCORTISONE OINTMENT

Keep out of the reach and sight of children.

Do not use Hydrocortisone ointment 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 required.

These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Hydrocortisone ointment contains.

The active substance is micronised hydrocortisone.

The other ingredients are Wool fat, liquid paraffin and white soft paraffin

What Hydrocortisone ointment looks like and contents of the pack

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

Hydrocortisone ointment is provided in 10g, 15g, 30g & 50g tubes. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Co-Pharma Ltd.

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

This leaflet was last approved in 08/2013.

150 x 170 mm