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Hydrocortisone Ointment

Document: leaflet MAH GENERIC_PL 00142-0130 change

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Hydrocortisone 0.5% and 1.0% ointment

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.

Index

j What Hydrocortisone ointment is and what it is used for Before you use _3 How to use _4 Possible side effects ^1 How to store ^1 Further information

j 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 there is either no infection or the infection is being treated by antibiotics.

^1 Before you use

Do not use Hydrocortisone ointment and tell your doctor if you:

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

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•    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.

Check with your doctor or pharmacist before using Hydrocortisone ointment 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 ointment to the face, particularly around the eyes. Do not use the ointment 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 ointment and contact your doctor

•    suffer with psoriasis.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.

If you become pregnant whilst using hydrocortisone ointment, tell your doctor immediately.

How to use

Always use Hydrocortisone ointment exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. For application to the skin.

Doses

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

•    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.

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This leaflet was last revised in January 2012



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If you use more Hydrocortisone ointment than you should

•    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.

If you forget to use Hydrocortisone ointment

If you forget to use the ointment, apply it as soon as you remember, unless it is nearly time to apply the next dose.

^1 Possible side effects

Like all medicines, Hydrocortisone ointment can cause side effects, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.

Stop using Hydrocortisone ointment and contact your doctor at once if the following allergic reaction happens swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

This is a very serious but rare side effect.

You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

•    a change in the colour of skin, or increased growth of hair in areas where the ointment is used

•    contact dermatitis - localised rash or irritation to the skin

Using more than the correct amount of ointment may:

•    thin the skin so it damages easily

•    allow the active ingredient to pass through the skin and affect other parts of the body (such as suppression of the hypothalamic pituitary adrenal axis showing symptoms such as amenorrhea (stopped periods), infertility, impotence in adults or slowed growth in children), especially in infants and children, if used under a nappy or airtight dressing and during pregnancy.

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If you feel unwell or have any unusual discomfort you do not understand, contact your doctor as soon as possible.

^1 How to store

Keep out of the reach and sight of children. Store in a cool place. Avoid freezing.

Do not use Hydrocortisone ointment after the expiry date stated on the label/carton/ bottle. 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.

^1 Further information What Hydrocortisone ointment contains

•    The active substance (the ingredient that makes the ointment work) is hydrocortisone. Each ointment contains either 0.5% w/w or 1 % w/w of the active ingredient.

•    The other ingredient is paraffin.

What Hydrocortisone ointment looks like and contents of the pack

Hydrocortisone ointment is white.

Pack sizes of 15g, 30g and 50g.

Marketing Authorisation Holder and manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

If you would like a leaflet with larger text, please contact 01271 311257.

More information on managing skin conditions may be obtained from:

National Eczema Society or the Skin Care Campaign, Hill House, Highgate Hill,

London N19 5NA

^actavis

Actavis, Barnstaple, EX32 8NS, UK