HYDROCORTISONE 2.5% CREAM

Active substance: HYDROCORTISONE

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Efcortelan Cream
hydrocortisone
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 get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What Efcortelan Cream is and what it is used for
2. Before you use Efcortelan Cream
3. How to use Efcortelan Cream
4. Possible side effects
5. How to store Efcortelan Cream
6. Further information

1. What Efcortelan Cream is and what it is used for
Efcortelan Cream contains a medicine called hydrocortisone. It belongs to a group of medicines called
steroids. It helps to reduce swelling and irritation.
Efcortelan Cream is used to:
 help reduce the redness and itchiness of certain skin problems. These skin problems include eczema,
dermatitis or insect bites
 help reduce inflammation of the outer ear.
2. Before you use Hydrocortisone

2. Before you use Efcortelan Cream
Do not use Efcortelan Cream:
 if you are allergic (hypersensitive) to hydrocortisone, or any of the other ingredients of Efcortelan
Cream (listed in Section 6)
 to treat any of the following skin problems, it could make them worse:
- viral infections, such as cold sores, herpes or chicken pox
- fungal infections, such as ringworm, athletes foot or thrush
- skin blisters or sores that are caused by an infection.
Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before
using Efcortelan Cream.
Take special care with Efcortelan Cream
Check with your doctor or pharmacist before using your medicine if:
 you are applying the cream under an airtight dressing, including a child's nappy. These dressings
make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up
using too much cream.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using this
medicine.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before using this medicine if you are pregnant, might become pregnant or
are breast-feeding.

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3. How to use Efcortelan Cream
Always use Efcortelan Cream exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Using this medicine
 You usually apply a small amount of Efcortelan Cream 2 to 3 times a day. This may be reduced as
your skin begins to get better.
 This cream is for use on your skin only.
 Do not use on large areas of the body for a long time (such as every day for many weeks or months)
- unless your doctor tells you to.
 If you are applying the cream on someone else make sure you wash your hands after use or wear
disposable plastic gloves.
 If your skin problem does not improve, talk to your doctor.
Guidance on how to apply the cream
1 Wash your hands.
2 Gently rub the correct amount of cream into the skin until it has all disappeared. You can measure how
much Efcortelan Cream to
use with your fingertip. This picture shows one fingertip unit.
[Pictogram]
3 Unless you are meant to apply the cream to your hands as a part of the treatment, wash them again after
using the cream.
For an adult
You should find that:
 two fingertips of cream will cover both hands or one foot
 three fingertips of cream will cover one arm
 six fingertips of cream will cover one leg
 fourteen fingertips of cream will cover the front and back of the body.
Do not worry if you find you need a little more or a little less than this. It is only a rough guide.
[Pictogram]
For a child
 The smaller the child the less you will need to use.
 A child of 4 years needs about a third of the adult amount.
 A course of treatment for a child should not normally last more than 7 days - unless your doctor has
told you to use it for longer.
If you apply Efcortelan Cream to your face
You should only apply the cream to your face if your doctor tells you to. The cream should not be used for
too long as the skin on your face thins easily.
If you use more Efcortelan Cream than you should
If, by mistake on a few occasions you use more than you should, do not worry. If you apply a lot or if a lot is
accidentally swallowed, it could make you ill. Talk to your doctor or go to hospital as soon as possible.
If you forget to use Efcortelan Cream
If you forget to apply your cream, apply it as soon as you remember. If it is close to the time you are next
meant to apply it, wait until this time.
If you stop using Efcortelan Cream
If you use Efcortelan Cream regularly make sure you talk to your doctor before you stop using it.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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4. Possible side effects
Like all medicines, Efcortelan Cream can cause side effects, although not everybody gets them.
STOP using Efcortelan Cream and tell your doctor as soon as possible if:
 you find that your skin condition gets worse or becomes swollen during treatment. You may be
allergic to the cream, have an infection or need other treatment.
Other side effects you may notice when using Efcortelan Cream include:
 irritation or itching where the cream is applied
 increased hair growth and changes in skin colour.
Side effects if you use Efcortelan Cream for a long time, you use a lot each time you apply it, or you apply it
under an airtight dressing or a nappy:
 thinning of your skin and it may also damage more easily
 weight gain, rounding of the face and high blood pressure. These are more likely to happen in infants
and children.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. How to store Hydrocortisone

5. How to store Efcortelan Cream





Keep out of the reach and sight of children.
Do not use Efcortelan Cream after the expiry date on the tube or carton (Exp). The expiry date refers
to the last day of that month.
Do not store above 25°C.
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 Efcortelan Cream contains
 The active ingredient is hydrocortisone. Each 1 g contains:
- 5 mg of hydrocortisone (0.5% w/w),
- 10 mg of hydrocortisone (1% w/w), or
- 25 mg of hydrocortisone (2.5% w/w).
 The other ingredients are:
chlorocresol, cetomacrogol 1000, cetostearyl alcohol, white soft paraffin, liquid paraffin,
sodium acid phosphate, phosphoric acid, sodium hydroxide and purified water.
What Efcortelan Cream looks like and contents of the pack
Within each carton is a tube with a plastic screw cap, which contains 15 g, 30 g or 50 g of cream.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chemidex Pharma Ltd, Chemidex House, Egham Business Village, Crabtree Road, Egham,
Surrey TW20 8RB.
Manufacturer
Purna Pharmaceuticals NV, Rijksweg 17, 2870 Puurs, Belgium.
This leaflet was last revised in
March 2010Cream
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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