Hydrocortisone 0.5% Cream
ESSENTIAL GENERICS
90-92/L/m/5
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 Hydrocortisone Cream is and what it is used for
2. Before you use Hydrocortisone Cream
3. How to use Hydrocortisone Cream
4. Possible side effects
5. How to store Hydrocortisone Cream
6. Further information
Hydrocortisone Cream contains a medicine called hydrocortisone. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation.
Hydrocortisone 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.
Do not use Hydrocortisone Cream:
• if you are allergic (hypersensitive) to hydrocortisone, or any of the other ingredients of Hydrocortisone 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 Hydrocortisone Cream.
Take special care with Hydrocortisone 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.
Always use Hydrocortisone 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 Hydrocortisone 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 Hydrocortisone Cream to use with your fingertip. This picture shows one fingertip unit.
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.
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 Hydrocortisone 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 Hydrocortisone 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 Hydrocortisone 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 Hydrocortisone Cream
If you use Hydrocortisone 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.
• Keep out of the reach and sight of children.
• Do not use Hydrocortisone 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.
Like all medicines, Hydrocortisone Cream can cause side effects, although not everybody gets them.
STOP using Hydrocortisone 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 Hydrocortisone Cream include:
• irritation or itching where the cream is applied
• increased hair growth and changes in skin colour.
Side effects if you use Hydrocortisone 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.
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.
What Hydrocortisone 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 Hydrocortisone 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, trading as Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB.
Manufacturer
Purna Pharmaceuticals NV, Rijksweg 17,
2870 Puurs, Belgium.
This leaflet was last revised in
July 2014
90-92/L/m/5