Active substance(s): HYDROCORTISONE
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- Hydrocortisone 0.5% topical cream. Hydrocortisone 1% topical cream. Color white shape No data. Imprint No data. This medicine is a white, cream.
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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.
Page 1 of 4
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.
4. Possible side effects
Page 2 of 4
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.
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
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.
Page 3 of 4
This leaflet was last revised in
July 2014
Page 4 of 4
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.
Page 1 of 4
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.
4. Possible side effects
Page 2 of 4
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.
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
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.
Page 3 of 4
This leaflet was last revised in
July 2014
Page 4 of 4
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Before using hydrocortisone butyrate
To make sure this is the right treatment for you, before you start using hydrocortisone butyrate it is important that your doctor knows:
- If you have any areas of infected skin.
- If you have rosacea or acne.
- If you are pregnant or breastfeeding.
- If you have ever had an allergic reaction to a skin preparation.
| Type of medicine | Used for | Also called | Available as |
How to use hydrocortisone butyrate
- Before you start using the preparation, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about topical steroids and will provide you with a full list of the side-effects that you may experience from using them.
- Apply a small amount to the areas of skin which are inflamed. Then gently rub it into the skin until it has disappeared. If you are using a scalp application, apply it to the affected area of scalp, rub it in gently, and then allow the area to dry again naturally.
- Do not use hydrocortisone butyrate on any open sores or areas of infected skin.
- The amount of topical steroid that you should apply is commonly measured by fingertip units (FTUs). One FTU is the amount of cream or ointment that is squeezed out along an adult's fingertip (that is, from the very end of the finger to the first crease in the finger). As a guide, one FTU is enough to cover an area twice the size of an adult hand. Your doctor will give you an idea of how many FTUs you will need to cover the area of your skin which is affected.
- Your doctor will tell you how often to apply hydrocortisone butyrate. It should not be applied more than twice a day, and once a day is often sufficient.
- If you are using more than one topical corticosteroid, make sure you know when and where to use each one. If you are unsure, check with your doctor or ask your pharmacist for further advice.
- After you have applied hydrocortisone butyrate, remember to wash your hands (unless your hands are the treated area).
- If you are using hydrocortisone butyrate for psoriasis, make sure you follow your doctor's instructions carefully. It should not be used for large areas of psoriasis or for long periods of time, as these can cause your symptoms to flare up again afterwards.
Getting the most from your treatment
_PG_1.jpg "Houdahgeo 6 0 1 Hydrocortisone Cream")
How to use hydrocortisone butyrate
- Before you start using the preparation, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about topical steroids and will provide you with a full list of the side-effects that you may experience from using them.
- Apply a small amount to the areas of skin which are inflamed. Then gently rub it into the skin until it has disappeared. If you are using a scalp application, apply it to the affected area of scalp, rub it in gently, and then allow the area to dry again naturally.
- Do not use hydrocortisone butyrate on any open sores or areas of infected skin.
- The amount of topical steroid that you should apply is commonly measured by fingertip units (FTUs). One FTU is the amount of cream or ointment that is squeezed out along an adult's fingertip (that is, from the very end of the finger to the first crease in the finger). As a guide, one FTU is enough to cover an area twice the size of an adult hand. Your doctor will give you an idea of how many FTUs you will need to cover the area of your skin which is affected.
- Your doctor will tell you how often to apply hydrocortisone butyrate. It should not be applied more than twice a day, and once a day is often sufficient.
- If you are using more than one topical corticosteroid, make sure you know when and where to use each one. If you are unsure, check with your doctor or ask your pharmacist for further advice.
- After you have applied hydrocortisone butyrate, remember to wash your hands (unless your hands are the treated area).
- If you are using hydrocortisone butyrate for psoriasis, make sure you follow your doctor's instructions carefully. It should not be used for large areas of psoriasis or for long periods of time, as these can cause your symptoms to flare up again afterwards.
Getting the most from your treatment
- If you are using a moisturiser along with this preparation, apply the moisturiser first. Then wait 10-15 minutes before applying hydrocortisone butyrate. This allows time for the moisturiser to be absorbed before the topical corticosteroid is applied. Your skin should be moist but not slippery when you apply hydrocortisone butyrate.
- Do not use hydrocortisone butyrate on your face unless a skin specialist doctor has said you should. If you have been told to use it on your face, be careful not to get any preparation near your eyes and do not use it for longer periods of time than you have been advised.
- Unless advised to do so by your doctor, do not apply a bandage or dressing to the area being treated, as this will increase absorption of the preparation and increase the risk of side-effects.
- Continue to use hydrocortisone butyrate until the flare-up has gone, and then stop it. A course of treatment for 7-14 days is often sufficient. If your symptoms have not improved after this time (or if they get worse), speak again with your doctor for further advice. Topical corticosteroids like hydrocortisone butyrate should not be used for long periods of time or on large areas of the body.
- After you finish using hydrocortisone butyrate, continue to use your moisturiser every day. This will help to prevent a further flare-up. Your doctor may also prescribe a less potent steroid cream for you to use when needed.
Can hydrocortisone butyrate cause problems?
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. You can reduce the risk of side-effects from hydrocortisone butyrate, by applying the preparation thinly, no more than twice a day, and to the affected areas only.
| What can I do if I experience this? | |
| These may occur in the first few days but usually get better after this | |
| Thinning of the skin, permanent stretch marks, allergic contact dermatitis, acne, rosacea, and hair growth at the site of application | These would normally only affect you if you use hydrocortisone butyrate for long periods of time |
| Hydrocortisone butyrate may get through your skin and into your bloodstream | This usually causes no problem unless you use hydrocortisone butyrate regularly on large areas of your skin |
Houdahgeo 6 0 1 Hydrocortisone Cream 1%
Speak with your doctor or pharmacist for further advice if you experience these or any other side-effects which you think may be due to hydrocortisone butyrate. Formz pro 8 6 – solid and surface modeler software.
How to store hydrocortisone butyrate
- Keep all medicines out of the reach and sight of children.
- Store in a cool, dry place, away from direct heat and light.
Important information about all medicines
Houdahgeo 6 0 1 Hydrocortisone Cream Usp
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