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ELIDEL 10MG/G CREAM

Active substance(s): PIMECROLIMUS

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Ref: 1361/070616/1/F

®

Elidel 10mg/g Cream
(pimecrolimus)
Patient Information Leaflet
Read all of this leaflet carefully before you start using Elidel cream
because it contains important information for you.
* 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Elidel 10mg/g cream and will be referred to as Elidel
cream throughout the leaflet.
What is in this leaflet:
1

What Elidel cream is and what it is used for

2

What you need to know before you use Elidel cream

3

How to use Elidel cream

4

Possible side effects

5

How to store Elidel cream

6

Contents of the pack and other information

1

What Elidel cream is and what it is used for

Elidel cream contains a medicine called pimecrolimus. It does not contain
any steroids.
Elidel cream specifically treats an inflammation of the skin called atopic
dermatitis (eczema). It works in the cells in the skin that cause the
inflammation and characteristic redness and itching of eczema.
The cream is used to treat signs and symptoms of mild or moderate
eczema (e.g. redness and itch) in children (aged 2 years and above),
teenagers and adults. When used to treat early signs and symptoms it can
prevent progression to severe flare-ups.
Elidel cream is for use only after other prescription medicines or emollients
have not worked for you or if your doctor recommends that other prescription
medicines should not be used.
You must talk to a doctor if you do not feel better or if you feel worse after 42
days.

2

What you need to know before you use Elidel cream

If your skin is infected, check with your doctor before using Elidel. Your
doctor may ask you to use an appropriate medicine to treat the infection.
When the infection at treatment sites is cleared, treatment with Elidel can be
started. If your skin becomes infected during treatment with Elidel, you
should inform your doctor. Your doctor may ask you to stop using Elidel until
the infection has been adequately controlled.
Elidel may be associated with an increased risk of a severe herpes simplex
skin infection (eczema herpeticum). Therefore if you develop painful sores
anywhere on your body, tell your doctor immediately. You should stop using
Elidel until the infection has cleared.
Elidel may cause reactions at the application site such as a feeling of
warmth and/or a burning sensation. These reactions are usually mild and
last only for a short time. Tell your doctor immediately if you have a severe
reaction to Elidel.
If you are using Elidel, do not cover the treated skin with bandages,
dressings or wraps. However, you can still wear normal clothing.
Avoid excessive exposure to sunlight, sun lamps and tanning beds during
treatment with Elidel. If you are outdoors after applying Elidel, wear loose
fitting clothing, use appropriate sunscreen products and minimise the
amount of time you spend in the sun.
If you have erythroderma (redness of almost the entire body) or a skin
condition called Netherton’s syndrome, speak to your doctor before you start
using Elidel.
Also speak to your doctor before using Elidel if you have any skin
malignancies (tumours).
If your lymph nodes become swollen during treatment with Elidel cream,
tell your doctor.
Children
The use of Elidel in patients under 2 years of age is not recommended until
further data become available.
Other medicines and Elidel cream
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Application of pimecrolimus to vaccination sites, as long as local reactions
persist is not recommended.
If you have extensive eczema, you may need to stop using Elidel before
having any vaccinations. Your doctor will be able to tell you if this is
necessary.
Elidel should not be used at the same time as ultraviolet light treatments
(such as UVA, PUVA, UVB) or systemic immunosuppressive medicines
(such as azathioprine or cyclosporin).

Carefully follow all instructions given to you by your doctor.

Interactions with other medicines that you take are unlikely to occur.

Read the following information before you use Elidel cream.

Elidel cream with food, drink and alcohol
In rare cases, you may experience flushing, rash, burning, itching or swelling
shortly after drinking alcohol.

Do not use Elidel cream:
* if you are allergic to Pimecrolimus or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Speak to your doctor before using Elidel if you have a weakened immune
system (immuno-compromised) whatever the cause.
Elidel cream is only used for atopic dermatitis. Do not use for other skin
conditions.
Elidel cream is for external use only. Do not use it in your nose, eyes or
mouth. If accidentlly applied to these areas, the cream should be thoroughly
wiped off and/or rinsed with water. You should take care not to swallow it, or
to accidentally transfer it into your mouth when, for example, it is applied to
the hands.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine. You should not use Elidel if you are pregnant.
It is not known whether the active substance in Elidel passes into the milk
after application to the skin. Do not apply Elidel to the breasts if
breast-feeding.
Driving and using machines
Elidel has no known effect on the ability to drive or use machines.
Elidel cream contains cetyl alcohol and stearyl alcohol which may
cause local skin reactions. Elidel also contains propylene glycol, which
may cause skin irritation.

Do not apply the ceam to areas of the skin affected by active viral
infection such as cold sores (herpes simplex) or chicken pox.
3

How to use Elidel cream

Always use this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
You can use Elidel on all skin areas, including the head, face and neck and
in the folds of the skin.

Ref: 1361/070616/1/B

®

Elidel 10mg/g Cream
(pimecrolimus)
Patient Information Leaflet (continued)
Apply the cream as follows:
* Wash and dry your hands.
* Open the tube (the first time you use the tube you will need to break the
seal using the spike in the top of the cap).
* Squeeze the cream onto your finger.
* Apply a thin layer of Elidel and completely cover the affected skin.
* Apply only on areas affected with eczema
* Rub in gently and fully.
* Replace the cap on the tube.
The cream should be applied twice daily, for instance once in the morning
and once in the evening. You can use moisturisers (emollients) with Elidel. If
you use moisturisers, they should be applied immediately after Elidel.
Do not bath, shower or swim right after applying Elidel. This could wash off
the cream.
How long to apply Elidel cream
Long term treatment should be intermittent and not continuous. Stop Elidel
as soon as signs of eczema have disappeared.
Continue using the cream for as long as your doctor advises. Stop the
treatment and consult your doctor if no improvement occurs after 6
weeks or if your eczema gets worse.
In the long-term treatment of eczema, begin using Elidel as soon as you
notice signs and symptoms (redness and itch). This helps to prevent
progression to severe flare-ups.

Uncommon side effects (affecting less than 1 in every 100 people)
* Skin infections such as impetigo (a bacterial skin infection), cold sores
(herpes simplex), shingles (herpes zoster), herpes simplex dermatitis
(eczema herpeticum), molluscum contagiosum (a viral skin infection),
warts and furuncles (boils).
* Application site reactions such as rash, pain, prickling sensation, slight
scaling of the skin, dryness, swelling and worsening of eczema symptoms.
Rare side effects (affecting less than 1 in 1000 people)
* Flushing, rash, burning, itching or swelling shortly after drinking alcohol.
* Changes in the skin color (becomes darker or lighter than the surrounding
skin).
Cases of cancer, including cancer of the lymph glands or skin, have been
reported in patients using Elidel. Cases of enlarged lymph glands have been
reported in patients using Elidel. However, a link to the treatment with Elidel
cream has not been established.
If any of the side effects gets severe, or if you notice any side effects not
mentioned in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more information on the
safety of this medicine.

If signs and symptoms return you should start treatment again.
If you apply more Elidel than you should
If you apply more cream to your skin than you needed to, just wipe it off.
If you forget to use Elidel cream
If you forget an application of the cream, apply it as soon as possible and
then continue your normal dosing routine. However, if it almost time for your
next application, skip the missed dose and continue your normal dosing
routine. Do not apply extra cream to make up for a missed dose.
If you stop using Elidel cream
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
If you accidentally swallow some Elidel cream
If you or someone else accidentally swallows Elidel cream, tell your doctor
immediately.

5

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C. Do not freeze
Use within 12 months after first opening.
Do not use this cream after the expiry date shown on the carton or tube
label. If your doctor tells you to stop taking the medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this medicine if
your doctor tells you to.
If your cream becomes discoloured or shows any signs of deterioration, ask
your pharmacist who will advise you what to do.
Medicines should not be disposed of via water waste or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6
4

Possible side effects

Like all medicines, Elidel cream can cause side effects, although not
everybody gets them.
The most common side effects of Elidel are reactions (such as discomfort) at
the application site. Such reactions are generally mild/moderate, occur early
in treatment and last only for a short time.
Some effects could be serious
Rare side effects (affecting less than 1 in 1000 people)
* angioedema – the signs include itching, hives (urticaria), red marks on the
hands, feet and throat, swelling of the throat and tongue, swelling around
the eyes and lips, difficulty breathing and swallowing.
Very rare side-effects (affecting less than 1 in 10,000 people)
* anaphylactic reaction: skin rash including red itchy skin, swelling of the
hands, feet, ankles, face, lips, mouth or throat (these symptoms are also
described as angioedema and may cause difficulty in swallowing or
breathing) and you may feel you are going to faint.
If you experience any of these symptoms soon after using Elidel cream,
stop using the cream and tell your doctor immediately.
Other side effects may include
Very common side effects (affecting more than 1 in 10 people)
* A feeling of warmth and/or burning at the application site.
Common side-effects (affecting more than 1 in 100 people)
* Irritation, itching and reddening of the skin where the cream has been
applied.
* Skin infections (such as folliculitis).

How to store Elidel cream

Contents of the pack and other Information

What this medicine contains:
The active substance is pimecrolimus. 1g of Elidel cream contains 10mg of
pimecrolimus.
The other ingredients are: propylene glycol, medium chain triglycerides,
oleyl alcohol, stearyl alcohol, cetyl alcohol, mono-and di-glycerides,
sodium cetostearyl sulphate, benzyl alcohol, citric acid anhydrous,
sodium hydroxide and purified water.
What this medicine looks like and contents of the pack
Elidel is a whitish, odourless, non-staining and easily spreadable cream.
The cream is available in tubes of 30g and 100g.
Manufacturer and Licence Holder
This medicine is manufactured by Novartis (Hellas) A.E.B.E., 12th km
National Road No1, 14451 Metamorfosi, Greece and is procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1361

Elidel 10mg/g Cream

Elidel is a registered trademark of Meda Pharma S. à.r.l.
Revision date: 07/06/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1361/070616/2/F

®

Elidel 10mg/g Cream
(pimecrolimus)
Patient Information Leaflet
Read all of this leaflet carefully before you start using Elidel cream
because it contains important information for you.
* 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Elidel 10mg/g cream and will be referred to as Elidel
cream throughout the leaflet.
What is in this leaflet:
1

What Elidel cream is and what it is used for

2

What you need to know before you use Elidel cream

3

How to use Elidel cream

4

Possible side effects

5

How to store Elidel cream

6

Contents of the pack and other information

1

What Elidel cream is and what it is used for

Elidel cream contains a medicine called pimecrolimus. It does not contain
any steroids.
Elidel cream specifically treats an inflammation of the skin called atopic
dermatitis (eczema). It works in the cells in the skin that cause the
inflammation and characteristic redness and itching of eczema.
The cream is used to treat signs and symptoms of mild or moderate
eczema (e.g. redness and itch) in children (aged 2 years and above),
teenagers and adults. When used to treat early signs and symptoms it can
prevent progression to severe flare-ups.
Elidel cream is for use only after other prescription medicines or emollients
have not worked for you or if your doctor recommends that other prescription
medicines should not be used.
You must talk to a doctor if you do not feel better or if you feel worse after 42
days.

2

What you need to know before you use Elidel cream

If your skin is infected, check with your doctor before using Elidel. Your
doctor may ask you to use an appropriate medicine to treat the infection.
When the infection at treatment sites is cleared, treatment with Elidel can be
started. If your skin becomes infected during treatment with Elidel, you
should inform your doctor. Your doctor may ask you to stop using Elidel until
the infection has been adequately controlled.
Elidel may be associated with an increased risk of a severe herpes simplex
skin infection (eczema herpeticum). Therefore if you develop painful sores
anywhere on your body, tell your doctor immediately. You should stop using
Elidel until the infection has cleared.
Elidel may cause reactions at the application site such as a feeling of
warmth and/or a burning sensation. These reactions are usually mild and
last only for a short time. Tell your doctor immediately if you have a severe
reaction to Elidel.
If you are using Elidel, do not cover the treated skin with bandages,
dressings or wraps. However, you can still wear normal clothing.
Avoid excessive exposure to sunlight, sun lamps and tanning beds during
treatment with Elidel. If you are outdoors after applying Elidel, wear loose
fitting clothing, use appropriate sunscreen products and minimise the
amount of time you spend in the sun.
If you have erythroderma (redness of almost the entire body) or a skin
condition called Netherton’s syndrome, speak to your doctor before you start
using Elidel.
Also speak to your doctor before using Elidel if you have any skin
malignancies (tumours).
If your lymph nodes become swollen during treatment with Elidel cream,
tell your doctor.
Children
The use of Elidel in patients under 2 years of age is not recommended until
further data become available.
Other medicines and Elidel cream
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Application of pimecrolimus to vaccination sites, as long as local reactions
persist is not recommended.
If you have extensive eczema, you may need to stop using Elidel before
having any vaccinations. Your doctor will be able to tell you if this is
necessary.
Elidel should not be used at the same time as ultraviolet light treatments
(such as UVA, PUVA, UVB) or systemic immunosuppressive medicines
(such as azathioprine or cyclosporin).

Carefully follow all instructions given to you by your doctor.

Interactions with other medicines that you take are unlikely to occur.

Read the following information before you use Elidel cream.

Elidel cream with food, drink and alcohol
In rare cases, you may experience flushing, rash, burning, itching or swelling
shortly after drinking alcohol.

Do not use Elidel cream:
* if you are allergic to Pimecrolimus or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Speak to your doctor before using Elidel if you have a weakened immune
system (immuno-compromised) whatever the cause.
Elidel cream is only used for atopic dermatitis. Do not use for other skin
conditions.
Elidel cream is for external use only. Do not use it in your nose, eyes or
mouth. If accidentlly applied to these areas, the cream should be thoroughly
wiped off and/or rinsed with water. You should take care not to swallow it, or
to accidentally transfer it into your mouth when, for example, it is applied to
the hands.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine. You should not use Elidel if you are pregnant.
It is not known whether the active substance in Elidel passes into the milk
after application to the skin. Do not apply Elidel to the breasts if
breast-feeding.
Driving and using machines
Elidel has no known effect on the ability to drive or use machines.
Elidel cream contains cetyl alcohol and stearyl alcohol which may cause
local skin reactions. Elidel also contains propylene glycol, which may cause
skin irritation.

Do not apply the ceam to areas of the skin affected by active viral
infection such as cold sores (herpes simplex) or chicken pox.
3

How to use Elidel cream

Always use this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
You can use Elidel on all skin areas, including the head, face and neck and
in the folds of the skin.

Ref: 1361/070616/2/B

®

Elidel 10mg/g Cream
(pimecrolimus)
Patient Information Leaflet (continued)
Apply the cream as follows:
* Wash and dry your hands.
* Open the tube (the first time you use the tube you will need to break the
seal using the spike in the top of the cap).
* Squeeze the cream onto your finger.
* Apply a thin layer of Elidel and completely cover the affected skin.
* Apply only on areas affected with eczema
* Rub in gently and fully.
* Replace the cap on the tube.
The cream should be applied twice daily, for instance once in the morning
and once in the evening. You can use moisturisers (emollients) with Elidel. If
you use moisturisers, they should be applied immediately after Elidel.
Do not bath, shower or swim right after applying Elidel. This could wash off
the cream.
How long to apply Elidel cream
Long term treatment should be intermittent and not continuous. Stop Elidel
as soon as signs of eczema have disappeared.
Continue using the cream for as long as your doctor advises. Stop the
treatment and consult your doctor if no improvement occurs after 6
weeks or if your eczema gets worse.
In the long-term treatment of eczema, begin using Elidel as soon as you
notice signs and symptoms (redness and itch). This helps to prevent
progression to severe flare-ups.

Uncommon side effects (affecting less than 1 in every 100 people)
* Skin infections such as impetigo (a bacterial skin infection), cold sores
(herpes simplex), shingles (herpes zoster), herpes simplex dermatitis
(eczema herpeticum), molluscum contagiosum (a viral skin infection),
warts and furuncles (boils).
* Application site reactions such as rash, pain, prickling sensation, slight
scaling of the skin, dryness, swelling and worsening of eczema symptoms.
Rare side effects (affecting less than 1 in 1000 people)
* Flushing, rash, burning, itching or swelling shortly after drinking alcohol.
* Changes in the skin color (becomes darker or lighter than the surrounding
skin).
Cases of cancer, including cancer of the lymph glands or skin, have been
reported in patients using Elidel. Cases of enlarged lymph glands have been
reported in patients using Elidel. However, a link to the treatment with Elidel
cream has not been established.
If any of the side effects gets severe, or if you notice any side effects not
mentioned in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more information on the
safety of this medicine.

If signs and symptoms return you should start treatment again.
If you use more Elidel than you should
If you apply more cream to your skin than you needed to, just wipe it off.
If you stop using Elidel cream
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
If you forget to use Elidel cream
If you forget an application of the cream, apply it as soon as possible and
then continue your normal dosing routine. However, if it almost time for your
next application, skip the missed dose and continue your normal dosing
routine. Do not apply extra cream to make up for a missed dose.
If you accidentally swallow some Elidel cream
If you or someone else accidentally swallows Elidel cream, tell your doctor
immediately.

5

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C. Do not freeze
Use within 12 months after first opening.
Do not use this cream after the expiry date shown on the carton or tube
label. If your doctor tells you to stop taking the medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this medicine if
your doctor tells you to.
If your cream becomes discoloured or shows any signs of deterioration, ask
your pharmacist who will advise you what to do.
Medicines should not be disposed of via water waste or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6
4

Possible side effects

Like all medicines, Elidel cream can cause side effects, although not
everybody gets them.
The most common side effects of Elidel are reactions (such as discomfort) at
the application site. Such reactions are generally mild/moderate, occur early
in treatment and last only for a short time.
Some effects could be serious
Rare side effects (affecting less than 1 in 1000 people)
* angioedema – the signs include itching, hives (urticaria), red marks on the
hands, feet and throat, swelling of the throat and tongue, swelling around
the eyes and lips, difficulty breathing and swallowing.
Very rare side-effects (affecting less than 1 in 10,000 people)
* anaphylactic reaction: skin rash including red itchy skin, swelling of the
hands, feet, ankles, face, lips, mouth or throat (these symptoms are also
described as angioedema and may cause difficulty in swallowing or
breathing) and you may feel you are going to faint.
If you experience any of these symptoms soon after using Elidel cream,
stop using the cream and tell your doctor immediately.
Other side effects may include
Very common side effects (affecting more than 1 in 10 people)
* A feeling of warmth and/or burning at the application site.
Common side-effects (affecting more than 1 in 100 people)
* Irritation, itching and reddening of the skin where the cream has been
applied.
* Skin infections (such as folliculitis).

How to store Elidel cream

Contents of the pack and other Information

What this medicine contains:
The active substance is pimecrolimus. 1g of Elidel cream contains 10mg of
pimecrolimus.
The other ingredients are: propylene glycol, medium chain triglycerides,
oleyl alcohol, stearyl alcohol, cetyl alcohol, mono-and di-glycerides,
sodium cetostearyl sulphate, benzyl alcohol, citric acid anhydrous,
sodium hydroxide and purified water.
What this medicine looks like and contents of the pack
Elidel is a whitish, odourless, non-staining and easily spreadable cream.
The cream is available in tubes of 30g and 100g.
Manufacturer and Licence Holder
This medicine is manufactured by Meda Pharma GmbH & Co. KG,
Benzstrasse 1, 61352 Bad Homburg, Germany and is procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1361

Elidel 10mg/g Cream

Elidel is a registered trademark of Meda Pharma S. à.r.l.
Revision date: 07/06/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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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