Elidel 10mg/G Cream
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:
0 What Elidel cream is and what it is used for 0 What you need to know before you use Elidel cream 0 How to use Elidel cream 0 Possible side effects 0 How to store Elidel cream 0 Contents of the pack and other information
0 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.
0 What you need to know before you use Elidel cream
Carefully follow all instructions given to you by your doctor.
Read the following information before you use Elidel cream.
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.
Do not apply the ceam to areas of the skin affected by active viral infection such as cold sores (herpes simplex) or chicken pox.
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).
Interactions with other medicines that you take are unlikely to occur.
Elidel cream with food, drink and alcohol
In rare cases, you may experience flushing, rash, burning, itching or swelling shortly after drinking alcohol.
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.
0 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.
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.
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.
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).
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.
^ How to store Elidel cream
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.
^ 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. a.r.l.
Revision date: 07/06/16
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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:
0 What Elidel cream is and what it is used for 0 What you need to know before you use Elidel cream 0 How to use Elidel cream 0 Possible side effects 0 How to store Elidel cream 0 Contents of the pack and other information
0 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.
0 What you need to know before you use Elidel cream
Carefully follow all instructions given to you by your doctor.
Read the following information before you use Elidel cream.
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.
Do not apply the ceam to areas of the skin affected by active viral infection such as cold sores (herpes simplex) or chicken pox.
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).
Interactions with other medicines that you take are unlikely to occur.
Elidel cream with food, drink and alcohol
In rare cases, you may experience flushing, rash, burning, itching or swelling shortly after drinking alcohol.
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.
0 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.
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.
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.
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).
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.
^ How to store Elidel cream
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.
^ 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. a.r.l.
Revision date: 07/06/16