10 mg / g cream 
pimecrolimus

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

-Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

-If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1.What Elidel cream is and what it is used for 
2.What you need to know before using Elidel cream 
3.How to use Elidel cream 
4. Possible side effects 
5.How to store Elidel cream 
6. Package contents and other information 

1.What Elidel cream is and what it is used for

Elidel cream contains a drug substance called pimecrolimus. Elidel contains no steroids (steroid).

Elidel cream is specially developed to treat inflammation of the skin, which is called atopic eczema. It acts in the skin cells that cause inflammation with its typical symptoms such as itching and redness associated with atopic eczema.

Elidel cream is used to treat the symptoms of mild to moderately severe atopic eczema in children from 2 years of age and up, adolescents, and adults. If a cream is used as soon as itching or redness occurs, Elidel can prevent eczema from flaring up.

Elidel cream should be used only if other medicines or plasticizers have not helped or if your doctor recommends that you do not use other prescription medicines.

You must talk to a doctor if you do not feel better or if you feel worse after 6 weeks.

2.What you need to know before using Elidel cream

Do not use Elidel

Follow all instructions from your doctor carefully.

Read the following information before using 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).

Take special care with Elidel cream

Elidel cream is not approved for children under 2 years of age and should therefore not be used in this age group. Consult your doctor.

Warnings and cautions

Talk to your doctor before using Elidel if your immune system is weakened for any reason.

Elidel cream is not approved for children under 2 years of age and should therefore not be used in this age group, without consulting your doctor.

Elidel cream should only be used for atopic eczema. Do not use it for other skin conditions.

Elidel cream should only be used for topical use. It must not be used in the nose, eyes, or mouth. If you accidentally get Elidel in these areas, carefully wipe off the cream and/or rinse with water. You should be careful not to swallow cream or accidentally get cream in your mouth through your hands after lubricating yourself.

Cream one must not be applied to skin areas that are affected by an ongoing viral infection, e.g. cold sores ( herpes simplex) or chickenpox.

If you have any skin infection, ask your doctor for advice before using Elidel. Your doctor may prescribe a suitable medicine for the treatment of infection. When the treatment site is completely free of infection, you can start treatment with Elidel. If you get a skin infection during treatment with Elidel, contact your doctor. Your doctor may ask you to stop Elidel treatment for a while until the skin infection has been adequately treated.

Treatment with Elidel may increase the risk of developing a severe herpes simplex skin infection ( eczema herpeticum). Contact your doctor immediately if you get painful sores on your body. You should stop using Elidel until the infection has healed.

Elidel can give rise to mild and transient reactions on the skin areas where the cream has been applied, such as. a warm and/or burning sensation. In case of a violent reaction, you should consult your doctor.

The treated skin must not be covered with bandages or dressings. However, you can use your usual clothes.

Avoid strong sunlight, sunlamps, and tanning beds while you are being treated with Elidel. When staying outdoors after applying a cream, wear loose-fitting clothing, use suitable sunscreen, and do not stay in the sun for too long.

If you have erythrodermia ( redness all over your body) or have a skin condition called Netherton’s syndrome, talk to your doctor before using Elidel.

Before using Elidel, talk to your doctor if you have any skin tumors 

If your lymph nodes swell during treatment with Elidel cream, consult your doctor.

Children

The use of Elidel in children 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 in skin areas where vaccination has taken place and as long as a local reaction persists is not recommended.

If you have very extensive atopic eczema, you may need to stop using Elidel before getting vaccinated. Consult your doctor for further instructions.

Elidel should not be used concomitantly with ultraviolet light therapy (eg UVA, PUVA, UVB) or when taking immunosuppressive drugs (eg azathioprine or ciclosporin) by mouth or as an injection.

It is unlikely that Elidel and other medicines could affect each other.

Elidel with food, drink, and alcohol

In rare cases, you may experience flushing, rash, burning sensation, itching, or swelling after consuming alcohol.

Pregnancy and breastfeeding

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 if the active ingredient in Elidel passes into breast milk when Elidel is applied to the skin. Elidel must not be used on the breasts if you are breast-feeding.

Driving and using machines

Elidel has no known effect on the ability to drive and use machines.

Elidel contains cetyl alcohol, stearyl alcohol, benzyl alcohol, and propylene glycol (E 1520).

Cetyl alcohol and stearyl alcohol may cause local skin reactions (eg contact dermatitis). Benzyl alcohol can cause allergic reactions and mild local irritation. Propylene glycol (E 1520) may cause skin irritation.

3.How to use Elidel cream

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Elidel can be used on all skin surfaces, including the head, face, neck, and skin folds.

To apply the cream:

  • Wash and dry your hands.
  • Open the tube. (The first time you use the tube, break the seal using the tip on top of the lid).
  • Press cream on the finger.
  • Apply a thin layer of Elidel only on skin areas with eczema so that this area is completely covered.
  • Gently rub in Elidel completely.
  • Put the lid on the tube again.

Elidel should be used twice a day, e.g. once in the morning and once in the evening. You can use emollient cream together with Elidel. If you use emollients, apply them immediately after Elidel.

Do not bathe, shower, or swim immediately after using Elidel, as the cream can then be rinsed off.

How long should Elidel be used?

Long-term treatment should be temporary and not continuous. Treatment should be stopped as soon as the symptoms of eczema are gone.

Use Elidel for as long as your doctor prescribes it.

Discontinue treatment and contact your doctor if no improvement occurs after 6 weeks or if eczema worsens.

For long-term treatment of atopic eczema, use Elidel immediately when itching or redness occurs. This prevents eczema from flaring up and this gives better control of eczema in the long run. If signs and symptoms of eczema recur, resume treatment.

If you take more Elidel cream then you should

If you have accidentally taken too much of Elidel, you can just wipe off the excess.

If you forget to use Elidel cream

If you forget to apply Elidel, apply a cream as soon as possible and then continue with the treatment as before. If it is almost time for the next application, skip the missed dose and continue treatment as before. Do not apply extra cream to compensate for a missed dose.

If you stop using Elidel cream

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you have accidentally swallowed Elidel cream

If you or anyone else has accidentally swallowed Elidel, contact your doctor as soon as possible.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common side effect when using Elidel is irritation or discomfort where the cream is applied. These side effects are usually mild to moderate, transient and usually occur mainly at the beginning of treatment.

Some side effects can be serious

Rare (may affect up to 1 in 1,000 people)

  • Angioedema: symptoms are itching, hives ( urticaria ), red rash on hands, feet, and throat, swelling of throat and tongue, swelling around eyes and lips, difficulty breathing and swallowing.

Very rare (may affect up to 1 in 10,000 people)

  • anaphylactic reaction: reddening of the skin with red itchy skin, swelling of the hands, feet, ankles, face, lips, mouth, and throat (these symptoms are also described as angioedema and may cause difficulty swallowing or breathing) and you may feel dizzy

If you experience any of these symptoms shortly after using Elidel cream, stop using cream one and contact your doctor as soon as possible.

Other side effects may be

Very common (may affect more than 1 user in 10)

  • Transient heat and/or burning sensation at the place where you applied the cream.

Common (may affect up to 1 in 10 people)

  • Irritation, itching, and redness on the skin surface that has been lubricated.
  • Skin infections, e.g. inflammation of the hair follicles (which can cause small blisters).

Uncommon (may affect up to 1 in 100 people)

  • Skin infections such as smallpox (impetigo), herpes simplex (cold sores), shingles ( herpes zoster), herpes simplex dermatitis ( eczema herpeticum), mollusks (a viral infection of the skin), warts, and abscesses.
  • Local skin reactions where the cream is applied; rash, pain, stinging sensation, slight peeling of the skin, dryness, and swelling, or worsening of the symptoms of eczema.

Rare (may affect up to 1 in 1,000 people)

  • Redness of the face, rash, burning sensation, itching, or swelling shortly after consuming alcohol.
  • Discoloration of the skin where the cream is smeared in (may become lighter or darker).

Cases of cancer such as lymph node cancer or skin cancer have been reported in patients using Elidel.

Cases of enlarged lymph nodes have been reported in patients using Elidel. However, no causal link has been established.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.How to store Elidel cream

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and tube. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Do not freeze.

Store in the original package. Close the tube tightly.

Opened tube should be used within 12 months. It may be a good idea to note the date when the tube opens on the carton.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is pimecrolimus. 1 gram of Elidel cream contains 10 mg of pimecrolimus.
  • The other ingredients are medium-chain triglycerides, oleyl alcohol, propylene glycol (E 1520), stearyl alcohol, cetyl alcohol, mono- and diglycerides, sodium cetostearyl sulfate, benzyl alcohol, anhydrous citric acid, sodium hydroxide, purified water.
  • This medicine contains 10 mg of benzyl alcohol and 50 mg of propylene glycol (E 1520) per 1 g of cream. See section 2.

What the medicine looks like and the contents of the pack

Elidel is a whitish, odorless cream. It does not cause stains and can be easily lubricated. The cream one is available in pack sizes of 5 g, 15 g, 30 g, 60 g, and 100 g. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Meda AB, Box 906, 170 09 Solna

Tel.08-630 19 00

e-mail: info@meda.se

Manufacturer:

MEDA Pharma GmbH & Co.

Benzstrasse 1

61352 Bad Homburg

Germany

or

MEDA Manufacturing

Avenue JF Kennedy

BP 90100

33700 Mérignac

Cedex

France

Consult your doctor or pharmacist if you have any questions or are unsure about your medicine.

Muhammad Nadeem

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