Label: Information for the User

Elidel 10 mg/g Cream

Pimecrolimus

Read the entire label carefully before starting to use Elidel Cream

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

2.What you need to know before starting to use Elidel Cream

3.How to use Elidel Cream

4.Possible adverse effects

5Storage of Elidel Cream

6.Contents of the package and additional information

Elidel cream contains a medication called pimecrolimus. It does not contain any steroids.Elidel cream specifically treats a skin inflammation called atopic dermatitis (eczema). It acts on the skin cells that cause inflammation and the characteristic redness and itching of eczema.

Elidel cream is used to treat the signs and symptoms of mild to moderate eczema (e.g. redness and itching), in children from 3 months and up to 17 years, and adults. Using Elidel at the first signs and symptoms of the disease prevents it from progressing and a severe outbreak from occurring.

Elidel cream should only be used after other medications that your doctor has prescribed or moisturizers have not worked for you or if your doctor recommends that you should not use other medications.

If it worsens or does not improve after 6 weeks, consult your doctor.

Follow all instructions given by your doctor carefully.

Read the following information before using Elidel cream.

Do not use Elidel cream:

- If you areallergic(hypersensitive) to pimecrolimus or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to use Elidel if you have aweakened immune system(immunocompromised) for any reason.

Elidel cream must only be used for atopic dermatitis.Do not use it for other skin conditions.

Elidel cream is only for external use. Do not apply the cream to your nose, eyes, or mouth. If the cream is accidentally applied to these areas, remove it and/or rinse with water. Be careful not to accidentally ingest it or introduce it into your mouth when, for example, applying it to your hands.

Do not apply the cream to areas of the skin affected by an active viral infection, such as herpes labialis (simple herpes) or varicella.

If your skin is infected, confirm with your doctor before using Elidel. Your doctor may recommend that you use an appropriate medication to treat the infection. Elidel treatment can be initiated when the infection has cleared up in the treatment area. If you start with a skin infection while being treated with Elidel, inform your doctor, as it may be necessary to interrupt treatment until the infection is under control.

Elidel may be associated with an increased risk of severe herpes simplex infection (eczema herpeticum). Therefore, if you developpainful lesionsin any part of your body, inform your doctor immediately, as you will need to discontinue Elidel treatment until the infection has cleared up.

Elidel may causereactions at the application site, such as a sensation of heat and/or burning. These reactions are usually mild and transient. Inform your doctor immediately if you have a severe reaction to Elidel. If you are using Elidel, do not cover the skin being treated with bandages, dressings, or occlusive dressings. However, you may wear normal clothing.

While being treated with Elidel,you should avoid excessive exposure to sunlight, sunlamps, and tanning beds. If you are outdoors after applying Elidel, wear loose clothing, use suitable sunscreens, and try to spend as little time as possible in the sun. If you have erythroderma (redness of almost the entire body) or a skin condition called Netherton syndrome, consult your doctor before starting to use Elidel.

Also, consult your doctor before using Elidel if you have anyskin conditions (tumors)

Inform your doctor if yourlymph nodes growduring Elidel cream treatment.

Children

Elidel is not recommended for use in patients under 3 months.

Other medications and Elidel cream

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is not recommended to apply pimecrolimus to the area where a vaccine has been administered while the local reaction continues.

If you have extensive eczema, inform your doctor before receiving avaccine, as you may need to discontinue Elidel use.

Elidel should not be used withphototherapy with ultraviolet light(such as UVA, PUVA, UVB) or systemic immunosuppressive medications (such as azathioprine or cyclosporine).

It is unlikely that interactions will occur with other medications you are using.

Use of Elidel cream with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before starting to use this medication.Do not use Elidel if you are pregnant.

We do not know if the active ingredient in Elidel passes into breast milk after topical application. Do not apply Elidel to your nipples during breastfeeding.

Driving and operating machinery

Elidel has no known effects on the ability to drive or operate machinery.

Elidel contains cetyl alcohol and stearic alcohol that may cause local skin reactions (e.g., contact dermatitis). Additionally, Elidel also contains 10 mg of benzyl alcohol per 1 g of cream, which may cause allergic reactions and mild local irritation. Elidel also contains 50 mg of propylene glycol (E 1520) per 1 g of cream, which may cause skin irritation.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You can use Elidel on any skin area, including the head, face, neck, and skin folds.

Apply the cream as follows:

• Wash and dry your hands.

• Open the tube (the first time you use it, you will need to break the seal with the tip inserted in the cap).

• Put a little cream on your finger.

• Apply a thin layer of Elidel and cover the affected skin completely.

• Apply only to the affected areas with eczema.

• Gently rub until the cream is completely absorbed.

• Close the tube again.

The cream must be applied twice a day, for example, once in the morning and once at night. You can use moisturizers (emollients) along with Elidel. If you use moisturizers, they can be applied immediately after using Elidel.

Do not bathe, shower, or swim immediately after applying Elidel, as the cream may disappear from the areas where it has been applied.

For how long can you use Elidel

Long-term treatment should be intermittent and not continuous. Stop treatment with Elidel as soon as the eczema symptoms disappear.

Continue using the cream for the time your doctor indicates.

Stop treatmentand consult your doctor,if after 6 weeks of treatment you do not observe improvement, or if the disease worsens.

In long-term eczema treatments, start using Elidel as soon as the first signs and symptoms (redness and itching) appear to prevent symptoms from becoming a severe outbreak. If the signs and symptoms return, you should resume treatment.

If you use more Elidel cream than you should

If you apply more cream than you need on your skin, just remove it.

If you forget to use Elidel cream

If you ever forget to use the cream, apply it as soon as possible and then continue with the usual routine. However, if it is almost time for the next application, skip the missed dose and continue with the usual routine. Do not apply an extra dose of cream to compensate for the missed doses.

If you interrupt treatment with Elidel cream

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

If you accidentally ingest Elidel

If you or anyone else accidentally ingests Elidel, inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most common side effects of Elidel are reactions (such as discomfort) at the application site. These reactions are generally mild or moderate, temporary, and occur at the beginning of treatment.

Some effects can be severe

Rare side effects(less than 1 in 1,000 patients)

•Angioedema– which includes itching, urticaria, red marks on the hands, feet, and throat, inflammation of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.

Very rare side effects(less than 1 in 10,000 patients)

•Anaphylactic reaction: skin rashes such as skin redness with itching, swelling of the hands, feet, ankles, face, lips, mouth, or throat (these symptoms are also described as angioedema and can cause difficulty swallowing or breathing) and you may feel like you are going to faint.

If you experience any of these symptomsrapidly after using Elidel cream,stop using the cream and report to your doctor immediately.

Other side effects may include

Very common side effects(more than 1 in 10 patients)

• Sensation of heat and/or burning at the application site.

Common side effects(more than 1 in 100 patients)

• Irritation, itching, and redness of the skin where the cream has been applied.

• Skin infections (such as folliculitis).

Rare side effects(less than 1 in 100 patients)

• Skin infections such as impetigo (bacterial skin infection), herpes labialis (simple herpes), herpes zoster, herpes simplex dermatitis (eczema herpeticum), molluscum contagiosum (viral skin infection), warts, and furuncles.

• Reactions at the application site such as rash, pain, sensation of prickling, mild skin peeling, dryness, swelling, and worsening of eczema symptoms.

Rare side effects(less than 1 in 1,000 patients)

• Redness of the skin, skin rash, burning, itching, or swelling, shortly after alcohol consumption.

• Changes in skin color (it becomes darker or lighter than the surrounding skin).

Cases of cancer, including lymph node or skin cancer, have been reported in patients treated with Elidel.

Cases of lymphadenopathy have been reported in patients using Elidel. However, its relationship to Elidel cream treatment has not been confirmed.

If you consider that any of the side effects you are experiencing are severeor if you notice any side effect not mentioned in this leaflet,inform your doctor or pharmacist.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the container and tube after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

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

Store in the original container. Keep the tube perfectly closed.

Once the tube is opened, its contents must be used within a period of 12 months. It may be helpful to write the date when you open the tube in the space provided on the container.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Elidel Cream

• The active ingredient is pimecrolimus. 1 gram of Elidel cream contains 10 mg of pimecrolimus.

• The other components are: medium-chain triglycerides, oleic alcohol, propylene glycol (E1520), stearic alcohol, cetyl alcohol, monoglycerides and diglycerides, sodium cetoestearate 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) in 1 gram of cream. See section 2.

Appearance of Elidel Cream and Contents of the Package

Elidel is a white, odorless, non-staining cream that is easy to spread. The cream is available in 5 g, 15 g, 30 g, 60 g, and 100 g tubes. Not all packages are necessarily available in your country.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Responsible Manufacturer

MEDA Manufacturing

Av. J. F. Kennedy

33700 Mérignac (France)

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria: Elidel 10 mg/g Cream

Belgium: Elidel 10 mg/g cream

Bulgaria?????? 10 mg/g ????

Cyprus: Elidel cream 10 mg/g

Czech Republic: Elidel 10 mg/g cream

Denmark: Elidel 10 mg/g Cream

Estonia: Elidel 10 mg/g cream

Finland: Elidel 10 mg/g emulsion

Germany: Elidel 10 mg/g CreamGreece: Elidel,κρ?μα10 mg/g

Hungary: Elidel 10 mg/g cream

Iceland: Elidel 10 mg/g cream

Italy: Elidel 10 mg/g cream

Latvia: Elidel 10 mg/g cream

Lithuania: Elidel 10 mg/g cream

Luxembourg: Elidel 10 mg/g Cream

Malta: Elidel 10 mg/g cream

Netherlands: Elidel 10 mg/g cream

Norway: Elidel 10 mg/g cream

Poland: Elidel 10 mg/g cream

Portugal: Elidel 10 mg/g cream

Romania: Elidel 10 mg/g cream

Slovakia: Elidel 10 mg/g cream

Slovenia: Elidel 10 mg/g cream

Spain: Elidel 10 mg/g cream

Sweden: Elidel 10 mg/g cream

United Kingdom: Elidel 10 mg/g cream

For any doubt or additional information you may need about this medicine, consult your doctor or pharmacist.

Last review date of this leaflet:10/2021

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) {http://www.aemps.gob.es/