ELIDEL 10 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Elidel 10 mg/g Cream

Pimecrolimus

Read all of this leaflet carefully before you start using Elidel cream

• 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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 Storage of Elidel cream

1. 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 is used to treat a skin condition called atopic dermatitis (eczema). It works by acting on the skin cells that cause inflammation and the characteristic redness and itching of eczema.

The cream is used to treat the signs and symptoms of mild or moderate eczema (such as redness and itching), in children from 3 months to 17 years and adults. Using Elidel at the first signs and symptoms of the disease prevents it from progressing and causing a severe flare-up.

Elidel cream should only be used after other medicines that you have been prescribed or emollients have not worked or if your doctor recommends that you should not use other medicines.

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

2. What you need to know before you use Elidel cream

Follow your doctor's instructions carefully.

Read the following information before using Elidel cream.

Do not use Elidel cream:

• If you are allergic (hypersensitive) to pimecrolimus or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

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

Elidel cream is for external use only. 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. You should be careful not to swallow it or put it in your mouth accidentally, for example, when applying it to your hands.

Do not apply the cream to areas of skin affected by an active viral infectionsuch as cold sores (herpes simplex) or chickenpox.

If your skin is infected, check with your doctor before using Elidel. Your doctor may recommend that you use a suitable medicine to treat the infection. Treatment with Elidel can start when the infection in the treatment area has healed. If you start with a skin infection while being treated with Elidel, you should inform your doctor, as it may be necessary to interrupt treatment until the infection is under control.

Elidel may be associated with a higher risk of skin infection with severe herpes simplex (eczema herpeticum). Therefore, if you develop painful lesionson any part of your body, inform your doctor immediately, as you should interrupt the use of Elidel until the infection has healed.

Elidel may cause reactions at the application sitesuch as a feeling of heat and/or burning. These reactions are usually mild and temporary. 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 can 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 suffer from erythroderma (redness of almost the entire body) or a skin condition called Netherton's syndrome, consult your doctor before starting to use Elidel.

Also, consult your doctor before using Elidel if you have any skin disease (tumors)

Tell your doctor if your lymph nodes growduring treatment with Elidel cream.

Children

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

Other medicines and Elidel cream

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pimecrolimus should not be applied to the area where a vaccine has been administered while the local reaction persists.

If you have extensive eczema, before receiving a vaccine, inform your doctor that you are using Elidel, as it may be necessary to interrupt its use.

Elidel should not be used together with ultraviolet light treatments(such as UVA, PUVA, UVB) or systemic immunosuppressive medicines (such as azathioprine or cyclosporin).

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

Using Elidel cream with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.If you are pregnant, you should not use Elidel.

It is not known whether the active ingredient of Elidel passes into breast milk after topical application. Do not apply Elidel to the breasts during breastfeeding.

Driving and using machines

Elidel has no known effects on the ability to drive or use machines.

Elidel contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (such as 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.

3. How to use Elidel cream

Follow your doctor's instructions exactly. If you are unsure, consult your doctor or pharmacist.

You can use Elidel on any area of the skin, 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 into the cap).
• Put a small amount of cream on your finger.
• Apply a thin layer of Elidel and cover the affected skin completely.
• Apply only to areas affected with eczema.
• Rub gently until the cream disappears completely.
• Replace the cap on the tube.

The cream should be applied twice a day, for example, once in the morning and once in the evening. You can use moisturizing products (emollients) with Elidel. If you use moisturizing products, 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.

How long you can use Elidel

Long-term treatment should be intermittent and not continuous. Interrupt treatment with Elidel as soon as the signs of eczema disappear.

Continue using the cream for the time your doctor tells you.

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

In long-term treatments for eczema, start using Elidel as soon as the first signs and symptoms appear (redness and itching) to prevent the symptoms from developing into a severe flare-up. If the signs and symptoms return, you should restart treatment.

If you use more Elidel cream than you should

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

If you forget to use Elidel cream

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

If you stop using Elidel cream

If you have any further questions about the use of this medicine, 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine 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. These reactions are generally mild or moderate, temporary, and occur at the start of treatment.

Some effects may be serious

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

• Angioedema – which includes itching, hives, 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 redness of the skin with itching, swelling of the hands, feet, ankles, face, lips, mouth, or throat (these symptoms are also described as angioedema and may cause difficulty swallowing or breathing) and you may feel like you are going to faint.

If you experience any of these symptomssoon after using Elidel cream, interrupt the use of the cream and inform your doctor immediately.

Other side effects may include

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

• Feeling 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).

Uncommon side effects(less than 1 in 100 patients)

• Skin infections such as impetigo (bacterial skin infection), cold sores (herpes simplex), herpes zoster, herpes simplex dermatitis (eczema herpeticum), molluscum contagiosum (viral skin infection), warts, and boils.
• Reactions at the application site such as rash, pain, feeling of pinching, mild peeling of the skin, 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 consuming alcohol.
• Changes in skin color (becoming darker or lighter than the surrounding skin).

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

Cases of lymphadenopathy have been reported in patients using Elidel. However, it has not been confirmed whether this is related to treatment with Elidel cream.

If you think any of the side effects you are experiencing are seriousor if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects:

If you experience 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 through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 packaging and the tube after “EXP”. The expiry date refers to the last day of the month shown.

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

Store in the original package. Keep the tube tightly closed.

Once the tube is opened, the contents should be used within 12 months. It may be helpful to write the date you open the tube on the packaging.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Elidel cream

• The active ingredient is pimecrolimus. 1 gram of Elidel cream contains 10 mg of pimecrolimus.
• The other ingredients are: medium-chain triglycerides, oleic acid, propylene glycol (E1520), stearyl alcohol, cetyl alcohol, mono- and diglycerides, sodium cetearyl 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 gram of cream. See section 2.

Appearance of Elidel cream and pack contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Manufacturer

MEDA Manufacturing

Av. J. F. Kennedy

33700 Mérignac (France)

You can obtain 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 under the following names:

Austria: Elidel 10 mg/g Creme

Belgium: Elidel 10 mg/g crème

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

Cyprus: Elidel cream 10 mg/g

Czech Republic: Elidel 10 mg/g krém

Denmark: Elidel 10 mg/g Creme

Estonia: Elidel 10 mg/g kreem

Finland: Elidel 10 mg/g emulsiovoide

Germany: Elidel 10 mg/g Creme Greece: Elidel, κρ?μα 10 mg/g

Hungary: Elidel 10 mg/g krém

Iceland: Elidel 10 mg/g krem

Italy: Elidel 10 mg/g crema

Latvia: Elidel 10 mg/g krems

Lithuania: Elidel 10 mg/g kremas

Luxembourg: Elidel 10 mg/g Creme

Malta: Elidel 10 mg/g cream

Netherlands: Elidel 10 mg/g crème

Norway: Elidel 10 mg/g krem

Poland: Elidel 10 mg/g krem

Portugal: Elidel 10 mg/g creme

Romania: Elidel 10 mg/g crema

Slovakia: Elidel 10 mg/g krém

Slovenia: Elidel 10 mg/g krema

Spain: Elidel 10 mg/g crema

Sweden: Elidel 10 mg/g kräm

United Kingdom: Elidel 10 mg/g cream

For any further information or questions you may have about this medicine, consult your doctor or pharmacist.

Date of last revision of this leaflet:10/2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) {http://www.aemps.gob.es/