Elidel

Package Leaflet: Information for the Patient

Elidel, 10 mg/g, Cream

Pimecrolimus

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What Elidel is and what it is used for
• 2. Important information before using Elidel
• 3. How to use Elidel
• 4. Possible side effects
• 5. How to store Elidel
• 6. Contents of the pack and other information

1. What Elidel is and what it is used for

Elidel is an anti-inflammatory medicine for use on the skin. It does not contain steroids.
The medicine works on the skin cells that cause inflammation, characteristic redness of the skin
and itching.

Indications

Treatment of patients from 3 months of age with mild or moderate atopic dermatitis,
when topical corticosteroids are not recommended or are not possible.
These may include:

• intolerance to topical corticosteroids,
• lack of response to topical corticosteroids,
• use on the skin of the face and neck, where long-term intermittent treatment with corticosteroids may be inappropriate.

2. Important information before using Elidel

Follow your doctor's instructions carefully.
Read the package leaflet before using the medicine.

When not to use Elidel

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6.)

Warnings and precautions

Before starting treatment with Elidel, discuss it with your doctor.
Elidel should not be used if you have a weakened immune system (immunity is impaired).
Elidel is not intended for use in infants under 3 months of age.
Elidel is intended only for use in atopic dermatitis. It should not be used for other skin diseases.
In patients with severe atopic dermatitis, during treatment with Elidel, there may be an increased risk of bacterial skin infections (eczema herpeticum).
Elidel should not be used on areas with malignant or pre-malignant skin changes.
You should inform your doctor before starting treatment with Elidel about any malignancies (tumors) or impaired (impaired) immune system.
Elidel is intended only for use on the skin. It should not be used on mucous membranes, including the nasal mucosa, eyes, and oral mucosa. In case of accidental contact with the eyes or mucous membranes, the medicine should be removed immediately and rinsed with water.
Be careful not to swallow the medicine or accidentally get it into the mouth, e.g. when applying it to the hands.
Do not use the medicine on skin surfaces infected with viruses, such as those that cause cold sores (herpes simplex) or chickenpox.
If the skin is infected, your doctor may prescribe a suitable medicine to treat the infection. Only after the infection has been treated can Elidel treatment be started. If an infection occurs during treatment with Elidel, you should inform your doctor.
In such a case, the doctor will recommend stopping the use of Elidel until the infection is treated.
Elidel may increase the risk of severe skin infection with the herpes virus (eczema herpeticum). If painful blisters appear on the body, you should immediately inform your doctor. Elidel treatment should be stopped until the infection is treated.
Elidel may cause reactions at the site of application, such as a feeling of heat or burning. These reactions are usually mild and short-lived. You should inform your doctor if you experience severe reactions during treatment with Elidel.
When using Elidel, do not cover the treated skin with a bandage or dressing, but you can wear normal clothes.
During treatment with Elidel, avoid excessive exposure to sunlight, sunlamps, and tanning beds. If you are going to be outdoors after applying Elidel, you should protect your skin with appropriate clothing and use a sunscreen with a high sun protection factor (UV) and limit your time in the sun as much as possible.
It is not recommended to use Elidel in case of erythroderma (redness of almost the entire body) or a skin disease called Netherton's syndrome. Before starting treatment with Elidel, you should inform your doctor about these diseases.
If you experience swelling of the lymph nodes while using Elidel, you should see a doctor immediately.
In patients with severe infection and/or damaged skin, systemic concentrations may be higher.
You should consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Elidel and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Pimecrolimus is not recommended for use at the vaccination site during local reactions.
In case of extensive atopic dermatitis, treatment with Elidel may be discontinued before administration of any vaccines. Your doctor will inform you if this is necessary.
Elidel should not be used at the same time as treatment with radiation (e.g. UVB, UVA, PUVA) or immunosuppressive medicines (e.g. azathioprine or cyclosporine).
During treatment with Elidel, avoid excessive exposure of the skin to sunlight.
The occurrence of interactions with other medicines is unlikely.

Elidel with food, drink, and alcohol

In rare cases, shortly after consuming alcohol, a sudden feeling of heat, rash, burning sensation, itching, or swelling may occur.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Do not use Elidel during pregnancy.
It is not known whether the active substance in Elidel passes into breast milk after application to the skin. Do not use Elidel on the breast skin during breastfeeding.

Driving and using machines

Elidel has no influence or negligible influence on the ability to drive and use machines.

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

Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Elidel contains 50 mg of propylene glycol (E 1520) in 1 g of cream. Propylene glycol (E 1520) may cause skin irritation. Due to the presence of propylene glycol, the medicine should not be used on open wounds or large areas of damaged or injured skin (e.g. burned) without consulting a doctor or pharmacist.
Benzyl alcohol may cause allergic reactions and mild local irritation.

3. How to use Elidel

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Use in adults

Elidel is applied to the affected areas of the skin, including the head, face, and neck, as well as skin folds.
The medicine is usually applied as described below.

• Wash and dry your hands.
• Open the tube (for the first time, pierce the seal with the spike on the cap).
• Squeeze the cream onto your finger.
• Apply a thin layer of Elidel to the affected areas of the skin.
• Use Elidel only on areas of the skin where atopic dermatitis (atopic eczema) is present.
• Gently and completely rub the medicine into the skin.
• Close the tube with the cap.

Elidel should be applied twice a day, e.g. once in the morning and once in the evening. During treatment with Elidel, moisturizers can be used. When using moisturizers, apply them directly after using Elidel.
Do not bathe, shower, or swim immediately after applying Elidel, as this may wash off the cream.

How long to use Elidel

The medicine can be used for a short or long period, with intervals, to prevent relapse of the disease.
Stop using Elidel as soon as the symptoms of atopic eczema disappear.
Continue using Elidel for as long as your doctor recommends.
Stop treatment and consult your doctor if there is no improvement or worsening of atopic eczema symptoms after 6 weeks.
In long-term treatment of atopic eczema, Elidel should be reapplied as soon as symptoms appear (redness of the skin and itching). This helps prevent relapse of the disease. If symptoms of the disease return, consult your doctor. The doctor will consider whether to restart treatment.

Use in children and adolescents

Due to the lack of sufficient data, Elidel should not be used in children under 3 months of age.
The dosage and method of administration in infants (from 3 to 23 months), children (from 2 to 11 years), and adolescents (from 12 to 17 years) are the same as for adult patients.

Use in elderly patients

Atopic dermatitis (atopic eczema) is rare in people over 65 years of age.
It has not been assessed whether the response to the medicine in elderly patients differs from that in younger patients.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using more Elidel than recommended

If you have applied too much cream to the skin, wipe it off.

Missing a dose of Elidel

If you miss a dose of Elidel, apply it as soon as possible and then continue with the usual recommended dosage.

Stopping treatment with Elidel

If you have any further questions about using this medicine, consult your doctor.

Accidental ingestion of Elidel

If you accidentally swallow Elidel, inform your doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects associated with the use of Elidel are reactions (e.g. discomfort) at the site of application. These reactions are usually mild and/or moderate, occur at the beginning of treatment, and are short-lived.
Very common(occur in more than 1 in 10 patients)
Feeling of heat or burning at the site of application.
Common(occur in less than 1 in 10 patients)
Irritation, itching, and redness at the site of application. Skin infections (folliculitis).
Uncommon(occur in less than 1 in 100 patients)
Skin infections such as boils, eczema herpeticum (bacterial skin infection), cold sores, shingles, herpes simplex infection (eczema herpeticum), molluscum contagiosum (viral skin infection), skin warts (warts). Skin reactions at the site of application, such as rash, pain, paresthesia (tingling, numbness), flaking, dryness, swelling, and worsening of atopic dermatitis symptoms.
Rare(occur in less than 1 in 1000 patients)
Alcohol intolerance, feeling of heat, rash, burning sensation, itching, or swelling shortly after drinking alcohol. Allergic reactions, which can cause angioedema (swelling, usually of the face, limbs, and joints), skin rash, or urticaria. Changes in skin color (a patch of skin may become darker or lighter than the surrounding skin).
Very rare(occur in less than 1 in 10,000 patients)
Severe allergic reactions (anaphylactic reactions) with symptoms such as sudden shortness of breath and chest pain or tightness, swelling of the eyelids, face, and lips.
If you experience any of these symptoms, stop using the medicine and consult your doctor immediately.
There have been reports of malignancies, including lymphoma and skin cancer, in patients using Elidel.
Patients using Elidel have experienced lymph node enlargement, but a link to treatment with Elidel has not been established.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Elidel

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C, do not freeze.
Store in the original package.
Store the tubes tightly closed.
Do not use this medicine after the expiry date stated on the package.
After opening the tube, the medicine can be used for 12 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Elidel contains

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

What Elidel looks like and contents of the pack

White cream, homogeneous, odorless, non-staining, and easily spreadable.
Aluminum tube with an inner epoxy coating, closed with a screw cap with a spike to puncture the membrane closing the tube, in a cardboard box.
1 tube of 5 g
1 tube of 15 g
1 tube of 30 g
1 tube of 100 g
Not all pack sizes may be marketed.

Marketing authorization holder:

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw

Manufacturer:

MEDA Manufacturing
Avenue J. F. Kennedy
33700 Mérignac
France
To obtain more detailed information about this medicine, contact the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
tel.: 22 546 64 00
[logo of the marketing authorization holder]
Date of last revision of the leaflet:02/2024