Elidel

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Elidel, 10 mg/g, cream

Pimecrolimus

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Elidel and what is it 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 is Elidel and what is it 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 use of glucocorticosteroids is not recommended or is not possible.
These may include:

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

2. Important information before using Elidel

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

When not to use Elidel

Warnings and precautions

Before starting treatment with Elidel, discuss it with your doctor.
Elidel should not be used if the patient has 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, treatment with Elidel may increase the risk of bacterial skin infections (eczema herpeticum).
Elidel should not be used on areas with malignant or premalignant skin changes.
Inform your doctor before starting treatment with Elidel about any malignant tumors (cancer) or impaired (weakened) 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.
The medicine should not be used on skin surfaces infected with viruses, such as herpes simplex (cold sore) or chickenpox.
If the skin is infected, the doctor may prescribe a suitable medicine to treat the infection. Only after the infection has been treated can treatment with Elidel be started. If an infection occurs during treatment with Elidel, inform your doctor. In this 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 herpes virus (eczema herpeticum). If painful blisters appear on the body, inform your doctor immediately. Treatment with Elidel should be stopped until the infection is treated.
Elidel may cause reactions at the application site, such as a feeling of heat or burning.
These reactions are usually mild and disappear quickly. Inform your doctor if you experience severe reactions while using 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, 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, inform your doctor if you have these diseases.
If you experience swelling of the lymph nodes while using Elidel, see your doctor immediately.
In patients with severe infection and/or damaged skin, systemic concentrations may be higher.
Consult your doctor, even if the above warnings refer to situations that have occurred in the past.

Elidel and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to use.
Pimecrolimus is not recommended for use at the vaccination site during local reactions.
In case of widespread atopic dermatitis, treatment with Elidel may be interrupted 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 broken skin (e.g., burned skin) without consulting a doctor or pharmacist. Benzyl alcohol may cause allergic reactions and mild local irritation.

• Alkohol cetylowy i alkohol stearylowy mogą powodować miejscowe reakcje skórne (np. kontaktowe zapalenie skóry).
  Lek Elidel zawiera 50 mg glikolu propylenowego (E 1520) w 1 g kremu. Glikol propylenowy (E 1520) może powodować podrażnienie skóry. Z powodu zawartości glikolu propylenowego leku nie należy stosować na otwarte rany lub duże powierzchnie zranionej lub uszkodzonej skóry (np. oparzonej) bez konsultacji z lekarzem lub farmaceutą. Alkohol benzylowy może wywoływać reakcje alergiczne i łagodne miejscowe podrażnienie.

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 with atopic dermatitis (atopic eczema).
• 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 breaks, 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 the treatment and consult your doctor if there is no improvement or worsening of symptoms after 6 weeks.
In the long-term treatment of atopic eczema, Elidel should be reapplied as soon as symptoms appear (redness of the skin and itching). This helps prevent the disease from coming back. If the symptoms of the disease return, consult your doctor. The doctor will consider whether to restart the 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) rarely occurs 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 Elidel

If you have any further doubts 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 application site. These reactions are usually mild and/or moderate, occur at the beginning of treatment, and are short-lived.
Very common(occurring in more than 1 in 10 patients)
Feeling of heat or burning at the application site.
Common(occurring in less than 1 in 10 patients)
Irritation, itching, and redness at the application site. Skin infections (folliculitis).
Uncommon(occurring in less than 1 in 100 patients)
Skin infections such as furuncles, eczema herpeticum (bacterial skin infection), herpes simplex, shingles, herpes simplex infection (eczema herpeticum), molluscum contagiosum (viral skin infection), skin wart (warts). Skin reactions at the application site, such as rash, pain, paresthesia (tingling, numbness), flaking, dryness, swelling, and worsening of atopic dermatitis symptoms.
Rare(occurring in less than 1 in 1,000 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. Skin color changes (a fragment of the skin may become darker or lighter than the surrounding skin).
Very rare(occurring 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 malignant tumors, including lymphoma and skin cancer, in patients using Elidel.
Patients using Elidel have experienced lymph node enlargement, but a link to Elidel treatment has not been established.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, National Institute of Pharmacy and Nutrition: 1051 Budapest, Zrínyi u. 3., Tel: +36 1 888 6792, Fax: +36 1 888 6791, e-mail: [[email protected]](mailto:[email protected])
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.
Do not store above 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
After first 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 is pimecrolimus. 1 g of cream contains 10 mg of pimecrolimus.
• The other excipients are sodium hydroxide, 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 easy to spread.
Aluminum tube with an inner protective coating, closed with a polypropylene cap, in a cardboard box.
1 tube of 15 g

Marketing authorization holder in Hungary, in the country of export:

Viatris Healthcare Limited
Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland

Manufacturer:

MEDA Manufacturing
Avenue J.F. Kennedy, 33700 Merignac, France

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Hungarian, export license number: OGYI-T-9011/01

Parallel import license number: 328/24

Date of leaflet approval: 22.08.2024

[Information about the trademark]