Elidel

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Elidel (Elidel), 10 mg/g, cream
Pimecrolimus
Elidel and Elidel are the same brand names of the medicine written in Polish and
Bulgarian.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

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 package and other information

1. What Elidel is and what it is used for

Elidel is a non-steroidal anti-inflammatory medicine for topical use on the skin.
Elidel acts on skin cells that cause inflammation, characteristic redness of the skin, and itching.
Indications
Treatment of patients from 3 months of age with mild to moderate atopic dermatitis, when topical corticosteroids are not recommended or cannot be used.
These may include the following cases:

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

2. Important information before using Elidel

You must strictly follow all your doctor's instructions.
Please read this leaflet carefully before using the medicine.

When not to use Elidel

• if the patient is allergic to the active substance or to 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.
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Do not use Elidel if the patient has a weakened immune system (immunocompromised).

Elidel is not intended for use in infants under 3 months of age.

Elidel is intended only for the treatment of atopic dermatitis. It should not be used for other skin diseases.

In patients with severe atopic dermat inflammans, treatment with Elidel may increase the risk of bacterial skin infections (impetigo).

Do not use Elidel on areas of skin with malignant or pre-malignant lesions.

Inform your doctor before starting Elidel treatment if you have any history of malignant tumours (cancer) or a weakened (impaired) immune system.

Elidel is for topical use only. Do not apply it to mucous membranes, including the nasal mucosa, eyes, or oral mucosa. In case of accidental contact with eyes or mucous membranes, immediately remove the product and rinse thoroughly with water.

Take care not to swallow the medicine or allow it to accidentally enter the mouth, for example when applied to the hands.

Do not use Elidel on skin areas infected with viruses, such as those causing cold sores (herpes simplex) or chickenpox.

If the skin is infected, your doctor may prescribe appropriate treatment to clear the infection. Elidel treatment should only begin after the infection has resolved. If an infection occurs during treatment with Elidel, inform your doctor immediately. In such cases, your doctor may advise discontinuing Elidel until the infection has cleared.

Elidel may increase the risk of severe viral skin infection caused by herpes virus (herpetic eruption). If painful skin ulcers develop, contact your doctor immediately. Treatment with Elidel should be stopped until the infection has resolved.

Elidel may cause local reactions at the application site, such as a sensation of warmth or burning. These reactions are usually mild and resolve quickly. Inform your doctor if you experience severe reactions during treatment with Elidel.

Do not cover or bandage the treated skin area while using Elidel, although you may wear normal clothing.

During treatment with Elidel, avoid excessive exposure to sunlight, sunlamps, or tanning beds. If you need to be outdoors after applying Elidel, protect your skin with appropriate clothing, use suitable sunscreen products (UV filters), and minimise sun exposure as much as possible.

The use of Elidel is not recommended in cases of erythroderma (reddening of almost the entire body) or a skin condition called Netherton’s syndrome. Inform your doctor if you have either of these conditions before starting treatment with Elidel.

If swollen lymph nodes occur during treatment with Elidel, contact your doctor immediately.

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In patients with severe infection and/or damaged skin, systemic concentrations may be higher.

Consult your doctor, even if the above warnings refer to conditions that occurred in the past.

Elidel with other medicines

Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.

The use of pimecrolimus at the vaccination site is not recommended during local reactions.

In cases of extensive atopic rash, treatment with Elidel may need to be paused before any vaccinations. Your doctor will advise whether this is necessary.

Elidel should not be used concurrently with phototherapy (e.g. UVB, UVA, PUVA) or immunosuppressive medicines (e.g. azathioprine or cyclosporine).

Avoid excessive exposure of the skin to sunlight during treatment with Elidel.

Interactions with other medicines are unlikely.

Elidel with food, drink, and alcohol

Rarely, shortly after alcohol consumption, sudden flushing, rash, burning sensation, itching, or swelling may occur.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Do not use Elidel during pregnancy.

It is unknown whether the active ingredient in Elidel passes into human milk after topical application. Do not apply Elidel to the skin of the breasts during breastfeeding.

Driving and using machines

Elidel has no effect or negligible effect on the ability to drive and operate machinery.

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) per 1 g of cream. Propylene glycol (E 1520) may cause skin irritation. Due to its propylene glycol content, Elidel should not be used on open wounds or large areas of broken or damaged skin (e.g. burned skin) 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 exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
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Use in adults
Elidel should be applied to affected areas of the skin, including the head, face, neck, and skin folds.
The medicine is usually used as described below:

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

Elidel should be used twice daily, for example once in the morning and once in the evening. During treatment with Elidel, moisturizing agents may be used. If using moisturizers simultaneously, apply them immediately after applying 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 may be used short-term or intermittently long-term to prevent disease relapses.
Stop using Elidel immediately after symptoms of atopic eczema have resolved.
Continue using Elidel as long as your doctor recommends.
Discontinue treatment and contact your doctor if there is no improvement after 6 weeks, or if symptoms of atopic eczema worsen.
For long-term management of atopic eczema, Elidel should be reapplied immediately upon recurrence of symptoms (skin redness and itching). This helps prevent disease relapse. If symptoms return, contact your doctor. Your doctor will consider whether to restart treatment.

Use in children and adolescents
Due to insufficient data, Elidel must not be used in infants under 3 months of age.
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 in adult patients.

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

Use of more than the recommended dose of Elidel
If more cream than recommended has been applied to the skin, wipe it off.

Missed dose of Elidel
If you miss a dose of Elidel, apply it as soon as possible and then continue with the usual recommended dosing schedule.
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Stopping Elidel
If you have any further questions about the use of this medicine, consult your doctor.

Accidental ingestion of Elidel
In case of accidental ingestion of Elidel, inform your doctor immediately.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The most commonly observed adverse reactions associated with the use of Elidel are reactions at the application site (e.g.
sensation of discomfort). These reactions are generally mild and (or) moderate in severity,
occur at the beginning of treatment, and are short-lived.
Very common (occur in more than 1 in 10 patients)
Sensation of warmth or burning at the application site.
Common (occur in less than 1 in 10 patients)
Irritation, itching, and redness at the application site. Skin infections (folliculitis).
Uncommon (occur in less than 1 in 100 patients)
Skin infections such as boils, impetigo (bacterial skin infection), herpes simplex,
shingles, herpes-induced dermatitis (vesicular rash), molluscum contagiosum (viral skin infection),
skin papillomas (warts). Skin reactions at the application site,
such as rash, pain, paraesthesia (pricking, tingling sensation), peeling, dryness, swelling, and
worsening of symptoms of atopic dermatitis.
Rare (occur in less than 1 in 1000 patients)
Alcohol intolerance, hot flushes, rash, burning sensation, itching, or swelling occurring shortly
after alcohol consumption. Allergic reactions, which may cause angioedema (swelling, most commonly in the face, limbs, and joint areas), skin rash, or urticaria. Changes in skin colour (areas of skin may become darker or lighter in comparison to 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, eyelid, facial, and lip swelling.
If any of the listed symptoms occur, use of the medicine should be stopped immediately and medical advice should be sought.
Cases of malignancies, including lymphoma and skin cancers, have been reported in patients using Elidel.
Cases of lymphadenopathy (swollen lymph nodes) have been observed in patients treated with Elidel;
however, a causal relationship with Elidel treatment has not been established.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
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Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Elidel medicine

Keep this medicine out of 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 stated month.
After first opening the tube, the medicine may be used for 12 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 ingredients 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
A white, homogeneous, odourless cream that does not leave stains and spreads easily.
Aluminium tube with a polypropylene cap, packed in a cardboard box.
1 tube of 15 g.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Bulgaria, country of export:
Mylan Ltd.
Office building Serdika, 48 Sitnyakovo Blvd., 7th floor, 1505 Sofia, Bulgaria
Manufacturer:
MEDA Manufacturing
Avenue J. F. Kennedy, 33700 Mérignac, France
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Bulgaria, country of export: 20030658
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Parallel import authorisation number: 20/26
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