Package leaflet: Information for the patient

Warning! Keep this leaflet. The packaging information in a foreign language.
Elidel, 10 mg/g, cream
Pimecrolimus
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Elidel is and what it is used for
Important information before using Elidel
How to use Elidel
Possible side effects
How to store Elidel
Contents of the pack 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 aged 3 months and older with mild to moderate atopic dermatitis, when topical application of glucocorticosteroids is not recommended or not possible.
Such cases may include:

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

2. Important information before using Elidel

Carefully follow all your doctor's instructions.
Read the entire leaflet 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.
Elidel must not be used if the patient has a weakened immune system (impaired immunity).
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 dermatitis, treatment with Elidel may be associated with an increased risk of bacterial skin infections (impetigo).
Elidel must not be applied to 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 if you have a weakened (impaired) immune system.
Elidel is for topical use only. It must not be applied 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 enter the mouth accidentally, for example when applied to the hands.
Do not use the medicine on skin areas infected with viruses such as those causing cold sores (herpes simplex) or chickenpox.
If the skin is infected, your doctor may recommend appropriate treatment to resolve the infection. Elidel treatment should only begin after the infection has healed. If an infection occurs during treatment with Elidel, inform your doctor immediately. In such cases, the doctor may advise discontinuing Elidel until the infection has resolved.
Elidel may increase the risk of severe herpes simplex virus skin infection (herpetic eczema). If painful skin lesions develop, contact your doctor immediately. Treatment with Elidel should be stopped until the infection has healed.
Elidel may cause local reactions at the application site, such as warmth or burning sensation. These reactions are usually mild and resolve quickly. Inform your doctor if severe reactions occur during treatment with Elidel.
When using Elidel, do not cover the treated skin with bandages or dressings, but normal clothing may be worn.
During treatment with Elidel, avoid excessive exposure to sunlight, sunlamps, and tanning beds. If going outdoors after applying Elidel, protect the skin with appropriate clothing, use suitable sunscreen products with UV filters, and minimise sun exposure.
Elidel is not recommended in cases of erythroderma (redness affecting almost the entire body) or a skin condition known as Netherton's syndrome. Inform your doctor if you have either of these conditions before starting treatment with Elidel.
If lymph node swelling occurs during treatment with Elidel, seek medical advice immediately.
Systemic concentrations may be higher in patients with severe infection and/or damaged skin.
Consult your doctor even if the above warnings relate to conditions that occurred in the past.

Elidel and other medicines

Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to use.
The use of pimecrolimus at the site of vaccination is not recommended during local reactions.
In cases of extensive atopic dermatitis, treatment with Elidel may need to be paused before receiving 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 drugs (e.g. azathioprine or cyclosporine).
Avoid excessive skin exposure to light during treatment with Elidel.
The likelihood of interactions with other medicines is low.

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 the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Elidel should not be used during pregnancy.
It is not known whether the active substance in Elidel passes into human breast milk after topical application. Do not apply Elidel to the skin of the breasts during breastfeeding.

Driving and operating machinery

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 injured 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 as directed by the doctor. If in doubt, consult your doctor or pharmacist.
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 the cream onto a fingertip.
Apply a thin layer of Elidel to the affected areas of the skin.
Use Elidel only on areas of 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, emollients may be used. When using emollients 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 long-term intermittently to prevent disease relapses.
Discontinue Elidel immediately after symptoms of atopic eczema have resolved.
Continue using Elidel as long as directed by your doctor.
Stop 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 restarted immediately upon appearance of symptoms (skin redness and itching). This helps prevent disease relapse. If symptoms return, contact your doctor. The doctor will consider whether to restart treatment.
Use in children and adolescents
Due to insufficient data, Elidel must not be used in children under 3 months of age.
Dosage and method of administration in infants (from 3 to 23 months of age), children (from 2 to 11 years of age), and adolescents (from 12 to 17 years of age) are the same as in adult patients.
Use in elderly patients
Atopic dermatitis (atopic eczema) rarely occurs 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 a dose of Elidel is missed, apply it as soon as possible and then continue with the usual recommended dosing schedule.
Stopping Elidel treatment
If you have any further doubts about using 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 any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The most commonly observed adverse reactions associated with the use of Elidel are reactions (e.g.
feeling of discomfort) at the application site. These reactions are mild and (or) moderate in intensity,
occur at the beginning of treatment and are short-lived.
Very common (occur in more than 1 out of 10 patients)
Sensation of warmth or burning at the application site.
Common (occur in less than 1 out of 10 patients)
Irritation, itching, and redness at the application site. Skin infections (folliculitis).
Uncommon (occur in less than 1 out of 100 patients)
Skin infections such as boils, impetigo (bacterial skin infection), herpes simplex, shingles, herpes-induced dermatitis (herpetic rash), molluscum contagiosum (viral skin infection), skin papillomas (warts). Skin reactions at the application site, such as rash, pain, paresthesia (pricking or tingling sensation), scaling, dryness, swelling, and worsening of symptoms of atopic dermatitis.
Rare (occur in less than 1 out of 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. Skin discoloration (areas of skin may become darker or lighter compared to surrounding skin).
Very rare (occur in less than 1 out of 10,000 patients)
Severe allergic reactions (anaphylactic reactions) with symptoms such as sudden shortness of breath, chest pain or tightness, eyelid, facial, or lip swelling.
If any of the listed symptoms occur, the use of the medicine should be stopped immediately and a doctor should be consulted.
Cases of malignancies, including lymphoma and skin cancers, have been reported in patients using Elidel.
Cases of lymph node enlargement have been observed in patients using Elidel; however, a causal relationship with Elidel treatment has not been established.
Reporting of adverse reactions
If any adverse reactions occur, including those 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
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.
Store in the original packaging.
Keep tubes tightly closed.
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 medicine can be used for up to 12 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging 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 or almost white, homogeneous, odourless cream that does not leave stains and spreads easily.
Aluminium tube, internally coated with a protective varnish made of phenolic-epoxy resin, fitted with a polypropylene cap, packed in a cardboard box.
1 tube containing 15 g
For further information, contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Latvia, country of export:
Viatris Healthcare Limited
Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland
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, Poland
Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in Latvia, country of export: 02-0184
Parallel import authorisation number: 142/24