Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is 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, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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.
The medicine acts on skin cells causing 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 glucocorticosteroids are not recommended or cannot be used.
These may include the following cases:

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

2. Important information before using Elidel

You must strictly follow all your doctor's instructions.
Read this entire 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.
Elidel must not be used 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 dermatitis, treatment with Elidel may increase the 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 treatment with Elidel if you have any history of malignant tumours (cancer) or a weakened (compromised) 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 wash off the product 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 prescribe appropriate treatment to cure the infection. Treatment with Elidel may only be started after the infection has resolved. If an infection occurs during treatment with Elidel, inform your doctor immediately. In such cases, your doctor may advise stopping Elidel until the infection has cleared.
Elidel may increase the risk of severe herpes simplex virus skin infection (herpetic rash). If painful skin lesions develop, contact your doctor immediately. Treatment with Elidel should be discontinued 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 severe reactions occur during treatment with Elidel.
Do not cover or bandage the treated skin area when using Elidel, although normal clothing may be worn.
During treatment with Elidel, avoid excessive exposure to sunlight, sunlamps, and tanning beds. If outdoors after applying Elidel, protect the skin with appropriate clothing, use suitable sunscreen products with UV filters, and minimize sun exposure.
Use of Elidel is not recommended in cases of erythroderma (widespread redness of nearly the entire body) or in patients with 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, consult your doctor immediately.
In patients with severe infection and/or damaged skin, systemic concentrations of the active substance may be higher.
Consult your doctor even if the above warnings refer to conditions that occurred in the past.

Elidel and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
The use of pimecrolimus at vaccination sites is not recommended when local reactions are present.
In cases of extensive atopic eruption, treatment with Elidel may need to be paused before administering any vaccines. 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 exposure of the skin to sunlight 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 may be pregnant, or is planning to become pregnant, she should consult a 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 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 as directed by a physician. 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 a small amount of cream onto a fingertip.
Apply a thin layer of Elidel to the affected areas of the skin.
Elidel should only be applied to 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, emollients may be used. When using emollients at the same time, they should be applied immediately after 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 with intermittent treatment to prevent disease relapse.
Discontinue Elidel immediately once symptoms of atopic eczema have resolved.
Continue using Elidel for as long as directed by your doctor.
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 restarted immediately upon the reappearance 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 should not be used in infants under 3 months of age.
The dosage and method of administration in infants (aged 3 to 23 months), children (aged 2 to 11 years), and adolescents (aged 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 has been applied to the skin than recommended, wipe off the excess.
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 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.
feeling of discomfort). These reactions are generally mild and/or moderate, 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 (e.g. 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 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 pigmentation changes (areas of skin becoming darker or lighter in comparison 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, treatment with 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 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Reporting adverse reactions helps to improve the safety information available for this 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 container. 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 should 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 package 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 internally coated with an epoxy-phenolic protective layer, closed with a polypropylene cap, packed in a cardboard box.
1 tube containing 15 g
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Hungary, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Hungary, country of export: OGYI-T-9011/01
Parallel import authorisation number: 272/23