Package leaflet: Information for the patient

Warning! Keep this leaflet. The 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 doubts, 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 effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 an anti-inflammatory medicine for topical use on the skin. It does not contain steroids.
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 use 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.
Do not use Elidel if the patient has a weakened immune system (impaired immunity).
Elidel must not be used 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 used on areas of skin with malignant or pre-malignant lesions.
Inform your doctor before starting treatment with Elidel if you have any history of malignant tumors (cancers) 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 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 apply Elidel to 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. Treatment with Elidel may only begin after the infection has resolved. If an infection develops 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 with herpes simplex (herpetic eruption). If painful skin lesions develop, contact your doctor immediately. Treatment with Elidel should be stopped until the infection has resolved.
Elidel may cause local application site reactions 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 going outdoors after applying Elidel, protect the skin with appropriate clothing, use suitable sunscreen products with UV filters, and minimize sun exposure.
Elidel is not recommended in cases of erythroderma (redness affecting almost the entire body) or in patients with a skin condition called 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, contact your doctor immediately.
Systemic (whole-body) exposure levels 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

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
Pimecrolimus (the active ingredient in Elidel) should not be used at the site of vaccination while local reactions are present.
In cases of extensive atopic dermatitis, 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 with immunosuppressive drugs (e.g. azathioprine or cyclosporine).
Avoid excessive skin exposure to light during treatment with Elidel.
Interactions with other medicines are unlikely.

Elidel with food, drink, and alcohol

Rarely, shortly after consuming alcohol, a sudden flush reaction, 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 become pregnant, consult your doctor or pharmacist before using this medicine.
Do not use Elidel during pregnancy.
It is not known whether the active ingredient 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 or negligible effect on the ability to drive or 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. Because of 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 exactly as your doctor has told you. If you are unsure, please 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 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 applied twice daily, for example once in the morning and once in the evening. During treatment with Elidel, emollients may be used. If using emollients at the same time, apply them immediately 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 may be used short-term or intermittently long-term to prevent flare-ups of the disease.
Stop using Elidel immediately once symptoms of atopic eczema have resolved.
Continue using Elidel for 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 the first signs of a flare-up (skin redness and itching). This helps prevent recurrence of the disease. If symptoms return, contact your doctor. Your doctor will decide 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.
The dosage and method of application 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 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.
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, contact your doctor immediately.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most commonly occurring adverse reactions associated with the use of Elidel are reactions at the application site (e.g. discomfort). 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 in 10 patients):
Sensation of warmth or burning at the site of application.

Common (occur in fewer than 1 in 10 patients):
Irritation, itching, and redness at the application site. Skin infections (folliculitis).

Uncommon (occur in fewer than 1 in 100 patients):
Skin infections such as boils, impetigo (bacterial skin infection), herpes simplex, shingles, herpes-associated dermatitis (vesicular rash), molluscum contagiosum (viral skin infection), skin papillomas (warts). Skin reactions at the application site such as rash, pain, paresthesia (pricking, tingling sensation), scaling, dryness, swelling, and worsening of symptoms of atopic dermatitis.

Rare (occur in fewer than 1 in 1,000 patients):
Alcohol intolerance, hot flushes, rash, burning sensation, itching, or swelling shortly after alcohol consumption. Allergic reactions which may cause vasomotor edema (swelling, most commonly in the face, limbs, and joint areas), skin rash, or urticaria. Changes in skin pigmentation (areas of skin may become darker or lighter in comparison to surrounding skin).

Very rare (occur in fewer than 1 in 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, 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 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 any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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, Phone: +48 22 4921301, Fax: +48 22 4921309, Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Elidel

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 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 per 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 stain 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 of 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:
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 Hungary, country of export: OGYI-T-9011/01
Parallel import authorisation number: 328/24