Elidel

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Elidel, 10 mg/g, cream

Pimecrolimus

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 skin cells that cause inflammation, characteristic red skin discoloration
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

All the doctor's instructions should be followed carefully.
The contents of the leaflet should be read before using the medicine.

When not to use Elidel

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6.)

Warnings and precautions

Before starting treatment with Elidel, the doctor should be consulted.
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 in other skin diseases.
In patients with severe atopic dermatitis, during treatment with Elidel, there may be an increased risk of bacterial skin infections (eczema herpeticum).
Elidel should not be used on areas with malignant or premalignant skin changes.
The doctor should be informed 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.
Caution should be exercised to avoid swallowing the medicine or accidentally getting it into the mouth, e.g. when applied to the hands.
The medicine should not be used on skin surfaces infected with viruses, such as those causing cold sores (herpes simplex) 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, the doctor should be informed. 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 the herpes virus (eczema herpeticum). If painful blisters appear on the body, the doctor should be informed immediately. Treatment with Elidel should be stopped until the infection is treated.
Elidel may cause reactions at the site of application, such as a feeling of heat or burning.
These reactions are usually mild and disappear quickly. The doctor should be informed in case of severe reactions during treatment with Elidel.
When using Elidel, the treated skin should not be covered with a bandage or dressing, but normal clothing can be worn.
During treatment with Elidel, excessive exposure to sunlight, sunlamps, and tanning beds should be avoided. If the patient is outdoors after using Elidel, they should protect their skin with appropriate clothing and use suitable sunscreens (UV) and limit their 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, the doctor should be informed about these diseases.
In case of swelling of the lymph nodes during treatment with Elidel, the doctor should be consulted immediately.
In patients with severe infection and/or damaged skin, systemic concentrations may be higher.
The doctor should be consulted, even if the above warnings refer to situations that have occurred in the past.

Elidel and other medicines

The doctor should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pimecrolimus is not recommended for use at the vaccination site during local reactions.
In case of widespread atopic dermatitis, treatment with Elidel may be suspended before administration of any vaccines. The doctor will inform the patient 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, excessive exposure of the skin to sunlight should be avoided.
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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 breast milk after application to the skin. Elidel should not be applied to 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 injured skin (e.g. burned skin) without consulting a doctor or pharmacist. Benzyl alcohol may cause allergic reactions and mild local irritation.

• 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. In case of doubts, the doctor or pharmacist should be consulted.

Use in adults

Elidel is applied to the affected areas of the skin, including the head, face, and neck, as well as in skin folds.
The medicine is usually used as described below.

• Hands should be washed and dried.
• The tube should be opened (for the first time, the closure should be pierced using the spike contained in the cap).
• Cream should be squeezed onto the finger.
• A thin layer of Elidel should be applied to the affected areas of the skin.
• The medicine should only be used on areas of the skin where atopic dermatitis (atopic eczema) is present.
• The medicine should be gently and completely rubbed into the skin.
• The tube should be closed with the cap.

Elidel should be used 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, they should be applied directly after using Elidel.
Bathing, showering, or swimming should not be done immediately after using Elidel, as this may wash off the cream.

How long to use Elidel

The medicine may be used for a short or long period, with breaks, to prevent relapses of the disease.
Use of Elidel should be stopped immediately after the symptoms of atopic eczema have disappeared.
Elidel should be used for as long as the doctor recommends.
Treatment should be stopped and the doctor consulted if there is no improvement or worsening of symptoms after 6 weeks.
In long-term treatment of atopic eczema, Elidel should be reapplied as soon as symptoms appear (redness of the skin and itching). This helps prevent relapse of the disease. If symptoms of the disease return, the doctor should be consulted. The doctor will consider whether to restart treatment.

Use in children and adolescents

Due to the lack of sufficient data, Elidel cannot 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 in 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 the effect of the medicine is considered too strong or too weak, the doctor should be consulted.

Using more than the recommended dose of Elidel

In case of using more cream on the skin, it should be wiped off.

Missing a dose of Elidel

In case of missing a dose of Elidel, it should be used as soon as possible and then the usual recommended dose should be continued.

Stopping use of Elidel

In case of any further doubts about using this medicine, the doctor should be consulted.

Accidental ingestion of Elidel

In case of accidental ingestion of Elidel, the doctor should be informed immediately.

4. Possible side effects

Like all medicines, Elidel 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 site of application. Such reactions are usually mild and/or moderate,
occur at the beginning of treatment, and are short-lived.
Very common(occur in more than 1 in 10 patients)
Feeling of heat or burning at the site of application.
Common(occur in less than 1 in 10 patients)
Irritation, itching, and redness at the site of application. Skin infections (folliculitis).
Uncommon(occur 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 site of application,
such as rash, pain, paresthesia (tingling sensation), flaking, dryness, swelling, and worsening of atopic dermatitis symptoms.
Rare(occur in less than 1 in 1000 patients)
Alcohol intolerance, feeling of heat, rash, burning sensation, itching, or swelling shortly after drinking alcohol. Allergic reactions, which can cause angioedema (swelling, most often in the face, limbs, and joints), skin rash, or urticaria. Changes in skin color (a fragment of the skin may become darker or lighter than 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, swelling of the eyelids, face, and lips.
In case of any of the above symptoms, the use of the medicine should be stopped immediately and the doctor consulted.
Cases of malignant tumors, including lymphoma and skin cancer, have been reported in patients using Elidel.
Cases of lymph node enlargement have been reported in patients using Elidel, but a link to treatment with Elidel has not been established.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Elidel

The medicine should be stored out of sight and reach of children.
It should not be stored at a temperature above 25°C. It should not be frozen.
It should be stored in the original packaging.
The tubes should be kept tightly closed.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
After opening the tube, the medicine can be used for 12 months.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Elidel contains

• The active substance of the medicine 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, triglycerides of medium-chain fatty acids, 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

Cream with a white color, homogeneous, odorless, non-staining, and easily spreadable.
Aluminum tube, internally coated with a protective varnish of phenol-epoxy resin with a polypropylene cap in a cardboard box.
1 tube of 15 g
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in Latvia, the 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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Latvia, the country of export: 02-0184

Parallel import authorization number: 142/24

Date of approval of the leaflet: 04.04.2024

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