ELIDEL <1 mg/g Cream

Зміст інструкції

1. WHAT IS ELIDEL CREAM AND WHAT IS IT USED FOR
2. WHAT YOU NEED TO KNOW BEFORE USING ELIDEL CREAM
3. HOW TO USE ELIDEL CREAM
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ELIDEL CREAM
6. PACKAGE CONTENTS AND OTHER INFORMATION

ELIDEL 10 mg/g cream
Pimecrolimus

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Elidel cream is and what it is used for
• 2. What you need to know before you use Elidel cream
• 3. How to use Elidel cream
• 4. Possible side effects
• 5. How to store Elidel cream
• 6. Contents of the pack and other information

1. WHAT IS ELIDEL CREAM AND WHAT IS IT USED FOR

Elidel crema contains a medicinal substance called pimecrolimus. It does not contain steroids.
Elidel crema specifically treats a skin inflammation called atopic dermatitis
(eczema). It acts on the skin cells responsible for inflammation, redness and
itching characteristic of eczema.
The cream is used to treat the signs and symptoms of mild to moderate eczema (e.g.
redness and itching) in children (from 2 years of age onwards), adolescents and adults. When used
to treat the first signs and symptoms of the disease, it can prevent severe flare-ups.
Elidel crema should only be used after other prescription medications or emollients
have not helped you or if your doctor has recommended not to use other prescription medications
.
See your doctor if you do not feel better or if you feel worse after 6 weeks.

2. WHAT YOU NEED TO KNOW BEFORE USING ELIDEL CREAM

Follow all instructions given to you by your doctor carefully.
Read the following information before using Elidel cream.

Do not use Elidel cream

• if you are allergic(hypersensitive) to pimecrolimus or any of the excipients of Elidel cream (listed in section 6).

Take special care with Elidel cream
Elidel is not approved for use in children under 2 years of age.Therefore, it should not be
used in this age group. Ask your doctor for advice.

Warnings and precautions
Talk to your doctor before using Elidel if you have a weakened immune system
(immunocompromised), whatever the cause.

Elidel cream must only be used for atopic dermatitis.Do not use it for other skin conditions.

Elidel cream is for external use only.Do not use it in the nose, eyes, or mouth. In case of
accidental application to these areas, clean them carefully and/or rinse thoroughly. Be
careful not to swallow it, or accidentally get it inside your mouth when, for example
it is applied to your hands.

Do not apply the cream to areas of skin affected by an active viral infectionsuch as infections from herpes

simplexor chickenpox.

If you have a skin infection, consult your doctor before using Elidel. Your doctor will ask you to
use an appropriate medicine to treat the infection. You can start treatment
with Elidel as soon as the infection in the treated areas has disappeared. If a skin infection appears during treatment
with Elidel, inform your doctor. Your doctor may ask you to stop
therapy with Elidel until the infection is adequately controlled.
Treatment with Elidel may be associated with an increased risk of developing a serious
skin infection from herpes simplex (herpetic eczema). Therefore, immediately inform
your doctor if painful soresform anywhere on your body. You must stop
treatment with Elidel until the infection has disappeared.
The use of Elidel may cause the onset of reactions at the application sitesuch as a sensation of
warmth and/or burning. These reactions are usually mild and last only for a short time. If
you experience severe reactions with the use of Elidel, immediately inform your doctor.
During treatment with Elidel, do not cover the treated skin area with bandages or dressings.
However, you can continue to wear your normal clothes.
During therapy with Elidel, avoid excessive exposure to sunlight, sunbeds and tanning beds.
If you are outdoors after applying Elidel, wear protective clothing, use appropriate sunscreen products and minimize your time in the sun.
If you suffer from erythroderma (redness of almost the entire body) or a skin condition
called Netherton syndrome, talk to your doctor before starting treatment with Elidel.
Before starting treatment with Elidel, also talk to your doctor if you have any type of

malignant skin tumor.
Tell your doctor if you experience swollen lymph nodesduring treatment with Elidel cream.

Children
The use of Elidel in patients under 2 years of age is not recommended until further data are
available.

Other medicines and Elidel cream
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
The application of pimecrolimus to vaccination sites, while local reactions persist, is not
recommended.
If you have extensive eczema, you may need to stop treatment
with Elidel before any vaccination. Your doctor will tell you if this is necessary.
Elidel should not be used at the same time as ultraviolet treatments(such as
UVA, PUVA, UVB) or with systemic immunosuppressant drugs (such as azathioprine
or cyclosporine).

Use of Elidel cream with food, drinks and alcohol
In rare cases, you may experience reactions such as a sensation of warmth, rash, burning sensation, itching or
swelling shortly after consuming alcohol .
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.Do not
use Elidel if you are pregnant.
It is not known whether Elidel passes into breast milk after application to the skin. If you are breastfeeding,
do not apply Elidel to your breasts.

Driving and using machines
Elidel has no known effects on the ability to drive or operate machinery.
Elidel cream contains cetyl alcohol, stearyl alcohol, benzyl alcohol and propylene glycol (E 1520).
Cetyl alcohol and stearyl alcohol can cause local skin reactions (e.g. contact dermatitis). Benzyl alcohol can cause allergic reactions and mild local irritation. Propylene glycol (E 1520) can cause skin irritation.

3. HOW TO USE ELIDEL CREAM

Use this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, ask your doctor or pharmacist.
Elidel can be applied to all areas of the skin, including the head, face and neck, and skin folds.

Apply the cream as described below:

• Wash and dry your hands.
• Open the tube (if you are using the tube for the first time, you must break the seal using the pointed part on the outside of the cap).
• Squeeze the cream onto your finger.
• Apply a thin layer of Elidel and completely cover the affected skin area.
• Apply only to areas of skin affected by eczema.
• Massage gently.
• Close the tube with the cap.

The cream should be applied twice a day, for example once in the morning and once
in the evening. Emollients (moisturizers) can be used together with Elidel. If emollients are used,
they should be applied immediately after Elidel.
Do not bathe, shower or swim immediately after applying Elidel. These activities
may wash the cream away.

How long to apply Elidel
Long-term treatment should be intermittent and not continuous. As soon as the signs
of eczema disappear, stop treatment with Elidel.
Continue to use the cream for the entire duration of the therapy recommended by your doctor.

If you do not see improvements after 6 weeks or if the eczema worsens,
stop treatmentand consult your doctor.
In the long-term treatment of eczema, start using Elidel as soon as you notice the presence of
signs and symptoms (redness and itching). This may help prevent progression to severe
flare-ups.
If signs and symptoms reappear, start treatment again.

If you use more Elidel than you should
If you apply more cream to the skin than necessary, simply remove it.

If you forget to use Elidel
If you forget to apply the cream, apply it as soon as you can and then continue following the usual
application schedule. However, if it is almost time for the next application, skip the missed
application and continue following the usual application schedule. Do not apply a double dose of
cream to make up for a missed application.

If you stop treatment with Elidel
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

If you accidentally ingest Elidel
Immediately inform your doctor if you or someone else accidentally ingests Elidel.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Elidel cream can cause side effects, although not everybody gets them.
The most common side effects of Elidel are reactions at the application site (such as
discomfort). These reactions are generally mild/moderate, occur at the beginning of treatment and
last only for a short period.

Some side effects may be serious
Rare side effects(occur in less than 1 in 1,000 people)

• Angioedema - the signs include itching, hives, red marks on hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.

Very rare side effects(occur in less than 1 in 10,000 people)

• Anaphylactic reactions: skin rash including itchy and reddened skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (these symptoms are also described as angioedema and

can cause difficulty swallowing or breathing) and may feel a sense of
fainting.

If any of these symptoms occurshortly after using Elidel cream, stop the
treatment and inform your doctor immediately.

Other side effects
Very common side effects(occur in more than 1 in 10 people)

• Sensation of heat and/or burning at the application site.

Common side effects(occur in more than 1 in 100 people)

• Irritation, itching and redness of the skin where the cream has been applied.
• Skin infections (such as folliculitis).

Uncommon side effects(occur in less than 1 in 100 people)

• Skin infections such as impetigo (a bacterial skin infection), herpes simplex, herpeszoster(shingles), herpes simplex dermatitis (eczema herpeticum), molluscum contagiosum (a viral skin infection), warts and boils.
• Reactions at the application site such as rash, pain, tingling sensation, mild skin peeling, dryness, swelling and worsening of eczema symptoms.

Rare side effects(occur in less than 1 in 1,000 people)

• Sensation of heat, rash, burning, itching or swelling shortly after drinking alcohol.
• Change in skin color (becoming darker or lighter than the surrounding area).

Cases of cancer, including cancer of the lymph nodes or skin cancer, have been reported in patients treated with Elidel.
Cases of lymphadenopathy have been reported in patients treated with Elidel. However, a correlation with the use of Elidel has not been
confirmed.

If any of the side effects gets worse, or if you notice any side effect

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE ELIDEL CREAM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the tube. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Do not freeze.
Store in the original packaging. Keep the tube tightly closed.
After first opening, the tube must be used within 12 months. Write the date of opening the tube
in the space provided on the carton.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Elidel cream contains

• The active ingredient is pimecrolimus. 1 gram of Elidel cream contains 10 mg of pimecrolimus.
• The excipients are: medium-chain triglycerides, oleyl alcohol, propylene glycol (E 1520), stearyl alcohol, cetyl alcohol, mono and diglycerides, sodium cetostearyl sulfate, benzyl alcohol, anhydrous citric acid, sodium hydroxide, purified water.

This medicine contains 10 mg of benzyl alcohol and 50 mg of propylene glycol (E 1520) per 1 g of
cream. See section 2.

Description of the appearance of Elidel and contents of the pack
Elidel is a white, odorless, colorless and easily spreadable cream. The cream is available in tubes
of 5g, 15 g, 30 g, 60 g and 100 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Healthcare Limited
Damastown Industrial Park, Mulhuddart,
Dublin 15,
DUBLIN,
Ireland

Manufacturer
Meda Pharma GmbH & Co. KG,
Benzstrasse 1, 61352 Bad Homburg, Germany
MEDA Manufacturing, Avenue J. F. Kennedy, 33700 Merignac, France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: Elidel 10 mg/gCreme
Belgium: Elidel 10 mg/g crème
Bulgaria: Елидел 10 mg/g крем
Croatia Elidel 10 mg/g krema
Cyprus: Elidel cream 10 mg/g
Czech Republic: Elidel 10 mg/g krém
Denmark: Elidel 10 mg/g Creme
Estonia: Elidel 10 mg/g kreem
Finland: Elidel 10 mg/g emulsiovoide
Germany: Elidel 10 mg/g Creme
Greece: Elidel, κρέμα 10 mg/g
Hungary: Elidel 10 mg/g krém
Iceland: Elidel 10 mg/g krem
Italy: Elidel 10 mg/g crema
Latvia: Elidel 10 mg/g krēms
Lithuania: Elidel 10 mg/g kremas
Luxembourg: Elidel 10 mg/g Creme
Malta: Elidel 10 mg/g cream
Netherlands: Elidel 10 mg/g crème
Norway: Elidel 10 mg/g krem
Poland: Elidel 10 mg/g krem
Portugal: Elidel 10 mg/g creme
Romania: Elidel 10 mg/g cremă
Slovakia: Elidel 10 mg/g krém
Slovenia: Elidel 10 mg/g krema
Spain: Elidel 10 mg/g crema
Sweden: Elidel 10 mg/g kräm
United Kingdom: Elidel 10 mg/g cream
If you have any questions or doubts about the medicine, ask your doctor or pharmacist.