Elidel 10 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Elidel 10 mg/g cream
Pimecrolimus
Read the entire leaflet carefully before you start using Elidel cream
- Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Elidel cream is and what it is used for
- What you need to know before using Elidel cream
- How to use Elidel cream
- Possible adverse effects
- Storage of Elidel cream
- Contents of the pack and other information
1. What Elidel cream is and what it is used for
Elidel cream contains a medicine called pimecrolimus. It does not contain any steroid. Elidel cream specifically treats a skin inflammation known as atopic dermatitis (eczema). It works on the skin cells that cause inflammation and the characteristic redness and itching 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 3 months of age up to 17 years, and in adults. Using Elidel at the first signs and symptoms of the disease helps prevent it from worsening and a severe flare-up from occurring.
Elidel cream should only be used after other prescribed medications or emollients have not worked, or if your doctor advises that you should not use other medications.
If your condition worsens or does not improve after 6 weeks, consult your doctor.
2. What you need to know before using Elidel cream
Carefully follow all your doctor's instructions.
Read the following information before using Elidel cream.
Do not use Elidel cream:
- If you are allergic (hypersensitive) to pimecrolimus or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before starting to use Elidel if you have a weakened immune system (immunocompromised), regardless of the cause.
Elidel cream should only be used for atopic dermatitis. Do not use it for other skin diseases.
Elidel cream is for external use only. Do not apply the cream in your nose, eyes, or mouth. If the cream is accidentally applied to these areas, remove it and/or rinse thoroughly with water. Be careful not to swallow it or accidentally introduce it into your mouth, for example when applying it to your hands.
Do not apply the cream to areas of skin affected by an active viral infection, such as cold sores (herpes simplex) or chickenpox.
If your skin is infected, consult your doctor before using Elidel. Your doctor may recommend using an appropriate medicine to treat the infection. Treatment with Elidel may begin once the infection in the treatment area has healed. If you develop a skin infection while being treated with Elidel, inform your doctor, as treatment may need to be interrupted until the infection is under control.
Elidel may be associated with an increased risk of severe herpes simplex skin infection (eczema herpeticum). Therefore, if you develop painful lesions anywhere on your body, inform your doctor immediately, as you should stop using Elidel until the infection has healed.
Elidel may cause reactions at the application site, such as a sensation of warmth and/or burning. These reactions are usually mild and temporary. Inform your doctor immediately if you experience a severe reaction to Elidel. If you are using Elidel, do not cover the treated skin with bandages, dressings, or occlusive dressings. However, you may wear normal clothing.
While being treated with Elidel, you should avoid excessive exposure to sunlight, sunlamps, and tanning booths. If you go outdoors after applying Elidel, wear loose-fitting clothing, use appropriate sunscreens, and try to spend as little time as possible in the sun. If you have erythroderma (reddening of almost the entire body) or a skin disease called Netherton syndrome, consult your doctor before starting to use Elidel.
Also, consult your doctor before using Elidel if you have any skin disease (tumors).
Inform your doctor if your lymph nodes swell during treatment with Elidel cream.
Children
Elidel is not recommended for use in patients under 3 months of age.
Other medicines and Elidel cream
Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
The application of pimecrolimus is not recommended in the area where a vaccine has been administered, as long as a local reaction persists.
If you have extensive eczema, inform your doctor that you are using Elidel before receiving a vaccine, as it may be necessary to interrupt treatment.
Elidel should not be used together with ultraviolet light treatments (such as UVA, PUVA, UVB) or systemic immunosuppressive medicines (such as azathioprine or cyclosporine).
It is unlikely that interactions will occur with other medicines you may be using.
Use of Elidel cream with food, drinks, and alcohol
In rare cases, flushing, rash, burning, itching, or swelling may occur after alcohol consumption.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before starting to use this medicine. You should not use Elidel if you are pregnant.
It is not known whether the active ingredient in Elidel passes into breast milk after topical application. Do not apply Elidel to the breasts during breastfeeding.
Driving and using machines
Elidel has no known effect on the ability to drive or use machinery.
Elidel contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis). In addition, Elidel also contains 10 mg of benzyl alcohol per 1 g of cream, which may cause allergic reactions and mild local irritation. Elidel also contains 50 mg of propylene glycol (E 1520) per 1 g of cream, which may cause skin irritation.
3. How to use Elidel cream
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
You may use Elidel on any area of the skin, including the head, face, neck, and skin folds.
Apply the cream as follows:
- Wash and dry your hands.
- Open the tube (the first time you use it, you must break the seal using the point built into the cap).
- Place a small amount of cream on one finger.
- Apply a thin layer of Elidel to completely cover the affected skin area.
- Apply only to areas affected by eczema.
- Gently rub in until the cream has completely disappeared.
- Recap the tube.
The cream should be applied twice daily, for example, once in the morning and once at night. You may use moisturizing products (emollients) together with Elidel. If you use moisturizers, they may be applied immediately after using Elidel.
Do not bathe, shower, or swim immediately after applying Elidel, as the cream may be washed off the treated areas.
How long you can use Elidel
Long-term treatment should be intermittent and not continuous. Discontinue treatment with Elidel as soon as signs of eczema have disappeared.
Continue using the cream for as long as your doctor has instructed.
Stop treatment and consult your doctor if there is no improvement after 6 weeks of treatment, or if your condition worsens.
For long-term management of eczema, start using Elidel as soon as the first signs and symptoms appear (redness and itching) to help prevent symptoms from developing into a severe flare-up. If signs and symptoms recur, treatment should be restarted.
If you use more Elidel cream than you should
If you apply more cream than needed, simply wipe off the excess.
If you forget to use Elidel cream
If you ever forget to apply the cream, apply it as soon as possible and then continue with your usual dosing schedule. However, if it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not apply extra cream to make up for a missed dose.
If you stop treatment with Elidel cream
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
If Elidel is accidentally swallowed
If you or anyone else accidentally swallows Elidel, inform your doctor immediately.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most common adverse effects of Elidel are reactions (such as discomfort) at the application site. These reactions are usually mild or moderate, transient, and occur at the beginning of treatment.
Some effects may be serious
Rare adverse effects (less than 1 in 1,000 patients)
- Angioedema – including pruritus, urticaria, red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
Very rare adverse effects (less than 1 in 10,000 patients)
- Anaphylactic reaction: skin rashes such as skin redness with itching, swelling of the hands, feet, ankles, face, lips, mouth or throat (these symptoms are also described as angioedema and may cause difficulty swallowing or breathing), and you may feel like you are about to faint.
If you experience any of these symptoms shortly after using Elidel cream, stop using the cream and inform your doctor immediately.
Other adverse effects may include
Very common adverse effects (more than 1 in 10 patients)
- Sensation of warmth and/or burning at the application site.
Common adverse effects (more than 1 in 100 patients)
- Irritation, itching and redness of the skin where the cream has been applied.
- Skin infections (such as folliculitis).
Uncommon adverse effects (less than 1 in 100 patients)
- Skin infections such as impetigo (bacterial skin infection), cold sores (herpes simplex), herpes zoster, herpes simplex dermatitis (eczema herpeticum), molluscum contagiosum (viral skin infection), warts and boils.
- Reactions at the application site such as rash, pain, stinging sensation, slight flaking of the skin, dryness, swelling, and worsening of eczema symptoms.
Rare adverse effects (less than 1 in 1,000 patients)
- Skin redness, skin rash, burning, itching or swelling, shortly after alcohol consumption.
- Changes in skin color (becoming darker or lighter than the surrounding skin).
Cases of cancer, including lymph node or skin cancer, have been reported in patients treated with Elidel.
Cases of lymphadenopathy have been reported in patients using Elidel. However, a causal relationship with treatment with Elidel cream has not been established.
If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Elidel cream
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and tube after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.
Do not store above 25°C. Do not freeze.
Store in the original packaging. Keep the tube tightly closed.
After opening the tube, the contents should be used within 12 months. You may find it helpful to write the date you opened the tube in the space provided on the packaging.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Elidel cream
- The active substance is pimecrolimus. One gram of Elidel cream contains 10 mg of pimecrolimus.
- The other components are: medium-chain triglycerides, oleic alcohol, propylene glycol (E1520), stearic alcohol, cetyl alcohol, monoglycerides 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 gram of cream. See section 2.
Appearance of Elidel cream and contents of the pack
Elidel is a white, odourless cream that does not stain and is easy to spread. The cream is available in tubes of 5 g, 15 g, 30 g, 60 g and 100 g. Not all pack sizes may be available in your country.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Manufacturer
MEDA Manufacturing
Av. J. F. Kennedy
33700 Mérignac (France)
For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain
This medicine is authorized in the European Economic Area member states under the following names:
Austria: Elidel 10 mg/g Creme
Belgium: Elidel 10 mg/g crème
Bulgaria: ?????? 10 mg/g ????
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, κρ?μα 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 krems
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 crema
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 further questions or need additional information about this medicine, consult your doctor or pharmacist.
Date of the most recent review of this leaflet: 10/2021
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): {http://www.aemps.gob.es/}