Patient Medication Information: uses, side effects, how to take - Elidel
What is ELIDEL® used for?
ELIDEL® is used to treat a skin condition called atopic dermatitis (also known as eczema) in adults and children aged 3 months and older.
- It is used in patients who do not have a weakened immune system.
- Your doctor will prescribe ELIDEL® to you if other medicines have not worked for you or are not suitable for you.
- It is used for short periods of time. It can be used for intermittent treatment, as directed by your doctor. Intermittent treatment means taking breaks between the periods of time that you use ELIDEL®.
How does ELIDEL® work?
ELIDEL® cream works differently than medicines called corticosteroids, to treat inflammation of the skin which causes redness and itching of eczema.
What are the ingredients in ELIDEL®?
Medicinal ingredients: pimecrolimus
Non-medicinal ingredients: benzyl alcohol, cetyl alcohol, citric acid, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides and water.
ELIDEL® comes in the following dosage forms:
As a cream, 1% w/w.
Do not use ELIDEL® if you:
- are allergic to pimecrolimus or to any ingredients of ELIDEL®.
- have any infections of your skin at the site to be treated including chicken pox or herpes.
- are immunocompromised (have any problems with your immune system).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ELIDEL®. Talk about any health conditions or problems you may have, including if you:
- have had skin cancer or if you have skin cancer.
- have skin lesions that your doctor has told you could become skin cancer.
- have a rare and inherited skin condition called Netherton’s syndrome.
- are receiving any form of light therapy (phototherapy or UV) for your skin.
are pregnant or are planning to become pregnant.
- are breastfeeding or are planning to breastfeed.
Other warnings you should know about:
Avoid sunlight and sun lamps, tanning salons and any treatment with UVA or UVB light. If you need to be outdoors after applying ELIDEL®, wear clothing that protects the treated area from the sun. In addition, you should ask your doctor what other type of protection from the sun you should use.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Before you use any other ointments, lotions, or creams on your skin, discuss it with your doctor or pharmacist.
How to use ELIDEL®:
- Use ELIDEL® exactly as your doctor has told you to.
- Follow all instructions given to you by your doctor.
- Wash and dry your hands before applying ELIDEL®.
- Apply a thin layer of ELIDEL® to fully cover all skin areas that your doctor has diagnosed as eczema.
- Only apply ELIDEL on areas of your skin that your doctor has diagnosed as eczema
- If your hands are not being treated, wash your hands with soap and water after applying ELIDEL®.
- ELIDEL® should be applied twice a day, about 12 hours apart.
- ELIDEL® is for external topical use only. Do not use it in your nose, eyes or mouth. If your hands are being treated, avoid accidental transfer to these areas. If accidentally applied to the nose, eyes or mouth, the cream should be thoroughly wiped off and rinsed well with water.
- Do not cover the skin being treated with bandages, dressings, or wraps. You can wear normal clothing.
- Do not bathe, shower or swim right after applying ELIDEL® since this could wash off the cream.
- Before applying ELIDEL® after a bath or shower, be sure your skin is completely dry.
How Long Should I Use ELIDEL®?
ELIDEL® usually begins to provide relief from the symptoms of eczema within 1 week. It is important to use ELIDEL® as instructed by your doctor.
If you do not notice an improvement in your eczema within the first 3 weeks of treatment or if your eczema gets worse, you should stop using ELIDEL® and talk to your doctor.
Usual dose:
Apply a thin later to fully cover the affected skin area twice a day.
Overdose:
If you think you have used too much ELIDEL®, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed dose:
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not take a double dose to make up for a missed dose.
What are possible side effects from using ELIDEL®?
These are not all the possible side effects you may feel when taking ELIDEL®. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- burning, feeling of warmth or redness at skin application site
- headache
- nasopharyngitis (nose and throat infection)
- flu-like symptoms, common cold, congestion, stuffy nose and sore throat, fever, viral infection and cough
- flushing of the face or skin irritations (rash, burning, itching or swelling) in patients who drink alcohol while using ELIDEL®
- skin discoloration
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| COMMON | |||
| Burning, feeling of warmth or redness at skin application site if this is severe or if it lasts more than 1 week. | X | ||
| RARE | |||
| Allergic reactions: difficulty breathing, difficulty swallowing, fever, hives, itching, rash, skin rashes, swelling of your tongue or throat | X | ||
| Herpes skin infections including cold sores, chicken pox or shingles: itching or tingling of the skin, fever, fluid-filled blisters that can be painful, skin pain, skin rash, sores, scabs or crusting of skin. | X | ||
| Swollen lymph nodes: tenderness or pain in lymph nodes, bumps in your neck, armpits or groin. | X | ||
| Warts: skin growths often with a rough texture. | X |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at room temperature (15°C to 30°C). Do not freeze. Use within 12 months after opening the tube.
Keep ELIDEL® out of the reach and sight of children.
If you want more information about ELIDEL®:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); by contacting the sponsor: Bausch Health, Canada Inc., 2150 St-Elzéar Blvd. West, Laval, (Quebec) H7L 4A8; or by calling 1-800-361-4261.