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ELIDEL- pimecrolimus cream


  1. It Is Not Known If Elidel Cream, 1% Is Safe To Use For A Long Period Of Time. A Very Small Number Of People Who Have Used Elidel Cream, 1% Have Developed Cancer (for Example, Skin Cancer Or Lymphoma). But A Link That Elidel Cream, 1% Use Caused These Cancers Has Not Been Shown. Because Of This Concern:
  2. What Is Elidel Cream, 1%?
  3. Who Should Not Use Elidel Cream, 1%?
  4. Before Using Elidel Cream, 1%, Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  5. How Should I Use Elidel Cream, 1%?
  6. What Should I Avoid While Using Elidel Cream, 1%?
  7. What Are The Possible Side Effects Of Elidel Cream, 1%?
  8. Other Common Side Effects Include:
  9. How Should I Store Elidel Cream, 1%?
  10. Active Ingredient:
  11. Manufactured For:
  12. Patient Information
  13. The Safety Of Using Elidel Cream For A Long Period Of Time Is Not Known. A Very Small Number Of People Who Have Used Elidel Cream Have Had Cancer (for Example, Skin Or Lymphoma). However, A Link With Elidel Cream Use Has Not Been Shown. Because Of This Concern:
  14. What Is Elidel Cream?
  15. Do Not Use Elidel Cream:
  16. Before You Start Using Elidel Cream, Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  17. How Should I Use Elidel Cream?
  18. To Apply Elidel Cream:
  19. What Should I Avoid While Using Elidel Cream?
  20. What Are The Possible Side Effects Of Elidel Cream?
  21. How Should I Store Elidel Cream?
  22. Inactive Ingredients:
  23. Manufactured By:
  24. Distributed By:
  25. Patients Using Elidel Cream, 1% Should Receive The Following Information And Instructions:

It Is Not Known If Elidel Cream, 1% Is Safe To Use For A Long Period Of Time. A Very Small Number Of People Who Have Used Elidel Cream, 1% Have Developed Cancer (for Example, Skin Cancer Or Lymphoma). But A Link That Elidel Cream, 1% Use Caused These Cancers Has Not Been Shown. Because Of This Concern: 

Do not use ELIDEL Cream, 1% continuously for a long time.
Use ELIDEL Cream, 1% only on areas of your skin that have eczema.
Do not use ELIDEL Cream, 1% on a child under 2 years of age.

What Is Elidel Cream, 1%? 

ELIDEL Cream, 1% is a prescription medicine used on the skin (topical) to treat mild to moderate eczema (atopic dermatitis). ELIDEL Cream, 1% is for adults and children age 2 years and older who do not have a weakened immune system. ELIDEL Cream, 1% is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. ELIDEL Cream, 1% is for use after other prescription medicines have not worked for you or if your doctor recommends that other prescription medicines should not be used.

It is not known if ELIDEL Cream, 1% is safe and effective in people who have a weakened immune system.

ELIDEL Cream, 1% is not for use in children under 2 years of age

Who Should Not Use Elidel Cream, 1%? 

Do not use ELIDEL Cream, 1%if you are allergic to pimecrolimus or any of the ingredients in ELIDEL Cream, 1%.

Before Using Elidel Cream, 1%, Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

have a skin disease called Netherton's syndrome (a rare inherited condition).
have any infection on your skin including chicken pox or herpes.
have been told you have a weakened immune system.
are pregnant or plan to become pregnant. It is not known if ELIDEL Cream, 1% will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if ELIDEL Cream, 1% passes into your breast milk. You and your doctor should decide if you will use ELIDEL Cream, 1% or breastfeed. You should not do both.

Tell your doctor about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor about all the skin medicines and products you use.

Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

How Should I Use Elidel Cream, 1%? 

Use ELIDEL Cream, 1% exactly as your doctor tells you to use it.
Stop ELIDEL Cream, 1% when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor.
Wash your hands before using ELIDEL Cream, 1%. If you apply ELIDEL Cream, 1% after a bath or shower, make sure your skin is dry.
Apply a thin layer of ELIDEL Cream, 1% only to the affected skin areas, two times each day, as directed by your doctor.
Use the smallest amount of ELIDEL Cream, 1% to help control the signs and symptoms of eczema.
If you apply ELIDEL Cream, 1% to another person, or if you have eczema and are not treating your hands, it is important for you to wash your hands with soap and water after applying ELIDEL Cream, 1%. This should remove any cream left on your hands.
Do not bathe, shower or swim right after applying ELIDEL Cream, 1%. This could wash off the cream.
You can use moisturizers with ELIDEL Cream, 1%. Ask your doctor first about the products that are right for you. People with eczema can have very dry skin, so it is important to keep up good skin care practices. If you use moisturizers, apply them after ELIDEL Cream, 1%.
Call your doctor if your symptoms get worse with ELIDEL Cream, 1% or your symptoms do not improve after 6 weeks of treatment.

What Should I Avoid While Using Elidel Cream, 1%? 

You should not use sun lamps, tanning beds, or get treatment with ultraviolet light therapy during treatment with ELIDEL Cream, 1%.
Limit your time in the sun during treatment with ELIDEL Cream, 1% even when the medicine is not on your skin. If you need to be outdoors after applying ELIDEL Cream, 1%, wear loose fitting clothing that protects the treated area from the sun. Ask your doctor what other types of protection from the sun you should use. It is not known how ELIDEL Cream, 1% may affect your skin with exposure to ultraviolet light.
Do not cover the skin being treated with bandages, dressings or wraps. You can wear normal clothing.
ELIDEL Cream, 1% is for use on the skin only. Do not get ELIDEL Cream, 1% in your eyes, nose, mouth, vagina, or rectum (mucous membranes). If you get ELIDEL Cream, 1% in any of these areas, burning or irritation can happen. Wipe off any ELIDEL Cream, 1% from the affected area and then rinse the area well with cold water.
Do not swallow ELIDEL Cream, 1%. If you do, call your doctor.
Avoid using ELIDEL Cream, 1% on skin areas that have cancers or pre-cancers.

What Are The Possible Side Effects Of Elidel Cream, 1%? 

ELIDEL Cream, 1% may cause serious side effects.

The most common side effect at the skin application site is burning or a feeling of warmth. These side effects are usually mild or moderate, happen during the first few days of treatment, and usually clear up in a few days.

Other Common Side Effects Include: 

headache
common cold or stuffy nose, sore throat
cough
flu (influenza)
fever
viral infection. Some people may get viral skin infections (like cold sores, chicken pox, shingles, or warts) or swollen lymph nodes (glands).

Tell your doctor if you get a skin infection or if you have any side effect (for example, swollen glands) that bothers you or that does not go away.

These are not all the possible side effects with ELIDEL Cream, 1%. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Elidel Cream, 1%? 

Store ELIDEL Cream, 1% at room temperature between 68 to 77 F (20 to 25 C).
Do not freeze ELIDEL Cream, 1%.
Keep ELIDEL Cream, 1% and all medicines out of the reach of children.

General information about the safe and effective use of ELIDEL Cream, 1%

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ELIDEL Cream, 1% for conditions other than which it was prescribed. Do not give ELIDEL Cream, 1% to other people even if they have the same symptoms you have. It may harm them.

You can ask your doctor or pharmacist for information about ELIDEL Cream, 1% that is written for health professionals.

For more information, go to www.Elidel.com or call 1-800-321-4576.

Active Ingredient: 

pimecrolimus

Manufactured For: 


Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA


By:
MEDA Manufacturing
33700 Merignac, France

U.S. Patent 6,423,722

Produced under license from MEDA Pharma S.A.R.L.,
Luxembourg, by Valeant International Bermuda.

Elidel is a trademark of MEDA PHARMA
S.A.R.L. used under license.

Valeant Pharmaceuticals North America LLC

Rev. 12/2017
9460401
25329.1

Patient Information 

ELIDEL[EL -ee-del] (pimecrolimus) Cream 1%

You must read and followallinstructions before using ELIDEL Cream.

Read the Medication Guide you get every time you or a family member gets ELIDEL Cream. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about ELIDEL Cream, ask your doctor or pharmacist.

The Safety Of Using Elidel Cream For A Long Period Of Time Is Not Known. A Very Small Number Of People Who Have Used Elidel Cream Have Had Cancer (for Example, Skin Or Lymphoma). However, A Link With Elidel Cream Use Has Not Been Shown. Because Of This Concern: 

  • Do not use ELIDEL Cream continuously for a long time.
  • Use ELIDEL Cream only on areas of your skin that have eczema.
  • Do not use ELIDEL Cream on a child under 2 years old.

What Is Elidel Cream? 

ELIDEL Cream is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis). ELIDEL Cream is in a class of medicines called topical calcineurin inhibitors. ELIDEL Cream is for adults and children age 2 years and older who do not have a weakened immune system. ELIDEL Cream is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. ELIDEL Cream is for use after other prescription medicines have not worked for you or if your doctor recommends that other prescription medicines should not be used.

Do Not Use Elidel Cream: 

  • on children under 2 years of age
  • if you are allergic to ELIDEL Cream or anything in it.

Before You Start Using Elidel Cream, Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

  • have a skin disease called Netherton s syndrome (a rare inherited condition)
  • have any infection on your skin including chicken pox or herpes
  • have been told you have a weakened immune system
  • are pregnant, breastfeeding, or planning to become pregnant.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Tell your doctor about all the skin medicines and products you use.

Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

How Should I Use Elidel Cream? 

  • Use ELIDEL Cream exactly as prescribed.
  • Use ELIDEL Cream only on areas of your skin that have eczema.
  • Use ELIDEL Cream for short periods, and if needed, treatment may be repeated with breaks in between.
  • Stop ELIDEL Cream when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor.
  • Follow your doctor s advice if symptoms of eczema return after a treatment with ELIDEL Cream.
  • Call your doctor if:
    • your symptoms get worse with ELIDEL Cream
    • you get an infection on your skin
    • your symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema.

To Apply Elidel Cream: 

  • Wash your hands before using ELIDEL Cream. When applying ELIDEL Cream after a bath or shower, make sure your skin is dry.
  • Apply a thin layer of ELIDEL Cream only to the affected skin areas, twice a day, as directed by your doctor.
  • Use the smallest amount of ELIDEL Cream needed to control the signs and symptoms of eczema.
  • If you are a caregiver applying ELIDEL Cream to a patient, or if you are a patient who is not treating your hands, wash your hands with soap and water after applying ELIDEL Cream. This should remove any cream left on the hands.
  • Do not bathe, shower or swim right after applying ELIDEL Cream. This could wash off the cream.
  • You can use moisturizers with ELIDEL Cream. Make sure you check with your doctor first about the products that are right for you. Because the skin of patients with eczema can be very dry, it is important to keep up good skin care practices. If you use moisturizers, apply them after ELIDEL Cream.

What Should I Avoid While Using Elidel Cream? 

  • Do not use sun lamps, tanning beds, or get treatment with ultraviolet light therapy during treatment with ELIDEL Cream.
  • Limit sun exposure during treatment with ELIDEL Cream even when the medicine is not on your skin. If you need to be outdoors after applying ELIDEL Cream, wear loose fitting clothing that protects the treated area from the sun. Ask your doctor what other types of protection from the sun you should use.
  • Do not cover the skin being treated with bandages, dressings or wraps. You can wear normal clothing.
  • Do not use ELIDEL Cream in the eyes. If ELIDEL Cream gets in your eyes rinse your eyes with cold water.
  • Do not swallow ELIDEL Cream. If you do, call your doctor.

What Are The Possible Side Effects Of Elidel Cream? 

The most common side effect at the skin application siteis burning or a feeling of warmth. These side effects are usually mild or moderate, happen during the first 5 days of treatment, and usually clear up in a few days. Call your doctor if the burning feeling is severe or lasts for more than 1 week.

Other side effects includeheadache, common cold or stuffy nose, sore throat, influenza, fever, viral infection, and cough. Some people may get viral skin infections (like cold sores, chicken pox, shingles, or warts) or swollen lymph nodes (glands).

Talk to your doctor if you have a skin infection or if side effects (for example, swollen glands) continue or bother you.

These are not all the side effects with ELIDEL Cream. Ask your doctor or pharmacist for more information.

How Should I Store Elidel Cream? 

  • Store ELIDEL Cream at room temperature between 59 to 86 F (15 to 30 C).
  • Keep ELIDEL Cream and all medicines out of the reach of children.

General advice about ELIDEL Cream

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use ELIDEL Cream only for the condition for which it was prescribed. Do not give ELIDEL Cream to other people even if they have the same symptoms you have, as it may not be right for them.

This Medication Guide summarizes the most important information about ELIDEL Cream. If you would like more information, talk with your doctor.

Your doctor or pharmacist can give you information about ELIDEL Cream that is written for health care professionals. For more information, you can also visit the Novartis Internet site at www.elidel.com or call the ELIDEL Cream help line at 877-4 ELIDEL (877-435-4335).

Inactive 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Manufactured By: 

Novartis Pharma Produktions GmbH

Wehr, Germany

Distributed By: 

Novartis Pharmaceuticals Corp.

East Hanover, New Jersey 07936

This Medication Guide has been approved by the U.S. Food and Drug Administration

MAY 2009 T2009-66/T2009-67

Novartis

Patients Using Elidel Cream, 1% Should Receive The Following Information And Instructions: 

ELIDEL Cream, 1% may cause serious side effects.It is not known if ELIDEL Cream, 1% is safe to use for a long period of time. A very small number of people who have used ELIDEL Cream, 1% have had cancer (for example, skin or lymphoma). However, a link with ELIDEL Cream, 1% use has not been shown. Because of this concern:
A patient should not use ELIDEL Cream, 1% continuously for a long time.
ELIDEL Cream, 1% should be used only on areas of skin that have eczema.
ELIDEL Cream, 1% is not for use on a child under 2 years old.
A patient should not use sun lamps, tanning beds, or get treatment with ultraviolet light therapy during treatment with ELIDEL Cream, 1%.
A patient should limit sun exposure during treatment with ELIDEL Cream, 1% even when the medicine is not on the skin. If a patient needs to be outdoors after applying ELIDEL Cream, 1%, the patient should wear loose fitting clothing that protects the treated area from the sun. The physician should advise the patient about other types of protection from the sun.
A patient should not cover the skin being treated with bandages, dressings or wraps. A patient can wear normal clothing.
ELIDEL Cream, 1% is for use on the skin only. Do not get ELIDEL Cream, 1% in your eyes, nose, mouth, vagina, or rectum (mucous membranes). If you get ELIDEL Cream, 1% in any of these areas, burning or irritation can happen. Wipe off any ELIDEL Cream, 1% from the affected area and then rinse the area well with cold water. ELIDEL Cream, 1% is for external use only.
A patient should use ELIDEL Cream, 1% for short periods, and if needed, treatment may be repeated with breaks in between.
Wash hands before using ELIDEL Cream, 1%. When applying ELIDEL Cream, 1% after a bath or shower, the skin should be dry.
Apply a thin layer of ELIDEL Cream, 1% only to the affected skin areas, twice a day, as directed by the physician.
Use the smallest amount of ELIDEL Cream, 1% needed to control the signs and symptoms of eczema.
A patient should not bathe, shower or swim right after applying ELIDEL Cream, 1%. This could wash off the cream.
A patient can use moisturizers with ELIDEL Cream, 1%. They should be sure to check with the physician first about the products that are right for them. Because the skin of patients with eczema can be very dry, it is important they keep up good skin care practices. If a patient uses moisturizers, he or she should apply them after ELIDEL Cream, 1%.



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