PROTOPIC- tacrolimus ointment 
Astellas Pharma US Inc.

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MEDICATION GUIDE

 

PROTOPIC®  [pro-TOP-ik]

(tacrolimus)

Ointment 0.03%

Ointment 0.1%

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

What is the most important information I should know about PROTOPIC Ointment?

The safety of using PROTOPIC Ointment for a long period of time is not known. A very small number of people who have used PROTOPIC Ointment have had cancer (for example, skin or lymphoma). However, a link with PROTOPIC Ointment has not been shown. Because of this concern:

PROTOPIC Ointment comes in two strengths:

Talk to your doctor for more information.

What is PROTOPIC Ointment?

PROTOPIC Ointment is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis). PROTOPIC Ointment is in a class of medicines called topical calcineurin inhibitors. It is for adults and children 2 years of age and older who do not have a weakened immune system. PROTOPIC Ointment is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between.

PROTOPIC Ointment 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.

Who should not use PROTOPIC Ointment?

PROTOPIC Ointment should not be used:

What should I tell my doctor before starting PROTOPIC Ointment?

Before you start using PROTOPIC, you and your doctor should talk about all of your medical conditions, including if you:

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

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 PROTOPIC Ointment?

To apply PROTOPIC Ointment:

What should I avoid while using PROTOPIC Ointment?

What are the possible side effects of PROTOPIC Ointment?

Please read the first section of this Medication Guide.

The most common side effects of PROTOPIC Ointment at the skin application site are stinging, burning, or itching of the skin treated with PROTOPIC. These side effects are usually mild to moderate, are most common during the first few days of treatment, and usually go away as your skin heals.

Other side effects include acne, swollen or infected hair follicles, headache, increased sensitivity of the skin to hot or cold temperatures, or flu-like symptoms such as the common cold and stuffy nose, skin tingling, upset stomach, muscle pain, swollen glands (enlarged lymph nodes), or skin infections including cold sores, chicken pox or shingles.

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

While you are using PROTOPIC, drinking alcohol may cause the skin or face to become flushed or red and feel hot.

These are not all the side effects with PROTOPIC Ointment. 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 PROTOPIC Ointment?


General advice about PROTOPIC Ointment

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

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

Your doctor or pharmacist can give you information about PROTOPIC Ointment that is written for health care professionals. For more information, you can also visit the PROTOPIC website at www.protopic.com or call 1-800-727-7003.

What are the ingredients in PROTOPIC Ointment?

Active Ingredient: tacrolimus, either 0.03% or 0.1%

Inactive Ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum and white wax.

Product of Japan

Manufactured by:

Astellas Pharma Tech Co., Ltd. Toyama Technology Center, 2-178 Kojin-machi, Toyama city, Toyama 930-0809, Japan

Marketed by:

Astellas Pharma US, Inc.

Northbrook, IL 60062

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

Revised: May 2012

12D030-PRT-SPL

Revised: 05/2012
 
Astellas Pharma US Inc.