MEDICATION GUIDE

TACROLIMUS (ta-KROE-li-mus)

Ointment 0.03%

Ointment 0.1%

Read the Medication Guide every time you or a family member gets tacrolimus 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 tacrolimus ointment, ask your doctor or pharmacist.

What is the most important information I should know about tacrolimus ointment?

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

Because of this concern:

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Do not use tacrolimus ointment continuously for a long time.

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Use tacrolimus ointment only on areas of your skin that have eczema.

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Do not use tacrolimus ointment on a child under 2 years old.

Tacrolimus ointment comes in two strengths:

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Only tacrolimus ointment 0.03% is for use on children aged 2 to 15 years.

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Either tacrolimus ointment 0.03% or 0.1% can be used by adults and children 16 years and older.

Talk to your doctor for more information.

What is tacrolimus ointment?

Tacrolimus ointment is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis).

Tacrolimus 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. Tacrolimus ointment is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between.

Tacrolimus 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 tacrolimus ointment?

Tacrolimus ointment should not be used:

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on children younger than 2 years of age.

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if you are allergic to tacrolimus ointment or anything in it. See the end of this Medication Guide for a complete list of ingredients.

What should I tell my doctor before starting tacrolimus ointment?

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

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have a skin disease called Netherton's syndrome (a rare inherited condition).

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have any infection on your skin including chicken pox or herpes.

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have been told you have a weakened immune system.

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are pregnant, breastfeeding, or planning to become pregnant.

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 tacrolimus ointment?

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Use tacrolimus ointment exactly as prescribed.

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Use tacrolimus ointment only on areas of your skin that have eczema.

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Use tacrolimus ointment for short periods, and if needed, treatment may be repeated with breaks in between.

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Stop tacrolimus ointment when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor.

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Follow your doctor's advice if symptoms of eczema return after treatment with tacrolimus ointment.

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Call your doctor if:

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your symptoms get worse with tacrolimus ointment.

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you get an infection on your skin.

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your symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema.

To apply tacrolimus ointment:

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Wash your hands before applying tacrolimus ointment.

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Apply a thin layer of tacrolimus ointment twice daily to the areas of skin affected by eczema.

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Use the smallest amount of tacrolimus ointment needed to control the signs and symptoms of eczema.

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If you are a caregiver applying tacrolimus ointment to a patient, or if you are a patient who is not treating your hands, wash your hands with soap and water after applying tacrolimus. This should remove any ointment left on the hands.

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Do not bathe, shower, or swim right after applying tacrolimus. This could wash off the ointment.

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You can use moisturizers with tacrolimus ointment. 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 tacrolimus ointment.

What should I avoid while using tacrolimus ointment?

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Do not use ultraviolet light therapy, sun lamps, or tanning beds during treatment with tacrolimus ointment.

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Limit sun exposure during treatment with tacrolimus ointment even when the medicine is not on your skin. If you need to be outdoors after applying tacrolimus ointment, 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.

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Do not cover the skin being treated with bandages, dressings or wraps. You can wear normal clothing.

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Avoid getting tacrolimus ointment in the eyes or mouth. Do not swallow tacrolimus ointment. If you do, call your doctor.

What are the possible side effects of tacrolimus ointment?

Please read the first section of this Medication Guide.

The most common side effects of tacrolimus ointment at the skin application site are stinging, burning, or itching of the skin treated with tacrolimus. 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 tacrolimus ointment, drinking alcohol may cause the skin or face to become flushed or red and feel hot. These are not all the side effects with tacrolimus ointment. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088.

How should I store tacrolimus ointment?

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Store tacrolimus ointment at room temperature (59° to 86°F). Do not leave tacrolimus ointment in your car in cold or hot weather. Make sure the cap on the tube is tightly closed.

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Keep tacrolimus ointment and all medicines out of the reach of children.

General advice about tacrolimus ointment

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use tacrolimus ointment for a condition for which it was not prescribed. Do not give tacrolimus 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 tacrolimus ointment. If you would like more information, talk with your doctor.

Your doctor or pharmacist can give you information about tacrolimus ointment that is written for health care professionals. For more information about tacrolimus ointment, contact Sandoz Inc. at 1-800-525-8747.

What are the ingredients in tacrolimus ointment?

Active Ingredient: tacrolimus, either 0.03% or 0.1%

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

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at

1-800-FDA-1088 or http://www.fda.gov/medwatch.

Distributed by:

Mayne Pharma

Raleigh, NC 27609

46335897
Rev. September 2023