TACROLIMUS- tacrolimus ointment
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
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:
Tacrolimus ointment comes in two strengths:
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:
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:
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?
To apply tacrolimus ointment:
What should I avoid while using tacrolimus ointment?
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 ointment. 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?
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.
E. FOUGERA & CO.
A division of
Fougera PHARMACEUTICALS INC.
Melville, New York 11747