MYCOPHENOLATE MOFETIL- mycophenolate mofetil tablet 
Qualitest Pharmaceuticals

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MEDICATION GUIDE

Mycophenolate Mofetil
Tablets
500 mg

Read the Medication Guide that comes with mycophenolate mofetil capsules and tablets before you start taking it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about mycophenolate mofetil capsules and tablets?
Mycophenolate mofetil capsules and tablets can cause serious side effects:

• Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take mycophenolate mofetil capsules and tablets during pregnancy have a higher risk of miscarriage during the first 3 months (first trimester), and a higher risk that their baby will be born with birth defects.

If you are a female who can become pregnant:

• your doctor must talk with you about acceptable birth control methods (contraceptive counseling) to use while taking mycophenolate mofetil capsules and tablets.

• you should have one pregnancy test immediately before starting mycophenolate mofetil capsules and tablets and another pregnancy test 8 to 10 days later.  Pregnancy tests should be repeated during routine follow-up visits with your doctor.  Talk to your doctor about the results of all our pregnancy tests.

• you must use acceptable birth control during your entire mycophenolate mofetil capsules and tablets therapy and for 6 weeks after stopping mycophenolate mofetil capsules and tablets, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. Mycophenolate mofetil decreases blood levels of the hormones in birth control pills that you take by mouth. Birth control pills may not work as well while you take mycophenolate mofetil capsules and tablets, and you could become pregnant.  If you take birth control pills while using mycophenolate mofetil capsules and tablets you must also use another form of birth control.  Talk to your doctor about other birth control methods that you can use while taking mycophenolate mofetil capsules and tablets.

If you plan to become pregnant, talk with your doctor. Your doctor will decide if other medicines to prevent rejection may be right for you.

If you become pregnant while taking mycophenolate mofetil capsules and tablets, do not stop taking mycophenolate mofetil capsules and tablets.  Call your doctor right away.  In certain situations, you and your doctor may decide that taking mycophenolate mofetil capsules and tablets is more important to your health than the possible risks to your unborn baby.

You and your doctor should report your pregnancy to Mycophenolate Pregnancy Registry (1-800-617-8191). 

The purpose of this registry is to gather information about the health of you and your baby.

• Increased risk of getting serious infections. Mycophenolate mofetil weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with mycophenolate mofetil and can lead to death. These serious infections can include:

• Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. Viral infections that can happen with mycophenolate mofetil include:

• A brain infection called Progressive Multifocal Leukoencephalopathy (PML). In some patients, mycophenolate mofetil may cause an infection of the brain that may cause death. You are at risk for this brain infection because you have a weakened immune system. You should tell your doctor right away if you have any of the following symptoms:

• Fungal infections. Yeasts and other types of fungal infections can happen with mycophenolate mofetil and can cause serious tissue and blood infections (see “What are the possible side effects of mycophenolate mofetil capsules and tablets?”)

Call your doctor right away if you have any of the following signs and symptoms of infection:

• Increased risk of getting certain cancers. People who take mycophenolate mofetil capsules and tablets have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor if you have:

See the section “What are the possible side effects of mycophenolate mofetil capsules and tablets?” for information about other serious side effects.

What is mycophenolate mofetil capsules and tablets?
Mycophenolate mofetil capsules and tablets is a prescription medicine to prevent rejection (antirejection medicine) in people who have received a kidney, heart or liver transplant. Rejection is when the body’s immune system perceives the new organ as a “foreign” threat and attacks it.

Mycophenolate mofetil capsules and tablets is used with other medicines called cyclosporines (Sandimmune®, Gengraf®, Neoral®) and corticosteroids.

Mycophenolate mofetil capsules and tablets has been used safely and works in children who received a kidney transplant as it does in adults. It is not known if mycophenolate mofetil capsules and tablets is safe and works in children who receive a heart or liver transplant.

Who should not take mycophenolate mofetil capsules and tablets?
Do not take mycophenolate mofetil capsules and tablets if you are allergic to mycophenolate mofetil or any of the ingredients in mycophenolate mofetil capsules and tablets.
See the end of this Medication Guide for a complete list of ingredients in mycophenolate mofetil capsules and tablets.

What should I tell my doctor before taking mycophenolate mofetil capsules and tablets?

Tell your doctor about all of your medical conditions, if you:

Tell your healthcare provider about all of the medicines you are taking including prescription and nonprescription medicines, vitamins and herbal supplements. Some medicines may affect the way mycophenolate mofetil capsules and tablets works, and mycophenolate mofetil capsules and tablets may affect how some medicines work. Especially tell your doctor if you take:

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor.

How should I take mycophenolate mofetil capsules and tablets?

What should I avoid while taking mycophenolate mofetil capsules and tablets?

What are the possible side effects of mycophenolate mofetil capsules and tablets?
Mycophenolate mofetil capsules and tablets can cause serious side effects:

• See “What is the most important information I should know about mycophenolate mofetil capsules and tablets?”

• Low blood cell counts. People taking high doses of mycophenolate mofetil each day may have a decrease in blood counts, including

Your doctor will do blood tests before you start taking mycophenolate mofetil capsules and tablets and during treatment with mycophenolate mofetil tablets to check your blood cell counts.

Tell your doctor right away if you have any signs of infection (see “What is the most important information I should know about mycophenolate mofetil capsules and tablets?") or any unexpected bruising or bleeding. Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness or fainting.

• Stomach problems. Stomach and intestinal bleeding can happen in people who take high doses of mycophenolate mofetil. Bleeding can be severe and you may have to be hospitalized for treatment

Common side effects include:

Side effects that happen more often in children than in adults taking mycophenolate mofetil capsules and tablets include:

These are not all of the possible side effects of mycophenolate mofetil capsules and tablets. Tell your doctor about any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1800-FDA-1088 or to Endo Pharmaceuticals at 1-800-462-3636.

How should I store mycophenolate mofetil capsules and tablets?

General Information about mycophenolate mofetil capsules and tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolate mofetil capsules and tablets for a condition for which it was not prescribed. Do not give mycophenolate mofetil capsules and tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about mycophenolate mofetil capsules and tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mycophenolate mofetil capsules and tablets that is written for healthcare professionals. For more information, call 1-800-444-4011.

What are the ingredients in mycophenolate mofetil capsules and tablets?
Active Ingredient:
mycophenolate mofetil

Inactive Ingredients: Mycophenolate mofetil 500 mg tablets: croscarmellose sodium, FD&C Blue no. 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, iron oxide red, titanium dioxide.

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

Cytovene-IV, and Valcyte are registered trademarks of Hoffmann-La Roche Inc. Bactrim and Bactrim DS are trademarks of Hoffmann-La Roche Inc. Any other trademarks in this document are the property of their respective owners.

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL  35811

Manufactured by:
Patheon Pharmaceuticals Inc.
Cincinnati, OH 45237

Issued: August 2013

For additional copies of this Medication Guide, please call 1-800-444-4011.

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© 2013 Endo Pharmaceuticals Inc.  All rights reserved.

Revised: 08/2013
 
Qualitest Pharmaceuticals