MYCOPHENOLATE MOFETIL- mycophenolate mofetil capsule 
MYCOPHENOLATE MOFETIL- mycophenolate mofetil tablet, coated 
Apotex Corp

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MEDICATION GUIDE
Mycophenolate Mofetil Capsules, USP 250 mg
Mycophenolate Mofetil Tablets, USP 500 mg
(MYE-koe-FEN-oh-late MOE-fe-til)

Read the Medication Guide that comes with mycophenolate mofetil 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?
Mycophenolate mofetil can cause serious side effects:

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

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

What is mycophenolate mofetil?

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

Mycophenolate mofetil 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 is safe and works in children who receive a heart or liver transplant. 

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

What should I tell my doctor before taking mycophenolate mofetil?
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 works, and mycophenolate mofetil 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 or nurse 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?

What should I avoid while taking mycophenolate mofetil? 

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

Your doctor will do blood tests before you start taking mycophenolate mofetil and during treatment with mycophenolate mofetil 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?”). or any unexpected bruising or bleeding.  Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness or fainting.

Common side effects include:

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

These are not all of the possible side effects of mycophenolate mofetil. 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 1-800-FDA-1088.

How should I store mycophenolate mofetil?

General Information about mycophenolate mofetil

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolate mofetil for a condition for which it was not prescribed. Do not give mycophenolate mofetil 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. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mycophenolate mofetil that is written for healthcare professionals.

What are the ingredients in mycophenolate mofetil capsules, USP and mycophenolate mofetil tablets, USP?

Active Ingredient: mycophenolate mofetil

Inactive Ingredients:

Mycophenolate mofetil capsules, USP 250 mg: croscarmellose sodium, magnesium stearate. The capsule shells contain gelatin, iron oxide red, sodium lauryl sulfate, titanium dioxide, indigo carmine and edible ink; may also contain shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, iron oxide black, potassium hydroxide and purified water.

Mycophenolate mofetil tablets, USP 500 mg: microcrystalline cellulose, croscarmellose sodium, iron oxide black, iron oxide red, magnesium stearate, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, titanium dioxide and polyethylene glycol.

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.

APOTEX INC.
MYCOPHENOLATE MOFETIL CAPSULES, USP 250 mg
MYCOPHENOLATE MOFETIL TABLETS, USP 500 mg

Manufactured by    Manufactured for
Apotex Research Pvt. Ltd.,  Apotex Corp.
Bangalore – 560 099   Weston, Florida
India 33326

Issued: November 2015
Revision 2

Revised: 11/2015
Apotex Corp