MYCOPHENOLATE MOFETIL - mycophenolate mofetil capsule 
MYCOPHENOLATE MOFETIL - mycophenolate mofetil tablet, film coated 
JUBILANT CADISTA PHARMACEUTICALS, INC.

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MEDICATION GUIDE

Mycophenolate Mofetil Capsules, USP
Mycophenolate Mofetil Tablets, USP
(mye” koe fen’ oh late moe’ fe til)

Rx Only

Read the Medication Guide that comes with Mycophenolate Mofetil Capsules and/or 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?

Mycophenolate can cause serious side effects:

Mycophenolate 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, and you could become pregnant. If you take birth control pills while using mycophenolate 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.

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

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

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?” for information about other serious side effects.

What is mycophenolate?

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

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

Who should not take Mycophenolate?

Do not take mycophenolate if you are allergic to mycophenolate mofetil or any of the ingredients in Mycophenolate Mofetil Capsules and/or Tablets. See the end of this Medication Guide for a complete list of ingredients in Mycophenolate Mofetil Capsules and/or Tablets.

What should I tell my doctor before taking mycophenolate?

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 works, and mycophenolate 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?

What should I avoid while taking mycophenolate?

What are the possible side effects of mycophenolate?

Mycophenolate can cause serious side effects:

Your doctor will do blood tests before you start taking mycophenolate and during treatment with mycophenolate 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?”), 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 include:

These are not all of the possible side effects of mycophenolate. 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 or 1-800-313-4623.

How should I store mycophenolate?

General Information about mycophenolate:

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolate for a condition for which it was not prescribed. Do not give mycophenolate 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. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mycophenolate that is written for healthcare professionals. For more information or additional copies of Medication Guide, please call 1-800-313-4623.

What are the ingredients in Mycophenolate Mofetil Capsules and/or Tablets?

Active Ingredient: Mycophenolate Mofetil, USP

Inactive Ingredients:
Mycophenolate Mofetil 250 mg capsules: croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain FD&C blue #2, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide and the printing ink contains shellac, propylene glycol, and black iron oxide.

Mycophenolate Mofetil 500 mg tablets: croscarmellose sodium, FD&C blue #2 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone (K-90), red iron oxide, talc, and 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 by:

Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801,USA
0267/MG 
Rev. # 08/2015.

Revised: 8/2015
JUBILANT CADISTA PHARMACEUTICALS, INC.