MYCOPHENOLATE MOFETIL- mycophenolate mofetil capsule 
MYCOPHENOLATE MOFETIL- mycophenolate mofetil tablet, film coated 
Zydus Pharmaceuticals (USA) Inc.

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Mycophenolate Mofetil Capsules

Mycophenolate Mofetil Tablets

Read the Medication Guide that comes with mycophenolate mofetil capsules and mycopheolate mofetil 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 healthcare provider 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:

     If you are a female and are able to become pregnant

     •   your healthcare provider must talk with you about effective birth control methods (contraceptive counseling)

     •   you should have a negative pregnancy test within 1 week before you start to take mycophenolate mofetil

     •   you must use 2 different types of effective birth control at the same time, for 4 weeks before you start taking mycophenolate mofetil, during your entire mycophenolate mofetil therapy and for 6 weeks after stopping mycophenolate mofetil, unless you choose to avoid sexual intercourse completely (abstinence). 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, and you could become pregnant

If you plan to become pregnant, talk with your healthcare provider. Your healthcare provider will decide if other medicines to prevent rejection may be right for you. In certain situations, you and your healthcare provider may decide that taking mycophenolate mofetil is more important to your health than the possible risks to your unborn baby.

•   If you get pregnant while taking mycophenolate mofetil, do not stop taking mycophenolate mofetil. Call your healthcare provider right away. You and your healthcare provider should report any cases of pregnancies to

        ∙     FDA MedWatch at 1-800-FDA-1088.

        ∙     Zydus Professional Drug Safety at 1-877-993-8779..

Talk to your healthcare provider about joining the National Transplantation Pregnancy Registry at 1-877-955-6877.

•     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. Types of infections can include:

           ∙     Weakness on one side of the body

           ∙     You do not care about things that you usually care about (apathy)

           ∙     You are confused or have problems thinking

           ∙     You can not control your muscles

  •     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?")

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

           ∙     Temperature of 100.5°F or greater

           ∙     Cold symptoms, such as a runny nose or sore throat

           ∙     Flu symptoms, such as an upset stomach, stomach pain, vomiting or diarrhea

           ∙     Earache or headache

           ∙     Pain during urination

           ∙     White patches in the mouth or throat

           ∙     Unexpected bruising or bleeding

           ∙     Cuts, scrapes or incisions that are red, warm and oozing pus

∙  Increased risk of getting certain cancers. People who take mycophenolate mofetil have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your healthcare provider if you have:

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. These medicines work together to prevent rejection to your transplanted organ.

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 capsules and mycopheolate mofetil tablets. See the end of this Medication Guide for a complete list of ingredients in mycophenolate mofetil capsules and mycopheolate mofetil tablets.

What should I tell my healthcare provider before taking mycophenolate mofetil?

Tell your healthcare provider 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 healthcare provider if you take:

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

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:

        ∙    white blood cells, especially neutrophils. Neutrophils fight against bacterial infections. You have a higher chance of getting an infection when your white blood cell count is low. This is most common from 3 months to 6 months after your transplant

        ∙    red blood cells. Red blood cells carry oxygen to your body tissues.You have a higher chance of getting severe anemia when your red blood cell count is low.

        ∙    platelets. Platelets help with blood clotting

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

         Tell your healthcare provider 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 healthcare provider 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:

                              •   stomach area pain                               •   sore throat

                              •   fever                                                       •   colds (respiratory tract infections)  

                              •   infection                                                 •   high blood pressure  

                              •   pain                                                        •   low white blood cell count  

                              •   blood infection (sepsis)                         •   low red blood cell count  

                              •   diarrhea

                              •   vomiting

These are not all of the possible side effects of mycophenolate mofetil. Tell your healthcare provider 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 to Zydus Professional Drug Safety at 1-877-993-8779.

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. Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779.

What are the ingredients in mycophenolate mofetil capsules and mycopheolate mofetil tablets?

Active Ingredient: mycophenolate mofetil

Inactive Ingredients:

Mycophenolate Mofetil Capsules, 250 mg:

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue # 1, FD&C red # 3, gelatin, magnesium stearate, povidone (K-90), pregelatinized starch, sodium lauryl sulfate and titanium dioxide.

Mycopheolate Mofetil Tablets, 500 mg:

Colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, 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.

Revised: 4/2011
Zydus Pharmaceuticals (USA) Inc.