MYCOPHENOLATE MOFETIL- mycophenolate mofetil capsule 
MYCOPHENOLATE MOFETIL- mycophenolate mofetil tablet, film coated 
Teva Pharmaceuticals USA Inc

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MEDICATION GUIDE

Mycophenolate Mofetil Capsules USP, 250 mg

Mycophenolate Mofetil Tablets USP, 500 mg

Rx only

Read the Medication Guide that comes with mycophenolate mofetil capsules and mycophenolate mofetil tablets before you start taking them 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 mycophenolate mofetil tablets?

Mycophenolatemofetil capsules andmycophenolatemofetiltablets can cause serious side effects:

If you are a female who can become pregnant:

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 take birth control pills while using mycophenolate mofetil 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.

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, do not stop taking mycophenolate mofetil. Call your doctor right away. In certain situations, you and your doctor may decide that taking mycophenolate mofetil 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 mofetil capsules and mycophenolate mofetil tablets?” for information about other serious side effects.

What are mycophenolate mofetil capsules and mycophenolate mofetil tablets?

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

Mycophenolate mofetil capsules and mycophenolate mofetil tablets have been used safely and work in children who received a kidney transplant as they do in adults. It is not known if mycophenolate mofetil capsules and mycophenolate mofetil tablets are safe and work in children who receive a heart or liver transplant.

Who should not take mycophenolate mofetil capsules or mycophenolate mofetil tablets?

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

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

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

What are the possible side effects of mycophenolate mofetil capsules and mycophenolate mofetil tablets?

Mycophenolate mofetil capsules and mycophenolate mofetil tablets can cause serious side effects:

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

These are not all of the possible side effects of mycophenolate mofetil capsules and mycophenolate mofetil 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 1-800-FDA-1088 or to Teva USA, PHARMACOVIGILANCE at 1-866-832-8537.

How should I store mycophenolate mofetil capsules and mycophenolate mofetil tablets?

General information about mycophenolate mofetil capsules and mycophenolate mofetil tablets

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

This Medication Guide summarizes the most important information about mycophenolate mofetil capsules and mycophenolate mofetil 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 mycophenolate mofetil tablets that is written for healthcare professionals. For more information, call 1-888-838-2872.

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

Active Ingredient: mycophenolate mofetil, USP

Inactive Ingredients:

Mycophenolate mofetil capsules, 250 mg: black iron oxide, croscarmellose sodium, D&C red #28, D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, magnesium stearate, povidone, pregelatinized starch, propylene glycol, shellac glaze, and titanium dioxide.

Mycophenolate mofetil tablets, 500 mg: croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.

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

For additional copies of this Medication Guide, please call 1-888-838-2872.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

 
Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. G 8/2013

Revised: 05/2014
 
Teva Pharmaceuticals USA Inc