MYCOPHENOLATE MOFETIL- mycophenolate mofetil capsule 
MYCOPHENOLATE MOFETIL- mycophenolate mofetil tablet 
Accord Healthcare Inc.

----------

                                                                                                      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 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:

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?" for information about other serious side effects.

What are mycophenolate mofetil capsules and tablets?

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

Mycophenolate mofetil capsule and tablet 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 capsule and tablet 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 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 capsules and tablets?

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

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 capsules and tablets and during treatment with mycophenolate mofetil capsules and 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.

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 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 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.

What are the ingredients in mycophenolate mofetil capsules and tablets?

Active Ingredient:
mycophenolate mofetil

Inactive Ingredients:

Mycophenolate mofetil capsules 250 mg: croscarmellose sodium, magnesium stearate, povidone (K-90), microcrystalline cellulose, hydroxypropyl cellulose and talc. The capsule shells contain FD&C blue #2, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, iron oxide black and potassium hydroxide.

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

Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA

Manufactured By:
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210.
INDIA.



10 4847 8 662665


Issued August 2015

Revised: 12/2015
Accord Healthcare Inc.