MYCOPHENOLATE MOFETIL - mycophenolate mofetil powder, for suspension 
Ascend Laboratories, LLC

----------

SPL MEDGUIDE


Mycophenolate Mofetil for oral suspension USP 200 mg/ml
(mye" koe fen' oh late moe' fe til)

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


If you are a female who can become pregnant:


Mycophenolate mofetil for oral suspension 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 for oral suspension, and you could become pregnant. If you take birth control pills while using mycophenolate mofetil for oral suspension 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 for oral suspension.
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 for oral suspension, do not stop taking mycophenolate mofetil for oral suspension. Call your doctor right away. In certain situations, you and your doctor may decide that taking mycophenolate mofetil for oral suspension 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 oral suspension?” for information about other serious side effects.
What is mycophenolate mofetil for oral suspension?
Mycophenolate mofetil for oral suspension 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 for oral suspension are used with other medicines called cyclosporines (Sandimmune®, Gengraf®, Neoral®) and corticosteroids.
Mycophenolate mofetil for oral suspension 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 for oral suspension is safe and works in children who receive a heart or liver transplant.

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

What should I tell my doctor before taking mycophenolate mofetil for oral suspension?
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 for oral suspension works, and mycophenolate mofetil for oral suspension 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 for oral suspension?


What should I avoid while taking mycophenolate mofetil for oral suspension?


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


Your doctor will do blood tests before you start taking mycophenolate mofetil for oral suspension and during treatment with mycophenolate mofetil for oral suspension 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 for oral suspension?”).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 for oral suspension 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 for oral suspension. 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 1800-FDA-1088.

How should I store mycophenolate mofetil for oral suspension?


General information about mycophenolate mofetil for oral suspension
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolate mofetil for oral suspension for a condition for which it was not prescribed. Do not give mycophenolate mofetil for oral suspension 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 for oral suspension. 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 for oral suspension?
Active Ingredient: Mycophenolate mofetil USP
Inactive Ingredients:
Mycophenolate mofetil for oral suspension 200mg/ml: Sorbitol, sodium citrate dehydrate, citric acid anhydrous, methylparaben, xanthum gum, aspartame, soybeanlecithin and N & A gum fruit flavour.

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 in India by:
Alkem Laboratories Limited
H.O.: ALKEM HOUSE,
Senapati Bapat Marg, Lower Parel,
Mumbai – 400 013, INDIA

Distributed by:
Ascend Laboratories, LLC,
Montvale, NJ 07645


PT2156-01
 Revised: July, 2015

Revised: 10/2015
Ascend Laboratories, LLC