MYCOPHENOLIC ACID- mycophenolic acid tablet, delayed release 
CONCORD BIOTECH LIMITED

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MEDICATION GUIDE

Mycophenolic Acid Delayed-Release Tablets

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Read the Medication Guide that comes with mycophenolic acid delayed-release tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have any questions about mycophenolic acid delayed-release tablets, ask your doctor.

What is the most important information I should know about Mycophenolic acid delayed-release tablets?

Mycophenolic acid delayed-release tablets can cause serious side effects, including:

   Mycophenolate Pregnancy Registry (1-800-617-8191)

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

Call your doctor right away if you have any of these signs and symptoms of infection:

See the section "What are the possible side effects of mycophenolic acid delayed-release tablets?" for other serious side effects.

What are mycophenolic acid delayed-release tablets?

Mycophenolic acid delayed-release tablets are a prescription medicine given to prevent rejection (antirejection medicine) in people who have received a kidney transplant. Rejection is when the body's immune system senses the new organ as "foreign" and attacks it.

Mycophenolic acid delayed-release tablets are used with other medicines containing cyclosporine (Sandimmune®, Gengraf®, and Neoral®) and corticosteroids.

Mycophenolic acid delayed-release tablets can be used to prevent rejection in children who are 5 years or older and are stable after having a kidney transplant. It is not known if mycophenolic acid delayed-release tablets is safe and works in children younger than 5 years.

It is not known how mycophenolic acid delayed-release tablets works in children who have just received a new kidney transplant.

Who should not take mycophenolic acid delayed-release tablets?

Do not take mycophenolic acid delayed-release tablets if you are allergic to mycophenolic acid (MPA), mycophenolate sodium, mycophenolate mofetil, or any of the ingredients in mycophenolic acid delayed-release tablets. See the end of this Medication Guide for a complete list of ingredients in mycophenolic acid delayed-release tablets.

What should I tell my doctor before I start taking mycophenolic acid delayed-release tablets?

Tell your healthcare provider about all of your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Some medicines may affect the way mycophenolic acid delayed-release tablets works and mycophenolic acid delayed-release tablets may affect how some medicines work. Especially tell your doctor if you take:

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

How should I take mycophenolic acid delayed-release tablets?

What should I avoid while taking mycophenolic acid delayed-release tablets?

What are the possible side effects of mycophenolic acid delayed-release tablets?

Mycophenolic acid delayed-release tablets can cause serious side effects.

See "What is the most important information I should know about mycophenolic acid delayed-release tablets?"

Stomach and intestinal bleeding can happen in people who take mycophenolic acid delayed-release tablets. Bleeding can be severe and you may have to be hospitalized for treatment.

The most common side effects of taking mycophenolic acid delayed-release tablets include:

In people with a new transplant:

In people who take mycophenolic acid delayed-release tablets for a long time (long-term) after transplant:

Your healthcare provider will do blood tests before you start taking mycophenolic acid delayed-release tablets and during treatment with mycophenolic acid delayed-release tablets 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 mycophenolic acid delayed-release tablets?"), or any unexpected bruising or bleeding. Also, tell your healthcare provider if you have unusual tiredness, dizziness, or fainting.

These are not all the possible side effects of mycophenolic acid delayed-release tablets. Your healthcare provider may be able to help you manage these side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or

You may also report side effects to Concord Biotech Limited, at Telephone: 1-844-553-5534, Fax : 1-844-552-5515.

How should I store mycophenolic acid delayed-release tablets?

General information about mycophenolic acid delayed-release tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolic acid delayed-release tablets for a condition for which it was not prescribed. Do not give mycophenolic acid delayed-release tablets to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about mycophenolic acid delayed-release tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mycophenolic acid delayed-release tablets that is written for healthcare professionals.

What are the ingredients in mycophenolic acid delayed-release tablets?

Active ingredient: mycophenolic acid (as mycophenolate sodium)

Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, talc, magnesium stearate. The enteric coating of the tablet consists of methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, iron oxide yellow, sodium lauryl sulfate, FD&C blue #2(180mg) or iron oxide red (360mg).

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

Any trademarks in this document are the property of their respective owners.

Manufactured by:

Concord Biotech Limited

Valthera, Ahmedabad-382225

Gujarat, India.

Revised on: June-2020

Revised: 6/2020
CONCORD BIOTECH LIMITED