Mycophenolate delayed-release tablets

What is this medication?

MYCOPHENOLATE SODIUM (mye koe FEN oh late SOE dee um) is used to decrease the immune system's response to a transplanted organ.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Myfortic

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• anemia or other blood disorder
• cancer
• diarrhea
• immune system problems
• infection (especially a viral infection such as chickenpox, cold sores, or herpes)
• kidney disease
• recently received or scheduled to receive a vaccination
• stomach problems
• an unusual or allergic reaction to mycophenolate, mycophenolic acid, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food. Do not cut, chew, or crush the tablets. Swallow the tablets whole. Do not touch broken tablets. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 5 years old for selected conditions, precautions do apply.

Patients over 65 years of age may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• live vaccines

This medicine may also interact with the following medications:

• acyclovir or valacyclovir
• azathioprine
• birth control pills
• certain antibiotics like ciprofloxacin and amoxicillin; clavulanic acid
• cyclosporine
• ganciclovir or valganciclovir
• medicines for cholesterol like cholestyramine and colestipol
• metronidazole
• norfloxacin
• other mycophenolate medicines
• probenecid
• rifampin
• sevelamer
• stomach acid blockers like magnesium hydroxide and aluminum hydroxide

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care professional for regular checks on your progress. You will need frequent blood checks during the first few months you are receiving the medicine.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

This medicine can cause birth defects. Do not get pregnant while taking this drug. Females will need to have a negative pregnancy test before starting this medicine. If sexually active, use 2 reliable forms of birth control together for 4 weeks before starting this medicine, while you are taking this medicine, and for 6 weeks after you stop taking this medicine. Birth control pills alone may not work properly while you are taking this medicine. If you think that you might be pregnant talk to your doctor right away.

Males who get this medicine must use a condom during sex with females who can get pregnant. If you get a woman pregnant, the baby could have birth defects. The baby could die before they are born. You will need to continue wearing a condom for 90 days after stopping the medicine. Tell your health care provider right away if your partner becomes pregnant while you are taking this medicine. Do not donate sperm while taking this medicine or for 90 days after stopping it.

If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.

Do not give blood while taking this medicine or for 6 weeks after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• bloody, dark, or tarry stools
• changes in vision
• dizziness
• fever, chills or any other sign of infection
• unusual bleeding or bruising
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• diarrhea
• difficulty sleeping
• loss of appetite
• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.