Tacrolimus Extended Release Oral Tablet (TACROLIMUS EXTENDED-RELEASE - ORAL)

Instructions

Swallow the medicine without crushing or chewing it.

Take the medicine on an empty stomach.

Empty stomach means waiting at least 2 hours after a meal.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Avoid grapefruit juice while on this medicine.

Do not take antacids 2 hours before or 2 hours after taking this medicine.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

This medicine may cause higher blood sugar levels or diabetes. Please follow your doctor's instructions and check your blood sugar level regularly while on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine may increase the risk of cancer. Ask your doctor about the benefits and risks.

Do not use the medication any more than instructed.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

This medicine can cause birth defects. Speak with your doctor about birth control methods that should be used while on this medicine.

This medicine may damage sperm. Men should use reliable birth control while taking this medicine.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Always refill this medicine before it runs out.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• agitated feeling or trouble sleeping
• decreased appetite
• diarrhea
• headaches
• high blood sugar
• high blood pressure
• nausea and vomiting
• shakiness
• stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• decreased awareness or responsiveness
• loss of balance
• bleeding or bruising
• chest pain
• changes in memory, mood, or thinking
• difficulty concentrating
• confusion
• dizziness
• ear problems (ringing in the ears, hearing loss)
• swelling of the legs, feet, and hands
• fainting
• fever or chills
• numbness or tingling in hands and feet
• severe or persistent headache
• fast or irregular heart beats
• signs of kidney damage (such as change in urine color or bubbly urine)
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• muscle aches, spasms or abnormal movements
• muscle weakness
• ringing in the ears
• seizures
• shortness of breath
• slurred speech
• dark, tarry stool
• blurring or changes of vision
• severe or persistent vomiting
• sudden or unexplained change in weight

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.