Panobinostat Oral Capsule (PANOBINOSTAT - ORAL)

Instructions

Swallow the medicine without crushing or chewing it.

Keep the medicine in its original container.

This medicine may be taken with or without food.

Swallow with a full glass (8 oz) of water unless your doctor gives you different instructions.

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.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

You may need to cycle between periods of taking the medicine and taking breaks from the medicine to allow your body to recover. Follow your instructions carefully.

Drink plenty of water while on this medicine.

Avoid grapefruit and grapefruit juice while on this medicine.

Avoid starfruit, pomegranate and pomegranate juice while on this medicine.

If you vomit after taking a dose, do not take an extra dose. Take your next dose at the usual time.

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

If you forget to take a dose on time, take it as soon as you remember. If it is less than 12 hours to the next dose, do not take the missed dose. Return to your normal dosing schedule. Do not take 2 doses of this medicine 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.

Tell your doctor if symptoms do not get better or if they get worse.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

Keep using this medicine for the full number of days that it is prescribed. Do not stop the medicine even if you start to feel better.

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

Cautions

Avoid getting medicine on the skin or in the eyes. If this happens, wash the skin with soap and water. For eyes, open eyelid and flush with plenty of water and tell your doctor right away.

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

This medicine is associated with an increased risk of serious heart problems and heart attack. Please speak with your doctor about the risks and benefits of using this medicine. Contact your doctor immediately if you experience chest pain or difficulty breathing.

Do not use the medication any more than instructed.

Please check with your doctor before drinking alcohol while on this medicine.

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.

Please tell your doctor if you have moderate to severe diarrhea while on this medicine. Do not treat the diarrhea with over-the-counter diarrhea medicine.

Do not breastfeed while on this medicine.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while taking this medicine and for 3 months after stopping to prevent pregnancy.

Men with a female partner who is of childbearing age must use reliable birth control during sexual activity while taking this medicine and for 6 months after stopping to prevent pregnancy.

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.

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.

• decreased appetite
• diarrhea
• swelling of the legs, feet, and hands
• lack of energy and tiredness
• nausea and vomiting
• stomach upset or abdominal pain
• weakness
• weight loss

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

• severe or persistent abdominal pain
• bleeding or bruising
• chest or jaw pain
• confusion
• cough that does not go away
• coughing up blood or vomit that looks like coffee grounds
• severe, watery or bloody diarrhea
• dry mouth
• fainting
• fever or chills
• severe or persistent headache
• fast, irregular, or slow heartbeat
• lightheadedness
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• pale or blue skin, lips or fingernails
• shortness of breath
• sore throat
• difficulty speaking
• bloody or dark, tarry stools
• excessive thirst
• urinating less often
• blood in urine
• severe or persistent vomiting

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.