Pirfenidone capsules or tablets

What is this medication?

PIRFENIDONE (peer FEH nih done) is used to treat idiopathic pulmonary fibrosis.

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

COMMON BRAND NAME(S): ESBRIET

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

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

• kidney disease
• liver disease
• smoke tobacco
• an unusual or allergic reaction to pirfenidone, or 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 with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of the medicine in children. Special care may be needed.

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. If you miss 14 or more days of taking the medication, call your care team before starting again.

What may interact with this medication?

This medicine may interact with the following medications:

• certain antiinfectives like ciprofloxacin, thiabendazole
• certain medicines for asthma like zafirlukast, zileuton, montelukast
• certain medicines for depression, anxiety, or psychotic disturbances
• certain medicines for irregular heart beat like amiodarone, mexiletine
• certain medicines for seizures like carbamazepine, phenytoin, fosphenytoin
• disulfiram
• stomach acid blockers like cimetidine
• vemurafenib

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?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

If you smoke, tell your doctor if you notice this medicine is not working well for you. Talk to your doctor if you are a smoker or if you decide to stop smoking.

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.

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
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• sunburn

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

• changes in taste
• diarrhea
• dizziness
• headache
• joint pain
• nausea; vomiting
• stomach pain
• trouble sleeping
• weak or tired
• weight loss

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). 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.