When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to pirfenidone.

How to Use This Medicine:
Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine at the same time each day.
• It is best to take this medicine with food or milk.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. If you miss a dose for 14 days or more, tell your doctor right away. You may need to start at a lower dose again.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines and foods can affect how pirfenidone works. Tell your doctor if you are using the following:
  
  • Ciprofloxacin
  • Enoxacin
  • Fluvoxamine

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or stomach or bowel problems.
• This medicine may cause the following problems:
  
  • Liver problems
  • Stomach or bowel problems
• Stop smoking before treatment with pirfenidone and avoid smoking while you are using this medicine.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Diarrhea, nausea, vomiting, heartburn, stomach pain or upset
• Severe sunburn or increased sensitivity of the skin to sunlight

If you notice these less serious side effects, talk with your doctor:

• Cough, runny or stuffy nose, sore throat
• Headache, dizziness, trouble sleeping
• Joint or muscle pain
• Weight loss

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088