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 nintedanib or if you are pregnant.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Swallow the capsule whole with water or another liquid. Do not crush, break, or chew it, because it has a bitter taste.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose.
• 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 can affect how nintedanib works. Tell your doctor if you are using the following:
  
  • Carbamazepine, erythromycin, ketoconazole, phenytoin, rifampicin, St John's wort
  • Blood thinner (including aspirin, warfarin)
• Do not smoke while you are being treated with this medicine, because this will cause the medicine to not work as well.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. You may need to have a negative pregnancy test before starting this medicine. Use an effective form of birth control during treatment and for at least 3 months after the last dose.
• Tell your doctor if you are breastfeeding, or if you have liver disease, bleeding problems, or heart or blood vessel disease. Tell your doctor if you have stomach or digestion problems or have had recent surgery in your abdomen.
• This medicine may cause the following problems:
  
  • Liver problems
  • Increased risk of bleeding, heart attack, or stroke
  • Increased risk of a tear (perforation) in your digestive system
• 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
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, unusual sweating, faintness
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Severe diarrhea, nausea, vomiting, stomach pain
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding or bruising

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

• Weight loss or loss of appetite

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