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Read the Patient Information Leaflet if available from your pharmacist before you start taking nintedanib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually twice daily (about 12 hours apart). The dosage is based on your medical condition and response to treatment. Follow your doctor's instructions carefully.

Swallow the capsule whole. Do not crush or chew because the drug has a bitter taste.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if your condition worsens.

Diarrhea, nausea, vomiting, abdominal pain, decreased appetite, and weight loss may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Diarrhea, nausea, and vomiting can be persistent and/or severe. Your doctor may have you drink more fluids if these symptoms occur and prescribe medications to treat the diarrhea, nausea, and vomiting.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: unusual bruising/bleeding, cough/stuffy chest, symptoms of liver problems (such as dark urine, yellowing eyes/skin).

Get medical help right away if you have any very serious side effects, including: symptoms of a heart attack (such as chest/jaw/left arm pain, unusual sweating), symptoms of a stroke (such as weakness on one side of body, sudden vision problems, slurred speech), severe stomach/abdominal pain, abdominal swelling.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking nintedanib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, heart disease (such as chest pain, heart attack), blood clots, bleeding problems, recent abdominal surgery, stomach/intestinal problems (such as ulcers).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss the use of reliable forms of birth control during treatment with this medication and for at least 3 months after your last dose of nintedanib. If you become pregnant, or think you may be pregnant, tell your doctor right away.

It is unknown if nintedanib passes into breast milk. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran).

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of nintedanib from your body, which may affect how nintedanib works. Examples include rifamycins (such as rifampicin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Missed Doses:

If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Notes:

Do not share this medication with others.

Lab and/or medical tests (such as liver function) should be done before you start taking this medication and while you are taking it. In women, a pregnancy test should also be done before starting treatment. Keep all medical and lab appointments.