Uses of Dabigatran Etexilate:

• It is used to thin the blood so that clots will not form.
• It is used to treat blood clots.

What do I need to tell my doctor BEFORE I take Dabigatran Etexilate?

• If you have an allergy to dabigatran etexilate or any other part of dabigatran etexilate.
• If you are allergic to dabigatran etexilate; any part of dabigatran etexilate; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have bleeding problems.
• If you have had a heart valve replaced.
• If you have kidney problems.
• If you are taking any of these drugs: Dronedarone or ketoconazole.
• If you are taking rifampin.
• If you are taking or will be taking another drug like this one.
• If you are breast-feeding. Do not breast-feed while you take dabigatran etexilate.

This is not a list of all drugs or health problems that interact with dabigatran etexilate.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take dabigatran etexilate with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Dabigatran Etexilate?

• Tell all of your health care providers that you take dabigatran etexilate. This includes your doctors, nurses, pharmacists, and dentists. This medicine may need to be stopped before certain types of surgery as your doctor has told you. If dabigatran etexilate is stopped, your doctor will tell you when to start taking dabigatran etexilate again after your surgery or procedure.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor. Rarely, some bleeding problems have been deadly.
• If you fall or hurt yourself, or if you hit your head, call your doctor right away. Talk with your doctor even if you feel fine.
• If you are 65 or older, use dabigatran etexilate with care. You could have more side effects.
• If you are pregnant or you get pregnant while taking dabigatran etexilate, call your doctor right away.

How is this medicine (Dabigatran Etexilate) best taken?

Use dabigatran etexilate as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking dabigatran etexilate as you have been told by your doctor or other health care provider, even if you feel well.
• Take with or without food.
• Swallow whole. Do not chew, open, or crush.
• Take with a full glass of water.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is less than 6 hours until the next dose, skip the missed dose and go back to the normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Very bad dizziness or passing out.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Feeling confused.
• Feeling very tired or weak.
• Very bad headache.
• Very bad swelling.
• Very bad belly pain.
• Joint pain or swelling.

What are some other side effects of Dabigatran Etexilate?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach.
• Stomach pain or heartburn.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Dabigatran Etexilate?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep capsules in the bottle they come in and do not move to a pill holder.
• Keep lid tightly closed.
• Throw away any unused capsules left in bottle after 4 months.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time dabigatran etexilate is refilled. If you have any questions about dabigatran etexilate, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.