Dabigatran Etexilate Oral Pellet (DABIGATRAN PELLETS - ORAL)

Instructions

This medicine may be given by spooning the contents of the packet directly into the mouth. Drink apple juice as needed to make sure the entire dose is swallowed. The pellets may also be mixed in 30-60 mL of apple juice or 10 mL of applesauce, mashed bananas, or mashed carrots. Eat or drink the entire mixture right away without chewing the medicine. If any medicine remains in the cup after drinking the mixture, add more juice and make sure the whole dose is swallowed.

Eat or drink the medicine immediately after mixing with soft food or liquid. Do not store for later use.

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Keep the medicine in the aluminum bag until you are ready to use it.

Discard any unused packets 60 days after opening the aluminum bag.

Do not take this medicine with milk or milk products (such as yogurt).

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is less than 6 hours to the next dose, do not take the missed dose. Return to your normal dosing schedule. Do not take 2 doses of this medicine at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

Do not suddenly stop taking this medicine. Check with your doctor before stopping.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

This medicine is not approved for use by adults.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine may cause bleeding from the stomach or bowels. Stop this medicine and call your doctor right away if you have pain in the stomach, red or dark tarry stools, or vomit that looks like coffee grounds.

Do not use the medication any more than instructed.

Please check with your doctor before drinking alcohol while on this medicine.

Call your doctor right away if you notice any unusual bleeding or bruising.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• diarrhea
• nosebleeds
• stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• bleeding or bruising
• coughing up blood or vomit that looks like coffee grounds
• dizziness
• fainting
• severe or persistent headache
• sudden leg pain, swelling, warmth or redness
• shortness of breath
• bloody or dark, tarry stools
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• unusual or unexplained tiredness or weakness
• blood in urine
• sudden change or loss of vision

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.