DABIGATRAN

(da Large a tran) Brand: Pradaxa

What is the most significant information I must know about dabigatran?

• You must not take dabigatran if you have an artificial heart valve, or if you have any active bleeding from a surgery, injury, or another cause.

• Because dabigatran keeps your blood from coagulating (clotting) to prevent unwanted blood clots, this medication can also create it easier for you to bleed, even from a minor injury such as a fall or a bump on the head. Avoid activities that may magnify your risk of bleeding or injury. Contact your doctor or search abnormal medical attention if you have bleeding that will not stop.

• Do not stop taking dabigatran without your doctor's advice. Stopping the medicine can magnify your risk of stroke.

What is dabigatran?

• Dabigatran keeps the platelets in your blood from coagulating (clotting).

• Dabigatran is used to prevent blood clots and to reduce the risk of stroke in people with a determined type of heart rhythm disorder.

• Dabigatran may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking dabigatran?

• You must not take dabigatran if you are allergic to it, if you have an artificial heart valve, or if you have any active bleeding from a surgery, injury, or another cause.

• To create certain dabigatran is safety for you, speak your doctor if you have:

· kidney disease;

· a history of stomach ulcer or bleeding; or

· if you are older than 75.

• FDA pregnancy category C. It is not known whether dabigatran will harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant while using this medication.

• It is not known whether dabigatran passes into breast milk or if it could harm a nursing child. Speak your doctor if you are breast-feeding a baby.

How must I take dabigatran?

• Follow all directions on your prescription label. Do not take this medication in larger or less amounts or for longer than recommended.

• Because dabigatran keeps your blood from coagulating (clotting) to prevent unwanted blood clots, this medication can also create it easier for you to bleed, even from a minor injury such as a fall or a bump on the head. Contact your doctor or search abnormal medical attention if you fall or hit your head, or have any bleeding that will not stop.

• If you need surgery, dental work, or any type of medical test or treatment, speak the doctor or dentist onward of time if you have taken dabigatran within the past 12 hours. You may need to stop taking dabigatran for a short time till you have surgery or another medical procedures.

• Do not stop taking dabigatran without your doctor's advice. Stopping the medicine can magnify your risk of stroke. Your doctor may recommend other medicine to prevent blood clots if you need to stop taking dabigatran.

• Do not crush, chew, interrupt, or open a dabigatran capsule. Swallow the pill intact.

• Your kidney function may need to be checked with blood trials till and during treatment with dabigatran.

• Hold the capsules in their original container or blister pack. Do not put dabigatran capsules into a daily pill box or pill organizer.

• If you have received more than a 30-day supply of this medicine, do not open more than one bottle at a time. Open a new bottle only after all the capsules in the old bottle are gone.

• Store at room temperature, away from moisture and heat. Hold every capsule in the bottle or blister pack before you are ready to take the medication. Hold the bottle tightly closed when not in use.

• Throw away any unused capsules if it has been longer than 4 months since you first opened the bottle. Capsules stored in a blister pack must be thrown away after the expiration date on the label has passed.

What happens if I miss a dose?

• If you are smaller than 6 hours late in taking your medication, take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

• Try not to miss any doses of dabigatran to excellent prevent a stroke.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking dabigatran?

• Avoid activities that may magnify your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

• Avoid drinking alcohol. It may magnify your risk of bleeding in your stomach or intestines.

What are the possible side effects of dabigatran?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.

• Call your doctor at once if you have:

· any bleeding that will not stop;

· weakness, feeling like you might pass out;

· light bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

· blood in your urine or stools, black or tarry stools;

· coughing up blood or vomit that looks like coffee grounds;

· pink or brown urine;

· joint pain or swelling; or

· hard menstrual bleeding.

• General side effects may include:

· stomach pain or upset, indigestion, heartburn;

· nausea, diarrhea; or

· mild skin rash or itching.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect dabigatran?

• Till you take dabigatran, speak your doctor if you have recently received any another medications to treat or prevent blood clots, such as:

· heparin or warfarin (Coumadin);

· argatroban, bivalirudin, fondaparinux, lepirudin, rivaroxaban;

· abciximab, eptifibatide, tirofiban;

· dalteparin, enoxaparin, tinzaparin;

· anagrelide, cilostazol, clopidogrel, dipyridamole, eltrombopag, oprelvekin, prasugrel, romiplostim, ticagrelor, ticlopidine; or

· alteplase, reteplase, tenecteplase, urokinase.

• Speak your doctor about all another medicines you use, and those you start or stop using during your treatment with dabigatran, especially:

· rifampin;

· St. John's wort;

· tipranavir when given with ritonavir; or

· seizure medication--carbamazepine, phenytoin.

• This list is not complete. Another drugs may interact with dabigatran, including prescription and over-the-counter medicines, vitamins, and herbal commodity. Not all possible interactions are listed in this medicine manual.

Where can I get more information?

• Your pharmacist can provide more information about dabigatran.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.