Generic Name: Dabigatran etexilate

  • What is Pradaxa?

    Pradaxa is a blood thinner medicine used to reduce the risk of stroke and blood clots in people who have a heart condition called atrial fibrillation.

  • What is the most important information I should know about Pradaxa?

    Pradaxa can cause bleeding which can be serious, and sometimes lead to death. The risk of bleeding is increased because Pradaxa lessens the ability of your blood to clot. You may bruise more easily or it may take longer for your body to stop bleeding while taking Pradaxa. There is a higher risk of bleeding in those who are >75 years, have kidney problems, stomach or intestine bleeding that is recent or keeps coming back, stomach ulcers, or in those who take other medicines that increase the risk of bleeding (including aspirin or aspirin-containing products, long-term use of non-steroidal anti-inflammatory drugs [NSAIDs], warfarin, heparin, clopidogrel, and prasugrel).

    Call your doctor or get medical help right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time, such as unusual bleeding from the gums, nose bleeds, heavier than normal menstrual or vaginal bleeding, and severe or uncontrolled bleeding; pink or brown urine; red or black stools (looks like tar); bruises that happen without a known cause or get larger; coughing or vomiting blood (or your vomit looks like "coffee grounds"); unexpected pain, swelling, or joint pain; headaches; or feeling dizzy or weak.

    Pradaxa may need to be stopped, if possible, for one or more days before any surgery, or medical or dental procedure. If you need to stop taking Pradaxa for any reason, talk to the doctor who prescribed Pradaxa for you to find out when you should stop taking it. Your doctor will tell you when to start taking Pradaxa again after your surgery or procedure.

  • Who should not take Pradaxa?

    Do not take Pradaxa if you currently have certain types of abnormal bleeding or have had a serious allergic reaction to Pradaxa.

  • What should I tell my doctor before I take the first dose of Pradaxa?

    Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Pradaxa. Also, talk to your doctor about your complete medical history, especially if you have kidney problems, have ever had bleeding problems or stomach ulcers, have any other medical condition, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed, or plan to have any surgery or a medical or dental procedure.

  • What is the usual dosage?

    The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

    Adults: The recommended dose is 150 milligrams (mg) twice a day. If you have kidney problems, your doctor may prescribe a lower dose.

  • How should I take Pradaxa?

    Take Pradaxa exactly as prescribed by your doctor. Do not take Pradaxa more often than your doctor tells you to.

    Take Pradaxa with or without food. Swallow Pradaxa capsules whole. Do not break, chew, or empty the pellets from the capsule.

  • What should I avoid while taking Pradaxa?

    Your doctor will decide how long you should take Pradaxa. Do not stop taking Pradaxa without first talking with your doctor. Stopping Pradaxa may increase your risk of stroke.

    Do not run out of Pradaxa. Refill your prescription before you run out.

  • What are possible food and drug interactions associated with Pradaxa?

    If Pradaxa is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Pradaxa with the following: rifampin or medicines that increase your risk of bleeding (including aspirin or aspirin-containing products, long-term use of non-steroidal anti-inflammatory drugs [NSAIDs], warfarin, heparin, clopidogrel, and prasugrel).

  • What are the possible side effects of Pradaxa?

    Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

    Side effects may include: allergic reactions (such as hives, rash, itching), indigestion, upset stomach, burning, stomach pain

    Tell your doctor or get medical help right away if you get any of the following symptoms of a serious allergic reaction with Pradaxa: chest pain or chest tightness, swelling of your face or tongue, trouble breathing/wheezing, or feeling dizzy or faint.

  • Can I receive Pradaxa if I am pregnant or breastfeeding?

    The effects of Pradaxa during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

  • What should I do if I miss a dose of Pradaxa?

    If you miss a dose of Pradaxa, take the missed dose as soon as you remember. If your next dose is less than 6 hours away, skip the missed dose. Do not take two doses at once.

  • How should I store Pradaxa?

    Store at room temperature. After opening the bottle, use Pradaxa within 30 days. Safely throw away any unused Pradaxa after 30 days. Store Pradaxa in the original package to keep it dry.

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