The Who, When, How to Take and Store PRADAXA (dabigatran)

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What is PRADAXA?
PRADAXA is a medicine used to prevent stroke and blood clots in people who have a atrial fibrillation. 

How to take PRADAXA?

  • PRADAXA should be taken orally, twice daily, with or without food. 
  • Swallow PRADAXA capsules whole. Do not break, chew, or empty the pellets from the capsule.
  • If you miss a dose of PRADAXA, take it as soon as you remember. If your next dose is less than 6 hours away, skip the missed dose. Do not take two doses of PRADAXA at the same time.

Who should not take PRADAXA?

If you have the following problems, you might not be suitable to take PRADAXA.  Tell you doctors if you: 

  • have types of abnormal bleeding
  • have kidney problems
  • have liver problems
  • history of serious reaction to PRADAXA
  • have ever had bleeding problems
  • are taking other medication (aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin (Coumadin, Jantoven), heparin, clopidogrel (Plavix), prasugrel (Effient), ketoconazole, cyclosporine, itraconazole and tacrolimus) that might increase your risk of bleeding
  • have ever had stomach ulcers
  • are pregnant or plan to become pregnant. It is not known if PRADAXA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if PRADAXA passes into your
  • breast milk.
  • Are going to have surgery or dental procedure 

What are the possible side effects of PRADAXA?

Since PRADAXA lessens the ability of your blood to clog, it might increase our risk of bleeding.  As a result, you might bruise more easily and take longer for any bleeding to stop. 

Other common side-effects of PRADAXA include:

  • indigestion, upset stomach, or burning
  • stomach pain 

When do you need to get medical attention right away?
If you see any of the following signs or symptoms of bleeding:

  • unusual bleeding or bleeding for a long time from the gums
  • nose bleeds that happen often
  • menstrual bleeding or vaginal bleeding that is heavier than normal
  • bleeding that is severe or you cannot control
  • pink or brown urine
  • red or black stools (looks like tar)
  • bruises that happen without a known cause or get larger
  • cough up blood or blood clots
  • vomit blood or your vomit looks like “coffee grounds”
  • unexpected pain, swelling, or joint pain
  • headaches, feeling dizzy or weak
  • chest pain or chest tightness
  • swelling of your face or tongue
  • trouble breathing or wheezing
  • feeling dizzy or faint 

How to store PRADAXA?

  • Store PRADAXA at room temperature between 59°F to 86°F (15°C to 30°C). 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. Keep the bottle tightly closed. 

Source: dabigatran package insert, 2011 

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