PRADAXA PI PDF

Below is a summary of the recommendations for assessing kidney function before starting dabigatran: Kidney function should be assessed in all patients prior to beginning dabigatran therapy. While on treatment, kidney function should be assessed in clinical situations where a decline in kidney function is suspected. Such situations include low blood volume, dehydration and when certain medications are taken at the same time. In elderly patients aged 75 years or over or in patients with moderate kidney impairment, kidney function should be assessed at least once a year. The Cockcroft-Gault formula is: The sponsor of dabigatran in Australia, Boehringer Ingelheim Pty Ltd, has written to health professionals to advise them of these recommendations and the PI and Consumer Medicine Information have been updated. Other important considerations A specific antidote antagonising the pharmacodynamic effect of dabigatran is not currently available.

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What is Pradaxa? Pradaxa dabigatran is an anticoagulant thrombin inhibitor that helps prevent the formation of blood clots. Pradaxa is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation. This medicine is used when the atrial fibrillation is not caused by a heart valve problem.

Pradaxa is also used after hip replacement surgery to prevent a type of blood clot called deep vein thrombosis DVT , which can lead to blood clots in the lungs pulmonary embolism. Important Information Pradaxa can cause you to bleed more easily. Call your doctor at once if you have: bleeding gums, nosebleeds , heavy menstrual periods or abnormal vaginal bleeding , blood in your urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Many other drugs can increase your risk of bleeding when used with dabigatran. Tell your doctor about all medicines you have recently used. Pradaxa can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia epidural , especially if you have a genetic spinal defect, if you have a spinal catheter in place, if you have a history of spinal surgery or repeated spinal taps, or if you are also using other drugs that can affect blood clotting.

This type of blood clot can lead to long-term or permanent paralysis. Get emergency medical help if you have symptoms of a spinal cord blood clot such as back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Do not stop taking Pradaxa without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke. Before taking this medicine You should not take Pradaxa if you are allergic to dabigatran, or if you have: an artificial heart valve; or active bleeding from a surgery, injury, or other cause. Dabigatran can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia epidural.

This type of blood clot could cause long-term paralysis, and may be more likely to occur if: you have a genetic spinal defect; you have a spinal catheter in place; you have a history of spinal surgery or repeated spinal taps; you have recently had a spinal tap or epidural anesthesia; you are taking an NSAID - Advil , Aleve , Motrin , and others; or you are using other medicines to treat or prevent blood clots.

Pradaxa may cause you to bleed more easily, especially if: you have a stomach ulcer or bleeding in your stomach or intestines; you have kidney disease especially if you also take dronedarone or ketoconazole ; you take certain other medicines that can increase bleeding risk, such as aspirin , clopidogrel Plavix , heparin , prasugrel , warfarin Coumadin , Jantoven ; you take an NSAID nonsteroidal anti-inflammatory drug on a regular basis, such as ibuprofen Advil, Motrin , naproxen Aleve , diclofenac , indomethacin , meloxicam , and others; or you are older than To make sure Pradaxa is safe for you, tell your doctor if you have: kidney disease; a bleeding disorder that is inherited or caused by disease; a stomach ulcer; or if you have been taking rifampin.

Tell your doctor if you are pregnant or if you become pregnant. Taking Pradaxa during pregnancy may cause bleeding in the mother or the newborn baby. However, the risk of blood clots is higher during pregnancy. The benefit of preventing a blood clot may outweigh any risks to the baby.

You should not breast-feed while using dabigatran. How should I take Pradaxa? Take Pradaxa exactly as prescribed by your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Take this medicine with a full glass of water. You may take Pradaxa with or without food. Swallow the capsule whole and do not crush, chew, break, or open it. Because Pradaxa keeps your blood from coagulating clotting to prevent unwanted blood clots, this medicine can also make 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 seek emergency 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, tell the doctor or dentist ahead of time if you have taken Pradaxa within the past 12 hours.

Your kidney function may need to be checked before and during treatment with Pradaxa. Stopping the medication can increase your risk of stroke. If you have received more than a day supply of this medication, 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. Keep each capsule in the bottle or blister pack until you are ready to take the medicine. Keep the capsules in their original container or blister pack. Do not put Pradaxa capsules into a daily pill box or pill organizer. 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 should be thrown away after the expiration date on the label has passed. See also: Pradaxa dosage information in more detail What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not take two doses at one time. To best prevent a stroke, try not to miss any doses. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at What should I avoid while taking Pradaxa? Avoid activities that may increase your risk of bleeding or injury.

Use extra care to prevent bleeding while shaving or brushing your teeth. Avoid alcohol. Heavy drinking can increase your risk of stomach bleeding. Pradaxa side effects Get emergency medical help if you have signs of an allergic reaction to Pradaxa: hives ; pain or tight feeling in your chest, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain , numbness or muscle weakness in your lower body, or loss of bladder or bowel control. Call your doctor at once if you have: any bleeding that will not stop; headache , weakness, dizziness , or feeling like you might pass out; easy bruising, unusual bleeding nose, mouth, vagina, or rectum , purple or red pinpoint spots under your skin; easy bruising, unusual bleeding, purple or red spots under your skin; blood in your urine or stools, black or tarry stools; cough with bloody mucus or vomit that looks like coffee grounds; pink or brown urine;.

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Dabigatran (Pradaxa) and risk of bleeding: Information for health professionals

PRADAXA is used to: reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to blood clots forming and increase your risk of a stroke. People who take PRADAXA and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move paralysis. Your risk of developing a spinal or epidural blood clot is higher if: a thin tube called an epidural catheter is placed in your back to give you certain medicine you take NSAIDs or a medicine to prevent blood from clotting you have a history of difficult or repeated epidural or spinal punctures you have a history of problems with your spine or have had surgery on your spine. If you take PRADAXA and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness especially in your legs and feet , loss of control of the bowels or bladder incontinence.

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What is Pradaxa? Pradaxa dabigatran is an anticoagulant thrombin inhibitor that helps prevent the formation of blood clots. Pradaxa is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation. This medicine is used when the atrial fibrillation is not caused by a heart valve problem. Pradaxa is also used after hip replacement surgery to prevent a type of blood clot called deep vein thrombosis DVT , which can lead to blood clots in the lungs pulmonary embolism. Important Information Pradaxa can cause you to bleed more easily. Call your doctor at once if you have: bleeding gums, nosebleeds , heavy menstrual periods or abnormal vaginal bleeding , blood in your urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

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