DABIGATRAN SPC PDF

This medicine is authorised for use in the European Union. Pradaxa contains the active substance dabigatran etexilate. Expand section Collapse section How is Pradaxa used? Pradaxa is available as capsules 75, and mg and can only be obtained with a prescription. All patients at increased risk of bleeding should be monitored closely and the doctor may reduce the dose of Pradaxa. In all patients, kidney function should also be assessed before starting treatment to exclude patients with severely reduced kidney function, and should be re-assessed during treatment if any worsening is suspected.

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More What is dabigatran? Dabigatran is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation. Dabigatran 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.

Dabigatran may also be used for purposes not listed in this medication guide. Important Information Dabigatran 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. Dabigatran can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia epidural. Tell any doctor who treats you that you are taking dabigatran. Do not stop taking dabigatran 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 dabigatran if you are allergic to it, or if you have: an artificial heart valve; or active bleeding from a surgery, injury, or other cause. 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.

Dabigatran 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 Tell your doctor if you have ever had: 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 dabigatran 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 dabigatran? Follow all directions on your prescription label and read all medication guides or instruction sheets.

Use the medicine exactly as directed. Take dabigatran with a full glass of water. You may take dabigatran with or without food. Swallow the capsule whole and do not crush, chew, break, or open it.

Because dabigatran 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 dabigatran within the past 12 hours. Your kidney function may need to be checked before and during treatment with dabigatran.

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 dabigatran 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.

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 dabigatran?

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. Dabigatran side effects Get emergency medical help if you have signs of an allergic reaction: 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

People who are at high risk include those who have: an abnormal heartbeat atrial fibrillation recently had surgery to replace a hip or knee joint Dabigatran is only available on prescription. It comes as capsules. You can take dabigatran with or without food. The most common side effect of dabigatran is bleeding more easily than normal, such as having nosebleeds, bleeding gums and bruising.

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More Warning Do not stop taking dabigatran etexilate without talking to the doctor who ordered it for you. Stopping dabigatran etexilate when you are not supposed to may raise the chance of blood clots. This includes stroke in certain people. You may need to stop dabigatran etexilate before certain types of dental or health care. Your doctor will tell you when to start taking it again. Follow what your doctor tells you closely.

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