Pradaxa

Stopping early any blood thinner, including PRADAXA, increases the risk of having a sudden blocking of a blood vessel by a blood clot. This can lead to death or severe injury.

If you need to stop PRADAXA, your doctor may give you another blood thinner.

You may bleed very seriously or severely in any part of your body while you are taking PRADAXA.

In order to help prevent serious bleeding with PRADAXA, it is important to take PRADAXA exactly as prescribed by your doctor.

In rare occasions, where you need emergency surgery or other urgent procedure or have obvious or hidden uncontrolled bleeding, you may have to discontinue taking PRADAXA. In these situations, PRAXBIND (idarucizumab), a specific antidote for reversing the effect of PRADAXA, can be used to immediately and completely reverse the blood-thinning effect of PRADAXA.

Your doctor will tell you when it is appropriate for you to resume taking PRADAXA.

BEFORE you use PRADAXA talk to your doctor, nurse, or pharmacist if you:

• Have moderately reduced kidney function.
• Are dehydrated.
• Have a disease or have had an operation recently that increases your risk of bleeding. Examples are a blood clotting disease, a stomach ulcer, a biopsy, a very serious injury, or an inflammation of parts of your heart caused by bacteria.
• Are older than 75 years old.
• Have severe or life-threatening liver disease, or high liver enzymes.
• Are going to have a surgery, including a surgery on your brain, back, eye or other invasive or dental procedure. Your doctor may ask you to stop PRADAXA temporarily for a few days before the surgery.
• Are pregnant or plan to become pregnant. The effects of PRADAXA on pregnancy and the unborn child are not known.
• Are about to give birth.
• Are less than 18 years old.
• Weigh less than 50 kg.

You should be aware that prescription medicines carry some risks and that all possible risks may not be known at this stage.

As PRADAXA acts on the blood clotting system, most side effects are related to signs of bruising or bleeding.

Although rare, PRADAXA can cause very serious or severe bleeding that can occur in any part of your body. These bleedings may reduce your physical abilities or even lead to death.

If you fall or injure yourself while taking PRADAXA, especially if you hit your head, please seek urgent medical attention. You may need to be checked by a doctor, as you may be at increased risk of bleeding.

Patients treated with PRADAXA may experience the following side effects:

• abdominal pain, diarrhea, heartburn, nausea, reflux of gastric juice, upset stomach, vomiting;
• difficulty swallowing;
• bruising;
• hives, itching, rash.

PRADAXA can cause abnormal blood test results for kidney and liver function, number of platelets and number of red blood cells (anemia). Your doctor will ask for blood tests and will interpret the results.

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with PRADAXA:

• Antacids, used to treat heartburns. If you need to take an antacid, take it at least two hours after taking PRADAXA.
• Antibiotics, including rifampicin and clarithromycin.
• Antidepressants, in particular selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs).
• Antifungal drugs, including oral itraconazole and posaconazole.
• Antiretroviral drugs, used to treat HIV, including nelfinavir, ritonavir, saquinavir, and tipranavir.
• Blood thinners, including clopidogrel, prasugrel (EFFIENT) or ticagrelor (BRILINTA).
• Drugs used to prevent organ rejection after transplantation, including cyclosporine and tacrolimus.
• Drugs used to treat epilepsy, including carbamazepine.
• Drugs used to treat irregular heartbeats, including amiodarone (CORDARONE), dronedarone (MULTAQ) and quinidine.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include aspirin (ASA), diclofenac, ibuprofen and naproxen.
• Proton pump inhibitors, used to treat heartburns.
• St. John’s Wort, a herbal medicine.
• Verapamil, used to lower blood pressure.

Know the medicines you take. Keep a list of them and show it to your doctor, dentist and pharmacist when you get a new medicine or whenever you seek medical treatment.

Before you start taking PRADAXA and regularly after, your doctor will test your kidney function.

Take PRADAXA exactly as prescribed.

PRADAXA should be taken with a full glass of water and can be taken with or without food. If PRADAXA upsets your stomach, take it with meals or within 30 minutes after meals. If PRADAXA still upsets your stomach, consult your physician or pharmacist. It is important to continue taking PRADAXA as prescribed.

Swallow the capsule(s) whole. Do not chew or open the capsule. Do not sprinkle the pellets on food or mix with liquids.

Usual Adult dose:

If your doctor has given you PRADAXA to take twice a day, it is important to take it regularly at the same time each day at approximately 12 hour intervals.

• After knee or hip replacement surgery: 220 mg once daily, taken as two (2) capsules of 110 mg at the same time.

Depending on your kidney function or other drugs you may be taking, your doctor may prescribe a lower dose of 150 mg once daily (taken as two capsules of 75 mg at the same time).

Take PRADAXA for as long as the doctor tells you.

• To treat blood clots and prevent them from re-occurring in the veins of your leg(s) or in your lung(s): 300 mg a day, taken as one (1) capsule of 150 mg twice daily.

You will start taking PRADAXA following 5 to 10 days treatment with an injectable blood thinner.

The doctor will determine how long you should take PRADAXA so take it until your doctor tells you to stop.

If you are 80 years and older and/or the doctor thinks you are more likely to bleed: 220 mg a day, taken as one (1) capsule of 110 mg, twice daily.

• For patients who have irregular heartbeats (atrial fibrillation): 300 mg a day, taken as one (1) capsule of 150 mg, twice daily.

Switching to PRADAXA:

If you are currently taking the blood thinner warfarin or receive a blood thinner given by injection, and your doctor has decided PRADAXA is appropriate for you, make sure you ask your doctor when and how best to switch and start taking PRADAXA.

Overdose:

If you think you have taken too much PRADAXA, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you take more than the recommended dose of PRADAXA, you may have an increased risk of bleeding. Your doctor can perform a blood test to assess the risk of bleeding.

For situations when rapid reversal of the blood-thinning effect of PRADAXA is required, PRAXBIND (idarucizumab), a specific antidote for reversing the effect of PRADAXA, can be available in hospitals and emergency rooms.

Missed dose:

For all treatments, if you forget to take PRADAXA, do not take a double dose to make up for the missed dose.

• After knee or hip replacement surgery: Take your next dose at the same time next day.
• To treat blood clots and prevent them from re-occurring in the veins of your leg(s) or in your lung(s): Take it as soon as you remember, but if it is almost time for your next dose (less than 6 hours before your next dose), take your next dose when you are supposed to.
• For patients who have irregular heartbeats (atrial fibrillation): Take it as soon as you remember, but if it is almost time for your next dose (less than 6 hours before your next dose), take your next dose when you are supposed to.

If you had knee or hip replacement surgery or are receiving treatment for prevention of blood clots in the veins of your legs and lungs and stop taking PRADAXA before your doctor told you to, you are at risk of developing a blood clot in a vein of your leg or in the lungs, which can be life-threatening.

If you have atrial fibrillation and stop taking PRADAXA without talking to your doctor, you are at risk of suffering from a stroke or other complications due to blood clot formation, which can be fatal or lead to severe disability.