Pradaxa 150 mg capsulas duras

Prescribing Information for the Patient

Pradaxa 150mg Hard Capsules

dabigatrán etexilato

Read this entire prescribing information carefully before starting to take this medication, because it contains important information for you.

• Keep this prescribing information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prescribing information. See section 4.

1.What is Pradaxa and how is it used

2.What you need to know before starting to take Pradaxa

3.How to take Pradaxa

4.Possible adverse effects

5.Storage of Pradaxa

6.Contents of the package and additional information

Pradaxa contains the active ingredient dabigatrán etexilate and belongs to a group of medications known as anticoagulants. It works by blocking a substance in the body involved in the formation of blood clots.

Pradaxa is used in adults for:

• preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body if you have a type of irregular heart rhythm called non-valvular atrial fibrillation and have at least one additional risk factor.

• treating blood clots in the veins of your legs and lungs and to prevent new blood clots from forming in the veins of your legs and lungs.

Pradaxa is used in children for:

• treating blood clots and preventing new blood clots from forming.

Do not take Pradaxa

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you are currently experiencing bleeding.
• if you have any disease in an organ of the body that increases the risk of severe bleeding (e.g., stomach ulcer, head injury or bleeding, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be congenital, unknown or caused by other medicines.
• if you are taking medicines to prevent blood clotting in the blood (e.g., warfarin, rivaroxaban, apixaban or heparin), except when changing from one anticoagulant treatment to another, while having a venous or arterial catheter and heparin is administered through this catheter to keep it open or while your normal heart rhythm is being restored by a procedure called catheter ablation for atrial fibrillation.
• if your liver function is severely reduced or if you have any liver disease that may be fatal.
• if you are taking ketoconazole oral or itraconazole, medicines used in the treatment of fungal infections.
• if you are taking ciclosporin oral, a medicine used to prevent organ rejection after a transplant.
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had an artificial heart valve implanted that requires permanent anticoagulant treatment.

Warnings and precautions

Consult your doctor before starting to take Pradaxa. During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you are to undergo surgery.

Inform your doctorif you have or have had any disorder or disease, especially any of the following:

• If you have an increased risk of bleeding, for example:

• if you have recently experienced bleeding.
• if you have had a surgical tissue extraction (biopsy) in the last month.

• if you have had a severe injury (e.g., a bone fracture, a head injury or any injury that required surgical treatment).
• if you have inflammation of the oesophagus or stomach.
• if you have problems with reflux of stomach acid into the oesophagus.

• if you are taking medicines that may increase the risk of bleeding. See“Other medicines and Pradaxa”below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen or piroxicam.
• if you have a bacterial infection of the heart (bacterial endocarditis).
• if you know that your kidneys are not functioning properly or if you are dehydrated (the symptoms include feeling thirsty and passing small amounts of dark-coloured (concentrated) or foamy urine).
• if you are over 75 years old.
• ifyou are an adult andyou weigh50kgor less.
• only if used in children: if the child has an infection in the brain or around it.

• if you have had a heart attack or if you have been diagnosed with diseases that increase the risk of having a heart attack.

• if you have a liver disease associated with changes in blood tests. The use of this medicine is not recommended in this case.

Be especially careful with Pradaxa

• if you are to undergo surgery:

In this case,Pradaxa must be temporarily interrupted due to an increased risk of bleeding during and shortly after surgery.It is very important that you take Pradaxa exactly as instructed by your doctor before and after surgery.

• if surgery requires the placement of a catheter or injection into the spine (e.g., for epidural or spinal anaesthesia or for pain relief):

• It is very important that you take Pradaxa exactly as instructed by your doctor before and after surgery.
• Inform your doctor immediately if you experience numbness or weakness in your legs or problems with your intestines or bladder after the end of anaesthesia, as this requires urgent attention.

• if you fall or are injured during treatment, especially if you hit your head. Seek urgent medical attention. You may need a doctor to examine you, as you may have an increased risk of bleeding.

• if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), inform your doctor so that they can decide if your treatment needs to be modified.

Other medicines and Pradaxa

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.Particularly, inform your doctor before takingPradaxa if you are taking any of the following medicines:

• Medicines to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines used in the treatment of fungal infections (e.g., ketoconazole, itraconazole), except when applied to the skin.
• Medicines used in the treatment of abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil).

If you are taking medicines that contain verapamil, your doctor may instruct you to use a reduced dose of Pradaxa according to the disease for which you have been prescribed it. See section3.

• Medicines used to prevent organ rejection after a transplant (e.g., tacrolimus, ciclosporin).
• A combination product ofglecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• Anti-inflammatory and pain-relieving medicines (e.g., acetylsalicylic acid, ibuprofen, diclofenac).
• St. John's Wort, a medicinal herb for depression.
• Antidepressants called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (two antibiotics).
• Antiviral medicines for HIV/AIDS (e.g., ritonavir).
• Certain medicines used to treat epilepsy (e.g., carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effects of Pradaxa on pregnancy and the fetus are unknown. Do not use this medicine if you are pregnant unless your doctor tells you it is safe to do so. If you are of childbearing age, avoid becoming pregnant during treatment with Pradaxa.

Do not breastfeed during treatment with Pradaxa.

Driving and operating machines

Pradaxa has no known effects on the ability to drive and operate machines.

Pradaxa capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. Pradaxa granulated coating is available for the treatment of children under 12 years old when they are able to swallow soft foods.

Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, consult your doctor again.

Take Pradaxa as recommended for the following situations:

Prevention of arterial or systemic thromboembolism developed after abnormal heart rhythm and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of blood clots in the veins of your legs and lungs

The recommended dose is 300 mg administered in the form ofone capsule of 150 mg twice a day.

If you are80 years of age or older, the recommended dose is 220 mg administered in the form ofone capsule of 110 mg twice a day.

If you are usingmedicines containing verapamil, you should be instructed on a reduced dose of Pradaxa of 220 mg taken in the form ofone capsule of 110 mg twice a day, as your risk of bleeding may increase.

If you have apotentially higher risk of bleeding, your doctor may decide to prescribe a dose of 220 mg administered in the form ofone capsule of 110 mg twice a day.

You can continue taking this medication if necessary to restore your normal heart rhythm by a procedure called cardioversion or by a procedure calledablation with catheter for atrial fibrillation. Take Pradaxa as instructed by your doctor.

If you have had a medical device (vascular endoprosthesis) placed in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with vascular endoprosthesis placement, you can receive treatment with Pradaxa once your doctor has decided that normal blood coagulation has been achieved. Take Pradaxa as instructed by your doctor.

Treatment of blood clots and prevention of recurrence of blood clots in children

Pradaxa should be taken twice a day, one dose in the morning and one dose in the evening, approximately at the same time every day. The administration interval should be as close as possible to 12 hours.

The recommended dose depends on weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Follow all other medications unless your doctor tells you to stop using one.

The table 1 shows the single doses and total daily doses of Pradaxa in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.

Table1:Table of posology for Pradaxa capsules

Single doses that require combinations of more than one capsule:

300 mg:two capsules of 150 mg or
four capsules of 75 mg

260 mg:one capsule of 110 mg plus one capsule of 150 mg or
one capsule of 110 mg plus two capsules of 75 mg

220 mg:two capsules of 110 mg

185 mg:one capsule of 75 mg plus one capsule of 110 mg

150 mg:one capsule of 150 mg or

two capsules of 75 mg

How to take Pradaxa

Pradaxa can be taken with or without food. The capsule should be swallowed whole with a glass of water, to ensure release in the stomach. Do not break, chew, or open the capsule to take only its contents, as this may increase the risk of bleeding.

Instructions for opening the blisters

The following images illustrate how to extract the Pradaxa capsules from the blister:

Separate an individual blister from the blister strip through the perforated line.

Remove the rear sheet and extract the capsule.

• Do not press the capsules through the blister sheet.
• Do not remove the blister sheet until the capsule is needed.

Instructions for the bottle

• Press and turn to open.
• After removing the capsule, put the closure capsule back in the bottle and close the bottle immediately after taking your dose.

Change in anticoagulant treatment

Do not change your anticoagulant treatment without specific instructions from your doctor.

If you take more Pradaxa than you should

Taking too much of this medicationincreases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. There are specific treatment options available.

If you forget to take Pradaxa

A missed dose can be taken up to 6 hours before the next dose.

A missed dose should be omitted if the remaining time before the next dose is less than 6 hours. Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Pradaxa

Take Pradaxa exactly as prescribed. Do not interrupt your treatment with this medication without consulting your doctor first, as the risk of developing a blood clot may be higher if you interrupt treatment too soon. Contact your doctor if you experience indigestion after taking Pradaxa.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Pradaxa works on blood clotting; therefore, most side effects are related to signs such as bruising or bleeding.Severe or life-threatening bleeding episodes, which are the most serious side effects, can occur regardless of their location and may cause disability, be potentially fatal, or even cause death. In some cases, these bleeding episodes may not be apparent.

If you experience any bleeding episode that does not stop on its own or if you experience signs of excessive bleeding (exceptional weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to keep you under close observation or change your medication.

Inform your doctor immediately if you experience a severe allergic reaction that causes difficulty breathing or dizziness.

The possible side effects are listed below, grouped by frequency of occurrence.

Prevention of cerebral or systemic vascular occlusion due to blood clot formation developed after abnormal heart rhythm

Frequent (may affect up to 1 in 10 people):

• Bleeding may occur from the nose, stomach, or intestines, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin
• Decreased number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Feeling like vomiting

Rare (may affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur from hemorrhoids, rectum, or brain
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Decreased number of platelets in the blood
• Decreased hemoglobin level in the blood (the substance present in red blood cells)
• Allergic reaction
• Sudden change in skin that affects color and physical appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflex of stomach acid into the esophagus
• Vomiting
• Difficulty swallowing
• Anomalies in liver function tests

Rare (may affect up to 1 in 10,000 people):

• Bleeding may occur in a joint, surgical incision site, wound, injection site, or catheter site in a vein
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes facial or throat swelling
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction
• Decreased proportion of blood cells
• Increased liver enzymes
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems

Unknown frequency (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decreased number or even absence of leukocytes (which help fight infections)
• Hair loss

In a clinical trial, the rate of heart attacks with Pradaxa was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of blood clots in the veins of your legs and/or lungs

Frequent (may affect up to 1 in 10 people):

• Bleeding may occur from the nose, stomach, or intestines, rectum, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin
• Indigestion

Rare (may affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur in a joint or wound
• Bleeding may occur from hemorrhoids
• Decreased number of red blood cells in the blood
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Allergic reaction
• Sudden change in skin that affects color and physical appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflex of stomach acid into the esophagus
• Vomiting
• Difficulty swallowing
• Anomalies in liver function tests
• Increased liver enzymes

Rare (may affect up to 1 in 10,000 people):

• Bleeding may occur in a surgical incision site, injection site, or catheter site in a vein or from the brain
• Decreased number of platelets in the blood
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes facial or throat swelling
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction
• Difficulty swallowing

Unknown frequency (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decreased hemoglobin level in the blood (the substance present in red blood cells)
• Decreased proportion of blood cells
• Decreased number or even absence of leukocytes (which help fight infections)
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems
• Hair loss

In the clinical trial program, the rate of heart attacks with Pradaxa was higher than with warfarin. The overall incidence was low. No imbalance in the rate of heart attacks was observed in patients treated with dabigatran compared to patients treated with placebo.

Treatment of blood clots and prevention of recurrence of blood clots in children

Frequent (may affect up to 1 in 10 people):

• Decreased number of red blood cells in the blood
• Decreased number of platelets in the blood
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction
• Sudden change in skin that affects color and physical appearance
• Formation of hematomas
• Nasal bleeding
• Reflex of stomach acid into the esophagus
• Vomiting
• Feeling like vomiting
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

Rare (may affect up to 1 in 100 people):

• Decreased number of leukocytes (which help fight infections)
• Bleeding may occur from the stomach or intestines, brain, rectum, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin
• Decreased hemoglobin level in the blood (the substance present in red blood cells)
• Decreased proportion of blood cells
• Itching
• Coughing up blood or sputum with blood spots
• Abdominal pain or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems

Unknown frequency (frequency cannot be estimated from available data):

• Decreased number or even absence of leukocytes (which help fight infections)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or wound, surgical incision site, injection site, or catheter site in a vein
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Anomalies in liver function tests

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directlythrough the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, blister pack, or bottle after “CAD”. The expiration date is the last day of the month indicated.

Blister pack:Store in the original packaging to protect it from moisture.

Bottle:Once opened, the medication must be used within 4months. Keep the bottle perfectly closed. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pradaxa

• The active ingredient is dabigatran. Each hard capsule contains 150mg of dabigatran etexilate (in the form of mesilate).

• The other components aretartric acid, gum arabic, hypromellose, dimethicone 350, talc, and hydroxypropylcellulose.

• The capsule coating contains carrageenan, potassium chloride, titanium dioxide, indigo carminee and hypromellose.

• The black ink contains shellac,iron oxide black and potassium hydroxide.

Appearance of the product and contents of the pack

Pradaxa 150mg are hard capsules(approximately 22×8mm)with a light blue opaque cap and a white opaque body. The Boehringer Ingelheim logo is printed on the cap and the code “R150”, on the hard capsule body.

This medicinal product is available in packs containing 10×1, 30×1 or 60×1 hard capsules, a multiple pack containing 3packs of 60×1 hard capsules (180hard capsules) or a multiple pack containing 2packs of 50×1 hard capsules (100hard capsules) in perforated aluminium unit dose blisters. Additionally, Pradaxa is available in packs containing 60×1 hard capsules in white perforated aluminium unit dose blisters.

This medicinal product is also available in polypropylene (plastic) bottles with 60hard capsules.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Responsible Person

Boehringer Ingelheim Pharma GmbH & Co.KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

and

Boehringer Ingelheim France

100-104 avenue de France

75013 Paris

France

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Last approval date of this leaflet:

The detailed information on this medicinal product isavailable on the website of the European Medicines Agency:http://www.ema.europa.eu/.