Pradaxa 150 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pradaxa 150mg hard capsules

dabigatran etexilate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents

1. What Pradaxa is and what it is used for
2. What you need to know before taking Pradaxa
3. How to take Pradaxa
4. Possible side effects
5. How to store Pradaxa
6. Contents of the pack and other information

1. What Pradaxa is and what it is used for

Pradaxa contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in blood clot formation.

Pradaxa is used in adults to:

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

• treat blood clots in the veins of your legs and lungs and to prevent the recurrence of blood clots in the veins of your legs and lungs.

Pradaxa is used in children to:

• treat blood clots and to prevent the recurrence of blood clots.

2. What you need to know before taking Pradaxa

Do not take Pradaxa

• if you are allergic to dabigatran etexilate or to 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 a disease in an organ of your body that increases the risk of serious bleeding (e.g., stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be congenital, of unknown cause, or caused by other medicines.
• if you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment, while you have 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 impaired or you have a liver disease that could be life-threatening.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation.
• 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 lifelong anticoagulant treatment.

Warnings and precautions

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

Tell your doctor if you have or have had any disorder or illness, especially any of the following:

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

• if you have recently had bleeding.

• if you have undergone a surgical tissue removal (biopsy) within the last month.

• if you have suffered a serious injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment).

• if you have inflammation of the oesophagus or stomach.

• if you have problems with gastric juice reflux into the oesophagus.

• if you are receiving medicines that may increase the risk of bleeding. See “Other medicines and Pradaxa” below.

• if you are using anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam.

• if you have an infection in the heart (bacterial endocarditis).

• if you know you have reduced kidney function or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark [concentrated]/foamy urine).

• if you are over 75 years old.

• if you are an adult and weigh 50 kg or less.

• only if used in children: if the child has an infection in or around the brain.

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

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

Take special care with Pradaxa

• If you need to undergo surgery:

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

• If surgery requires 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 before and after surgery exactly as directed by your doctor.

• Inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia wears off, as this situation requires urgent medical attention.

• If you fall or get injured during treatment, especially if you hit your head. Seek urgent medical help. You may need to be examined by a doctor, as you may be at increased risk of bleeding.

• If you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether treatment adjustment may be necessary.

Other medicines and Pradaxa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, you must inform your doctor before taking Pradaxa 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 to treat fungal infections (e.g., ketoconazole, itraconazol), except if applied only on the skin
• Medicines used to treat abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil)

If you are taking medicines containing verapamil, your doctor may advise you to use a reduced dose of Pradaxa depending on the condition for which it has been prescribed. See section 3.

• Medicines used to prevent organ rejection after transplantation (e.g., tacrolimus, cyclosporine)
• A combination product of glecaprevir 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 herbal remedy for depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-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 unborn baby are unknown. You should not use this medicine during pregnancy unless your doctor tells you it is safe. If you are of childbearing age, you should avoid becoming pregnant while being treated with Pradaxa.

Breastfeeding is not recommended during treatment with Pradaxa.

Driving and using machines

Pradaxa has no known effects on the ability to drive or operate machinery.

3. How to take Pradaxa

Pradaxa capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. Pradaxa granules for oral suspension are available for treatment of children under 12 years of age, as soon as they are able to swallow soft foods.

Always follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor again.

Take Pradaxa as recommended for the following conditions:

Prevention of stroke or systemic embolism due to blood clots caused by irregular heartbeat, 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 given as one 150 mg capsule twice daily.

If you are 80 years of age or older, the recommended dose is 220 mg given as one 110 mg capsule twice daily.

If you are taking medicines containing verapamil, you will be prescribed a reduced dose of Pradaxa of 220 mg given as one 110 mg capsule twice daily, because your risk of bleeding may be increased.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg given as one 110 mg capsule twice daily.

You may continue taking this medicine if your normal heart rhythm is restored by a procedure called cardioversion or by a procedure called catheter ablation for atrial fibrillation. Take Pradaxa exactly as directed by your doctor.

If you have received a medical device (vascular stent) implanted in a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stent placement, you may be treated with Pradaxa once your doctor has determined that normal blood clotting control has been achieved. Take Pradaxa exactly as directed by your doctor.

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

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

The recommended dose depends on body weight and age. Your doctor will determine the correct dose. Your doctor may adjust your dose during treatment. Continue taking all other medications unless your doctor tells you to stop any of them.

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

Table 1: Dosing table for Pradaxa capsules

Single doses requiring combinations of more than one capsule:

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

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

220 mg: two 110 mg capsules

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

150 mg: one 150 mg capsule or
two 75 mg capsules

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 blister packs

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

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

Peel back the backing film and remove the capsule.

• Do not push the capsules through the blister foil.
• Do not peel back the blister foil until the capsule is needed.

Instructions for the bottle

• Press and twist to open.
• After removing the capsule, replace the closure cap on the bottle and close the bottle tightly immediately after taking your dose.

Switching 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 medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

If you forget to take Pradaxa

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

A missed dose should be omitted if less than 6 hours remain before the next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Pradaxa

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Pradaxa acts on blood clotting; therefore, most adverse effects are related to signs such as bruising or bleeding. Episodes of major or severe bleeding may occur, which represent the most serious adverse effects and, regardless of their location, may lead to disability, may be potentially fatal, or even result in death. In some cases, this bleeding may not be obvious.

If you experience any episode of bleeding that does not stop on its own, or if you experience signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to monitor you closely or switch your medication.

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

The possible adverse effects are listed below, grouped according to their frequency of occurrence.

Prevention of cerebrovascular or systemic vascular occlusion due to blood clots following irregular heartbeat

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

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

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

• Bleeding
• Bleeding may occur from hemorrhoids, rectum, or brain
• Bruising
• Coughing up blood or sputum with blood streaks
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function tests

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

• Bleeding may occur in a joint, at a surgical incision site, in a wound, at an injection site, or at the site where a venous catheter is inserted
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with dark red, raised, itchy bumps caused by an allergic reaction
• Decrease in blood cell count
• Increase in liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders

Frequency not known (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in the number or even absence of white blood cells (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 the legs and lungs, including prevention of recurrence of blood clots in the legs and/or lungs

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

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

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

• Bleeding
• Bleeding may occur in a joint or wound
• Bleeding may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Bruising
• Coughing up blood or sputum with blood streaks
• Allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Feeling nauseous
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or watery stools
• Abnormal liver function tests
• Increase in liver enzymes

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

• Bleeding may occur at a surgical incision site, at an injection site, at the site where a venous catheter is inserted, or from the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with dark red, raised, itchy bumps caused by an allergic reaction
• Difficulty swallowing

Frequency not known (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in blood cell count
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders
• Hair loss

In the clinical trial program, the rate of heart attacks with Pradaxa was higher than with warfarina. 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):

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Skin rash with dark red, raised, itchy bumps caused by an allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Bruising
• Nosebleed
• Gastric juice reflux into the esophagus
• Vomiting
• Feeling nauseous
• Frequent loose or watery stools
• Indigestion
• Hair loss
• Increase in liver enzymes

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur from the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in urine that turns the urine pink or red), or under the skin
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in blood cell count
• Itching
• Coughing up blood or sputum with blood streaks
• Abdominal pain or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders

Frequency not known (frequency cannot be estimated from available data):

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or wound, at a surgical incision site, at an injection site, or at the site where a venous catheter is inserted
• Bleeding may occur from hemorrhoids
• Stomach or intestinal ulcer (including esophageal ulcer)
• Abnormal liver function tests

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pradaxa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, blister pack, or bottle after "EXP". The expiry date refers to the last day of the month indicated.

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

Bottle: After first opening, the medicine should be used within 4 months. Keep the bottle tightly closed. Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Pradaxa

• The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).

• The other components are tartaric acid, arabic gum, hypromellose, simethicone 350, talc and hydroxypropylcellulose.

• The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine and hypromellose.

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

Nature of the product and contents of the container

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

This medicine is available in packs containing 10 × 1, 30 × 1 or 60 × 1 hard capsules, a multipack containing 3 packs of 60 × 1 hard capsules (180 hard capsules), or a multipack containing 2 packs of 50 × 1 hard capsules (100 hard capsules) in perforated aluminum unit-dose blisters. Additionally, Pradaxa is available in packs containing 60 × 1 hard capsules in white perforated aluminum unit-dose blisters.

This medicine is also available in polypropylene (plastic) bottles containing 60 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Manufacturer

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

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent approval of this package leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.