Pradaxa: detailed information

Patient Information Leaflet

Pradaxa 75 mg hard capsules

dabigatran etexilate
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Pradaxa is and what it is used for
What you need to know before taking Pradaxa
How to take Pradaxa
Possible side effects
How to store Pradaxa
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 blocks the action of a substance in the body involved in blood clotting.
Pradaxa is used in adults for:

preventing the formation of blood clots in veins following surgery to replace the knee or hip.

Pradaxa is used in children for:

treating blood clots and preventing the formation of new 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 organ injuries that increase the risk of severe bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent brain or eye surgery).
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place and heparin is administered through it to keep it open, or when your heartbeat is being restored to normal via a procedure called trans-catheter ablation for atrial fibrillation.
if you have severely reduced liver function or a liver disease that could potentially 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 transplant rejection.
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
if you have had an artificial heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Pradaxa. You may also need to consult your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for surgery.
Inform your doctor if you currently have or have previously had any medical condition or illness, especially any of the following:

if you are at increased risk of bleeding, such as:
if you have recently experienced bleeding.
if you have undergone a biopsy (surgical removal of tissue) within the previous month.
if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgical intervention).
if you suffer from inflammation of the oesophagus or stomach.
if you have gastroesophageal reflux disease (acid reflux into the oesophagus).
if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Pradaxa” below.
if you are taking non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, ibuprofen, piroxicam.
if you have an infection of the heart (bacterial endocarditis).
if you know that your kidney function is reduced or if you are dehydrated (symptoms include feeling thirsty and reduced urination of dark, concentrated, or foamy urine).
if you are over 75 years of age.
if you are an adult weighing 50 kg or less.
only for use in children: if the child has an infection around or within the brain.
if you have had a heart attack or if you have been diagnosed with conditions that increase your risk of having a heart attack.
if you have liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with Pradaxa

if you are scheduled for surgery: In this case, Pradaxa will need to be temporarily discontinued due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Pradaxa exactly at the times instructed by your doctor, both before and after surgery.
if a procedure involves placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anaesthesia or for pain relief):
it is very important to take Pradaxa exactly at the times instructed by your doctor, both before and after the procedure.
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 urgent medical attention may be required.
if you fall or injure yourself during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may consider it necessary to examine you, as you may be at high 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, who will decide whether a change in therapy is needed.

Other medicines and Pradaxa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking Pradaxa if
you are taking any of the following medicines:

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines for treating fungal infections (e.g. ketoconazole, itraconazolo), unless applied topically only
Medicines for treating irregular heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a reduced dose of Pradaxa depending on the condition for which it has been prescribed. See also section 3
Medicines to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine)
The combination 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 medicine used for depression
Antidepressants called selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)
Rifampicin or clarithromycin (two antibiotics)
Antiviral medicines for acquired immunodeficiency syndrome (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 must not take this medicine during pregnancy unless your doctor tells you it is safe to do so. If you are a woman of childbearing potential, you must avoid pregnancy during treatment with Pradaxa.
You must not breastfeed while taking Pradaxa.

Driving and using machines
Pradaxa has no known effect on the ability to drive vehicles or operate machinery.

3. How to take Pradaxa

Take Pradaxa as recommended for the following conditions:

Prevention of blood clots after knee or hip replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you must take a reduced dose of Pradaxa of 75 mg, as the risk of bleeding may increase.

For both types of surgery, treatment must not be started if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, administration should begin with a dose of 2 capsules once daily.

After knee replacement surgery
You should start treatment with Pradaxa within 1–4 hours after completion of surgery, taking one single capsule. Afterwards, take two capsules once daily for a total of 10 days.

After hip replacement surgery
You should start treatment with Pradaxa within 1–4 hours after completion of surgery, taking one single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.

Treatment and prevention of blood clots in children
Pradaxa should be taken twice daily, one dose in the morning and one 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 the patient's weight and age. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.

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

Weight/age combinations		Single dose in mg	Total daily dose in mg
Weight in kg	Age in years	Single dose in mg	Total daily dose in mg
from 11 to less than 13 kg	from 8 to less than 9 years	75	150
from 13 to less than 16 kg	from 8 to less than 11 years	110	220
from 16 to less than 21 kg	from 8 to less than 14 years	110	220
from 21 to less than 26 kg	from 8 to less than 16 years	150	300
from 26 to less than 31 kg	from 8 to less than 18 years	150	300
from 31 to less than 41 kg	from 8 to less than 18 years	185	370
from 41 to less than 51 kg	from 8 to less than 18 years	220	440
from 51 to less than 61 kg	from 8 to less than 18 years	260	520
from 61 to less than 71 kg	from 8 to less than 18 years	300	600
from 71 to less than 81 kg	from 8 to less than 18 years	300	600
81 kg or more	from 10 to less than 18 years	300	600

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 gastric release. Do not break, chew, or remove the granules from the capsule, 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 pack.

Diagram with number 1 and a folded gray sheet with dashed lines and black arrows indicating the opening movement toward the

Separate one unit from the entire blister pack along the perforated line.

Diagram with number 2 and a black arrow indicating direction toward the

Lift the aluminium foil on the back and remove the capsule.

Do not push the capsules through the aluminium foil of the blister pack.
The aluminium foil of the blister pack should only be lifted when a capsule needs to be removed.

Instructions for opening the bottle

Open the bottle by pressing and turning the cap.
After removing the capsule, replace the cap on the bottle and close it tightly immediately after taking the dose.

Switching anticoagulant therapy
Do not change your anticoagulant treatment without receiving 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 an excessive number of capsules. Specific treatment options are available.

If you forget to take Pradaxa
Prevention of blood clots after knee or hip replacement surgery:
Continue with the remaining daily doses of Pradaxa at your usual time the next day.
Do not take a double dose to make up for a missed dose.

Treatment and prevention of recurrence of blood clots in children:
The missed dose may still be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped.
Do not double the dose to make up for a missed dose.

If you stop taking Pradaxa
Take Pradaxa exactly as prescribed. Do not stop taking this medicine without first talking to 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 stomach discomfort after taking Pradaxa.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Pradaxa acts on the blood coagulation system; therefore, most side effects are related to signs such as bruising or bleeding. Major or severe bleeding events may occur, which represent the most serious side effects and, regardless of location, may be disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you experience symptoms of excessive bleeding (unusual weakness, feeling of tiredness, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to perform a thorough check-up or change your treatment.
Contact your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.
The possible side effects are listed below, grouped according to frequency of occurrence.

Prevention of blood clots after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Abnormal liver function test results

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

Bleeding that may occur from the nose, stomach or intestines, penis/vagina, or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or after a wound, following surgery
Development of haematoma or haematoma occurring after surgery
Presence of blood in the stool, detected by laboratory test
Decrease in the number of red blood cells in the blood
Decrease in the proportion of blood cells
Allergic reaction
Vomiting
Diarrhoea with loose or watery stools
Feeling unwell
Wound discharge (leakage of fluid from the surgical wound)
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood

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

Bleeding
Bleeding that may occur in the brain, from a surgical incision, injection site, or catheter insertion site in a vein
Blood-stained discharge from the catheter insertion site in a vein
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the number of red blood cells in the blood after surgery
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
Sudden skin alteration changing its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Gastro-oesophageal reflux
Abdominal or stomach pain
Indigestion
Difficulty swallowing
Fluid leaking from a wound
Fluid leaking from a wound after surgery

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

Treatment of blood clots and prevention of recurrence of blood clots in children
Common (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
Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
Sudden skin alteration changing its colour and appearance
Haematoma formation
Nosebleed
Gastro-oesophageal reflux
Vomiting
Feeling unwell
Diarrhoea with loose or watery stools
Indigestion
Hair loss
Increased liver enzymes

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

Decrease in the number of white blood cells (which help fight infections)
Bleeding that may occur in the stomach or intestines, brain, rectum, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
Itching
Coughing up blood or blood-stained sputum
Abdominal or stomach pain
Inflammation of the oesophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood

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 that may occur in a joint or from a wound, surgical incision, injection site, or catheter insertion site in a vein
Bleeding that may occur from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Abnormal liver function test results

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Pradaxa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister or bottle after
Exp. The expiry date refers to the last day of that month.
Blister: Store in the original packaging to protect the medicine 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 the medicine from moisture.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Pradaxa contains

The active substance is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate).
The other components are tartaric acid, acacia gum, hypromellose, dimethicone 350, talc, and hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide, and hypromellose.
The printing ink contains shellac, black iron oxide, and potassium hydroxide.

Description of the appearance of Pradaxa and the contents of the pack
Pradaxa 75 mg capsules (approximately 18 x 6 mm) are hard capsules with an opaque white cap and an opaque white body. The Boehringer Ingelheim logo is printed on the cap and the code “R75” on the body of the hard capsule.
This medicinal product is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in aluminium blisters, divided into single doses. Pradaxa is also available in packs containing 60 x 1 hard capsules in white aluminium blisters, divided into single doses.
This medicinal product is also available in polypropylene (plastic) bottles containing 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization 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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien
SCS Boehringer Ingelheim Comm.V
Tél/Tel: +32 2 773 33 11

Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel: +370 5 2595942

България
Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ – клон България
Тел: +359 2 958 79 98

Luxembourg/Luxemburg
SCS Boehringer Ingelheim Comm.V
Tél/Tel: +32 2 773 33 11

Česká republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111

Magyarország
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe
Tel: +36 1 299 8900

Danmark
Boehringer Ingelheim Danmark A/S
Tlf: +45 39 15 88 88

Malta
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG
Tel: +49 (0) 800 77 90 900

Nederland
Boehringer Ingelheim b.v.
Tel: +31 (0) 800 22 55 889

Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti filiaal
Tel: +372 612 8000

Norge
Boehringer Ingelheim Norway KS
Tlf: +47 66 76 13 00

Ελλάδα
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300

Österreich
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870

España
Boehringer Ingelheim España S.A.
Tel: +34 93 404 51 00

Polska
Boehringer Ingelheim Sp. z o.o.
Tel: +48 22 699 0 699

France
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33

Portugal
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00

Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600

România
Boehringer Ingelheim RCV GmbH & Co KG
Viena - Sucursala Bucuresti
Tel: +40 21 302 2800

Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Slovenija
Boehringer Ingelheim RCV GmbH & Co KG
Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Boehringer Ingelheim RCV GmbH & Co KG
organizačná zložka
Tel: +421 2 5810 1211

Italia
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1

Suomi/Finland
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800

Κύπρος
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300

Sverige
Boehringer Ingelheim AB
Tel: +46 8 721 21 00

Latvija
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Tel: +371 67 240 011

United Kingdom (Northern Ireland)
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

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

Patient information leaflet

Pradaxa 110 mg hard capsules

dabigatran etexilate
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Pradaxa is and what it is used for
What you need to know before taking Pradaxa
How to take Pradaxa
Possible side effects
How to store Pradaxa
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 known as anticoagulants. It blocks the action of a substance in the body that is involved in blood clot formation.

Pradaxa is used in adults for:

preventing the formation of blood clots in the veins following surgery to replace the hip or knee.
preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one additional risk factor.
treating blood clots in the veins of the legs and lungs, and preventing new blood clots from forming in the veins of the legs and lungs.

Pradaxa is used in children for:

treating blood clots and preventing the formation of new blood clots.

2. What you should 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 lesions in an organ that increase the risk of severe bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent brain or eye surgery).
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place and you are receiving heparin through it to keep it open, or when your heartbeat is being restored to normal through a procedure called catheter ablation for atrial fibrillation.
if you have severely reduced liver function or a liver disease that could potentially lead to death.
if you are taking oral ketoconazole or itraconazolo, medicines used to treat fungal infections.
if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
if you have had a mechanical heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Pradaxa. You may also need to consult your doctor during treatment with this medicine if you develop symptoms or need to undergo surgery.
Tell your doctor if you have or have had any medical condition or illness, especially any of the following:

if you have an increased risk of bleeding, such as:
if you have recently experienced bleeding.
if you have undergone a biopsy (surgical removal of tissue) within the previous month.
if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgical intervention).
if you suffer from inflammation of the oesophagus or stomach.
if you have gastroesophageal reflux disease (acid reflux into the oesophagus).
if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Pradaxa” below.
if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
if you have an infection of the heart (bacterial endocarditis).
if you know that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and reduced urination of dark (concentrated)/foamy urine).
if you are over 75 years old.
if you are an adult and weigh 50 kg or less.
only for use in children: if the child has an active infection around or within the brain.
if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
if you have liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with Pradaxa

if you need to undergo surgery: In this case, you will need to temporarily stop taking Pradaxa due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Pradaxa exactly at the times instructed by your doctor, both before and after surgery.
if a procedure involves placement of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
it is very important to take Pradaxa exactly at the times instructed by your doctor, both before and after the procedure.
inform your doctor immediately if you experience numbness or weakness in your legs, or problems with your bowels or bladder after the anaesthesia wears off, as urgent medical attention is required.
if you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may decide that you need to be examined, as you may be at high 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, who will decide whether a change in therapy is necessary.

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines for fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
Medicines for irregular heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a lower dose of Pradaxa depending on the condition for which it has been prescribed. See section 3.
Medicines to prevent transplant rejection (e.g. tacrolimus, cyclosporine)
The combination 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 medicine used to treat depression
Antidepressants called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
Rifampicin or clarithromycin (two antibiotics)
Antiviral medicines for acquired immunodeficiency syndrome (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 must not take this medicine during pregnancy unless your doctor tells you it is safe to do so. If you are a woman of childbearing age, you must avoid becoming pregnant while being treated with Pradaxa.
You must not breastfeed while being treated with Pradaxa.

Driving and using machines
Pradaxa has no known effects on the ability to drive or operate machinery.

3. How to take Pradaxa

Take Pradaxa as recommended for the following conditions:

Prevention of blood clots after knee or hip replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).

If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).

If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).

If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you must take a reduced dose of Pradaxa of 75 mg, because the risk of bleeding may increase.

For both surgeries, treatment must not be started if there is bleeding at the surgical site. If treatment cannot be started until the day after surgery, administration should begin with a dose of 2 capsules once daily.

After knee replacement surgery
Begin treatment with Pradaxa within 1–4 hours after completion of surgery, taking one single capsule. Then take two capsules once daily for a total of 10 days.

After hip replacement surgery
Begin treatment with Pradaxa within 1–4 hours after completion of surgery, taking one single capsule. Then take two capsules once daily for a total of 28–35 days.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots caused by irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of such clots
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.

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

If you are taking medicines containing verapamil, you must take a reduced dose of Pradaxa of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.

If you are potentially at increased risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice daily.

You may continue taking this medicine if your heart rhythm needs to be restored to normal through a procedure called cardioversion. Take Pradaxa as instructed by your doctor.

If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Pradaxa once your doctor has determined that normal control of blood clotting has been achieved. Take Pradaxa as instructed by your doctor.

Treatment of blood clots and prevention of new blood clots in children
Pradaxa should be taken twice daily, one dose in the morning and one 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 the patient’s weight and age. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.

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

Table 1: Dosing table for Pradaxa capsules

Weight/Age Combinations		Single Dose in mg	Total Daily Dose in mg
Weight in kg	Age in years	Single Dose in mg	Total Daily Dose in mg
from 11 to less than 13 kg	from 8 to less than 9 years	75	150
from 13 to less than 16 kg	from 8 to less than 11 years	110	220
from 16 to less than 21 kg	from 8 to less than 14 years	110	220
from 21 to less than 26 kg	from 8 to less than 16 years	150	300
from 26 to less than 31 kg	from 8 to less than 18 years	150	300
from 31 to less than 41 kg	from 8 to less than 18 years	185	370
from 41 to less than 51 kg	from 8 to less than 18 years	220	440
from 51 to less than 61 kg	from 8 to less than 18 years	260	520
from 61 to less than 71 kg	from 8 to less than 18 years	300	600
from 71 to less than 81 kg	from 8 to less than 18 years	300	600
81 kg or more	from 10 to less than 18 years	300	600

How to take Pradaxa
Pradaxa can be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure gastric release. Do not break, chew, or remove the granules from the capsule, 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 pack.

Diagram with number 1 showing a folded sheet with dashed lines and black arrows indicating the

Separate one unit from the entire blister pack along the perforated line.

Numbered diagram with a black arrow pointing toward the

Lift the aluminium foil on the back and remove the capsule.

Do not push the capsules through the aluminium foil of the blister.
The aluminium foil of the blister should be lifted only when a capsule needs to be removed.

Instructions for opening the bottle

The bottle is opened by pressing and turning the cap.
After removing the capsule, replace the cap on the bottle and close it tightly immediately after taking the dose.

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

If you forget to take Pradaxa
Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of Pradaxa at the usual time the next day.
Do not take a double dose to make up for the missed dose.

Use in adults: prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots caused by irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of such clots
Use in children: treatment of blood clots and prevention of recurrence of blood clots
The missed dose may still be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped.
Do not double the dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Pradaxa acts on the blood's clotting system; therefore, most side effects are related to signs such as bruising or bleeding. Major or serious bleeding events may occur, which represent the most serious side effects and, regardless of location, may be disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to perform a thorough check-up or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.
The possible side effects are listed below, grouped according to frequency of occurrence.

Prevention of blood clots after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Abnormal liver function test results

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

Bleeding that may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or after a wound, following surgery
Haematoma formation or haematoma occurring after surgery
Presence of blood in the faeces, detected by laboratory test
Decrease in the number of red blood cells in the blood
Decrease in the proportion of blood cells
Allergic reaction
Vomiting
Diarrhoea with loose or watery stools
Feeling unwell
Wound secretion (fluid leakage from the surgical wound)
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

Bleeding
Bleeding that may occur in the brain, from a surgical incision, injection site, or catheter insertion site in a vein
Blood-stained discharge from the site of catheter insertion in a vein
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the number of red blood cells in the blood after surgery
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Sudden skin change altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Abdominal or stomach pain
Indigestion
Difficulty swallowing
Fluid leaking from a wound
Fluid leaking from a wound after surgery

Not known (frequency cannot be estimated from the available data):

Difficulty breathing or wheezing
Decrease in the number or even absence of white blood cells (which help fight infections)
Hair loss

Prevention of blood vessel blockage in the brain or elsewhere in the body due to blood clots formed as a result of irregular heartbeat
Common (may affect up to 1 in 10 people):

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

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

Bleeding
Bleeding that may occur from haemorrhoids, rectum, or brain
Haematoma formation
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden skin change altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Vomiting
Difficulty swallowing
Abnormal liver function test results

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

Bleeding that may occur in a joint, from a surgical incision, wound, injection site, or catheter insertion site in a vein
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Decrease in the proportion of blood cells
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the 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 study, the rate of heart attacks was higher with Pradaxa 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 veins of the legs and/or lungs
Common (may affect up to 1 in 10 people):

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

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

Bleeding
Bleeding that may occur in a joint or from a wound
Bleeding that may occur from haemorrhoids
Decrease in the number of red blood cells in the blood
Haematoma formation
Coughing up blood or blood-stained sputum
Allergic reaction
Sudden skin change altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Feeling unwell
Vomiting
Abdominal or stomach pain
Diarrhoea with loose or watery stools
Abnormal liver function test results
Increased liver enzymes

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

Bleeding that may occur from a surgical incision, injection site, catheter insertion site in a vein, or 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
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Difficulty swallowing

Not known (frequency cannot be estimated from the available data):

Difficulty breathing or wheezing
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
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 problems
Hair loss

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

Treatment of blood clots and prevention of formation of new blood clots in children
Common (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
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Sudden skin change altering its colour and appearance
Haematoma formation
Nosebleed
Reflux of gastric juices into the oesophagus
Vomiting
Feeling unwell
Diarrhoea with loose or watery stools
Indigestion
Hair loss
Increased liver enzymes

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

Decrease in the number of white blood cells (which help fight infections)
Bleeding that may occur in the stomach or intestine, brain, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
Itching
Coughing up blood or blood-stained sputum
Abdominal or stomach pain
Inflammation of the oesophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the 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 that may occur in a joint or from a wound, surgical incision, injection site, or catheter insertion site in a vein
Bleeding that may occur from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Abnormal liver function test results

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pradaxa

Keep this medicine out of the 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 that month.
Blister pack: Store in the original packaging to protect the medicine 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 the medicine from moisture.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use.
This will help protect the environment.

6. Package contents and other information

What Pradaxa contains

The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
The other ingredients are tartaric acid, acacia gum, hypromellose, dimethicone 350, talc and hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine and hypromellose.
The printing ink contains shellac, black iron oxide and potassium hydroxide.

Description of the appearance of Pradaxa and contents of the pack
Pradaxa 110 mg capsules are hard capsules (approximately 19 x 7 mm) with a pale blue, opaque cap and a pale blue, opaque body. The Boehringer Ingelheim logo is printed on the cap and the code "R110" on the body of the hard capsule.
This medicine is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules, in a multiple pack containing 3 packs of 60 x 1 hard capsules (180 hard capsules), or in a multiple pack containing 2 packs of 50 x 1 hard capsules (100 hard capsules), in aluminium blisters divisible into unit doses. Pradaxa is also available in packs containing 60 x 1 hard capsules in white aluminium blisters, divisible into unit doses.
This medicine is also available in polypropylene (plastic) bottles containing 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization 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 on this medicine, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
SCS Boehringer Ingelheim Comm.V Boehringer Ingelheim RCV GmbH & Co KG
Tél/Tel: +32 2 773 33 11 Lietuvos filialas
Tel: +370 5 2595942

България Luxembourg/Luxemburg
Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ – SCS Boehringer Ingelheim Comm.V
клон България Tél/Tel: +32 2 773 33 11
Тел: +359 2 958 79 98

Česká republika Magyarország
Boehringer Ingelheim spol. s r.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +420 234 655 111 Magyarországi Fióktelepe
Tel: +36 1 299 8900

Danmark Malta
Boehringer Ingelheim Danmark A/S Boehringer Ingelheim Ireland Ltd.
Tlf: +45 39 15 88 88 Tel: +353 1 295 9620

Deutschland Nederland
Boehringer Ingelheim Pharma GmbH & Co. KG Boehringer Ingelheim b.v.
Tel: +49 (0) 800 77 90 900 Tel: +31 (0) 800 22 55 889

Eesti Norge
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Norway KS
Eesti filiaal Tlf: +47 66 76 13 00
Tel: +372 612 8000

Ελλάδα Österreich
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870
Tηλ: +30 2 10 89 06 300

España Polska
Boehringer Ingelheim España S.A. Boehringer Ingelheim Sp. z o.o.
Tel: +34 93 404 51 00 Tel: +48 22 699 0 699

France Portugal
Boehringer Ingelheim France S.A.S. Boehringer Ingelheim Portugal, Lda.
Tél: +33 3 26 50 45 33 Tel: +351 21 313 53 00

Hrvatska România
Boehringer Ingelheim Zagreb d.o.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +385 1 2444 600 Viena - Sucursala Bucuresti
Tel: +40 21 302 2800

Ireland Slovenija
Boehringer Ingelheim Ireland Ltd. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +353 1 295 9620 Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland Slovenská republika
Vistor hf. Boehringer Ingelheim RCV GmbH & Co KG
Sími: +354 535 7000 organizačná zložka
Tel: +421 2 5810 1211

Italia Suomi/Finland
Boehringer Ingelheim Italia S.p.A. Boehringer Ingelheim Finland Ky
Tel: +39 02 5355 1 Puh/Tel: +358 10 3102 800

Κύπρος Sverige
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε. Boehringer Ingelheim AB
Tηλ: +30 2 10 89 06 300 Tel: +46 8 721 21 00

Latvija United Kingdom (Northern Ireland)
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Ireland Ltd.
Latvijas filiāle Tel: +353 1 295 9620
Tel: +371 67 240 011

More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu/ .

Patient Information Leaflet

Pradaxa 150 mg hard capsules

dabigatran etexilate
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Pradaxa is and what it is used for
What you need to know before taking Pradaxa
How to take Pradaxa
Possible side effects
How to store Pradaxa
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 the action of a substance in the body involved
in blood clot formation.
Pradaxa is used in adults for:

preventing blood clots in the brain (stroke) and in other blood vessels of the body when there is a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one additional risk factor.
treating blood clots in the veins of the legs and lungs and preventing the recurrence of blood clots in the veins of the legs and lungs.

Pradaxa is used in children for:

treating blood clots and preventing the formation of new 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 organ lesions that increase the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent brain or eye surgery).
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place and you are receiving heparin through it to keep it open, or when your heartbeat is being restored to normal by a procedure called catheter ablation for atrial fibrillation.
if you have severely reduced liver function or a liver disease that could potentially 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 transplant rejection episodes.
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
if you have had an artificial heart valve implanted that requires lifelong anticoagulant therapy.

if you have an increased risk of bleeding such as:
if you have recently experienced bleeding.
if you have undergone a biopsy (surgical removal of tissue) within the previous month.
if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
if you suffer from inflammation of the oesophagus or stomach.
if you have gastroesophageal reflux (acid reflux into the oesophagus).
if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Pradaxa” below.
if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
if you have an infection of the heart (bacterial endocarditis).
if you know that your kidney function is reduced or if you suffer from dehydration (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 weighing 50 kg or less.
only for use in children: if the child has an infection around or within the brain.
if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
if you have liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with Pradaxa

if you are scheduled for surgery: In this case, Pradaxa will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Pradaxa exactly at the times instructed by your doctor, both before and after surgery.
if a procedure involves placement of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia or for pain relief):
it is very important to take Pradaxa exactly at the times instructed by your doctor, both before and after the procedure.
inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anaesthesia wears off, as urgent treatment may be needed.
if you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may consider it necessary to examine you, as you may be at high 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, who will decide whether a change in therapy is needed.

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines for treating fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
Medicines for treating irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may instruct you to use a reduced dose of Pradaxa depending on the condition for which it has been prescribed. See section 3.
Medicines to prevent transplant rejection episodes (e.g. tacrolimus, cyclosporine)
The combination 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 medicine used to treat depression
Antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
Rifampicin or clarithromycin (two antibiotics)
Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
Some medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breast-feeding
The effects of Pradaxa on pregnancy and the unborn child are unknown. You must not take this medicine if you are pregnant unless your doctor tells you it is safe to do so. If you are a woman of childbearing age, you must avoid pregnancy during treatment with Pradaxa.
You must not breast-feed during treatment with Pradaxa.

Driving and using machines
Pradaxa has no known effect on the ability to drive vehicles or operate machinery.

3. How to take Pradaxa

Pradaxa capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 8 years of age, other age-appropriate dosage forms are available.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Take Pradaxa as recommended for the following conditions:
Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots forming as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs.
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of Pradaxa of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice daily.
You may continue taking this medicine if your heart rhythm needs to be restored to normal through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Take Pradaxa as directed by your doctor.
If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure known as percutaneous coronary intervention with stenting, you may be treated with Pradaxa after your doctor has determined that normal blood clotting control has been achieved. Take Pradaxa as directed by your doctor.
Treatment of blood clots and prevention of new blood clots in children.
Pradaxa should be taken twice daily, one dose in the morning and one 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 the patient's weight and age. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medications unless your doctor tells you to stop any of them.
Table 1 shows the individual and total daily doses of Pradaxa in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.
Table 1: Dosing table for Pradaxa capsules

Weight/Age Combinations		Single Dose in mg	Total Daily Dose in mg
Weight in kg	Age in years	Single Dose in mg	Total Daily Dose in mg
from 11 to less than 13 kg	from 8 to less than 9 years	75	150
from 13 to less than 16 kg	from 8 to less than 11 years	110	220
from 16 to less than 21 kg	from 8 to less than 14 years	110	220
from 21 to less than 26 kg	from 8 to less than 16 years	150	300
from 26 to less than 31 kg	from 8 to less than 18 years	150	300
from 31 to less than 41 kg	from 8 to less than 18 years	185	370
from 41 to less than 51 kg	from 8 to less than 18 years	220	440
from 51 to less than 61 kg	from 8 to less than 18 years	260	520
from 61 to less than 71 kg	from 8 to less than 18 years	300	600
from 71 to less than 81 kg	from 8 to less than 18 years	300	600
81 kg or more	from 10 to less than 18 years	300	600

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 gastric release. Do not break, chew, or remove granules from the capsule, 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 one unit of the blister from the entire strip along the perforated line.

Diagram with number 2 and a black arrow indicating the extraction movement toward the

Lift the aluminium foil on the back and remove the capsule.

Do not push the capsules through the aluminium foil of the blister.
The aluminium foil of the blister should be lifted only when a capsule needs to be removed.

Instructions for opening the bottle

The bottle is opened by pressing and turning the cap.
After removing the capsule, replace the cap on the bottle and close it tightly immediately after taking the dose.

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

If you forget to take Pradaxa
The missed dose can still be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped.
Do not double the dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Pradaxa acts on the blood clotting system; therefore, most of the side effects are related to signs such as bruising or bleeding. Major or serious bleeding events may occur, which represent the most serious side effects and, regardless of their location, may be disabling, life-threatening, or even fatal. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to perform a thorough check-up or change your treatment.
Contact your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.
The possible side effects are listed below, grouped according to their frequency of occurrence.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to formation of blood clots resulting from irregular heartbeat
Common (may affect up to 1 in 10 people):

Bleeding that may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the number of red blood cells in the blood
Abdominal or stomach pain
Indigestion
Diarrhea with loose or liquid stools
Feeling unwell

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

Bleeding
Bleeding that may occur from hemorrhoids, rectum, or brain
Formation of hematoma
Coughing up blood or bloody sputum
Decrease in the number of platelets in the blood
Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden skin changes altering its color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulcer)
Inflammation of the esophagus and stomach
Gastric acid reflux into the esophagus
Vomiting
Difficulty swallowing
Abnormal liver function test results

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

Bleeding that may occur in a joint, from a surgical incision, wound, injection site, or catheter insertion site in a vein
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Decrease in proportion of blood cells
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the available data):

Difficulty breathing or wheezing
Decrease in number or even absence of white blood cells (which help fight infections)
Hair loss

In a clinical study, the rate of heart attacks was higher with Pradaxa 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 veins of the legs and/or lungs
Common (may affect up to 1 in 10 people):

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

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

Bleeding
Bleeding that may occur in a joint or from a wound
Bleeding that may occur from hemorrhoids
Decrease in the number of red blood cells in the blood
Formation of hematoma
Coughing up blood or bloody sputum
Allergic reaction
Sudden skin changes altering its color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulcer)
Inflammation of the esophagus and stomach
Gastric acid reflux into the esophagus
Feeling unwell
Vomiting
Abdominal or stomach pain
Diarrhea with loose or liquid stools
Abnormal liver function test results
Increased liver enzymes

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

Bleeding that may occur from a surgical incision, injection site, catheter insertion site in a vein, or brain
Decrease in the number of platelets in the blood
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Difficulty swallowing

Not known (frequency cannot be estimated from the available data):

Difficulty breathing or wheezing
Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
Decrease in proportion of blood cells
Decrease in 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 problems
Hair loss

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

Treatment of blood clots and prevention of formation of new blood clots in children
Common (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
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Sudden skin changes altering its color and appearance
Formation of hematoma
Nosebleed
Gastric acid reflux into the esophagus
Vomiting
Feeling unwell
Diarrhea with loose or liquid stools
Indigestion
Hair loss
Increased liver enzymes

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

Decrease in the number of white blood cells (which help fight infections)
Bleeding that may occur in the stomach or intestine, brain, rectum, penis/vagina, urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
Decrease in proportion of blood cells
Itching
Coughing up blood or bloody sputum
Abdominal 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 problems

Not known (frequency cannot be estimated from the available data):

Absence of white blood cells (which help fight infections)
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Difficulty breathing or wheezing
Bleeding
Bleeding that may occur in a joint or from a wound, surgical incision, injection site, or catheter insertion site in a vein
Bleeding that may occur from hemorrhoids
Stomach or intestinal ulcer (including esophageal ulcer)
Abnormal liver function test results

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pradaxa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after
Exp. The expiry date refers to the last day of that month.
Blister: Store in the original packaging to protect the medicine 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 the medicine from moisture.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pradaxa contains

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, dimethicone 350, talc and hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine and hypromellose.
The printing ink for the black marking contains shellac, iron oxide black and potassium hydroxide.

Description of the appearance of Pradaxa and contents of the pack
Pradaxa 150 mg capsules (approximately 22 x 8 mm) are hard capsules 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 body of the hard capsule.
This medicine is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules, in a multiple pack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or in a multiple pack containing 2 packs of 50 x 1 hard capsules (100 hard capsules), all in aluminium blisters divisible into unit doses. Pradaxa is also available in packs containing 60 x 1 hard capsules in white aluminium blisters, divisible into unit doses.
This medicine is also available in polypropylene (plastic) bottles containing 60 hard capsules.
Not all 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 about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
SCS Boehringer Ingelheim Comm.V Boehringer Ingelheim RCV GmbH & Co KG
Tél/Tel: +32 2 773 33 11 Lietuvos filialas
Tel: +370 5 2595942

Česká republika Magyarország
Boehringer Ingelheim spol. s r.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +420 234 655 111 Magyarországi Fióktelepe
Tel: +36 1 299 8900

Danmark Malta
Boehringer Ingelheim Danmark A/S Boehringer Ingelheim Ireland Ltd.
Tlf: +45 39 15 88 88 Tel: +353 1 295 9620

Deutschland Nederland
Boehringer Ingelheim Pharma GmbH & Co. KG Boehringer Ingelheim b.v.
Tel: +49 (0) 800 77 90 900 Tel: +31 (0) 800 22 55 889

Eesti Norge
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Norway KS
Eesti filiaal Tlf: +47 66 76 13 00
Tel: +372 612 8000

Ελλάδα Österreich
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε. Boehringer Ingelheim RCV GmbH & Co KG
Tηλ: +30 2 10 89 06 300 Tel: +43 1 80 105-7870