PRADAXA 75 mg Hard Capsules

Андрій Попов

Доктор Андрій Попов - сімейний лікар зі спеціалізованою підготовкою у сфері лікування хронічного болю. Він проводить відеоконсультації для дорослих в Іспанії та по всій Європі: як для тих, хто вже місяцями живе з болем, який ніхто не зміг чітко пояснити, так і для тих, кому потрібно вирішити проблему зі здоров’ям без очікування кількох тижнів на прийом.

Його підхід простий: уважно вислухати, структурувати ваш випадок і надати практичний план дій, заснований на доказовій медицині та адаптований до вашої медичної історії й індивідуальних потреб.

Біль: у чому він може допомогти

Хронічний біль (понад 3 місяці)
Мігрень і повторювані або інтенсивні головні болі
Біль у шиї, попереку, спині та суглобах
Післятравматичний біль після травм або операцій
Біль неврологічного походження: невралгії, нейропатичний біль, фіброміалгія

Загальна медицина

Часті респіраторні інфекції (застуда, грип, тривалий кашель)
Гіпертонія, діабет і метаболічні порушення
Аналіз лабораторних досліджень та висновків МРТ/КТ (пояснено зрозумілою мовою)
Профілактична медицина та моніторинг здоров’я
Друга думка та корекція лікування (коли це клінічно доцільно)

Як проходить консультація

Кожна сесія триває до 30 хвилин. Розглядаються симптоми, анамнез, ліки та надані обстеження. Наприкінці ви отримуєте чіткий план лікування, визначені подальші кроки та критерії, коли може знадобитися подальший контроль. Якщо виявляються тривожні симптоми, лікар прямо повідомить, чи потрібна очна консультація або невідкладна медична допомога.

Записатися на відеоконсультацію

zł365

Інші варіанти часу

Сторінка містить загальну інформацію. За персональною рекомендацією зверніться до лікаря. У разі гострих або небезпечних симптомів зверніться до екстрених служб.

Інструкція із застосування PRADAXA

Зміст інструкції

Pradaxa 75 mg hard capsules
Pradaxa 110 mg hard capsules
1. What is Pradaxa and what is it used for
2. What you need to know before taking Pradaxa
Pradaxa before and after surgery exactly at the time indicated by your doctor.
Pradaxa 150 mg hard capsules
Pradaxa 20 mg coated granules, 30 mg coated granules, 40 mg coated granules, 50 mg coated granules, 110 mg coated granules, 150 mg coated granules
Pradaxa 6.25 mg/mL powder and solvent for oral solution

Pradaxa 75 mg hard capsules

dabigatran etexilate

Read this leaflet carefully before you start taking this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Pradaxa is and what it is used for
2. What you need to know before you take 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 is Pradaxa and what is it used for

preventing the formation of blood clots in the veins following surgery for knee or hip replacement.

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 impaired.
if you have ongoing bleeding.
if you have injuries to an organ that increase the risk of serious bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
if you have an increased tendency to bleed. This may be congenital, due to an unknown cause or due to other medicines.
if you are taking medicines to prevent the formation of blood clots (e.g. warfarin, rivaroxaban, apixaban or heparin), except when you are switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and

heparin is administered through it to keep it open or when your heartbeat is
restored to normal with a procedure called transcatheter ablation for atrial
fibrillation.

if you have severely reduced liver function or a liver disease that may in some way cause death.
if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
if you are taking oral cyclosporine, a medicine for the prevention of rejection episodes after organ transplantation.
if you are taking dronedarone, a medicine used to treat abnormal heartbeat.
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 permanent use of anticoagulants.

Warnings and precautions
Talk to your doctor before taking Pradaxa. You may also need to talk to your doctor
during treatment with this medicine if you experience symptoms or if you are to undergo
surgery.

Tell your doctorif you suffer from or have suffered from any medical condition or illness, in particular one
of those included in the following list:

if you have an increased risk of bleeding such as:
if you have had recent bleeding.
if you have undergone a biopsy (surgical removal of tissue) in the previous month.
if you have experienced serious injuries (e.g. bone fracture, head injury or any injury that required surgery).
if you suffer from inflammation of the esophagus or stomach.
if you have problems with stomach acid reflux into the esophagus.
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 suffer from a heart infection (bacterial endocarditis).
if you are aware that your kidney function is reduced or suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/frothy urine).
if you are over 75 years of age.
if you are an adult patient and weigh 50 kg or less.
for use in children only: if the child has an infection around or inside the brain.
if you have had a heart attack or have been diagnosed with conditions that increase the risk of developing a heart attack.
if you suffer from a liver disease, associated with changes in blood tests. In this case, the use of this medicine is not recommended.

Be particularly careful with Pradaxa

if you are to undergo surgery: In this case, Pradaxa will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the operation. It is very important to take Pradaxa before and after the operation exactly at the time told to you by your doctor.
if an operation involves the placement of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
it is very important to take Pradaxa before and after the operation exactly at the time told to you by your doctor.
immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has worn off, as urgent care is needed.
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 because 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), tell your doctor, who will decide whether it is necessary to change the therapy.

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 tell your doctor before taking Pradaxa if
you are taking any of the medicines listed below:

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 they are only applied to the skin
Medicines for treating altered heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine or verapamil, your doctor may tell you to use a reduced dose of Pradaxa based on the condition for which it has been prescribed. See also section 3
Medicines to prevent rejection episodes after organ transplantation (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 for treating depression
Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
Rifampicin or clarithromycin (two antibiotics)
Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Pradaxa on pregnancy and the fetus are unknown. You should 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 potential,
you should avoid pregnancy during treatment with Pradaxa.
You should not breastfeed during treatment with Pradaxa.

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

3. How to take Pradaxa

Pradaxa capsules can be used in adults and children aged 8 years and over who
are able to swallow the capsules whole. For the treatment of children under 8 years of age
there are other dosage forms appropriate for the age.
Take this medicine following the instructions of your doctor exactly. If you have doubts, consult
your doctor.

Take Pradaxa as recommended for the following conditions:
Prevention of blood clot formation after knee or hip replacement surgery
The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg).
If your kidney function is reducedby more than half or if you are 75 years or older, the dose
recommended is 150 mg once a day (taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine or verapamil, the recommended dose is

150 mg once a day(taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function has decreasedby
more than half, you must take a reduced dose of Pradaxa of 75 mgbecause the risk of
bleeding may increase.
For both procedures, treatment should not be started in case of bleeding at the surgical site. If treatment cannot be started until the day after the
surgical procedure, administration should begin with a dose of 2 capsules once a day.

After knee replacement surgery
You should start treatment with Pradaxa within 1-4 hours after the end of the surgical procedure,
taking a single capsule. Subsequently, you should take two capsules, once a day, for
a total of 10 days.

After hip replacement surgery
You should start treatment with Pradaxa within 1-4 hours after the end of the surgical procedure,
taking a single capsule. Subsequently, you should take two capsules, once a day, for
a total of 28-35 days.
Treatment of blood clots and prevention of the formation of new blood clots in
children.

Pradaxa must be taken twice a day, one dose in the morning and one in the evening, approximately at the
same time each day. The administration interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. The doctor will determine the correct dose. The
doctor may adjust the dose during treatment. Continue to use all other
medicines, unless your doctor tells you to stop taking any of them.
Table 1 shows the single and total daily doses of Pradaxa in milligrams (mg). The doses
depend on the weight in kilograms (kg) and the age in years of the patient.
Table 1: Dosage table for Pradaxa capsules

Weight/age combinations		Single dose in mg	c Total daily a dose in mg
Weight in kg	Age in years	Single dose in mg	c Total daily a 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	m 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	r 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	a 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	F 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 release at the gastric level. Do not break, chew or remove the granules from the
capsule as it may increase the risk of bleeding.

Instructions for opening the blisters
The following images illustrate how to remove Pradaxa capsules from the blister

Separate a unit from the blister from the whole blister along the perforated line

Subcutaneous injection with needle inserted at an angle showing the direction of movement and the formation of a small skin relief

Lift the aluminum foil located on the back and remove the
capsule.

Do not push the capsules through the aluminum foil of the blister.
The aluminum foil of the blister should only be lifted when it is necessary to remove a capsule.

Instructions for opening the bottle

The bottle opens by pressing and rotating the cap.
After removing the capsule, reposition the cap on the bottle and close it tightly immediately after taking the dose.

Changing anticoagulant treatment
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. Seek
immediate medical attention if you have taken an excessive number of capsules. Specific treatment options are available.

If you stop taking Pradaxa
Take Pradaxa exactly as prescribed. Do not stop taking this medicine without
talking to your doctor first, as the risk of developing a blood clot may be higher
if you stop treatment too soon. Contact your doctor if you experience stomach discomfort
after taking Pradaxa.
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 gets them.
Pradaxa acts on the blood coagulation system, therefore most of the side effects are related to signs such as bruises or bleeding. Major or severe bleeding events may occur, which constitute the most serious side effects, and which, regardless of location, can be disabling, life-threatening or even
lead to death. In some cases, these bleedings may not be apparent.
If you experience any bleeding that does not resolve spontaneously or if you experience symptoms of
excessive bleeding (exceptional weakness, feeling of fatigue, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately. Your doctor may decide to
subject you to a thorough check-up or change the treatment.
Immediately inform your doctor if you experience a severe allergic reaction causing difficulty
breathing or dizziness.
The possible side effects are listed below, grouped by how frequently they
occur.
Prevention of blood clot formation after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

Reduction in the amount of hemoglobin 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, at the level of the stomach or intestine, from penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red), from hemorrhoids, from the rectum, under the skin, in a joint, from a wound or following it, after a surgical intervention
Formation of a hematoma or hematoma that occurs after an operation
Presence of blood in the stool, detected by laboratory examination
Reduction in the number of red blood cells in the blood
Reduction in the proportion of blood cells
Allergic reaction
Vomiting
Diarrhea with soft or liquid stools
Feeling unwell
Secretion from the wound (exudation of fluid from the surgical wound)
Increased liver enzymes
Yellowing of the skin or the white 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, from the injection site or from the site of catheter insertion into a vein
Blood-stained secretion from the site of catheter insertion into a vein
Coughing up blood or sputum stained with blood
Reduction in the number of platelets in the blood
Reduction in the number of red blood cells in the blood after an operation
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
Sudden change in the skin that alters its color and appearance
Itching
Ulcer of the stomach or intestine (including esophageal ulcer)
Inflammation of the esophagus and stomach
Reflux of gastric juices into the esophagus
Pain in the abdomen or stomach
Indigestion
Difficulty swallowing
Fluid leaking from a wound
Fluid leaking from a wound after an operation

Not known (frequency cannot be estimated based on available data):

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

Treatment of blood clots and prevention of re-formation of blood clots in children.
Common (may affect up to 1 in 10 people):

Reduction in the number of red blood cells in the blood
Reduction in the number of platelets in the blood
Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
Sudden change in the skin that alters its color and appearance
Formation of a hematoma
Nose bleeding
Reflux of gastric juices into the esophagus
Vomiting
Feeling unwell
Diarrhea with soft or liquid stools
Indigestion
Hair loss
Increased liver enzymes

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

Reduction in the number of white blood cells (which help fight infections)
Bleeding that may occur at the level of the stomach or intestine, from the brain, from the rectum, from penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red) or under the skin
Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
Reduction in the proportion of blood cells
Itching
Coughing up blood or sputum stained with blood
Pain in the abdomen or stomach
Inflammation of the esophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or the white of the eyes, caused by problems with the liver or blood

Not known (frequency cannot be estimated based on 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, from a surgical incision, from the injection site or from the site of catheter insertion into a vein
Bleeding that may occur from hemorrhoids
Ulcer of the stomach or intestine (including esophageal ulcer)
Abnormal liver function test results

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 box, blister or bottle after
Exp. The expiry date refers to the last day of that month.
Blisters: Store in the original packaging to protect the medicine from moisture.
Bottle: Once opened, the medicine must 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 in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Package contents and other information

What Pradaxa contains

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

Description of Pradaxa’s appearance and package contents
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 medicine is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in aluminium blisters, divisible for single doses. Pradaxa is also available in packs containing 60 x 1 hard capsules in white aluminium blisters, divisible for single 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 on this medicine, contact the local representative of the Marketing Authorisation 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.
Τηλ: +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.
Τηλ: +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 medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu/ .

Pradaxa 110 mg hard capsules

dabigatran etexilate

Read this leaflet carefully before you start taking this medicine as 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 others, even if they have the same symptoms as you, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Pradaxa is and what it is used for
2. What you need to know before you take 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 is Pradaxa and what is it used for

preventing the formation of blood clots in the veins following surgery for knee or hip replacement.
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 further risk factor.
treating blood clots in the veins of the legs and lungs and preventing blood clots from reforming 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 impaired.
if you have ongoing bleeding.
if you have injuries to an organ that increase the risk of serious bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
if you have an increased tendency to bleed. This may be congenital, due to an unknown cause or due to other medicines.
if you are taking medicines to prevent blood clots from forming (e.g. warfarin, rivaroxaban, apixaban or heparin), except when you are switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and heparin is administered through it to keep it open, or when your heartbeat is restored to normal with a procedure called catheter ablation for atrial fibrillation.
if you have severely impaired liver function or a liver disease that could in any way cause death.
if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
if you are taking oral cyclosporine, a medicine for the prevention of rejection episodes after organ transplantation.
if you are taking dronedarone, a medicine used to treat abnormal heartbeat.
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 permanent anticoagulation.

Tell your doctorif you suffer from or have suffered from any medical condition or illness, in particular one
from the following list:

if you have an increased risk of bleeding such as:
if you have had recent bleeding.
if you have had a biopsy (surgical removal of tissue) in the previous month.
if you have had serious injuries (e.g. bone fracture, head injury or any injury that required surgery).
if you suffer from inflammation of the esophagus or stomach.
if you have problems with stomach acid reflux into the esophagus.
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 suffer from a heart infection (bacterial endocarditis).
if you are aware that your kidney function is reduced or you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/frothy urine).
if you are over 75 years of age.
if you are an adult patient and weigh 50 kg or less.
only for use in children: if the child has an infection around or inside the brain.
if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of developing a heart attack.
if you suffer from a liver disease, associated with changes in blood tests. In this case, the use of this medicine is not recommended.

Take special care with Pradaxa

if you need to undergo surgery: In this case, Pradaxa will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the operation. It is very important to take

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Pradaxa before and after surgery exactly at the time indicated by your doctor.

if a surgery involves the placement of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
it is very important to take Pradaxa before and after the surgery exactly at the time indicated by your doctor.
immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has ended, because urgent care is necessary.
if you fall or injure yourself during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may need to examine you because you may be at high risk of bleeding.
if you know you have a condition called antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), inform your doctor, who will decide whether it is necessary to change therapy.

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

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

Driving and operating machinery
Pradaxa has no known effects on the ability to drive vehicles and 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
there are other dosage forms appropriate for the age.
Take this medicine following exactly the instructions of your doctor. If you have doubts consult
your doctor.

150 mg once a day(taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function has decreasedby
more than half, you must take a reduced dose of Pradaxa of 75 mgbecause the risk of
bleeding may increase.
For both surgeries, treatment should not be started in case of bleeding at the surgical site. If treatment cannot be started until the day after surgery
surgical, administration should begin with a dose of 2 capsules once a day.

After knee replacement surgery
You should start treatment with Pradaxa within 1-4 hours after the end of the surgery,
taking a single capsule. Subsequently, you should take two capsules, once a day, for
a total of 10 days.

After hip replacement surgery
You should start treatment with Pradaxa within 1-4 hours after the end of the surgery,
taking a single capsule. Subsequently, you should take two capsules, once a day, for
a total of 28-35 days.
Prevention of blockage of blood vessels in the brain or the rest of the body due to
formation of blood clots developed following altered heartbeat and treatment of
blood clots in the veins of the legs and lungs including prevention of reformation of
blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice a day.
If you are 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice
a day.
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 a day, 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 a day.
You can continue to take this medicine if your heartbeat needs to be restored
to normal with a procedure called cardioversion. Take Pradaxa according to the instructions of
your doctor.
If you have had a medical device (stent) inserted into a blood vessel to keep it open
as part of a procedure called percutaneous coronary intervention with stent, you may be treated
with Pradaxa after your doctor has determined that normal blood coagulation control has been achieved. Take Pradaxa according to the instructions of your doctor.
Treatment of blood clots and prevention of the formation of new blood clots in
children.

Pradaxa must be taken twice a day, one dose in the morning and one in the evening, approximately at
the same time each day. The administration interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. The doctor will determine the correct dose. The
doctor may adjust the dose during treatment. Continue to use all other
medicines, unless your doctor tells you to stop taking any of them.
Table 1 shows the single and total daily doses of Pradaxa in milligrams (mg). The doses
depend on the weight in kilograms (kg) and the age in years of the patient.
Table 1: Dosage table for Pradaxa capsules

Weight/age combinations		Single dose in mg	Total daily dose in mg
Weight in kg	A ge 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	a from 8 to less than 11 years	110	220
from 16 to less than 21 kg	t from 8 to less than 14 years	110	220
from 21 to less than 26 kg	I 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	a 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	i from 8 to less than 18 years	300	600
z 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 or
one 110 mg capsule plus two 75 mg
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule plus one 110 mg
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 at the gastric level. Do not break, chew or remove granules from
the capsule as it may increase the risk of bleeding.

Instructions for opening the blisters
The following images illustrate how to remove Pradaxa capsules from the blister

Separate a unit of the blister from the whole blister along the perforated line

Diagram showing a black arrow indicating the direction of insertion of a needle under the skin

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

Do not push the capsules through the aluminum foil of the blister.
The aluminum foil of the blister should only be lifted when it is necessary to remove a capsule.

Instructions for opening the bottle

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

Changing anticoagulant treatment
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 clot formation after knee or hip replacement surgery
Continue with the remaining daily doses of Pradaxa at the usual time of the next day.
Do not take a double dose to make up for a missed dose.
Use in adults: prevention of blockage of blood vessels in the brain or the rest of the body
due to the formation of blood clots developed following altered heartbeat and
treatment of blood clots in the veins of the legs and lungs including prevention of
reformation of blood clots in the veins of the legs and lungs
Use in children: treatment of blood clots and prevention of reformation of blood
clots
The forgotten dose can still be taken up to 6 hours before the next dose.
If less than 6 hours remain until the next dose, the forgotten 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
talking to your doctor first because the risk of developing a blood clot may be higher
if you stop treatment too soon. Contact your doctor if you experience stomach problems
after taking Pradaxa.
If you have any doubts about using this medicine, ask 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 of the side effects are related to signs such as bruises or bleeding. Major or severe bleeding events may occur, which constitute the most serious side effects, and which, 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 resolve spontaneously or if you experience symptoms of excessive bleeding (exceptional weakness, feeling of fatigue, pallor, dizziness, headache or unexplained swelling) consult your doctor immediately. The doctor may decide to subject you to a thorough check-up or change the treatment.
Immediately inform your doctor if you experience a severe allergic reaction causing difficulty breathing or dizziness.
Possible side effects are listed below, grouped by the frequency with which they occur.
Prevention of blood clot formation after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

Reduction in the amount of hemoglobin 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, at the level of the stomach or intestine, from the penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red), from hemorrhoids, from the rectum, under the skin, in a joint, from a wound or following it, after surgery
Formation of a hematoma or hematoma that occurs after an operation
Presence of blood in the stool, detected by laboratory examination
Reduction in the number of red blood cells in the blood
Reduction in the proportion of blood cells
Allergic reaction
Vomiting
Diarrhea with loose or liquid stools
Feeling unwell
Secretion from the wound (exudation of liquid from the surgical wound)
Increased liver enzymes
Yellowing of the skin or the white part 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, from the injection site or from the site of catheter insertion into a vein
Bloody secretion from the site of catheter insertion into a vein
Coughing up blood or blood-streaked sputum
Reduction in the number of platelets in the blood
Reduction in the number of red blood cells in the blood after an operation
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
Sudden change in the skin that modifies its color and appearance
Itching
Ulcer of the stomach or intestine (including esophageal ulcer)
Inflammation of the esophagus and stomach
Reflux of gastric juices into the esophagus
Pain in the abdomen or stomach
Indigestion
Difficulty swallowing
Fluid leaking from a wound
Fluid leaking from a wound after surgery

Not known (frequency cannot be estimated based on available data):

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

Prevention of blockage of blood vessels in the brain or the rest of the body due to the formation of blood clots developed following an altered heartbeat
Common (may affect up to 1 in 10 people):

Bleeding that may occur from the nose, at the level of the stomach or intestine, from the penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red), or under the skin
Reduction in the number of red blood cells in the blood
Pain in the abdomen or stomach
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, from the rectum or in the brain
Formation of a hematoma
Coughing up blood or blood-streaked sputum
Reduction in the number of platelets in the blood
Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden change in the skin that modifies its color and appearance
Itching
Ulcer of the stomach or intestine (including esophageal ulcer)
Inflammation of the esophagus and stomach
Reflux of gastric juices 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, from a wound, from the injection site or from the site of catheter insertion into a vein
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
Reduction in the proportion of blood cells
Increased liver enzymes
Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood

Not known (frequency cannot be estimated based on available data):

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

In a clinical study, the percentage 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 the reformation 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, at the level of the stomach or intestine, from the rectum, from the penis/vagina or from the urinary tract (including the presence of blood in the urine which turns 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
Reduction in the number of red blood cells in the blood
Formation of a hematoma
Coughing up blood or blood-streaked sputum
Allergic reaction
Sudden change in the skin that modifies its color and appearance
Itching
Ulcer of the stomach or intestine (including esophageal ulcer)
Inflammation of the esophagus and stomach
Reflux of gastric juices into the esophagus
Feeling unwell
Vomiting
Pain in the abdomen or stomach
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 or from the injection site or from the site of catheter insertion into a vein or from the brain
Reduction 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
Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
Difficulty swallowing

Not known (frequency cannot be estimated based on available data):

Difficulty breathing or wheezing
Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
Reduction in the proportion of blood cells
Reduction in the number or even absence of white blood cells (which help fight infections)
Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood
Hair loss

In the clinical study program, the percentage 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 the formation of new blood clots in children.
Common (may affect up to 1 in 10 people):

Reduction in the number of red blood cells in the blood
Reduction in the number of platelets in the blood
Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
Sudden change in the skin that modifies its color and appearance
Formation of a hematoma
Bleeding from the nose
Reflux of gastric juices 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):

Reduction in the number of white blood cells (which help fight infections)
Bleeding that may occur at the level of the stomach or intestine, from the brain, from the rectum, from the penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red) or under the skin
Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
Reduction in the proportion of blood cells
Itching
Coughing up blood or blood-streaked sputum
Pain in the abdomen or stomach
Inflammation of the esophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood

Not known (frequency cannot be estimated based on 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, from a surgical incision, from the injection site or from the site of catheter insertion into a vein
Bleeding that may occur from hemorrhoids
Ulcer of the stomach or intestine (including esophageal ulcer)
Abnormal liver function test results

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system reported 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 box, blister or bottle after
Exp. The expiry date refers to the last day of that month.
Blisters: Store in the original packaging to protect the medicine from moisture.
Bottle: Once opened, the medicine must 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 in wastewater. Ask your pharmacist how to eliminate medicines that
you no longer use. This will help protect the environment.

6. Package contents and other information

What Pradaxa contains

The active ingredient is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesylate).
The other ingredients are tartaric acid, gum arabic, hypromellose, dimethicone 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.

Description of Pradaxa and package contents
Pradaxa 110 mg capsules are hard capsules (approximately 19 x 7 mm) with a light blue, opaque cap
and a light blue, opaque body. The Boehringer Ingelheim logo is printed on the cap and the code
“R110” 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 a multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or in
a multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in
aluminium blisters, divisible for single dose administration. Pradaxa is also available in packs containing
60 x 1 hard capsules in white aluminium blisters, divisible for single dose administration.
This medicinal product is also available in polypropylene (plastic) bottles containing 60 capsules
hard.
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 on this medicinal product, contact the local representative of the marketing
authorisation holder: