Patient Information Leaflet

Dabigatrán etexilato Viatris 150mg Hard Capsules EFG

Read this leaflet carefully before you start taking this medicine. It contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1.What isDabigatrán etexilato Viatrisand what is it used for

2.What you need to know before you start takingDabigatrán etexilato Viatris

3.How to takeDabigatrán etexilato Viatris

4.Possible side effects

5.Storage ofDabigatrán etexilato Viatris

6.Contents of the pack and additional information

This medicationcontains the active ingredient dabigatrán etexilato and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in the formation of blood clots.

Dabigatrán etexilatois used in adults for:

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

‑to treat blood clots in the veins of your legs and lungs and to prevent them from coming back.

Dabigatrán etexilatois used in children for:

‑to treat blood clots and to prevent them from coming back.

Do not take Dabigatrán etexilato Viatris

‑If you are allergic to dabigatrán etexilato or any of the other ingredients of this medicine (listed in section6).

‑If your kidney function is severely reduced.

‑If you are currently experiencing bleeding.

‑If you have any organ disease that increases the risk of severe bleeding (e.g., stomach ulcer, head injury or bleeding, recent brain or eye surgery).

‑If you are prone to bleeding. This tendency may be of birth, unknown cause, or caused by other medications.

‑If you are taking medications to prevent blood clotting in the blood (e.g., warfarin, rivaroxabán, apixabán, or heparin), except when changing anticoagulant treatment, while having a venous or arterial catheter, and heparin is administered through this catheter to keep it open, or while your normal heart rhythm is being restored by a procedure called catheter ablation for atrial fibrillation.

‑If your liver function is severely reduced or you have any liver disease that may be fatal.

‑If you are taking ketoconazol oral or itraconazol, medications used in the treatment of fungal infections.

‑If you are taking ciclosporina oral, a medication used to prevent organ rejection after a transplant.

‑If you are taking dronedarona, a medication used to treat abnormal heart rhythm.

‑If you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitisC.

‑If you have had a heart valve implanted that requires permanent anticoagulant treatment.

Warnings and precautions

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

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

‑If you present an increased risk of bleeding, for example:

• If you have recently experienced bleeding.
• If you have undergone a surgical tissue extraction (biopsy) in the last month.
• If you have suffered a severe injury (e.g., a bone fracture, a head injury, or any injury that required surgical treatment).
• If you have an inflammation of the esophagus or stomach.
• If you have problems with acid reflux in the esophagus.
• If you are taking medications that may increase the risk of bleeding. See “Other medications andDabigatrán etexilato Viatris” below.
• If you are taking anti-inflammatory medications such as diclofenaco, ibuprofeno, or piroxicam.
• If you have a heart infection (bacterial endocarditis).
• If you know that you have reduced kidney function or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark-colored, concentrated urine with foam).
• If you are over 75years old.
• If you are an adult and weigh 50kg or less.
• Only if used in children: if the child has an infection in the brain or around it.

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

‑If you have a liver disease associated with changes in blood tests. The use of this medication is not recommended in this case.

Be especially careful with Dabigatrán etexilato Viatris

‑If you need to undergo surgery:

In this case,dabigatrán etexilatomust be temporarily interrupted due to an increased risk of bleeding during and shortly after surgery. It is very important that you takedabigatrán etexilatoexactly at the times indicated by your doctor before and after surgery.

‑If a surgical procedure requires the placement of a catheter or injection in the spine (e.g., for epidural or spinal anesthesia or for pain relief):

• It is very important that you takedabigatrán etexilatoexactly at the times indicated by your doctor before and after surgery.
• Inform your doctor immediately if you experience numbness or weakness in your legs or intestinal or urinary problems after the end of anesthesia, as this situation requires urgent attention.

‑If you fall or injure yourself during treatment, especially if you hit your head. Seek urgent medical attention. You may need a doctor to examine you, as you may have a higher risk of bleeding.

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

Other medications and Dabigatrán etexilato Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.Particularly, you must inform your doctor before takingdabigatrán etexilato ifyou are taking any of the following medications:

‑Medications to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxabán, acetylsalicylic acid).

‑Medications used in the treatment of fungal infections (e.g., ketoconazol, itraconazol), except when applied only to the skin.

‑Medications used in the treatment of abnormal heart rhythm (e.g., amiodarona, dronedarona, quinidina, verapamilo). If you are taking medications that contain verapamilo, your doctor may indicate that you use a reduced dose ofdabigatrán etexilatoaccording to the disease for which it has been prescribed. See section3.

‑Medications used to prevent organ rejection after a transplant (e.g., tacrolimus, ciclosporina).

‑A combination product of glecaprevir and pibrentasvir (an antiviral medication used to treat hepatitisC).

‑Anti-inflammatory and pain-relieving medications (e.g., acetylsalicylic acid, ibuprofeno, diclofenaco).

‑St. John's Wort, a medicinal herb for depression.

‑Antidepressant medications called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors.

‑Rifampicina or claritromicina (two antibiotics).

‑Antiviral medications for HIV (e.g., ritonavir).

‑Certain medications used in the treatment of epilepsy (e.g., carbamazepina, phenitoína).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Natural breastfeeding is not recommended during treatment with dabigatrán etexilato.

Driving and operating machines

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

Dabigatran etexilate capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. There are other appropriate pharmaceutical forms available for children under 12 years of age as soon as they are able to swallow soft foods.

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

TakeDabigatran etexilate Viatrisas recommended for the following situations:

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

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

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

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

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

You can continue to take this medication if necessary to restore your normal heart rhythm by a procedure called cardioversion or by a procedure called catheter ablation for atrial fibrillation. Take dabigatran etexilate as your doctor has instructed you.

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

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

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

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

The table1 shows the single doses and total daily doses of dabigatran etexilate in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.

Table1: Dosing table for dabigatran etexilate capsules

Single doses that require combinations of more than one capsule:

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

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

220 mg: two capsules of 110 mg

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

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

How to take Dabigatran etexilate Viatris

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

Instructions for the bottle

• Press and turn to open.

• After removing the capsule, put the cap back on the bottle and close the bottle tightly immediately after taking your dose.

Change in anticoagulant treatment

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

If you take moreDabigatran etexilate Viatris than you should

Taking too much of this medication increases the risk of bleeding. If you have taken too much or accidentally ingested the medication, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Specific treatment options are available.

If you forgot to take Dabigatran etexilate Viatris

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

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

If you interrupt treatment with Dabigatran etexilate Viatris

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

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

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

Dabigatrán etexilate acts on blood coagulation; therefore, most side effects are related to signs such as bruising or bleeding. Severe or life-threatening bleeding episodes can occur, which can cause disability, be potentially fatal, or even lead to death. In some cases, these bleeding episodes may not be apparent.

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

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

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

Prevention of cerebral or systemic vascular obstruction by blood clot formation developed after abnormal heart rhythm

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

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

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

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

Very rare(may affect up to 1 in 1000people):

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

Frequency unknown(frequency cannot be estimated from available data):

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

In a clinical trial, the incidence of heart attacks with dabigatrán etexilate was numerically higher than with warfarin. The global incidence was low.

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

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

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

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

• Bleeding
• Bleeding can be in a joint or wound
• Bleeding can be from hemorrhoids
• Decreased number of red blood cells in the blood
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Allergic reaction
• Sudden change in skin that affects color and physical appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of stomach acid into the esophagus
• Feeling like vomiting
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Anomalies in liver function tests
• Increased liver enzymes

Very rare(may affect up to 1 in 1000people):

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

Frequency unknown(frequency cannot be estimated from available data):

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

In the clinical trial program, the incidence of heart attacks with dabigatrán etexilate was higher than with warfarin. The global incidence was low. No imbalance in the incidence of heart attacks was observed in patients treated with dabigatrán compared to patients treated with placebo.

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

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

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

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

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

Frequency unknown(frequency cannot be estimated from available data):

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains.Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, askyour pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofDabigatran etexilate Viatris

‑The active ingredient is dabigatran etexilate. Each hard capsule contains dabigatran etexilate mesilate, which corresponds to 150 mg of dabigatran etexilate.

‑The other components are tartaric acid (E334), hydroxypropylcellulose (E463), talc (E553b), and hypromellose (E464).

• The capsule coating contains Brilliant Blue FCF (E133), titanium dioxide (E171), and hypromellose (E464).

• The printing ink contains shellac (E904), propylene glycol (E1520), strong ammonia solution (E527), iron oxide black (E172), and potassium hydroxide (E525).

Appearance of the product and contents of the pack

Dabigatran etexilate Viatris 150mg are hard capsules approximately 21mm in length with an opaque blue-gray cap and an opaque white body containing yellowish pellets, with “VTRS” and “DC150” printed in black ink on the cap and body.

Dabigatran etexilate Viatris is available in packs containing 30, 60, or 180capsules in aluminio-OPA/aluminio/PVC blisters.

Dabigatran etexilate Viatris is also available in packs containing 10x1, 30x1, 60x1, 100x1, or 180x1capsules in pre-cut single-dose blisters of aluminio-OPA/aluminio/PVC.

Dabigatran etexilate Viatris is also available inpacks containing 100 or 180 capsules in HDPE bottles with child-resistant closures. The bottle contains a desiccant (silica gel).

Only some pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart

Dublin15

Ireland

Responsible Person

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca. 1

Hungary

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

GermanyDabigatranetexilat Viatris 150 mg Hartkapseln

AustriaDabigatranetexilat Viatris 150 mg Hartkapsel

BelgiumDabigatran Etexilate Viatris 150 mg harde capsules

Bulgaria?????????? ????????? ??????? 150 mg ?????? ???????

CyprusDabigatran Etexilate Viatris

CroatiaDabigatraneteksilat Viatris 150 mg tvrde kapsule

DenmarkDabigatran Etexilate Viatris

SpainDabigatrán etexilato Viatris 150 mg cápsulas duras EFG

SloveniaDabigatraneteksilat Viatris 150 mg trde kapsule

SlovakiaDabigatran Etexilate Viatris 150 mg tvrdé kapsuly

EstoniaDabigatran Etexilate Viatris

FinlandDabigatran Etexilate Viatris

FranceDABIGATRAN ETEXILATE VIATRIS SANTE 150 mg, gélule

GreeceDabigatran Etexilate/Viatris

HungaryDabigatran Etexilate Viatris 150 mg kemény kapszula

IcelandDabigatran Etexilate Viatris

ItalyDabigatran etexilato Viatris 150 mg capsule rigide

LatviaDabigatran Etexilate Viatris 150 mg cietas kapsulas

LithuaniaDabigatran etexilate Viatris 150 mg kietosios kapsules

LuxembourgDabigatran Etexilate Viatris 150 mg gélules

MaltaDabigatran Etexilate Viatris 150 mg hard capsules

NorwayDabigatran Etexilate Viatris

NetherlandsDabigatran etexilaat Viatris 150 mg harde capsules

PolandDabigatran Etexilate Viatris

PortugalDabigatrano etexilato Mylan 150 mg Cápsulas

Czech RepublicDabigatran Etexilate Viatris

RomaniaDabigatran Etexilat Viatris 150 mg capsule

SwedenDabigatran Etexilate Viatris

Last update of this leaflet:December 2024.

Other sources of information

The detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.