Prospect: information for the patient

Dabigatrán etexilate Viatris 110mg hard capsules EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

1.What is Dabigatrán etexilate Viatris and for what it is used

2.What you need to know before starting to take Dabigatrán etexilate Viatris

3.How to take Dabigatrán etexilate Viatris

4.Possible adverse effects

5.Storage of Dabigatrán etexilate Viatris

6.Contents of the package and additional information

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

Dabigatrán etexilato is used in adults for:

‑to prevent the formation of blood clots in veins after knee or hip replacement surgery.

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

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

Dabigatrán etexilato is used in children for:

‑to treat blood clots and 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 disease in an organ of the body that increases the risk of severe bleeding (e.g., stomach ulcer, injury or cerebral hemorrhage, recent brain or eye surgery).

‑If you are prone to bleeding. This tendency may be congenital, of 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 artificial implanted that requires permanent anticoagulant treatment.

Warnings and precautions

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

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

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

• If you have recently experienced bleeding.
• If you have had a surgical tissue extraction (biopsy) in the last month.
• If you have 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 reflux of stomach acid into the esophagus.
• If you are taking medications that may increase the risk of bleeding. See “Other medicines andDabigatrán etexilato Viatris” below.
• If you are taking anti-inflammatory medications such as diclofenaco, ibuprofeno, or piroxicam.
• If you have a bacterial infection in the heart (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 urine ([concentrated]/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 medicine is not recommended in this case.

Be especially careful withDabigatrán etexilato Viatris

‑If you are to undergo surgery:

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

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

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

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

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

Other medicines andDabigatrán etexilato Viatris

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

‑Medicines to reduce blood clotting (e.g., warfarin, fenprocumón, acenocumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxabán, acetylsalicylic acid).

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

‑Medicines used in the treatment of abnormal heart rhythm (e.g., amiodarona, dronedarona, quinidina, verapamilo). If you are taking medicines that contain amiodarona, quinidina, or verapamilo, your doctor may indicate that you use a reduced dose of dabigatrán etexilato according to the disease for which you have been prescribed. See section3.

‑Medicines used to prevent organ rejection after a transplant (e.g., tacrólimus, 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 plant 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, fenitoína).

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 medicine.

The effects of dabigatrán etexilato on pregnancy and the fetus are unknown. Do not use this medicine if you are pregnant unless your doctor tells you it is safe to do so. If you are fertile, 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 according to age for the treatment of children under 12 years old as soon as they are able to swallow soft foods.

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

TakeDabigatran etexilate Viatrisas recommended for the following situations:

Prevention of blood clot formation after knee or hip replacement surgery

The recommended dose is 220 mg once a day (administered in the form of 2 capsules of 110 mg).

If your kidney function is decreased by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once a day (administered in the form of 2 capsules of 75 mg).

If you are taking medications containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once a day (administered in the form of 2 capsules of 75 mg).

If you are taking medications containing verapamil and your kidney function is decreased by more than half, you should be instructed to take a reduced dose of dabigatran etexilate of 75 mg, as your risk of bleeding may increase.

In both types of surgery, treatment should not be initiated if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, dosing should be initiated with 2 capsules once a day.

After knee replacement surgery

Start treatment with dabigatran etexilate 1-4 hours after surgery, taking a single capsule. After that, take 2 capsules once a day for a total of 10 days.

After hip replacement surgery

Start treatment with dabigatran etexilate 1-4 hours after surgery, taking a single capsule. After that, take 2 capsules once a day for a total of 28-35 days.

Prevention of cerebral or systemic vascular obstruction due to blood clot formation 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 of one capsule of 150 mg twice a day.

If you are 80 years of age or older, the recommended dose is 220 mg administered in the form of one capsule of 110 mg twice a day.

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

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

You can continue taking this medication if necessary to restore your normal heart rhythm by a procedure called cardioversion. Take dabigatran etexilate as instructed by your doctor.

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

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. It is possible that your doctor will adjust the dose during treatment. Follow all other medications unless your doctor tells you to stop using one.

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

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 takeDabigatran 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 of anticoagulant treatment

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

If you take moreDabigatran etexilate Viatristhan you should

Taking too much of this medication increases the risk of bleeding. In case of overdose or accidental ingestion, 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 takeDabigatran etexilate Viatris

Prevention of blood clot formation after knee or hip replacement surgery

Take the remaining daily doses of dabigatran etexilate at the same time the next day. Do not take a double dose to compensate for the missed doses.

Use in adults: Prevention of cerebral or systemic vascular obstruction due to blood clot formation 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

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

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

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

If you interrupt treatment withDabigatran 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 higher 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 medications, this medication may cause side effects, although not everyone will experience them.

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

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 blood clot formation after knee or hip arthroplasty

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

• Decreased blood hemoglobin levels (the substance present in red blood cells)
• Anomalies in liver function tests

Poorly frequent(may affect up to 1 in 100 people):

• Bleeding may occur from the nose, stomach, or intestines, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), hemorrhoids, rectum, under the skin, from a joint, from a wound, or after surgery
• Formation of hematomas or bruising after surgery
• Blood detected in stool in a laboratory test
• Decreased red blood cell count
• Decreased proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Feeling like vomiting
• Suppuration of wounds (secretion of liquid from a surgical wound)
• Increased liver enzymes
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems

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

• Bleeding
• Bleeding may occur in the brain, at the site of a surgical incision, at the site of an injection, or at the site of a venous catheter
• Suppurative venous catheter site
• Coughing up blood or sputum with blood spots
• Decreased platelet count in blood
• Decreased red blood cell count after surgery
• 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
• Change in skin color and appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of stomach juice into the esophagus
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Liquid leaking from a wound
• Liquid leaking from a wound after surgery

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

• Difficulty breathing or wheezing
• Decreased white blood cell count (which helps fight infections)
• Hair loss

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

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

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

Poorly frequent(may affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur from hemorrhoids, rectum, or brain
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Decreased platelet count in blood
• Decreased hemoglobin levels in blood (the substance present in red blood cells)
• Allergic reaction
• Change in skin color and appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of stomach juice into the esophagus
• Vomiting
• Difficulty swallowing
• Anomalies in liver function tests
• Increased liver enzymes

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

• Bleeding may occur from a joint, surgical incision, wound, injection site, or venous catheter site, or from the brain
• Decreased platelet count in 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
• Decreased proportion of blood cells
• Increased liver enzymes
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems

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

• Difficulty breathing or wheezing
• Decreased white blood cell count (which helps fight infections)
• Hair loss

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

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

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

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

Poorly frequent(may affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur from a joint or wound
• Bleeding may occur from hemorrhoids
• Decreased red blood cell count
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Allergic reaction
• Change in skin color and appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of stomach juice into the esophagus
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Anomalies in liver function tests
• Increased liver enzymes

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

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

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

• Difficulty breathing or wheezing
• Decreased hemoglobin levels in blood (the substance present in red blood cells)
• Decreased proportion of blood cells
• Decreased white blood cell count (which helps fight infections)
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems
• Hair loss

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

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

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

• Decreased red blood cell count
• Decreased platelet count in blood
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction
• Change in skin color and appearance
• Formation of hematomas
• Nasal bleeding
• Reflux of stomach juice into the esophagus
• Vomiting
• Feeling like vomiting
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

Poorly frequent(may affect up to 1 in 100 people):

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

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

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

Reporting of side effects

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

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 containers and medications you no longer need at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of 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 110 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 package

Dabigatran etexilate Viatris 110mg are hard capsules approximately 19mm in length with an opaque blue-gray cap and an opaque blue-gray body, containing yellowish pellets, with “VTRS” and “DC110” printed in black ink on the cap and body.

Dabigatran etexilate Viatris is available in packages containing 10, 30, 60, or 180capsules in aluminum-OPA/aluminum/PVC blisters.

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

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

Only some package 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 more information about this medicine, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

GermanyDabigatranetexilat Viatris 110 mg Hartkapseln

AustriaDabigatranetexilat Viatris 110 mg Hartkapsel

BelgiumDabigatran Etexilate Viatris 110 mg harde capsules

Bulgaria?????????? ????????? ??????? 110 mg ?????? ???????

CyprusDabigatran Etexilate Viatris

CroatiaDabigatraneteksilat Viatris 110 mg tvrde kapsule

DenmarkDabigatran Etexilate Viatris

SpainDabigatrán etexilato Viatris 110 mg cápsulas duras EFG

SloveniaDabigatraneteksilat Viatris 110 mg trde kapsule

SlovakiaDabigatran Etexilate Viatris 110 mg tvrdé kapsuly

EstoniaDabigatran Etexilate Viatris

FinlandDabigatran Etexilate Viatris

FranceDABIGATRAN ETEXILATE VIATRIS SANTE 110 mg, gélule

GreeceDabigatran Etexilate/Viatris

HungaryDabigatran Etexilate Viatris 110 mg kemény kapszula

IcelandDabigatran Etexilate Viatris

ItalyDabigatran etexilato Viatris 110 mg capsule rigide

LatviaDabigatran Etexilate Viatris 110 mg cietas kapsulas

LithuaniaDabigatran etexilate Viatris 110 mg kietosios kapsules

LuxembourgDabigatran Etexilate Viatris 110 mg gélules

MaltaDabigatran Etexilate Viatris 110 mg hard capsules

NorwayDabigatran Etexilate Viatris

NetherlandsDabigatran etexilaat Viatris 110 mg harde capsules

PolandDabigatran Etexilate Viatris

PortugalDabigatrano etexilato Mylan 110 mg Cápsulas

Czech RepublicDabigatran Etexilate Viatris

RomaniaDabigatran Etexilat Viatris 110 mg capsule

SwedenDabigatran Etexilate Viatris

Last review date of this leaflet:December 2024.

Other sources of information

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