DABIGATRAN ETEXILATE VIATRIS 150 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dabigatran Etexilate Viatris 150mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Dabigatran Etexilate Viatris and what is it used for

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

Dabigatran etexilate is used in adults to:

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

- treat blood clots in the veins of your legs and lungs and to prevent them from happening again in the veins of your legs and lungs.

Dabigatran etexilate is used in children to:

- treat blood clots and prevent them from happening again.

2. What you need to know before you take Dabigatran Etexilate Viatris

Do not take Dabigatran Etexilate Viatris

- if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).

- if your kidney function is severely reduced.

- if you are currently 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 bleeding in the brain, recent brain or eye surgery).

- if you are prone to bleeding. This tendency may be inherited, of unknown cause, or caused by other medicines.

- if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching treatment, while having a venous or arterial catheter and being given heparin through this catheter to keep it open, or while your normal heartbeat is being restored through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation.

- if your liver function is severely reduced or you have a life-threatening liver disease.

- if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.

- if you are taking oral cyclosporin, a medicine used to prevent organ rejection after a transplant.

- if you are taking dronedarone, a medicine used to treat irregular heartbeat.

- if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.

- if you have been implanted with an artificial heart valve that requires permanent anticoagulant treatment.

Warnings and precautions

Talk to your doctor before you start taking dabigatran etexilate. During treatment with this medicine, you may also need to talk to your doctor if you experience any symptoms or if you need to have surgery.

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

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

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

- 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 careful with Dabigatran Etexilate Viatris

- If you need to have surgery:

In this case, dabigatran etexilate should be temporarily stopped due to an increased risk of bleeding during and after surgery. It is very important that you take dabigatran etexilate before and after surgery exactly at the times indicated by your doctor.

- If surgery 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 dabigatran etexilate before and after surgery exactly at the times indicated by your doctor.
• Tell your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder 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 you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), tell your doctor so that they can decide if it is necessary to modify treatment.

Other medicines and Dabigatran Etexilate Viatris

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 dabigatran etexilate if you are taking any of the following medicines:

- Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin)

- Medicines for the treatment of fungal infections (e.g. ketoconazole, itraconazole), except if only applied to the skin

- Medicines used to treat irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are using medicines that contain verapamil, your doctor may instruct you to use a reduced dose of dabigatran etexilate depending on the disease for which it was prescribed. See section 3.

- Medicines for the prevention of organ rejection after a transplant (e.g. tacrolimus, cyclosporin)

- A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)

- Anti-inflammatory and pain-relieving medicines (e.g. aspirin, ibuprofen, diclofenac)

- St. John's Wort, a herbal medicine for depression

- Antidepressant medicines called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors

- Rifampicin or clarithromycin (two antibiotics)

- Antiviral medicines for HIV (e.g. ritonavir)

- Certain medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The effects of dabigatran etexilate on pregnancy and the fetus are not known. You should not take this medicine if you are pregnant unless your doctor advises you to. If you are of childbearing age, you should avoid becoming pregnant during treatment with dabigatran etexilate.

Breastfeeding is not recommended during treatment with dabigatran etexilate.

Driving and using machines

Dabigatran etexilate has no known effects on the ability to drive or use machines.

3. How to take Dabigatran Etexilate Viatris

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 pharmaceutical forms suitable for children under 12 years of age as soon as they are able to swallow soft foods.

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor again.

Take Dabigatran Etexilate Viatris as recommended for the following situations:

Prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation and treatment of deep vein thrombosis and pulmonary embolism, including prevention of recurrent deep vein thrombosis and pulmonary embolism

The recommended dose is 300 mg administered as one 150 mg capsule twice daily.

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

If you are using medicines that contain verapamil, you should be instructed to use a reduced dose of dabigatran etexilate of 220 mg taken as one 110 mg capsule twice daily, as your risk of bleeding may be increased.

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

You can continue taking this medicine if you need to restore your normal heartbeat through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Take dabigatran etexilate as instructed by your doctor.

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

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

Dabigatran etexilate should be taken twice daily, 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. Continue using all other medicines unless your doctor tells you to stop using one.

Table 1 shows the single 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.

Table 1: Dosing table for dabigatran etexilate capsules.

Doses that require 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 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 immediately after taking your dose.

Changing anticoagulant treatment

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

If you take more Dabigatran Etexilate Viatris than you should

Taking too much of this medicine increases the risk of bleeding. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

Specific treatment options are available.

If you forget to take Dabigatran Etexilate Viatris

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

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

If you stop taking Dabigatran Etexilate Viatris

Take dabigatran etexilate exactly as prescribed. Do not stop your treatment with this medicine without consulting 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 indigestion after taking dabigatran etexilate.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Dabigatran etexilate acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding. Episodes of major or severe bleeding may occur, which are the most serious adverse effects and, regardless of their location, can cause disability, be potentially fatal, or even cause death. In some cases, these bleedings may not be apparent.

If you experience any episode of bleeding that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, fatigue, paleness, 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.

Possible adverse effects are detailed below, grouped according to their frequency of occurrence.

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

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

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

Uncommon(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
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastroesophageal reflux
• Vomiting
• Difficulty swallowing
• Abnormalities in liver function tests

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

• Bleeding may occur in a joint, at the site of a surgical incision, in a wound, at the site of an injection, or at the site of a catheter in a vein
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Decrease in the proportion of blood cells
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

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

In a clinical trial, the rate 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 the legs and lungs, including prevention of recurrent blood clots in the veins of the legs and/or lungs

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

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

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

• Bleeding
• Bleeding may occur in a joint or in a wound
• Bleeding may occur from hemorrhoids
• Decrease in the 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 color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastroesophageal reflux
• Feeling of nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormalities in liver function tests
• Increased liver enzymes

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

• Bleeding may occur at the site of a surgical incision, or at the site of an injection, or at the site of a catheter in a vein or from the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Difficulty swallowing

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

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

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

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

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

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Sudden change in skin color and physical appearance
• Formation of hematomas
• Nasal bleeding
• Gastroesophageal reflux
• Vomiting
• Feeling of nausea
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur in the stomach or intestine, brain, rectum, penis/vagina or urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the 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 whites of the eyes, caused by liver or blood problems

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

• Lack of white blood cells (which help fight infections)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or in a wound, in a surgical incision, at the site of an injection, or at the site of a catheter in a vein
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Abnormalities in liver function tests

Reporting of Adverse Effects

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

5. Storage of Dabigatran Etexilate Viatris

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

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

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofDabigatran Etexilate Viatris

- The active ingredient is dabigatran etexilate. Each hard capsule contains dabigatran etexilate mesilate, equivalent to 150 mg of dabigatran etexilate.

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

• The capsule shell 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 and Package Contents

Dabigatran Etexilate Viatris 150 mg are hard capsules approximately 21 mm long with a light blue opaque cap and a white opaque body containing pale yellow to 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 180 capsules in aluminum-OPA/aluminum/PVC blisters.

Dabigatran Etexilate Viatris is available in packs containing 10 x 1, 30 x 1, 60 x 1, 100 x 1, or 180 x 1 capsules in precut unit-dose aluminum-OPA/aluminum/PVC blisters.

Dabigatran Etexilate Viatris is also available in packs containing 100 or 180 capsules in HDPE bottles with child-resistant screw caps. The bottle contains a desiccant (silica gel).

Not all pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart

Dublin 15

Ireland

Manufacturer

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

You can request more information about this medicine by contacting 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 under the following names:

Germany Dabigatranetexilat Viatris 150 mg Hartkapseln

Austria Dabigatranetexilat Viatris 150 mg Hartkapsel

Belgium Dabigatran Etexilate Viatris 150 mg hard capsules

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

Cyprus Dabigatran Etexilate Viatris

Croatia Dabigatraneteksilat Viatris 150 mg tvrde kapsule

Denmark Dabigatran Etexilate Viatris

Spain Dabigatrán etexilato Viatris 150 mg hard capsules EFG

Slovenia Dabigatraneteksilat Viatris 150 mg trde kapsule

Slovakia Dabigatran Etexilate Viatris 150 mg tvrdé kapsuly

Estonia Dabigatran Etexilate Viatris

Finland Dabigatran Etexilate Viatris

France DABIGATRAN ETEXILATE VIATRIS SANTE 150 mg, gélule

Greece Dabigatran Etexilate/Viatris

Hungary Dabigatran Etexilate Viatris 150 mg kemény kapszula

Iceland Dabigatran Etexilate Viatris

Italy Dabigatran etexilato Viatris 150 mg capsule rigide

Latvia Dabigatran Etexilate Viatris 150 mg cietas kapsulas

Lithuania Dabigatran etexilate Viatris 150 mg kietosios kapsules

Luxembourg Dabigatran Etexilate Viatris 150 mg gélules

Malta Dabigatran Etexilate Viatris 150 mg hard capsules

Norway Dabigatran Etexilate Viatris

Netherlands Dabigatran etexilaat Viatris 150 mg harde capsules

Poland Dabigatran Etexilate Viatris

Portugal Dabigatrano etexilato Mylan 150 mg Cápsulas

Czech Republic Dabigatran Etexilate Viatris

Romania Dabigatran Etexilat Viatris 150 mg capsule

Sweden Dabigatran Etexilate Viatris

Date of the last revision of this leaflet:December 2024.

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.