Dabigatran etexilate Viatris 150 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Dabigatran etexilate Viatris 150 mg hard capsules EFG

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

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Dabigatran Etexilate Viatris is and what it is 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 blood clot formation.

Dabigatran etexilate is used in adults for:

• preventing 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.

• treating blood clots in the veins of your legs and lungs and to prevent the recurrence of blood clots in the veins of your legs and lungs.

Dabigatran etexilate is used in children for:

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

2. What you need to know before taking Dabigatran etexilate Viatris

Do not take Dabigatran etexilate Viatris

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

‑ if your kidney function is severely reduced.

‑ if you currently have bleeding.

‑ if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, brain injury or cerebral haemorrhage, recent brain or eye surgery).

‑ if you are prone to bleeding. This tendency may be congenital, 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 anticoagulant therapy, while you have 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 a liver disease that could be life-threatening.

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

‑ if you are taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation.

‑ if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.

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

‑ if you have had an artificial heart valve implanted that requires lifelong anticoagulant treatment.

Warnings and precautions

Talk to your doctor before starting dabigatran etexilate. During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you need to undergo surgery.

Tell your doctor if you have or have had any disorder or illness, especially any of the following:

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

• if you have recently had bleeding.
• if you have undergone a surgical tissue removal (biopsy) within the last month.
• if you have suffered a serious injury (e.g., a bone fracture, head injury, or any injury requiring surgical treatment).
• if you have inflammation of the oesophagus or stomach.
• if you have problems with gastric juice reflux into the oesophagus.
• if you are receiving medicines that may increase the risk of bleeding. See “Other medicines and Dabigatran etexilate Viatris” below.
• if you are using anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam.
• if you have an infection in the heart (bacterial endocarditis).
• if you know you have reduced kidney function or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark-coloured [concentrated] or foamy urine).
• if you are over 75 years old.
• if you are an adult and weigh 50 kg or less.
• only if used in children: if the child has a brain infection or infection around the brain.

‑ If you have had a heart attack or have been diagnosed with conditions 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.

Take special care with Dabigatran etexilate Viatris

‑ If you need to undergo surgery:

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

‑ If surgery requires the placement of a catheter or an injection into the spine (e.g., for epidural or spinal anaesthesia or for pain relief):

• It is very important that you take dabigatran etexilate before and after surgery exactly at the times instructed by your doctor.
• Inform your doctor immediately if you experience numbness or weakness in the legs or problems with bowel or bladder function after the anaesthesia ends, as this situation requires urgent medical attention.

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

‑ If you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether treatment adjustment may be necessary.

Other medicines and Dabigatran etexilate Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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, acetylsalicylic acid)

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

‑ Medicines used to treat abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil). If you are using medicines containing verapamil, your doctor may instruct you to use a reduced dose of dabigatran etexilate depending on the condition for which it has been prescribed. See section 3.

‑ Medicines used to prevent organ rejection after transplantation (e.g., tacrolimus, cyclosporine)

‑ A combination product containing 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 remedy for depression

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

‑ Rifampicin or clarithromycin (two antibiotics)

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

‑ Certain medicines used to treat epilepsy (e.g., carbamazepine, phenytoin)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The effects of dabigatran etexilate on pregnancy and the unborn child are unknown. You should not use this medicine during pregnancy unless your doctor tells you it is safe to do so. 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 and 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 age-appropriate pharmaceutical forms available for the treatment of children under 12 years of age once they are able to swallow soft foods.

Always follow exactly the dosing instructions for this medicine provided by your doctor. If you are unsure, please consult your doctor again.

Take Dabigatran etexilate Viatris as recommended for the following conditions:

Prevention of systemic or cerebral vascular blockage due to blood clot formation caused by irregular heartbeat, and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of such clots

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

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

If you are taking medications containing verapamil, you should be prescribed a reduced dose of dabigatran etexilate of 220 mg given as one 110 mg capsule twice daily, because your risk of bleeding may be increased.

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

You may continue taking this medicine if it becomes necessary to restore your normal heart rhythm through a procedure called cardioversion or through a catheter ablation procedure for atrial fibrillation. Take dabigatran etexilate exactly as directed by your doctor.

If you have had a medical device (vascular stent) placed in a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stent placement, you may receive treatment with dabigatran etexilate once your doctor has determined that normal blood clotting control has been achieved. Take dabigatran etexilate exactly as directed by your doctor.

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

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

The recommended dose depends on body weight and age. Your doctor will determine the correct dose. Your doctor may adjust your dose during treatment. Continue taking all other medications unless your doctor instructs you to stop any of them.

Table 1 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.

Table 1: Dosing table for dabigatran etexilate capsules.

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

Dabigatran etexilate can be taken with or without food. The capsule must 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 twist to open.
• After removing the capsule, replace the cap on the bottle and close the bottle tightly immediately after taking your dose.

Switching 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 at: 91 562 04 20, indicating the medication and the amount ingested.

Specific treatment options are available.

If you forget to take Dabigatran etexilate Viatris

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

A missed dose should be omitted if less than 6 hours remain before the next dose. 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 treatment with this medicine without first consulting your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience indigestion after taking dabigatran etexilate.

If you have any further questions about 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 everyone will experience them.

Dabigatran etexilate acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding. Major or severe bleeding episodes may occur, which represent the most serious adverse effects and, regardless of their location, may lead to disability, may be potentially fatal, or even result in death. In some cases, this bleeding 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 (unusual 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 causing difficulty breathing or dizziness.

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

Prevention of systemic or cerebral vascular occlusion due to blood clot formation following abnormal heart rhythm

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

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

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

• Bleeding
• Bleeding may occur from hemorrhoids, rectum, or brain
• Bruising
• Coughing up blood or sputum with blood streaks
• 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 the skin affecting color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function tests

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

• Bleeding may occur in a joint, at a surgical incision site, wound, injection site, or at the site where a venous catheter enters the body
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with dark red, raised, itchy bumps caused by an allergic reaction
• Decrease in blood cell counts
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders

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

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

In a clinical 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 legs and lungs, including prevention of recurrence of blood clots in the legs and/or lungs

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

• Bleeding may occur from the nose, stomach or intestine, rectum, penis/vagina, or urinary tract (including blood in urine which may turn 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 wound
• Bleeding may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Bruising
• Coughing up blood or sputum with blood streaks
• Allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Feeling nauseous
• Vomiting
• Abdominal pain or stomach ache
• Frequent loose or watery stools
• Abnormal liver function tests
• Increased liver enzymes

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

• Bleeding may occur at a surgical incision site, injection site, site where a venous catheter enters the body, or from the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with dark red, raised, 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 blood cell counts
• Decrease in number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders
• Hair loss

In the clinical trial program, the rate of heart attacks with dabigatran etexilate was higher than with warfarina. 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 recurrence of 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, raised, itchy bumps caused by an allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Bruising
• Nasal bleeding
• Gastric juice reflux into the esophagus
• Vomiting
• Feeling nauseous
• Frequent loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur from the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in urine which may turn 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 blood cell counts
• Itching
• Coughing up blood or sputum with blood streaks
• Abdominal pain or stomach ache
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders

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

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or wound, at a surgical incision site, injection site, or at the site where a venous catheter enters the body
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Abnormal liver function tests

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dabigatran Etexilate Viatris

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, blister pack, or bottle after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dabigatran Etexilate Viatris

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

• The other components 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), black iron oxide (E172) and potassium hydroxide (E525).

Appearance of the product and contents of the container

Dabigatran Etexilate Viatris 150 mg are hard capsules approximately 21 mm in length, with an opaque light blue cap and an opaque white body, containing pale yellow to yellowish pellets, printed with "VTRS" and "DC150" in black ink on both cap and body.

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

Dabigatran Etexilate Viatris is also available in packs containing 10 × 1, 30 × 1, 60 × 1, 100 × 1 or 180 × 1 capsules in single-dose precut blisters made of aluminium-OPA/aluminium/PVC.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland

Manufacturer Responsible

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 under the following names:

Germany Dabigatranetexilat Viatris 150 mg Hartkapseln
Austria Dabigatranetexilat Viatris 150 mg Hartkapsel
Belgium Dabigatran Etexilate Viatris 150 mg harde capsules
Bulgaria ?????????? ????????? ??????? 150 mg ?????? ???????
Cyprus Dabigatran Etexilate Viatris
Croatia Dabigatraneteksilat Viatris 150 mg tvrde kapsule
Denmark Dabigatran Etexilate Viatris
Spain Dabigatran Etexilate 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 Dabigatran etexilate Mylan 150 mg Capsules
Czech Republic Dabigatran Etexilate Viatris
Romania Dabigatran Etexilat Viatris 150 mg capsule
Sweden Dabigatran Etexilate Viatris

Date of the most recent revision of this leaflet: December 2024.

Other sources of information

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