Dabigatran Etexilate Viatris

Leaflet accompanying the packaging: patient information

Dabigatran Etexilate Viatris, 110 mg, hard capsules

dabigatran etexilate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dabigatran Etexilate Viatris and what is it used for
• 2. Important information 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 packaging and other information

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

Dabigatran Etexilate Viatris contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. Its action involves blocking a substance in the body that is involved in the formation of blood clots.

Dabigatran Etexilate Viatris is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery;
• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body in case of irregular heart rhythm called non-valvular atrial fibrillation and at least one additional risk factor;
• treat blood clots in the veins of the legs and lungs and prevent the recurrence of blood clots in the veins of the legs and lungs.

Dabigatran Etexilate Viatris is used in children to:

• treat blood clots and prevent the recurrence of blood clots.

2. Important information before taking Dabigatran Etexilate Viatris

When not to take Dabigatran Etexilate Viatris

• if the patient is allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe kidney impairment;
• if the patient is currently bleeding;
• if the patient has a disease of an internal organ that increases the risk of major bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery);
• if the patient has an increased tendency to bleed. It may be congenital, of unknown cause or caused by the use of other medicines.
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except in the following cases: change of anticoagulant treatment, insertion of a catheter into a vein or artery and administration of heparin to maintain its patency or to restore normal heart function through a procedure called catheter ablation in atrial fibrillation;
• if the patient has severe liver impairment or liver disease that may cause death;
• if the patient is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections;
• if the patient is taking oral cyclosporine, a medicine that prevents the rejection of a transplanted organ;
• if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders;
• if the patient is taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection;
• if the patient has an artificial heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting treatment with Dabigatran Etexilate Viatris, the patient should discuss it with their doctor.

The patient should also consult their doctor during treatment with this medicine if symptoms occur or if the patient requires surgery.

The patient should inform their doctorif they have or have had any medical conditions or diseases, especially those listed below:

• if the patient has an increased risk of bleeding, e.g.:
• if the patient has recently had bleeding
• if the patient has had a surgical biopsy within the last month
• if the patient has had a serious injury (e.g. bone fracture, head injury or any injury requiring surgical treatment)
• if the patient has esophagitis or gastritis
• if the patient has gastroesophageal reflux disease (GERD)
• if the patient is taking medicines that may increase the risk of bleeding. See "Dabigatran Etexilate Viatris and other medicines" below
• if the patient is taking anti-inflammatory medicines, such as diclofenac, ibuprofen, piroxicam
• if the patient has infective endocarditis (bacterial infection of the heart)
• if the patient has kidney impairment or dehydration (symptoms include thirst and passing less urine, which is dark and concentrated)
• if the patient is over 75 years old
• if the patient is an adult and weighs 50 kg or less
• only in the case of use in children: if the child has an infection around or inside the brain
• if the patient has had a heart attack or has been diagnosed with conditions that increase the risk of heart attack
• if the patient has liver disease that affects blood test results. In this case, the use of this medicine is not recommended.

When to be particularly careful when taking Dabigatran Etexilate Viatris

• if the patient needs to undergo surgery: In this case, it will be necessary to temporarily discontinue Dabigatran Etexilate Viatris due to the increased risk of bleeding during and after surgery. It is very important to take Dabigatran Etexilate Viatris before and after surgery exactly as the doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. to administer spinal or epidural anesthesia or to relieve pain):
• It is very important to take Dabigatran Etexilate Viatris before and after surgery exactly as the doctor has instructed.
• The patient should immediately inform their doctor if they experience numbness or weakness in their legs or problems with their bowels or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if the patient has fallen or injured themselves during treatment, especially if they have hit their head. They should seek urgent medical attention. It may be necessary for the patient to be examined by a doctor, as they may be at increased risk of bleeding.
• if the patient has a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), they should inform their doctor, who will decide whether to change the treatment.

Dabigatran Etexilate Viatris and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

In particular, before taking Dabigatran Etexilate Viatris, the patient should tell their doctor if they are taking any of the following medicines:

• anticoagulant medicines (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin)
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are used only on the skin
• medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). If the patient is taking medicines containing amiodarone, quinidine or verapamil, the doctor may recommend a reduced dose of Dabigatran Etexilate Viatris, depending on the condition for which the medicine was prescribed. See section 3.
• medicines that prevent the rejection of a transplanted organ (e.g. tacrolimus, cyclosporine)
• a combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C virus infection)
• anti-inflammatory and pain-relieving medicines (e.g. aspirin, ibuprofen, diclofenac)
• St. John's Wort, a herbal medicine used to treat depression
• antidepressant medicines called selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors
• rifampicin or clarithromycin (two antibiotics)
• antiviral medicines used to treat AIDS (e.g. ritonavir)
• certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effect of Dabigatran Etexilate Viatris on pregnancy and the unborn child is not known. This medicine should not be taken during pregnancy, unless the doctor considers it safe.

Women of childbearing age should avoid becoming pregnant while taking Dabigatran Etexilate Viatris.

This medicine should not be taken during breastfeeding.

Driving and using machines

Dabigatran Etexilate Viatris does not affect the ability to drive and use machines.

3. How to take Dabigatran Etexilate Viatris

Dabigatran Etexilate Viatris in the form of 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 for the treatment of children under 12 years of age, provided they are able to swallow soft food.

This medicine should always be taken exactly as the doctor has instructed.

In case of doubts, the patient should consult their doctor.

Dabigatran Etexilate Viatris should be used in accordance with the following recommendations for the following medical conditions:

Prevention of blood clot formation after hip or knee replacement surgery

The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg each).

If kidney function is reducedby more than half or if the patient is 75 years or older, the recommended dose is 150 mg once a day(taken as 2 capsules of 75 mg each).

In the case of taking medicines containing amiodarone, quinidine or verapamil, the recommended dose is 150 mg once a day(taken as 2 capsules of 75 mg each).

If the patient is taking medicines containing verapamil and kidney function is reducedby more than half, a reduced dose of 75 mgof Dabigatran Etexilate Viatris should be used, as the risk of bleeding may be increased.

In the case of both types of surgery, treatment should not be started if there is bleeding at the surgical site.

If it is not possible to start treatment on the day after surgery, it should be started with a dose of 2 capsules once a day.

After hip replacement surgery

Treatment with Dabigatran Etexilate Viatris should be started within 1-4 hours after the end of surgery, taking one capsule.

Then, 2 capsules should be taken once a day for a total of 28-35 days.

Prevention of blockage of blood vessels in the brain and body due to blood clot formation during irregular heart rhythm and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs

The recommended dose is 300 mg taken as one 150 mg capsule twice a day.

In patients aged 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice a day.

Patient taking medicines containing verapamilshould receive a reduced dose of Dabigatran Etexilate Viatris of 220 mg taken as one 110 mg capsule twice a day, due to the potential increased risk of bleeding.

In case of potentially increased risk of bleeding, the doctor may prescribe a dose of 220 mg taken as one 110 mg capsule twice a day.

The patient can continue taking this medicine if they need to restore normal heart function through a procedure called cardioversion.

Dabigatran Etexilate Viatris should be taken as instructed by the doctor.

In the case of implantation of a medical device (stent) into a blood vessel to maintain its patency through a procedure called percutaneous coronary intervention with stenting, the patient may receive treatment with Dabigatran Etexilate Viatris after the doctor has confirmed that coagulation control has been achieved.

Dabigatran Etexilate Viatris should be taken as instructed by the doctor.

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

Dabigatran Etexilate Viatris should be taken twice a day, one dose in the morning and one dose in the evening, at approximately the same time every day.

The interval between doses should be as close to 12 hours as possible.

The recommended dose depends on the patient's weight and age.

The doctor will determine the appropriate dose.

The doctor may adjust the dose during treatment.

The patient should continue taking all other medicines, unless the doctor instructs them to stop taking any of them.

Table 1 shows the single and total daily doses of Dabigatran Etexilate Viatris in milligrams (mg) based on the patient's weight in kilograms (kg) and age in years.

Doses that require combining 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 Viatris can be taken with or without food.

The capsule should be swallowed whole with a glass of water to ensure it reaches the stomach.

The capsule should not be broken, chewed or emptied, as this may increase the risk of bleeding.

Instructions for opening the bottle

• To open the bottle, press and turn the cap.
• After removing the capsule and taking the dose, the bottle should be tightly closed with the cap immediately.

Changing anticoagulant treatment

Anticoagulant treatment should not be changed without receiving detailed instructions from the doctor.

Taking a higher dose of Dabigatran Etexilate Viatris than recommended

Taking too much of this medicine increases the risk of bleeding.

In case of taking too many capsules, the patient should contact their doctor immediately.

There are specific treatment options available.

Missing a dose of Dabigatran Etexilate Viatris

Prevention of blood clot formation after hip or knee replacement surgery

The patient should continue taking the remaining daily doses of Dabigatran Etexilate Viatris at the same time the next day.

A double dose should not be taken to make up for a missed dose.

Use in adults: Prevention of blockage of blood vessels in the brain and body due to blood clot formation during irregular heart rhythm and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the 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 scheduled dose.

A missed dose should not be taken if there are less than 6 hours before the next scheduled dose.

In case of a missed dose, a double dose should not be taken to make up for it.

Stopping treatment with Dabigatran Etexilate Viatris

Dabigatran Etexilate Viatris should be taken exactly as instructed.

Treatment should not be stopped without consulting the doctor first, as stopping treatment too early may increase the risk of blood clots.

The patient should contact their doctor if they experience nausea after taking Dabigatran Etexilate Viatris.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dabigatran Etexilate Viatris can cause side effects, although not everybody gets them.

Dabigatran Etexilate Viatris affects blood clotting, so most side effects are related to symptoms such as bruising or bleeding.

Major or severe bleeding can occur, which are the most serious side effects and can lead to disability, life-threatening or even death, regardless of location, and may not be visible.

If bleeding occurs that does not stop on its own or if symptoms of excessive bleeding occur (exceptional weakness, fatigue, pallor, dizziness, headache or unexplained swelling), the patient should contact their doctor immediately.

The doctor may decide to monitor the patient or change the medicine.

The patient should immediately inform their doctor if they experience a severe allergic reaction causing difficulty breathing or dizziness.

The following side effects are listed by frequency of occurrence:

Prevention of blood clot formation after hip or knee replacement surgery

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

• decrease in hemoglobin levels in the blood (a substance contained in red blood cells)
• abnormal liver function test results.

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

• bleeding from the nose, stomach or intestines, rectum, penis or vagina or urinary tract (including blood in the urine, which turns the urine pink or red) or bleeding under the skin
• formation of hematomas or bruising after surgery
• blood in the stool in laboratory tests
• decrease in red blood cell count
• decrease in platelet count
• allergic reaction
• vomiting
• diarrhea
• nausea
• wound secretion (oozing of fluid from the surgical wound)
• increased liver enzyme activity
• jaundice (yellowing of the skin or whites of the eyes) due to liver or blood problems.

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

• bleeding
• bleeding from the brain, surgical wound, injection site or catheter insertion site
• blood-tinged drainage from the catheter insertion site
• coughing up blood or blood-tinged sputum
• decrease in platelet count
• decrease in red blood cell count after surgery
• severe allergic reaction causing difficulty breathing or dizziness
• severe allergic reaction causing swelling of the face or throat
• skin rash in the form of dark red, raised, itchy bumps, caused by an allergic reaction
• sudden change in skin color or appearance
• itching
• stomach or intestinal ulcer (including esophageal ulceration)
• esophagitis or gastritis
• gastroesophageal reflux disease (GERD)
• abdominal pain or stomach pain
• nausea
• diarrhea
• wound secretion (oozing of fluid from the surgical wound)
• increased liver enzyme activity.

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

• difficulty breathing or wheezing
• decrease in white blood cell count (which help fight infections)
• hair loss.

Prevention of blockage of blood vessels in the brain and body due to blood clot formation during irregular heart rhythm

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

• bleeding from the nose, stomach or intestines, rectum, penis or vagina or urinary tract (including blood in the urine, which turns the urine pink or red) or bleeding under the skin
• decrease in red blood cell count
• abdominal pain or stomach pain
• nausea
• diarrhea

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

• bleeding
• bleeding from the brain, surgical wound, injection site or catheter insertion site
• formation of hematomas
• coughing up blood or blood-tinged sputum
• decrease in platelet count
• decrease in hemoglobin levels in the blood (a substance contained in red blood cells)
• allergic reaction
• sudden change in skin color or appearance
• itching
• stomach or intestinal ulcer (including esophageal ulceration)
• esophagitis or gastritis
• gastroesophageal reflux disease (GERD)
• vomiting
• difficulty swallowing
• abnormal liver function test results.

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

• bleeding from the brain, surgical wound, injection site or catheter insertion site
• severe allergic reaction causing difficulty breathing or dizziness
• severe allergic reaction causing swelling of the face or throat
• skin rash in the form of dark red, raised, itchy bumps, caused by an allergic reaction
• decrease in platelet count
• increased liver enzyme activity
• jaundice (yellowing of the skin or whites of the eyes) due to liver or blood problems.

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

• difficulty breathing or wheezing
• decrease in white blood cell count (which help fight infections)
• hair loss.

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

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

• bleeding from the nose, stomach or intestines, rectum, penis or vagina or urinary tract (including blood in the urine, which turns the urine pink or red) or bleeding under the skin
• nausea

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

• bleeding
• bleeding from the brain, surgical wound, injection site or catheter insertion site
• bleeding from hematomas
• decrease in red blood cell count
• formation of hematomas
• coughing up blood or blood-tinged sputum
• allergic reaction
• sudden change in skin color or appearance
• itching
• stomach or intestinal ulcer (including esophageal ulceration)
• esophagitis or gastritis
• gastroesophageal reflux disease (GERD)
• nausea
• vomiting
• abdominal pain or stomach pain
• diarrhea
• abnormal liver function test results
• increased liver enzyme activity.

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

• bleeding from the brain, surgical wound, injection site or catheter insertion site
• decrease in platelet count
• severe allergic reaction causing difficulty breathing or dizziness
• severe allergic reaction causing swelling of the face or throat
• skin rash in the form of dark red, raised, itchy bumps, caused by an allergic reaction
• difficulty swallowing

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

• difficulty breathing or wheezing
• decrease in hemoglobin levels in the blood (a substance contained in red blood cells)
• decrease in red blood cell count
• decrease in white blood cell count (which help fight infections)
• jaundice (yellowing of the skin or whites of the eyes) due to liver or blood problems
• hair loss.

In clinical trials, the frequency of heart attack during treatment with Dabigatran Etexilate Viatris was numerically higher than during treatment with warfarin.

The overall number of cases was small.

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

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

• decrease in red blood cell count
• decrease in platelet count
• skin rash in the form of dark red, raised, itchy bumps, caused by an allergic reaction
• sudden change in skin color or appearance
• formation of hematomas
• nasal bleeding
• gastroesophageal reflux disease (GERD)
• vomiting
• nausea
• diarrhea
• nausea
• hair loss
• increased liver enzyme activity.

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

• decrease in white blood cell count (which help fight infections)
• bleeding from the stomach or intestines, brain, rectum, penis or vagina or urinary tract (including blood in the urine, which turns the urine pink or red) or bleeding under the skin
• decrease in hemoglobin levels in the blood (a substance contained in red blood cells)
• decrease in red blood cell count
• itching
• coughing up blood or blood-tinged sputum
• abdominal pain or stomach pain
• esophagitis or gastritis
• allergic reaction
• difficulty swallowing
• jaundice (yellowing of the skin or whites of the eyes) due to liver or blood problems.

Frequency not known (frequency cannot be estimated from the 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 from the brain, surgical wound, injection site or catheter insertion site
• bleeding from hematomas
• stomach or intestinal ulcer (including esophageal ulceration)
• abnormal liver function test results.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist.

Side effects can be reported directly to the Department of Medicines Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

By reporting side effects, more information can be gathered on the safety of the medicine.

Side effects can also be reported to the marketing authorization holder.

5. How to store Dabigatran Etexilate Viatris

The medicine should be stored out of sight and reach of children.

This medicine should not be taken after the expiry date stated on the carton, blister or bottle after: Expiry date (EXP).

The expiry date refers to the last day of the month stated.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste.

The patient should ask their pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Contents of the packaging and other information

What Dabigatran Etexilate Viatris contains

• The active substance is dabigatran etexilate.
• Each hard capsule contains dabigatran etexilate in the form of mesylate, which corresponds to 110 mg of dabigatran etexilate.
• The other ingredients are: tartaric acid (pellets), hydroxypropylcellulose, talc and hypromellose (type 2910).
• The capsule shell contains brilliant blue FCF (E 133), titanium dioxide (E 171) and hypromellose.
• The ink used for printing contains shellac, propylene glycol, concentrated ammonia, iron oxide black (E 172) and potassium hydroxide.

What Dabigatran Etexilate Viatris looks like and contents of the pack

Dabigatran Etexilate Viatris 110 mg is a hard capsule with a length of approximately 19 mm, with a light blue, opaque cap and a light blue, opaque body, filled with pellets in a color ranging from light yellow to yellowish, with the imprint "VTRS" above "DC110" in black ink on the cap and body.

Dabigatran Etexilate Viatris is available in packs containing 10, 30, 60 or 180 capsules in OPA/Aluminum/PVC/Aluminum blisters, in a cardboard box.

Dabigatran Etexilate Viatris is available in packs containing perforated single-dose blisters OPA/Aluminum/PVC/Aluminum containing 10 x 1, 30 x 1, 60 x 1, 100 x 1 or 180 x 1 capsules, in a cardboard box.

Dabigatran Etexilate Viatris is also available in cardboard boxes containing 100 or 180 capsules in HDPE bottles with a PP cap with a child-resistant closure and an aluminum seal.

The bottle also contains a desiccant (silica gel).

Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart

Dublin 15

DUBLIN

Ireland

Manufacturer/Importer

Mylan Hungary Kft.

Mylan Utca 1

Komárom 2900

Hungary

Mylan Germany GmbH

Benzstrasse 1

Bad Homburg 61352

Germany

To obtain more information on this medicine, the patient should contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

tel.: +48 22 546 64 00

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

Date of last revision of the leaflet: 12/2024