Dabigatran Etexilate Viatris

Leaflet attached to the packaging: patient information

Dabigatran Etexilate Viatris, 150 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 pack 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 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, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid), 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 restoration of normal heart function using a procedure called catheter ablation in atrial fibrillation;

• if the patient has severe liver impairment or liver disease that can 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 been implanted with 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. 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 feeling thirsty and passing reduced amounts of dark (concentrated) and/or foamy urine)
• 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 exercise special caution when taking Dabigatran Etexilate Viatris

• if the patient requires 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 reduce 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 may be necessary.
• if the patient has fallen or injured themselves during treatment, especially if they have hit their head. They should then 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 taking, have recently taken, or 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, acetylsalicylic acid)
• 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 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. acetylsalicylic acid, 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 hard 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 intended 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 instructed by the doctor.

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

Dabigatran Etexilate Viatris should be taken according to the following instructions for the following medical conditions:

Prevention of blood clots in the brain and body due to the formation of blood clots during irregular heart rhythm, as well as 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 over 80 years of age, 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, which is 220 mg taken as one 110 mg capsule twice a day, due to the possible 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 using a procedure called cardioversion or a procedure called catheter ablation in atrial fibrillation.

Dabigatran Etexilate Viatris should be taken according to the doctor's instructions.

In 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 they have achieved proper blood clotting control.

Dabigatran Etexilate Viatris should be taken according to the doctor's instructions.

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 as possible to 12 hours.

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).

The doses depend on the patient's weight in kilograms (kg) and age in years.

Doses requiring the combination 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 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.

Do not break, chew, or empty the pellets from the capsule, 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, immediately close the bottle tightly with the cap.

Changing anticoagulant treatment

Do not change anticoagulant treatment 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.

If the patient has taken too many capsules, they should immediately contact their doctor.

There are specific treatment options available.

Missing a dose of Dabigatran Etexilate Viatris

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

Do not take a missed dose if there is less than 6 hours before the next scheduled dose.

In case of a missed dose, do not take a double dose to make up for it.

Stopping treatment with Dabigatran Etexilate Viatris

Dabigatran Etexilate Viatris should be taken exactly as instructed.

Do not stop taking the medicine without consulting the doctor first, as stopping treatment too early may increase the risk of blood clots.

In case of nausea after taking Dabigatran Etexilate Viatris, the patient should contact their doctor.

If the patient has any further doubts about the use of this medicine, they 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.

Severe or life-threatening bleeding may occur, which is the most serious side effect and can lead to disability, life-threatening, or even death, regardless of the location.

In some cases, these bleeding events may not be visible.

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

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 according to their frequency:

Prevention of blood clots in the brain and body due to the formation of blood clots during irregular heart rhythm

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

• may experience nosebleeds, gastrointestinal or genital bleeding, or bleeding under the skin
• decrease in red blood cell count
• abdominal pain or stomach pain
• nausea
• diarrhea
• vomiting

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

• bleeding
• may experience bleeding from hemorrhoids or the rectum, or bleeding into the brain
• formation of hematomas
• coughing up blood or sputum stained with blood
• decrease in platelet count
• decrease in hemoglobin levels in the blood
• allergic reaction
• sudden change in skin color or appearance
• itching
• stomach or intestinal ulcers (including esophageal ulcers)
• esophagitis or gastritis
• gastroesophageal reflux disease (GERD)
• 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):

• may experience bleeding into a joint, due to injury, from a surgical wound, from an injection site, or from a catheter insertion site, or bleeding into the brain
• 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 white blood cell count
• increased liver enzyme activity
• jaundice of the skin or 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

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

The overall number of cases was small.

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):

• may experience nosebleeds, gastrointestinal or genital bleeding, or bleeding under the skin
• nausea

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

• bleeding
• may experience bleeding into a joint or due to injury
• may experience bleeding from hemorrhoids
• decrease in red blood cell count
• formation of hematomas
• coughing up blood or sputum stained with blood
• allergic reaction
• sudden change in skin color or appearance
• itching
• stomach or intestinal ulcers (including esophageal ulcers)
• 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):

• may experience bleeding from a surgical wound, injection site, or catheter insertion site, or bleeding into the brain
• 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
• decrease in red blood cell count
• decrease in white blood cell count (which help fight infections)
• jaundice of the skin or eyes due to liver or blood problems
• hair loss

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

The overall number of cases was small.

No difference in the frequency of heart attack was observed in patients treated with dabigatran compared to those receiving placebo.

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
• nosebleeds
• 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)
• may experience bleeding into the stomach or intestines, brain, rectum, genitals, or urinary tract (including blood in the urine, which stains the urine pink or red), or bleeding under the skin
• decrease in hemoglobin levels in the blood
• decrease in red blood cell count
• itching
• coughing up blood or sputum stained with blood
• abdominal pain or stomach pain
• esophagitis or gastritis
• allergic reaction
• difficulty swallowing
• jaundice of the skin or eyes due to liver or blood problems

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

• lack 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
• may experience bleeding into a joint or due to injury, from a surgical wound, from an injection site, or from a catheter insertion site
• may experience bleeding from hemorrhoids
• stomach or intestinal ulcers (including esophageal ulcers)
• 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 Drug Safety, 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 collected on the safety of this medicine.

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

5. How to store Dabigatran Etexilate Viatris

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

Do not use this medicine after the expiry date stated on the carton, blister, or bottle after EXP.

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

Store in the original package 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 no longer required.

This will help protect the environment.

6. Contents of the pack 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 150 mg of dabigatran etexilate.
• The other ingredients are: tartaric acid (pellets), hydroxypropyl cellulose, 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 solution, iron oxide black (E 172), and potassium hydroxide.

What Dabigatran Etexilate Viatris looks like and contents of the pack

Dabigatran Etexilate Viatris 150 mg is a hard capsule, approximately 21 mm long, with a light blue, opaque cap and a white, opaque body, filled with pellets that are yellow to yellowish in color, with the imprint "VTRS" above "DC150" in black ink on the cap and body.

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

Dabigatran Etexilate Viatris is available in packs containing perforated unit dose blisters made of 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, child-resistant, with 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 detailed information on this medicine, please 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