Dabigatran Etexilate Viatris

Leaflet accompanying the packaging: patient information

Dabigatran Etexilate Viatris, 75 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 you. 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 knee or hip replacement surgery.

Dabigatran Etexilate Viatris is used in children to:

• treat and prevent blood clots.

2. Important information before taking Dabigatran Etexilate Viatris

When not to take Dabigatran Etexilate Viatris

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:

• only in the case of use in children: if the child has an infection around or inside the brain

When to be particularly careful when taking Dabigatran Etexilate Viatris

• 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, after the anesthesia has worn off, they experience numbness or weakness in their legs or problems with their bowels or bladder, as urgent medical attention is required.

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, 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 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 to the patient. See also section 3.
• medicines used to prevent 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 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 instructions for the following medical conditions:

Prevention of blood clots after knee or hip 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 old or older, the recommended dose is 150 mg once a day(taken as 2 capsules of 75 mg each).

If the patient is 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 has reduced kidney functionby more than half, a reduced dose of 75 mgof Dabigatran Etexilate Viatris should be used, as the risk of bleeding may be increased.

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

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 knee 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 10 days.

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.

Treatment of blood clots and prevention of recurrent 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 to take 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), depending 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.

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

Instructions for opening the bottle

• To open the bottle, the cap should be pressed and turned.
• 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.

If too many capsules have been taken, the patient should contact their doctor immediately.

There are specific treatment options available.

Missing a dose of Dabigatran Etexilate Viatris

Prevention of blood clots after knee or hip replacement surgery

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

The patient should not take a double dose to make up for the missed dose.

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

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

The 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.

The patient should not stop taking the medicine without consulting their 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 the use of 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 the location, and in some cases, these bleeding episodes may not be visible.

If any bleeding occurs that does not stop by itself 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 are possible side effects, grouped by frequency of occurrence.

Prevention of blood clots after knee or hip 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):

• may experience nosebleeds, bleeding into the stomach or intestines, from the penis or vagina or urinary tract (including blood in the urine, which turns the urine pink or red), from hematomas, from the rectum, bleeding under the skin, into a joint, due to injury or after surgery
• formation of hematomas or bruising after surgery
• blood detected in the stool in a laboratory test
• 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 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
• may experience bleeding in the brain, from the surgical wound, from the injection site or from the catheter insertion site
• bloody secretion from the catheter insertion site
• coughing up blood or sputum stained with blood
• 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 and appearance
• itching
• stomach or intestinal ulcers (including esophageal ulcers)
• esophagitis and gastritis
• gastroesophageal reflux disease (GERD)
• abdominal pain or stomach pain
• nausea
• difficulty swallowing
• wound secretion
• wound secretion after surgery.

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

• difficulty breathing or wheezing
• decrease in or absence of white blood cells (which help fight infections)
• hair loss.

Treatment of blood clots and prevention of recurrent 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 and 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, from the brain, from the rectum, from the 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 platelet count
• itching
• coughing up blood or sputum stained with blood
• abdominal pain or stomach pain
• esophagitis and gastritis
• allergic reaction
• difficulty swallowing
• jaundice 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
• may experience bleeding into a joint or due to injury, from the surgical wound, from the injection site or from the catheter insertion site
• may experience bleeding from hematomas
• 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 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 the sight and reach of children.

This medicine should not be used 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 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, equivalent to 75 mg of dabigatran etexilate.
• The other ingredients are: tartaric acid (pellets), hydroxypropylcellulose, talc and hypromellose (type 2910).
• The capsule shell contains titanium dioxide (E 171) and hypromellose.
• The ink used for printing contains shellac, propylene glycol, ammonia, iron oxide black (E 172) and potassium hydroxide.

What Dabigatran Etexilate Viatris looks like and contents of the pack

Dabigatran Etexilate Viatris 75 mg is a hard capsule, approximately 19 mm long, with a white, opaque cap and a white, opaque body, filled with pellets that are yellow to yellowish in color, with the imprint "VTRS" above "DC75" in black ink on the cap and body.

Dabigatran Etexilate Viatris is available in packs containing 10, 30 or 60 capsules in blisters made of OPA/Aluminum/PVC/Aluminum, 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 or 60 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 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 Utka 1

Komárom 2900

Hungary

Mylan Germany GmbH

Benzstrasse 1

Bad Homburg 61352

Germany

To obtain more detailed information on this medicine, the patient should contact their 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