Dabigatran etexilate viatris

Package leaflet: Information for the patient

Dabigatran Etexilate Viatris, 110 mg, hard capsules
dabigatran etexilate
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Dabigatran Etexilate Viatris 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 Viatris is used in adults to:

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

Dabigatran Etexilate Viatris is used in children to:

• treat blood clots and prevent recurrence of blood clots.

2. Important information before using Dabigatran Etexilate Viatris

When not to use 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 function impairment;
• if the patient is currently experiencing bleeding;
• if the patient has an internal organ disease that increases the risk of major bleeding (e.g. stomach ulcer, intracranial bleeding or injury, recent brain or eye surgery);
• if the patient has an increased tendency to bleed, which may be congenital, of unknown cause, or caused by taking other medicines;
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except in the following cases: switching anticoagulant therapy, placement of a venous or arterial catheter with heparin to maintain its patency, or restoring normal heart rhythm using a procedure called catheter ablation in atrial fibrillation;
• if the patient has severe liver function impairment or liver disease which may be life-threatening;
• if the patient is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections;
• if the patient is taking oral cyclosporine, a medicine used to prevent 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 had a mechanical heart valve implanted, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran Etexilate Viatris, discuss this with your doctor.
You should also contact your doctor during treatment with this medicine if you experience any symptoms or if you require a surgical procedure.
The patient should inform the doctor if they currently have or have previously had any medical conditions or diseases, especially those listed below:

• if the patient has an increased risk of bleeding, for example:
• if the patient has recently experienced bleeding
• if the patient underwent a surgical tissue biopsy within the last month
• if the patient has suffered a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment)
• if the patient has inflammation of the oesophagus or stomach
• if the patient has gastro-oesophageal reflux (food regurgitating from the stomach into the oesophagus)
• if the patient is taking medicines that may increase the risk of bleeding. See section "Dabigatran Etexilate Viatris with other medicines" below
• if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, ibuprofen, piroxicam
• if the patient has an infection in or around the heart (bacterial endocarditis)
• if the patient has kidney function impairment or dehydration (symptoms include feeling thirsty and passing reduced amounts of dark [concentrated] and/or frothy urine)
• if the patient is aged 75 years or older
• if the patient is an adult weighing 50 kg or less
• only when used in children: if the child has an infection around or inside the brain
• if the patient has had a heart attack or has conditions increasing the risk of a heart attack
• if the patient has liver disease that affects blood test results. In such cases, use of this medicine is not recommended.

When to exercise special caution when using Dabigatran Etexilate Viatris

• if the patient requires surgery: In such cases, temporary discontinuation of Dabigatran Etexilate Viatris will be necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran Etexilate Viatris exactly as directed by the doctor both before and after surgery.
• if the surgical procedure involves insertion of a catheter or administration of an injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
• It is very important to take Dabigatran Etexilate Viatris exactly as directed by the doctor both before and after surgery.
• The patient should immediately inform the doctor if, after the anaesthesia wears off, they experience numbness or weakness in the legs or problems with the bowels or bladder, as urgent medical attention is required.
• if the patient falls or sustains an injury during treatment, especially if they hit their head. In such cases, immediate medical attention should be sought. A medical evaluation may be necessary, as the patient may be at increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), inform the doctor, who will decide whether any change in treatment is needed.

Dabigatran Etexilate Viatris with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular, before taking
Dabigatran Etexilate Viatris, inform the doctor if the patient is taking any of the following medicines:

• medicines that reduce blood clotting (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 applied only to 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 used to prevent rejection of transplanted organs (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 known as selective serotonin reuptake inhibitors or serotonin-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 unknown. This medicine should not be used during pregnancy unless the doctor determines it is safe. Women of childbearing potential should use effective contraception to prevent pregnancy while taking Dabigatran Etexilate Viatris.
Breastfeeding is not recommended while taking Dabigatran Etexilate Viatris.

Driving and using machines
Dabigatran Etexilate Viatris has no influence on the ability to drive or operate machinery.

3. How to take Dabigatran Etexilate Viatris

Dabigatran Etexilate Viatris capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. There are other age-appropriate formulations available for treating children under 8 years of age.
This medicine should always be taken as prescribed by your doctor. If you have any doubts, consult your doctor.
Dabigatran Etexilate Viatris should be taken according to 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 daily (taken as 2 capsules of 110 mg each).
If renal function is reduced by more than half or if the patient is 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg each).
If the patient is taking medications containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg each).
If the patient is taking medications containing verapamil and has reduced renal function by more than half, a reduced dose of 75 mg of Dabigatran Etexilate Viatris should be used, as the risk of bleeding may be increased.
For both types of surgery, treatment should not be started if there is active bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, it should be started with a dose of 2 capsules once daily.

After knee replacement surgery
Treatment with Dabigatran Etexilate Viatris should begin 1–4 hours after completion of surgery, taking one capsule. Then, two capsules should be taken once daily for a total of 10 days.

After hip replacement surgery
Treatment with Dabigatran Etexilate Viatris should begin 1–4 hours after completion of surgery, taking one capsule. Then, two capsules should be taken once daily for a total of 28–35 days.

Prevention of vascular occlusion in the brain and body due to blood clot formation in case of irregular heart rhythm, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of such clots
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
In patients 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
Patients taking medications containing verapamil should receive a reduced dose of Dabigatran Etexilate Viatris of 220 mg, taken as one 110 mg capsule twice daily, due to the potential increased risk of bleeding.
In cases of potentially increased bleeding risk, the doctor may prescribe a dose of 220 mg as one 110 mg capsule twice daily.
You may continue taking this medicine if a procedure called cardioversion is required to restore normal heart rhythm. Dabigatran Etexilate Viatris should be taken as directed by your doctor.

In case of implantation of a medical device (stent) into a blood vessel to maintain its patency via a procedure called percutaneous coronary intervention with stenting, the patient may receive Dabigatran Etexilate Viatris treatment after the doctor confirms adequate control of blood coagulation. Dabigatran Etexilate Viatris should be taken as directed by your doctor.

Treatment and prevention of recurrence of blood clots in children
Dabigatran Etexilate Viatris should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The interval between doses should be as close as possible to 12 hours.
The recommended dose depends on body weight and age. The doctor will determine the appropriate dose and may adjust it during treatment. Continue taking all other prescribed medications unless your doctor advises otherwise.

Table 1 shows the single and total daily doses of Dabigatran Etexilate Viatris in milligrams (mg). Doses depend on body weight in kilograms (kg) and patient age in years.
Table 1: Dosing table for Dabigatran Etexilate Viatris capsules

Single doses requiring 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: as two 110 mg capsules
185 mg: as one 75 mg capsule plus one 110 mg capsule
150 mg: as 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 down and turn the cap.
• After removing a capsule and taking the dose, immediately close the bottle tightly with the cap.

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

Taking more Dabigatran Etexilate Viatris than prescribed
Taking too high a dose of this medicine increases the risk of bleeding. If you have taken too many capsules, contact your doctor immediately. Specific treatment options are available.

Missed dose of Dabigatran Etexilate Viatris

Prevention of blood clots after knee or hip replacement surgery
Continue taking the remaining daily doses of Dabigatran Etexilate Viatris at the usual time on the following day. Do not take a double dose to make up for a missed dose.

Use in adults: Prevention of vascular occlusion in the brain and body caused by blood clots due to irregular heart rhythm, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of such clots
Use in children: Treatment of blood clots and prevention of recurrent blood clots

A missed dose may be taken up to 6 hours before the next scheduled dose.
Do not take a missed dose if less than 6 hours remain before the next scheduled dose. If a dose is missed, do not take a double dose to make up for it.

Stopping Dabigatran Etexilate Viatris
Dabigatran Etexilate Viatris should be taken exactly as prescribed. Do not stop taking this medicine without consulting your doctor first, as stopping treatment too early may increase the risk of developing a blood clot. Contact your doctor if you experience indigestion after taking Dabigatran Etexilate Viatris.
If you have any further questions about the use of this medicine, consult 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 Viatris affects blood clotting, so most adverse effects are related to symptoms such as bruising or bleeding. Severe or major bleeding may occur, which are the most serious adverse effects; regardless of location, they may lead to disability, life-threatening conditions, or even death. In some cases, these bleedings may not be visible.
If any bleeding does not stop on its own, or if symptoms of excessive bleeding occur (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to monitor you or change your treatment.
Inform your doctor immediately if you experience a serious allergic reaction causing difficulty breathing or dizziness.

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

Prevention of blood clots after surgery (knee or hip replacement)

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

• decrease in haemoglobin levels in the blood (a substance contained in red blood cells)
• abnormal laboratory test results indicating liver function abnormalities.

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

• bleeding from the nose, stomach or intestines, penis or vagina or urinary tract (including blood in urine, which may turn urine pink or red), from haemorrhoids, rectum, under the skin, into joints, due to injury or after injury, or following a surgical procedure
• formation of haematomas or bruising after surgery
• blood detected in stool in laboratory testing
• decrease in the number of red blood cells in the blood
• decrease in the number of blood cells
• allergic reaction
• vomiting
• frequent loose or watery stools
• nausea
• wound discharge (fluid oozing from the surgical wound)
• increased liver enzyme activity
• yellowing of the skin or whites of the eyes caused by problems with the liver or blood.

Rare (may affect up to 1 in 1000 people):

• bleeding
• bleeding in the brain, from the surgical incision site, injection site, or catheter insertion site
• blood-tinged discharge from the intravenous catheter 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 consisting of dark red, raised, itchy bumps due to an allergic reaction
• sudden change in skin colour and appearance
• itching
• stomach or intestinal ulcer (including oesophageal ulceration)
• inflammation of the oesophagus and stomach
• regurgitation of stomach contents into the oesophagus (reflux)
• abdominal pain or stomach pain
• indigestion
• difficulty swallowing
• oozing of fluid from the wound
• oozing of fluid from the surgical wound.

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

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

Prevention of blood vessel blockage in the brain and body caused by blood clots during irregular heart rhythm

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

• bleeding from the nose, stomach or intestines, penis or vagina or urinary tract (including blood in urine, which may turn urine pink or red), or under the skin
• decrease in red blood cell count
• abdominal pain or stomach pain
• indigestion
• frequent loose or watery stools
• nausea.

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

• bleeding
• bleeding from haemorrhoids or rectum, or bleeding into the brain
• formation of haematomas
• coughing up blood or blood-tinged sputum
• decrease in platelet count
• decrease in haemoglobin levels in the blood (a substance contained in red blood cells)
• allergic reaction
• sudden change in skin colour and appearance
• itching
• stomach or intestinal ulcer (including oesophageal ulceration)
• inflammation of the oesophagus and stomach
• regurgitation of stomach contents into the oesophagus (reflux)
• vomiting
• difficulty swallowing
• abnormal laboratory test results indicating liver function abnormalities.

Rare (may affect up to 1 in 1000 people):

• bleeding into joints, from the surgical incision site, due to injury, injection site, or intravenous catheter insertion site
• severe allergic reaction causing difficulty breathing or dizziness
• severe allergic reaction causing swelling of the face or throat
• skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• decrease in blood cell count
• increased liver enzyme activity
• yellowing of the skin or whites of the eyes caused by problems with the liver or blood.

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

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

In clinical trials, the incidence 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 legs and lungs, including prevention of recurrence of blood clots in the legs and (or) 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 urine, which may turn urine pink or red), or under the skin
• indigestion.

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

• bleeding
• bleeding into joints or following injury
• bleeding from haemorrhoids
• decrease in red blood cell count
• formation of haematomas
• coughing up blood or blood-tinged sputum
• allergic reaction
• sudden change in skin colour and appearance
• itching
• stomach or intestinal ulcer (including oesophageal ulceration)
• inflammation of the oesophagus and stomach
• regurgitation of stomach contents into the oesophagus (reflux)
• nausea
• vomiting
• abdominal pain or stomach pain
• frequent loose or watery stools
• abnormal laboratory test results indicating liver function abnormalities
• increased liver enzyme activity.

Rare (may affect up to 1 in 1000 people):

• bleeding from the surgical incision site, injection site, intravenous 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 consisting of dark red, raised, itchy bumps due to an allergic reaction
• difficulty swallowing.

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

• difficulty breathing or wheezing
• decrease in haemoglobin levels in the blood (a substance contained in red blood cells)
• decrease in blood cell count
• decrease in, or even absence of, white blood cells (which help fight infections)
• yellowing of the skin or whites of the eyes caused by problems with the liver or blood
• hair loss.

In the clinical trial programme, the incidence 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 incidence of heart attack was observed between patients treated with dabigatran and those receiving placebo.

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 consisting of dark red, raised, itchy bumps due to an allergic reaction
• sudden change in skin colour and appearance
• formation of haematomas
• nosebleeds
• regurgitation of stomach contents into the oesophagus (reflux)
• vomiting
• nausea
• frequent loose or watery stools
• indigestion
• 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 urine, which may turn urine pink or red), or under the skin
• decrease in haemoglobin levels in the blood (a substance contained in red blood cells)
• decrease in blood cell count
• itching
• coughing up blood or blood-tinged sputum
• abdominal pain or stomach pain
• inflammation of the oesophagus and stomach
• allergic reaction
• difficulty swallowing
• yellowing of the skin or whites of the eyes caused by problems with the liver or blood.

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 into joints or following injury, from the surgical incision site, injection site, or intravenous catheter insertion site
• bleeding from haemorrhoids
• stomach or intestinal ulcer (including oesophageal ulceration)
• abnormal laboratory test results indicating liver function abnormalities.

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects can also be reported to the responsible entity.

5. How to store Dabigatran Etexilate Viatris

Keep this 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 stated month.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures 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 mesilate, equivalent 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 printing ink contains shellac, propylene glycol, concentrated ammonium hydroxide, 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 available as hard capsules approximately 19 mm in length, with a light blue, opaque cap and a light blue, opaque body, filled with pale yellow to yellowish pellets, printed with "VTRS" above "DC110" in black ink on both cap and body.
Dabigatran Etexilate Viatris is available in packs containing 10, 30, 60 or 180 capsules in blisters made of OPA/Aluminium/PVC/Aluminium, in a cardboard outer.
Dabigatran Etexilate Viatris is also available in packs containing single-dose perforated blisters made of OPA/Aluminium/PVC/Aluminium, 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 packs containing 100 or 180 capsules in HDPE bottles with PP child-resistant closure and aluminium seal. The bottle also contains a desiccant (silica gel).
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel.: +48 22 546 64 00

This medicinal product is authorised in the European Economic Area member states under the following names: