Dabigatran etexilate viatris

Package leaflet: Information for the patient

Dabigatran Etexilate Viatris, 150 mg, hard capsules
dabigatran etexilate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

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 that contributes to blood clot formation.

Dabigatran Etexilate Viatris is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels in the body in patients with an 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 to prevent recurrence of blood clots in the veins of the legs and lungs.

Dabigatran Etexilate Viatris is used in children to:

• treat blood clots and to 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 currently has active bleeding;
• if the patient has an internal organ disease 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. This 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 and administration of heparin to maintain its patency, or restoration of normal heart rhythm using a procedure called catheter ablation in atrial fibrillation;
• if the patient has severe liver function impairment or liver disease that could lead to 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 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 ongoing 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 symptoms occur 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 has undergone surgical tissue sampling (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 regurgitation of food from the stomach into the oesophagus (reflux)
• 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 anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam
• if the patient has an infection in 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 foamy urine)
• if the patient is over 75 years of age
• if the patient is an adult weighing 50 kg or less
• only when used in children: if the child has an infection around or within the brain
• if the patient has had a heart attack or has been diagnosed with conditions increasing the risk of heart attack
• if the patient has liver disease affecting 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 surgery requires insertion of a catheter or 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 assistance is required.
• if the patient falls or injures themselves during treatment, especially if they hit their head. In such cases, urgent medical help should be sought. The patient may need to be examined by a doctor, as they may be at increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform the doctor, who will decide whether treatment needs to be changed.

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, tell 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 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 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 known as 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 unknown. This medicine should not be taken during pregnancy unless the doctor determines it is safe. Women of childbearing age should avoid becoming pregnant while taking Dabigatran Etexilate Viatris.
Breastfeeding should not be undertaken while taking Dabigatran Etexilate Viatris.

Driving and operating machinery
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. Other age-appropriate formulations are available for treating children under 8 years of age.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
Dabigatran Etexilate Viatris should be taken according to the following recommendations for the
following medical conditions:
Prevention of blood vessel blockage in the brain and elsewhere in the body caused by blood clots due to irregular heart function, 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.
For patients aged 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
Patients taking medicines containing verapamil should receive a reduced dose of Dabigatran Etexilate Viatris of 220 mg taken as one 110 mg capsule twice daily, due to a potentially increased risk of bleeding.
In cases of potentially increased bleeding risk, your 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 or a procedure known as catheter ablation for atrial fibrillation is required to restore normal heart rhythm. Dabigatran Etexilate Viatris should be taken as directed by your doctor.
If a medical device (stent) is implanted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Dabigatran Etexilate Viatris once your doctor has confirmed adequate control of blood clotting. Dabigatran Etexilate Viatris should be taken as directed by your doctor.
Treatment of blood clots and prevention of recurrent 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. Your doctor will determine the appropriate dose and may adjust it during treatment. Continue taking all other medications unless your doctor advises otherwise.
Table 1 shows the single and total daily doses of Dabigatran Etexilate Viatris in milligrams (mg). Doses are based 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.

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

Stopping Dabigatran Etexilate Viatris
Dabigatran Etexilate Viatris must 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 blood clots. 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Dabigatran Etexilate Viatris affects blood clotting, so most adverse reactions are related to symptoms such as bruising or bleeding. Severe or major bleeding may occur, which are the most serious adverse reactions, and regardless of location, may lead to disability, life-threatening situations, or even death. In some cases, these bleedings may not be visible.
If any bleeding does not stop spontaneously, or if symptoms of excessive bleeding occur (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. The doctor may decide to monitor the patient or change the treatment.
Inform your doctor immediately if a serious allergic reaction occurs causing difficulty in breathing or dizziness.

The possible adverse reactions listed below are grouped according to their frequency of occurrence.

Prevention of blockage of blood vessels in the brain and body caused by blood clots due to irregular heartbeat

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

• nosebleeds, bleeding into the stomach or intestines, from the penis or vagina, or from the urinary tract (including blood in urine, which may turn the urine pink or red), or bleeding under the skin
• decrease in the number of red blood cells in the blood
• abdominal pain or stomach ache
• indigestion
• frequent loose or watery stools
• nausea

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

• bleeding
• bleeding from haemorrhoids or rectum, or bleeding into the brain
• formation of bruises (haematomas)
• coughing up blood or blood-stained sputum
• decrease in the number of platelets in the blood
• decrease in haemoglobin levels in the blood (the 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 assessing liver function

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

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

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

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

In clinical trials, the incidence of myocardial infarction 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):

• nosebleeds, bleeding into the stomach or intestines, from the rectum, from the penis or vagina, or from the urinary tract (including blood in urine, which may turn the urine pink or red), or bleeding under the skin
• indigestion

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

• bleeding
• bleeding into a joint or following trauma
• bleeding from haemorrhoids
• decrease in the number of red blood cells in the blood
• formation of bruises (haematomas)
• coughing up blood or blood-stained 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 ache
• frequent loose or watery stools
• abnormal laboratory test results assessing liver function
• increased liver enzyme activity

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

• bleeding from a surgical incision site, from an injection site, from the site of intravenous catheter insertion, or bleeding into the brain
• decrease in the number of platelets in the blood
• severe allergic reaction causing difficulty in breathing or dizziness
• severe allergic reaction causing swelling of the face or throat
• skin rash with dark red, raised, itchy bumps caused by an allergic reaction
• difficulty swallowing

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

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

In the clinical trial programme, the incidence of myocardial infarction during treatment with Dabigatran Etexilate Viatris was higher than with warfarin. The overall number of cases was small. No difference in the incidence of myocardial infarction was observed between patients treated with dabigatran and 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 the number of red blood cells in the blood
• decrease in the number of platelets in the blood
• skin rash with dark red, raised, itchy bumps caused by an allergic reaction
• sudden change in skin colour and appearance
• formation of bruises (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 the number of white blood cells (which help fight infections)
• bleeding into the stomach or intestines, into the brain, from the rectum, from the penis or vagina, or from the urinary tract (including blood in urine, which may turn the urine pink or red), or bleeding under the skin
• decrease in haemoglobin levels in the blood (the substance contained in red blood cells)
• decrease in the number of blood cells
• itching
• coughing up blood or blood-stained sputum
• abdominal pain or stomach ache
• inflammation of the oesophagus and stomach
• allergic reaction
• difficulty swallowing
• yellowing of the skin or whites of the eyes caused by liver problems or blood disorders

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 in breathing or dizziness
• severe allergic reaction causing swelling of the face or throat
• difficulty breathing or wheezing
• bleeding
• bleeding into a joint or following trauma, from a surgical incision site, from an injection site, or from the site of intravenous catheter insertion
• bleeding from haemorrhoids
• stomach or intestinal ulcer (including oesophageal ulceration)
• abnormal laboratory test results assessing liver function

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 adverse reactions, additional information on the safety of the medicine can be collected.
Adverse reactions may also be reported to the responsible entity.

5. How to store Dabigatran Etexilate Viatris

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, 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 should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Following this advice helps
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 150 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 150 mg is available as hard capsules approximately 21 mm in length, with a light blue, opaque cap and a white, opaque body, filled with pellets ranging in colour from pale yellow to yellowish. The cap and body are printed with "VTRS" above "DC150" in black ink.
Dabigatran Etexilate Viatris is available in packs containing 30, 60, or 180 capsules in blisters made of OPA/Aluminium/PVC/Aluminium, in a cardboard outer carton.
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 a PP child-resistant closure and an 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 member states of the European Economic Area under the following names: