Dabigatran etexilate Viatris

Package leaflet: Information for the patient

Dabigatran etexilate Viatris 75 mg hard capsules

dabigatran etexilate
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Dabigatran etexilate Viatris is and what it is used for
2. What you need to know 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 blocks the action of a substance in the body involved in blood clot formation.
Dabigatran etexilate Viatris is used in adults for:

• preventing the formation of blood clots in the veins following knee or hip replacement surgery.

Dabigatran etexilate Viatris is used in children for:

• treating blood clots and preventing the formation of new blood clots.

2. What you need to know before taking Dabigatran etexilate Viatris

Do not take Dabigatran etexilate Viatris

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you have active bleeding.
• if you have lesions in an organ that increase the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent brain or eye surgery).
• if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
• if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place and heparin is administered through it to keep it open, or when your heartbeat is being restored to normal through a procedure called catheter ablation for atrial fibrillation.
• if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
• if you are taking oral ketoconazole or itraconazolo, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
• if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had a mechanical heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Dabigatran etexilate Viatris. You may also need to consult your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, particularly any of the following:

• if you have an increased risk of bleeding, such as:
  • if you have recently experienced bleeding.
  • if you have undergone a biopsy (surgical removal of tissue) in the past month.
  • if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
  • if you suffer from inflammation of the oesophagus or stomach.
  • if you have gastroesophageal reflux (acid reflux into the oesophagus).
  • if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabigatran etexilate Viatris” below.
  • if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
  • if you have an infection of the heart (bacterial endocarditis).
  • if you know that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and reduced urination of dark (concentrated)/foamy urine).
  • if you are over 75 years old.
  • if you are an adult weighing 50 kg or less.
  • only for use in children: if the child has an infection around or within the brain.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
• if you have liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with Dabigatran etexilate Viatris

• if you are scheduled for surgery: In this case, you will need to temporarily stop taking Dabigatran etexilate Viatris due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabigatran etexilate Viatris exactly at the time instructed by your doctor, both before and after surgery.
• if a procedure involves the placement of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia or for pain relief):
• it is very important to take Dabigatran etexilate Viatris exactly at the time instructed by your doctor, both before and after the procedure.
• inform your doctor immediately if you experience numbness or weakness in your legs, or bowel or bladder problems after the anaesthesia wears off, as urgent treatment may be required.
  • if you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may decide that you need to be examined, as you may be at high risk of bleeding.
  • if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is necessary.

Other medicines and Dabigatran etexilate Viatris
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking Dabigatran etexilate Viatris if you are taking any of the following medicines:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines for treating fungal infections (e.g. ketoconazole, itraconazole), unless applied only on the skin
• Medicines for treating irregular heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a lower dose of Dabigatran etexilate Viatris depending on the condition for which it has been prescribed. See also section 3
• Medicines to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine)
• The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John’s wort, a herbal medicine used for depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
• Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Viatris on pregnancy and the unborn baby are unknown. You must not take this medicine during pregnancy unless your doctor tells you it is safe to do so. If you are a woman of childbearing potential, you must avoid pregnancy during treatment with Dabigatran etexilate Viatris. You must not breastfeed while taking Dabigatran etexilate Viatris.

Driving and using machines
Dabigatran etexilate Viatris has no known effects on the ability to drive vehicles or operate machinery.

3. How to take Dabigatran etexilate Viatris

Dabigatran etexilate Viatris capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 12 years of age, as soon as they are able to swallow soft food, other age-appropriate dosage forms are available.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Take Dabigatran etexilate Viatris as recommended for the following 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).
If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you must take a reduced dose of Dabigatran etexilate Viatris of 75 mg, because the risk of bleeding may increase.
For both types of surgery, treatment must not be started if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, administration should begin with a dose of 2 capsules once daily.
After knee replacement surgery
You should start treatment with Dabigatran etexilate Viatris within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 10 days.
After hip replacement surgery
You should start treatment with Dabigatran etexilate Viatris within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.
Treatment and prevention 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 dosing interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medications unless your doctor tells you to stop any of them.
Table 1 shows the individual 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.
Table 1: Dosing table for Dabigatran etexilate Viatris capsules

Single doses requiring combinations 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 must be swallowed whole with a glass of water to ensure gastric release. Do not break, chew, or remove the granules from the capsule, as this may increase the risk of bleeding.

Instructions for opening the bottle

• The bottle is opened by pressing and turning the cap.
• After removing the capsule, replace the cap on the bottle and close it tightly immediately after taking the dose.

Switching anticoagulant treatment
Do not change your anticoagulant treatment without specific instructions from your doctor.

If you take more Dabigatran etexilate Viatris than you should
Taking an excessive amount of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

If you forget to take Dabigatran etexilate Viatris
Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Viatris at the usual time the next day.
Do not take a double dose to make up for the missed dose.

Treatment of blood clots and prevention of recurrence of blood clots in children
The missed dose may still be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped.
Do not double the dose to make up for the missed dose.

If you stop taking Dabigatran etexilate Viatris
Take Dabigatran etexilate Viatris exactly as prescribed. Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach problems after taking Dabigatran etexilate Viatris.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Dabigatran etexilato Viatris acts on the blood coagulation system; therefore, most side effects are related to signs such as bruising or bleeding. Major or serious bleeding events may occur, which represent the most serious side effects and, regardless of location, may be disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously or if you experience symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to carry out a thorough check-up or change your treatment.
Contact your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.
The possible side effects are listed below, grouped according to frequency of occurrence.

Prevention of blood clots after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

• Reduction in the amount of haemoglobin in the blood (the substance contained in red blood cells)
• Abnormal liver function test results

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

• Bleeding that may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or after it, following surgery
• Formation of haematoma or haematoma occurring after surgery
• Presence of blood in the stool, detected by laboratory testing
• Reduction in the number of red blood cells in the blood
• Reduction in the proportion of blood cells
• Allergic reaction
• Vomiting
• Diarrhoea with loose or liquid stools
• Feeling unwell
• Discharge from the wound (leakage of fluid from the surgical wound)
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood

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

• Bleeding
• Bleeding that may occur in the brain, from a surgical incision, injection site, or catheter insertion site in a vein
• Blood-stained discharge from the catheter insertion site in a vein
• Coughing up blood or blood-stained sputum
• Reduction in the number of platelets in the blood
• Reduction in the number of red blood cells in the blood after surgery
• Severe allergic reaction causing difficulty in breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
• Sudden skin changes altering its colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Inflammation of the oesophagus and stomach
• Reflux of gastric juices into the oesophagus
• Abdominal or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

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

• Breathing difficulties or wheezing
• Reduction in the number or even absence of white blood cells (which help fight infections)
• Hair loss

Treatment of blood clots and prevention of recurrence of blood clots in children
Common (may affect up to 1 in 10 people):

• Reduction in the number of red blood cells in the blood
• Reduction in the number of platelets in the blood
• Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
• Sudden skin changes altering its colour and appearance
• Haematoma formation
• Nosebleeds
• Reflux of gastric juices into the oesophagus
• Vomiting
• Feeling unwell
• Diarrhoea with loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Reduction in the number of white blood cells (which help fight infections)
• Bleeding that may occur in the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
• Reduction in the amount of haemoglobin in the blood (the substance contained in red blood cells)
• Reduction in the proportion of blood cells
• Itching
• Coughing up blood or blood-stained sputum
• Abdominal 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

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
• Breathing difficulties or wheezing
• Bleeding
• Bleeding that may occur in a joint or from a wound, surgical incision, injection site, or catheter insertion site in a vein
• Bleeding from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Abnormal liver function test results

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 that month.
Store in the original container to protect the medicine from moisture.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you
no longer use. 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 methanesulfonate equivalent to 75 mg of dabigatran etexilate.
• The other components are tartaric acid (E334), hydroxypropylcellulose (E463), talc (E553b) and hypromellose (E464).
• The capsule shell contains titanium dioxide (E171) and hypromellose (E464).
• The printing ink contains shellac (E904), propylene glycol (E1520), strong ammonia solution (527), iron oxide black (E172) and potassium hydroxide (E525).

Description of the appearance of Dabigatran etexilate Viatris and contents of the pack
Dabigatran etexilate Viatris 75 mg capsules are hard capsules approximately 19 mm in length, with an opaque white cap and an opaque white body, filled with pellets ranging in colour from light yellow to yellowish. "VTRS" is printed on "DC75" on both cap and body with black ink.
Dabigatran etexilate Viatris is available in packs containing 10, 30 or 60 capsules in aluminium-OPA/aluminium/PVC blisters.
Dabigatran etexilate Viatris is also available in packs containing 10 x 1, 30 x 1 or 60 x 1 capsules in aluminium-OPA/aluminium/PVC blisters, divided into single-dose units.
Dabigatran etexilate Viatris is also available in packs containing 100 or 180 capsules in HDPE bottles with child-resistant screw caps. The bottle also contains a desiccant (silica gel).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan, Italy

Manufacturer
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary
Mylan Germany GmbH, Benzstraße 1, 61352 Bad Homburg, Germany

Patient information leaflet

Dabigatran etexilate Viatris 110 mg hard capsules

dabigatran etexilate
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Dabigatran etexilate Viatris is and what it is used for
2. What you need to know 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 etexilato Viatris is and what it is used for

Dabigatran etexilato Viatris contains the active substance dabigatran etexilato and belongs to a group of medicines called anticoagulants. It works by blocking the action of a substance in the body involved in blood clot formation.
Dabigatran etexilato Viatris is used in adults for:

• preventing the formation of blood clots in the veins following knee or hip replacement surgery.
• preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one additional risk factor.
• treating blood clots in the veins of the legs and lungs, and preventing the recurrence of blood clots in the veins of the legs and lungs.

Dabigatran etexilato Viatris is used in children for:

• treating blood clots and preventing the formation of new blood clots.

2. What you need to know before taking Dabigatran etexilate Viatris

Do not take Dabigatran etexilate Viatris

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you are currently experiencing bleeding.
• if you have an organ injury that increases the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent brain or eye surgery).
• if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
• if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and heparin is administered through it to keep it open, or when your heartbeat is restored to normal by a procedure called trans-catheter ablation for atrial fibrillation.
• if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
• if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had a mechanical heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Dabigatran etexilate Viatris. You may also need to contact your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, especially one of the following:

• if you have an increased risk of bleeding, such as:
  • if you have recently experienced bleeding.
  • if you have undergone a biopsy (surgical removal of tissue) within the previous month.
  • if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
  • if you suffer from inflammation of the oesophagus or stomach.
  • if you have gastroesophageal reflux (acid reflux into the oesophagus).
  • if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabigatran etexilate Viatris” below.
  • if you are taking non-steroidal anti-inflammatory drugs such as diclofenac, ibuprofen, piroxicam.
  • if you have an infection of the heart (bacterial endocarditis).
  • if you know that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and reduced urination of dark (concentrated)/foamy urine).
  • if you are over 75 years old.
  • if you are an adult weighing 50 kg or less.
  • only for use in children: if the child has an infection around or within the brain.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
• if you have liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with Dabigatran etexilate Viatris

• if you are scheduled for surgery: In this case, Dabigatran etexilate Viatris will need to be temporarily discontinued due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabigatran etexilate Viatris exactly at the times prescribed by your doctor, both before and after surgery.

• if a procedure involves placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anaesthesia or for pain relief):

  • it is very important to take Dabigatran etexilate Viatris exactly at the times prescribed by your doctor, both before and after the procedure.
  • inform your doctor immediately if you experience numbness or weakness in the legs or problems with bowel or bladder function after the anaesthesia wears off, as urgent treatment may be required.

• if you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may consider it necessary to examine you, as you may be at high risk of bleeding.

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Other medicines and Dabigatran etexilate Viatris
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking Dabigatran etexilate Viatris if you are taking any of the following medicines:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines for fungal infections (e.g. ketoconazole, itraconazolo), unless applied only topically to the skin
• Medicines for abnormal heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a lower dose of Dabigatran etexilate Viatris depending on the condition for which it was prescribed. See section 3.
• Medicines to prevent transplant rejection (e.g. tacrolimus, cyclosporine)
• The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John’s wort, a herbal remedy used for depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
• Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Viatris on pregnancy and the unborn child are unknown. You must not take this medicine during pregnancy unless your doctor tells you it is safe to do so. If you are a woman of childbearing age, you must avoid becoming pregnant during treatment with Dabigatran etexilate Viatris. You must not breastfeed during treatment with Dabigatran etexilate Viatris.

Driving and using machines
Dabigatran etexilate Viatris has no known effects on the ability to drive vehicles or operate machinery.

3. How to take Dabigatran etexilate Viatris

Dabigatran etexilate Viatris capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 12 years of age as soon as they are able to swallow soft food, other age-appropriate dosage forms are available.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

Take Dabigatran etexilate Viatris as recommended for the following 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).
If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you must take a reduced dose of Dabigatran etexilate Viatris of 75 mg, because the risk of bleeding may increase.

For both procedures, treatment must not be started if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, administration should begin with a dose of 2 capsules once daily.

After knee replacement surgery
You should start treatment with Dabigatran etexilate Viatris within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 10 days.

After hip replacement surgery
You should start treatment with Dabigatran etexilate Viatris within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots formed as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of Dabigatran etexilate Viatris of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice daily.

You may continue taking this medicine if your heartbeat needs to be restored to normal through a procedure called cardioversion. Take Dabigatran etexilate Viatris as instructed by your doctor.

If you have had a medical device (stent) inserted into a blood vessel to keep it open as part of a procedure called percutaneous coronary intervention with stenting, you may be treated with Dabigatran etexilate Viatris after your doctor has determined that normal control of blood clotting has been achieved. Take Dabigatran etexilate Viatris as instructed by your doctor.

Treatment and prevention of new 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 dosing interval should be as close as possible to 12 hours.

The recommended dose depends on the patient's weight and age. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.

Table 1 shows the individual 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.

Table 1: Dosing table for Dabigatran etexilate Viatris capsules

Single doses requiring combinations 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 must be swallowed whole with a glass of water to ensure gastric release. Do not break, chew, or remove the granules from the capsule, as this may increase the risk of bleeding.

Instructions for opening the bottle

• The bottle is opened by pressing down and turning the cap.
• After removing the capsule, replace the cap on the bottle and close it tightly immediately after taking the dose.

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

If you take more Dabigatran etexilate Viatris than you should
Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken an excessive number of capsules. Specific treatment options are available.

If you forget to take Dabigatran etexilate Viatris
Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Viatris at your usual time the next day.
Do not take a double dose to make up for the missed dose.

Use in adults: prevention of blood vessel blockage in the brain or elsewhere in the body due to blood clots caused by irregular heartbeat, 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 recurrence of blood clots
The missed dose may still be taken if it is within 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped.
Do not double the dose to make up for a missed dose.

If you stop taking Dabigatran etexilate Viatris
Take Dabigatran etexilate Viatris exactly as prescribed. Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach discomfort after taking Dabigatran etexilate Viatris.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dabigatran etexilate Viatris acts on the blood clotting system; therefore, most side effects are related to signs such as bruising or bleeding. Major or severe bleeding events may occur, which represent the most serious side effects and, regardless of their location, may be disabling, life-threatening, or even fatal. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of tiredness, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to carry out a thorough check-up or change your treatment.
Contact your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.
The possible side effects are listed below, grouped according to how frequently they occur.

Prevention of blood clots after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

• Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
• Abnormal liver function test results

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

• Bleeding that may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or after it, following surgery
• Formation of a haematoma or haematoma occurring after surgery
• Presence of blood in the stool, detected by laboratory testing
• Decrease in the number of red blood cells in the blood
• Decrease in the proportion of blood cells
• Allergic reaction
• Vomiting
• Diarrhoea with loose or watery stools
• Feeling unwell
• Wound discharge (leakage of fluid from the surgical wound)
• Increased liver enzymes
• Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood

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

• Bleeding
• Bleeding that may occur in the brain, from a surgical incision, injection site, or catheter insertion site into a vein
• Blood-stained discharge from the site of catheter insertion into a vein
• Coughing up blood or blood-stained sputum
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgery
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Pronounced skin rash with lumps, dark red, swollen, itchy, due to an allergic reaction
• Sudden skin changes altering its colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Inflammation of the oesophagus and stomach
• Reflux of gastric juices into the oesophagus
• Abdominal or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

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

• Difficulty breathing or wheezing
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Hair loss

Prevention of blood vessel blockage in the brain or elsewhere in the body due to blood clots arising from irregular heartbeat
Common (may affect up to 1 in 10 people):

• Bleeding that may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal or stomach pain
• Indigestion
• Diarrhoea with loose or watery stools
• Feeling unwell

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

• Bleeding
• Bleeding that may occur from haemorrhoids, rectum, or brain
• Formation of a haematoma
• Coughing up blood or blood-stained sputum
• Decrease in the number of platelets in the blood
• Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
• Allergic reaction
• Sudden skin changes altering its colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Inflammation of the oesophagus and stomach
• Reflux of gastric juices into the oesophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding that may occur in a joint, from a surgical incision, wound, injection site, or catheter insertion site into a vein
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Pronounced skin rash with lumps, dark red, swollen, itchy, due to an allergic reaction
• Decrease in the proportion of blood cells
• Increased liver enzymes
• Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood

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

• Difficulty breathing or wheezing
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Hair loss

In a clinical study, the rate of heart attacks was higher with dabigatran etexilate than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of 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 that may occur from the nose, stomach or intestine, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
• Indigestion

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

• Bleeding
• Bleeding that may occur in a joint or from a wound
• Bleeding that may occur from haemorrhoids
• Decrease in the number of red blood cells in the blood
• Formation of a haematoma
• Coughing up blood or blood-stained sputum
• Allergic reaction
• Sudden skin changes altering its colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Inflammation of the oesophagus and stomach
• Reflux of gastric juices into the oesophagus
• Feeling unwell
• Vomiting
• Abdominal or stomach pain
• Diarrhoea with loose or watery stools
• Abnormal liver function test results
• Increased liver enzymes

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

• Bleeding that may occur from a surgical incision, injection site, catheter insertion site into a vein, or brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Pronounced skin rash with lumps, dark red, swollen, itchy, due to an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
• Decrease in the proportion of blood cells
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood
• Hair loss

In the clinical study programme, the rate of heart attacks was higher with dabigatran etexilate than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the incidence of heart attacks was observed compared to patients treated with placebo.

Treatment of blood clots and prevention of new 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
• Pronounced skin rash with lumps, dark red, swollen, itchy, due to an allergic reaction
• Sudden skin changes altering its colour and appearance
• Formation of a haematoma
• Nosebleed
• Reflux of gastric juices into the oesophagus
• Vomiting
• Feeling unwell
• Diarrhoea with loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding that may occur in the stomach or intestine, brain, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
• Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
• Decrease in the proportion of blood cells
• Itching
• Coughing up blood or blood-stained sputum
• Abdominal or stomach pain
• Inflammation of the oesophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood

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

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding that may occur in a joint or from a wound, surgical incision, injection site, or catheter insertion site into a vein
• Bleeding that may occur from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Abnormal liver function test results

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 that month.
Store in the original container to protect the medicine from moisture.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Pack contents and other information

What Dabigatran etexilate Viatris contains

• The active substance is dabigatran etexilate. Each hard capsule contains dabigatran etexilate mesilate equivalent to 110 mg of dabigatran etexilate.
• The other components are tartaric acid (E334), hydroxypropylcellulose (E463), talc (E553b) and hypromellose (E464).
• The capsule shell contains brilliant blue FCF (E133), titanium dioxide (E171) and hypromellose (E464).
• The printing ink contains shellac (E904), propylene glycol (E1520), strong ammonia solution (E527), black iron oxide (E172) and potassium hydroxide (E525).

Description of the appearance of Dabigatran etexilate Viatris and pack contents
Dabigatran etexilate Viatris 110 mg capsules are hard capsules approximately 19 mm in length, with an opaque light blue cap and an opaque light blue body, filled with pellets ranging in colour from light yellow to yellowish. "VTRS" is printed on "DC110" on both the cap and body in black ink.
Dabigatran etexilate Viatris is available in packs containing 10, 30, 60 or 180 capsules in aluminium-OPA/aluminium/PVC blisters.
Dabigatran etexilate Viatris is also available in packs containing 10 x 1, 30 x 1, 60 x 1, 100 x 1 or 180 x 1 capsules in aluminium-OPA/aluminium/PVC blisters, divided into single-dose units.
Dabigatran etexilate Viatris is also available in packs containing 100 or 180 capsules in HDPE bottles with child-resistant screw caps. The bottle also contains a desiccant (silica gel).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan, Italy

Manufacturer
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary
Mylan Germany GmbH, Benzstraße 1, 61352 Bad Homburg, Germany

Patient information leaflet

Dabigatran etexilato Viatris 150 mg hard capsules

dabigatran etexilate
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Dabigatran etexilato Viatris is and what it is used for
2. What you need to know before taking Dabigatran etexilato Viatris
3. How to take Dabigatran etexilato Viatris
4. Possible side effects
5. How to store Dabigatran etexilato 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 blocks the action of a substance in the body involved in blood clot formation.
Dabigatran etexilate Viatris is used in adults for:

• preventing blood clots in the brain (stroke) and in other blood vessels of the body when there is a type of irregular heart rhythm called non-valvular atrial fibrillation and at least one additional risk factor.
• treating blood clots in the veins of the legs and lungs and preventing blood clots from recurring in the veins of the legs and lungs.

Dabigatran etexilate Viatris is used in children for:

• treating blood clots and preventing the formation of new blood clots.

2. What you need to know before taking Dabigatran etexilate Viatris

Do not take Dabigatran etexilate Viatris

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you are experiencing active bleeding.
• if you have organ lesions that increase the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent brain or eye surgery).
• if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
• if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place and heparin is administered through it to keep it open, or when your heartbeat is restored to normal via a procedure called trans-catheter ablation for atrial fibrillation.
• if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
• if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had a mechanical heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Dabigatran etexilate Viatris. You may also need to contact your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, especially any of the following:

• if you are at increased risk of bleeding, such as:
  • if you have recently experienced bleeding.
  • if you have undergone a biopsy (surgical removal of tissue) within the previous month.
  • if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
  • if you suffer from inflammation of the oesophagus or stomach.
  • if you have gastroesophageal reflux (acid reflux into the oesophagus).
  • if you are taking medicines that may increase the risk of bleeding. See the section “Other medicines and Dabigatran etexilate Viatris” below.
  • if you are taking non-steroidal anti-inflammatory drugs such as diclofenac, ibuprofen, piroxicam.
  • if you have an infection of the heart (bacterial endocarditis).
  • if you know that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark, concentrated or foamy urine).
  • if you are over 75 years old.
  • if you are an adult weighing 50 kg or less.
  • only for use in children: if the child has an infection around or within the brain.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
• if you suffer from liver disease associated with abnormal blood test results. In such cases, use of this medicine is not recommended.

Take special care with Dabigatran etexilate Viatris

• if you are scheduled for surgery: In this case, you will need to temporarily stop taking Dabigatran etexilate Viatris due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabigatran etexilate Viatris exactly at the times instructed by your doctor, both before and after surgery.

• if a procedure involves placement of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia or for pain relief):

  • it is very important to take Dabigatran etexilate Viatris exactly at the times instructed by your doctor, both before and after the procedure.
  • inform your doctor immediately if you experience numbness or weakness in your legs, or problems with your bowel or bladder after the anaesthesia wears off, as urgent medical attention may be required.

• if you fall or injure yourself during treatment, especially if you receive a blow to the head. Contact your doctor immediately. Your doctor may consider it necessary to examine you, as you may be at high risk of bleeding.

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Other medicines and Dabigatran etexilate Viatris
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking Dabigatran etexilate Viatris if you are taking any of the following medicines:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines for treating fungal infections (e.g. ketoconazole, itraconazole), unless applied only topically to the skin
• Medicines for treating irregular heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may advise you to use a lower dose of Dabigatran etexilate Viatris depending on your condition. See section 3.
• Medicines to prevent transplant rejection (e.g. tacrolimus, cyclosporine)
• The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John’s wort, a herbal medicine used to treat depression
• Antidepressants called selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
• Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Viatris on pregnancy and the unborn baby are unknown. You must not take this medicine during pregnancy unless your doctor tells you it is safe to do so. If you are a woman of childbearing age, you must avoid pregnancy while being treated with Dabigatran etexilate Viatris. You must not breastfeed while taking Dabigatran etexilate Viatris.

Driving and using machines
Dabigatran etexilate Viatris has no known effect 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 and older who are able to swallow the capsules whole. For the treatment of children under 12 years of age as soon as they are able to swallow soft food, there are other age-appropriate dosage forms available.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Take Dabigatran etexilate Viatris as recommended for the following conditions:
Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots forming as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs.
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of Dabigatran etexilate Viatris of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice daily.
You may continue taking this medicine if your heart rhythm needs to be restored to normal through a procedure called cardioversion or via a procedure called trans-catheter ablation for atrial fibrillation. Take Dabigatran etexilate Viatris according to your doctor’s instructions.
If you have had a medical device (stent) inserted 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 after your doctor has determined that normal blood clotting control has been achieved. Take Dabigatran etexilate Viatris according to your doctor’s instructions.
Treatment of blood clots and prevention of formation of new 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 dosing interval should be as close as possible to 12 hours.
The recommended dose depends on the patient’s weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.
Table 1 shows the individual 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.
Table 1: Dosing table for Dabigatran etexilate Viatris capsules

Single doses requiring combinations 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 must be swallowed whole with a glass of water to ensure gastric release. Do not break, chew, or remove the granules from the capsule, as this may increase the risk of bleeding.

Instructions for opening the bottle

• The bottle is opened by pressing and turning the cap.
• After removing the capsule, replace the cap on the bottle and close it tightly immediately after taking the dose.

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

If you take more Dabigatran etexilate Viatris than you should
Taking an excessive amount of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

If you forget to take Dabigatran etexilate Viatris
The missed dose can still be taken if it is at least 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped.
Do not double the dose to make up for the missed dose.

If you stop taking Dabigatran etexilate Viatris
Take Dabigatran etexilate Viatris exactly as prescribed. Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach problems after taking Dabigatran etexilate Viatris.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Dabigatran etexilate Viatris acts on the blood clotting system; therefore, most side effects are related to signs such as bruising or bleeding. Major or serious bleeding events may occur and represent the most serious side effects, which, regardless of location, can be disabling, life-threatening, or even lead to death. In some cases, this bleeding may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to perform a thorough check-up or change your treatment.
Contact your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.
The possible side effects are listed below, grouped according to how frequently they occur.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots forming as a result of irregular heartbeat

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

• Bleeding that may occur from the nose, stomach or intestines, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
• Decrease in the number of red blood cells in the blood
• Stomach or abdominal pain
• Indigestion
• Diarrhoea with loose or watery stools
• Feeling unwell

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

• Bleeding
• Bleeding that may occur from haemorrhoids, rectum, or brain
• Haematoma formation
• Coughing up blood or blood-stained sputum
• Decrease in the number of platelets in the blood
• Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
• Allergic reaction
• Sudden skin changes altering its colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Inflammation of the oesophagus and stomach
• Reflux of gastric juices into the oesophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding that may occur in a joint, from a surgical incision, wound, injection site, or catheter insertion site in a vein
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
• Decrease in blood cell proportion
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

• Difficulty breathing or wheezing
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Hair loss

In a clinical study, the rate of heart attacks was higher with dabigatran etexilate than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of the legs and lungs, including prevention of re-formation of blood clots in the veins of the legs and/or lungs

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

• Bleeding that may occur from the nose, stomach or intestines, rectum, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
• Indigestion

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

• Bleeding
• Bleeding that may occur in a joint or from a wound
• Bleeding that may occur from haemorrhoids
• Decrease in the number of red blood cells in the blood
• Haematoma formation
• Coughing up blood or blood-stained sputum
• Allergic reaction
• Sudden skin changes altering its colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Inflammation of the oesophagus and stomach
• Reflux of gastric juices into the oesophagus
• Feeling unwell
• Vomiting
• Stomach or abdominal pain
• Diarrhoea with loose or watery stools
• Abnormal liver function test results
• Increased liver enzymes

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

• Bleeding that may occur from a surgical incision, injection site, catheter insertion site in a vein, or brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
• Decrease in blood cell proportion
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems
• Hair loss

In the clinical study programme, the rate of heart attacks was higher with dabigatran etexilate than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the incidence of heart attacks was observed compared to patients treated with placebo.

Treatment of blood clots and prevention of formation of new 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
• Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
• Sudden skin changes altering its colour and appearance
• Haematoma formation
• Nosebleeds
• Reflux of gastric juices into the oesophagus
• Vomiting
• Feeling unwell
• Diarrhoea with loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding that may occur in the stomach or intestines, brain, rectum, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
• Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
• Decrease in blood cell proportion
• Itching
• Coughing up blood or blood-stained sputum
• Stomach or abdominal pain
• Inflammation of the oesophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding that may occur in a joint or from a wound, surgical incision, injection site, or catheter insertion site in a vein
• Bleeding that may occur from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Abnormal liver function test results

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

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 which is stated on the carton, blister, or bottle after
Exp. The expiry date refers to the last day of that month.
Store in the original container to protect the medicine from moisture.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you
no longer use. This will help protect the environment.

6. Package contents and other information

What Dabigatran etexilate Viatris contains

• The active substance is dabigatran etexilate. Each hard capsule contains dabigatran etexilate mesilate equivalent to 150 mg of dabigatran etexilate.
• The other components are tartaric acid (E334), hydroxypropylcellulose (E463), talc (E553b) and hypromellose (E464).
• The capsule shell contains brilliant blue FCF (E133), titanium dioxide (E171) and hypromellose (E464).
• The printing ink contains shellac (E904), propylene glycol (E1520), strong ammonia solution (E527), black iron oxide (E172) and potassium hydroxide (E525).

Description of the appearance of Dabigatran etexilate Viatris and contents of the pack
Dabigatran etexilate Viatris 150 mg capsules are hard capsules approximately 21 mm in length, with a pale blue opaque cap and a white opaque body, filled with pellets ranging in colour from light yellow to yellowish. "VTRS" is printed on "DC150" on both cap and body in black ink.
Dabigatran etexilate Viatris is available in packs containing 30, 60 or 180 capsules in aluminium-OPA/aluminium/PVC blisters.
Dabigatran etexilate Viatris is also available in packs containing 10 x 1, 30 x 1, 60 x 1, 100 x 1 or 180 x 1 capsules in aluminium-OPA/aluminium/PVC blisters, divisible for single-dose administration.
Dabigatran etexilate Viatris is also available in packs containing 100 or 180 capsules in HDPE bottles with child-resistant screw caps. The bottle also contains a desiccant (silica gel).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturer
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary
Mylan Germany GmbH, Benzstraße 1, 61352 Bad Homburg, Germany