DABIGATRAN 75 mg Твердые Капсулы

Содержание инструкции

1. Dabigatran etexilato Viatris 75 mg hard capsules
   1. What is Dabigatran etexilate Viatris 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. Package Contents and Other Information
2. Dabigatran etexilate Viatris 110 mg hard capsules
   1. What is Dabigatran etexilate Viatris 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. Package contents and other information
3. Dabigatran etexilate Viatris 150 mg hard capsules
   1. What is Dabigatran etexilate Viatris 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. Package contents and other information

Dabigatran etexilato Viatris 75 mg hard capsules

dabigatran etexilato

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Dabigatran etexilate Viatris and what it is used for

Dabigatran etexilate Viatris contains the active ingredient dabigatran etexilate and belongs to a group
of medicines called anticoagulants. It blocks the action of a substance present in the body
involved in the formation of blood clots.
Dabigatran etexilate Viatris is used in adults for:

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

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 to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you have ongoing bleeding.
• if you have injuries to an organ that increase the risk of serious bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
• if you have an increased tendency to bleed. This can be congenital, due to an unknown cause or due to other medicines.
• if you are taking medicines to prevent blood clots from forming (e.g. warfarin, rivaroxaban, apixaban or heparin), except when you are switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and you are receiving heparin through it to keep it open, or when your heartbeat is

returned to normal with a procedure called catheter ablation for atrial
fibrillation.

• if you have severely reduced liver function or a liver disease that could in some way cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking oral cyclosporine, a medicine for the prevention of rejection episodes after organ transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heartbeat.
• if you are taking a combination product based on glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C
• if you have had an artificial heart valve implanted that requires permanent use of anticoagulants.

Warnings and precautions
Talk to your doctor before taking Dabigatran etexilate Viatris. You may also need to
talk to your doctor during treatment with this medicine if you experience symptoms or if you need to
undergo surgery.

Tell your doctorif you suffer from or have suffered from any medical condition or illness, in particular one
of those included in the following list:

• if you have an increased risk of bleeding such as:
• if you have had recent bleeding.
• if you have undergone a biopsy (surgical removal of tissue) in the past month.
• if you have experienced serious injuries (e.g. bone fracture, head injury or any injury that required surgery).
• if you suffer from inflammation of the esophagus or stomach.
• if you have problems with stomach acid reflux into the esophagus.
• if you are taking medicines that can increase the risk of bleeding. See the section “Other medicines and Dabigatran etexilate Viatris” below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you suffer from a heart infection (bacterial endocarditis).
• if you are aware that your kidney function is reduced or you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/frothy urine).
• if you are over 75 years of age.
• if you are an adult patient and weigh 50 kg or less.
• for use in children only: if the child has an infection around or inside the brain.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of developing a heart attack.
• if you suffer from a liver disease, associated with changes in blood tests. In this case, the use of this medicine is not recommended.

Be particularly careful with Dabigatran etexilate Viatris

• if you need to undergo surgery: In this case, Dabigatran etexilate Viatris will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the operation. It is very important to take Dabigatran etexilate Viatris before and after the operation exactly at the time told to you by your doctor.
• if an operation involves the presence of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take Dabigatran etexilate Viatris before and after the operation exactly at the time told to you by your doctor.
• immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has ended, because urgent care is needed.
• if you fall or get injured during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may need to examine you because 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), tell your doctor, who will decide whether it is necessary to change therapy.

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 tell your doctor before taking Dabigatran
etexilate Viatris if you are taking any of the medicines listed below:

• 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 they are only applied to the skin
• Medicines for treating altered heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine or verapamil, your doctor may tell you to use a reduced dose of Dabigatran etexilate Viatris based on the condition for which it has been prescribed. See also section 3
• Medicines to prevent rejection episodes after organ transplantation (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 for the treatment of depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Viatris on pregnancy and the fetus are unknown. You should not take
this medicine if you are pregnant unless your doctor tells you it is safe to do so. If you are a
woman of childbearing potential, you should avoid pregnancy during treatment with Dabigatran etexilate Viatris.
You should 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 and use machines.

3. How to take Dabigatran etexilate Viatris

Dabigatran etexilato Viatris capsules can be used in adults and children aged 8 years and over 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 ingest soft food, other dosage forms appropriate for their age are available.
Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor.

Take Dabigatran etexilato Viatris as recommended for the following conditions:
Prevention of blood clot formation after knee or hip replacement surgery
The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg).
If your kidney function is reducedby more than half or if you are75 years or older, the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine or verapamil, the recommended dose is

150 mg once a day(taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function has decreasedby more than half, you must take a reduced dose of Dabigatran etexilato Viatris of 75 mgbecause the risk of bleeding may increase.
For both procedures, treatment should not be started in case of bleeding at the surgical site. If treatment cannot be started until the day after the surgical procedure, administration should begin with a dose of 2 capsules once a day.

After knee replacement surgery
You should start treatment with Dabigatran etexilato Viatris within 1-4 hours after the end of the surgical procedure, taking a single capsule. Afterwards, you should take two capsules, once a day, for a total of 10 days.

After hip replacement surgery
You should start treatment with Dabigatran etexilato Viatris within 1-4 hours after the end of the surgical procedure, taking a single capsule. Afterwards, you should take two capsules, once a day, for a total of 28-35 days.
Treatment of blood clots and prevention of the formation of new blood clots in children.

Dabigatran etexilato Viatris must be taken twice a day, one dose in the morning and one in the evening, approximately at the same time each day. The administration interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. The doctor will establish the correct dose. The doctor may adjust the dose during treatment. Continue to use all other medicines, unless your doctor tells you to stop taking any of them.
Table 1 shows the single and total daily doses of Dabigatran etexilato Viatris in milligrams (mg). The doses depend on the weight in kilograms (kg) and the age in years of the patient.
Table 1: Dosage table for Dabigatran etexilato 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 etexilato Viatris
Dabigatran etexilato Viatris can be taken with or without food. The capsule must be swallowed whole with a glass of water, to ensure release at the gastric level. Do not break, chew or remove the granules from the capsule as it may increase the risk of bleeding.

Instructions for opening the bottle

• The bottle opens by pressing and rotating the cap.
• After removing the capsule, reposition the cap on the bottle and close it tightly immediately after taking the dose.

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

If you take more Dabigatran etexilato Viatris than you should
Taking too much of this medicine increases the risk of bleeding. Seek immediate medical attention if you have taken an excessive number of capsules. Specific treatment options are available.

If you forget to take Dabigatran etexilato Viatris
Prevention of blood clot formation after knee or hip replacement surgery

Continue with the remaining daily doses of Dabigatran etexilato Viatris at the usual time of the next day.
Do not take a double dose to make up for a missed dose.
Treatment of blood clots and prevention of re-formation of blood clots in children.
The missed dose may still be taken up to 6 hours before the next dose.
If less than 6 hours remain until 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 etexilato Viatris
Take Dabigatran etexilato 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 you stop treatment too soon. Contact your doctor if you experience stomach problems after taking Dabigatran etexilato Viatris.
If you have any doubts 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 everybody gets them.
Dabigatran etexilato Viatris acts on the blood coagulation system, therefore most of the side effects are
related to signs such as bruising or bleeding. Major or severe bleeding events may occur, which
constitute the most serious side effects, and which, regardless of location, can 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 resolve spontaneously or if you experience symptoms of
excessive bleeding (exceptional weakness, feeling of fatigue, paleness, dizziness, headache or
unexplained swelling) consult your doctor immediately. Your doctor may decide to subject you to
thorough monitoring or change the treatment.
Immediately inform your doctor if you experience a serious allergic reaction causing difficulty
breathing or dizziness.
Possible side effects are listed below, grouped by how frequently they occur.
Prevention of blood clot formation after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

• Reduction in the amount of hemoglobin 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, at the level of the stomach or intestine, from penis/vagina or from
  the urinary tract (including blood in the urine that colors it pink or red), from hemorrhoids, from the
  rectum, under the skin, in a joint, from a wound or following it, after surgery
• Formation of a hematoma or bruise that occurs after surgery
• Presence of blood in the stool, detected by laboratory examination
• Reduction in the number of red blood cells in the blood
• Reduction in the proportion of blood cells
• Allergic reaction
• Vomiting
• Diarrhea with loose or liquid stools
• Feeling unwell
• Secretion from the wound (exudation of fluid from the surgical wound)
• Increased liver enzymes
• Yellowing of the skin or the white 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, from the injection site or from the site of
  insertion of a catheter into a vein
• Bloody secretion from the site of insertion of a catheter into a vein
• Coughing up blood or sputum stained with blood
• Reduction in the number of platelets in the blood
• Reduction in the number of red blood cells in the blood after surgery
• Serious allergic reaction causing difficulty breathing or dizziness
• Serious allergic reaction causing swelling of the face or throat
• Notable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Pain in the abdomen or stomach
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

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

• Difficulty breathing 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 re-formation 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
• Notable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Formation of a hematoma
• Nosebleed
• Reflux of gastric juices into the esophagus
• Vomiting
• Feeling unwell
• Diarrhea 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 at the level of the stomach or intestine, from the brain, from the rectum, from
  penis/vagina or from the urinary tract (including blood in the urine that colors it pink or red) or under
  the skin
• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Reduction in the proportion of blood cells
• Itching
• Coughing up blood or sputum stained with blood
• Pain in the abdomen or stomach
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or the white of the eyes, caused by problems with the liver or blood

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

• Absence of white blood cells (which help fight infections)
• Serious allergic reaction causing difficulty breathing or dizziness
• Serious 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, from a surgical incision, from the injection site or
  from the site of insertion of a catheter into a vein
• Bleeding that may occur from hemorrhoids
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Abnormal liver function test results

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through 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 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 in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Dabigatran etexilate Viatris contains

• The active ingredient is dabigatran etexilate. Each hard capsule contains dabigatran etexilate mesylate corresponding to 75 mg of dabigatran etexilate.
• The other ingredients 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), black iron oxide (E172) and potassium hydroxide (E525).

Description of the appearance of Dabigatran etexilate Viatris and package contents
Dabigatran etexilate Viatris 75 mg capsules are hard capsules approximately 19 mm in length with
opaque white cap and opaque white body, filled with pellets ranging in color from light yellow to
yellowish, with “VTRS” printed on “DC75” on the cap and body with black ink.
Dabigatran etexilate Viatris is available in packs containing 10, 30 or 60 capsules in blisters
of aluminium-OPA/aluminium/PVC.
Dabigatran etexilate Viatris is available in packs containing 10 x 1, 30 x 1 or 60 x 1 capsules
in aluminium-OPA/aluminium/PVC blisters, divisible for single doses.
Dabigatran etexilate Viatris is also available in packs containing 100 or 180 capsules in
HDPE bottles with a child-resistant screw closure. 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

Dabigatran etexilate Viatris 110 mg hard capsules

dabigatran etexilate

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take Dabigatran etexilate Viatris
• 3. How to take Dabigatran etexilate Viatris
• 4. Possible side effects
• 5. How to store Dabigatran etexilate Viatris
• 6. Contents of the pack and other information

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

Dabigatran etexilate Viatris contains the active ingredient dabigatran etexilate and belongs to a group
of medicines called anticoagulants. It blocks the action of a substance present in the body
involved in the formation of blood clots.
Dabigatran etexilate Viatris is used in adults for:

• preventing the formation of blood clots in the veins following surgery for knee or hip replacement.
• preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of heart rhythm disturbance called non-valvular atrial fibrillation and at least one further risk factor.
• treating blood clots in the veins of the legs and lungs and preventing blood clots from reforming 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 to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you have ongoing bleeding.
• if you have injuries to an organ that increase the risk of serious bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
• if you have an increased tendency to bleed. This may be congenital, due to an unknown cause or due to other medicines.
• if you are taking medicines to prevent blood clots from forming (such as warfarin, rivaroxaban, apixaban or heparin), except when you are switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and you are receiving heparin through it to keep it open, or when your heartbeat is restored to normal with a procedure called transcatheter ablation for atrial fibrillation.
• if you have severely reduced liver function or a liver disease that may in some way cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking oral cyclosporine, a medicine to prevent rejection episodes after organ transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heartbeat.
• if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C
• if you have had an artificial heart valve implanted that requires permanent anticoagulation.

Warnings and precautions
Talk to your doctor before taking Dabigatran etexilate Viatris. You may also need to
talk to your doctor during treatment with this medicine if you experience symptoms or if you need to
undergo surgery.

Tell your doctorif you suffer from or have suffered from any medical condition or illness, in particular one
of those included in the following list:

• if you have an increased risk of bleeding such as:
• if you have had recent bleeding.
• if you have undergone a biopsy (surgical removal of tissue) in the past month.
• if you have experienced serious injuries (e.g. bone fracture, head injury or any injury that required surgery).
• if you suffer from inflammation of the esophagus or stomach.
• if you have problems with stomach acid reflux into the esophagus.
• 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 suffer from a heart infection (bacterial endocarditis).
• if you are aware that your kidney function is reduced or you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/foamy urine).
• if you are over 75 years of age.
• if you are an adult patient and weigh 50 kg or less.
• for use in children only: if the child has an infection around or inside the brain.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of developing a heart attack.
• if you suffer from a liver disease, associated with changes in blood tests. In this case, the use of this medicine is not recommended.

Be particularly careful with Dabigatran etexilate Viatris

• if you need to undergo surgery: In this case, Dabigatran etexilate Viatris will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the operation. It is very important

to take Dabigatran etexilate Viatris before and after the operation exactly at the time you have been
told by your doctor.

• if an operation involves the presence of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take Dabigatran etexilate Viatris before and after the operation exactly at the time you have been told by your doctor.
• immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has worn off, as urgent care is needed.
• if you fall or get injured during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may need to examine you because you may be at high risk of bleeding.
• if you know you have a condition called antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change therapy.

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 tell your doctor before taking Dabigatran
etexilate Viatris if you are taking any of the medicines listed below:

• 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 they are only applied to the skin
• Medicines for treating altered heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine or verapamil, your doctor may tell you to use a reduced dose of Dabigatran etexilate Viatris based on the condition for which it has been prescribed to you. See section 3.
• Medicines to prevent rejection episodes after organ transplantation (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 for the treatment of depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Viatris on pregnancy and the fetus are unknown. You should not take
this medicine if you are pregnant unless your doctor tells you it is safe to do so. If you are a
woman of childbearing potential, you should avoid pregnancy during treatment with Dabigatran etexilate Viatris.
You should 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 and operate machinery.

3. How to take Dabigatran etexilate Viatris

Dabigatran etexilate Viatris capsules can be used in adults and in children aged 8 years or 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 ingest soft food, other age-appropriate dosage forms are available.
Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor.

Take Dabigatran etexilate Viatris as recommended for the following conditions:
Prevention of blood clot formation after knee or hip replacement surgery
The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg).
If your kidney function is reducedby more than half or if you are75 years or older, the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine or verapamil, the recommended dose is

150 mg once a day(taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function has decreasedby more than half, you must take a reduced dose of Dabigatran etexilate Viatris of 75 mgbecause the risk of bleeding may increase.
For both procedures, treatment should not be started in case of bleeding at the surgical site. If treatment cannot be started until the day after surgery, administration should begin with a dose of 2 capsules once a day.

After knee replacement surgery
You should start treatment with Dabigatran etexilate Viatris within 1-4 hours after the end of the surgery, taking a single capsule. Subsequently, you should take two capsules, once a day, for a total of 10 days.

After hip replacement surgery
You should start treatment with Dabigatran etexilate Viatris within 1-4 hours after the end of the surgery, taking a single capsule. Subsequently, you should take two capsules, once a day, for a total of 28-35 days.
Prevention of blockage of blood vessels in the brain or the rest of the body due to the formation of blood clots that have developed following an irregular heartbeat and treatment of blood clots in the veins of the legs and lungs including prevention of the reformation of blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice a day.
If you are 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice a day.
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 a day, 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 a day.
You can continue to take this medicine if your heartbeat needs to be restored to normal with a procedure called cardioversion. 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 as part of a procedure called percutaneous coronary intervention with stent, you can be treated with Dabigatran etexilate Viatris after your doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate Viatris according to your doctor's instructions.
Treatment of blood clots and prevention of the formation of new blood clots in children.

Dabigatran etexilate Viatris must be taken twice a day, one dose in the morning and one in the evening, at approximately the same time each day. The administration interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. The doctor will establish the correct dose. The doctor may adjust the dose during treatment. Continue to use all other medicines, unless your doctor tells you to stop taking any of them.
Table 1 shows the single and total daily doses of Dabigatran etexilate Viatris in milligrams (mg). The doses depend on the weight in kilograms (kg) and the age in years of the patient.
Table 1: Dosage 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 release at the gastric level. 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 opens by pressing and rotating the cap.
• After removing the capsule, reposition the cap on the bottle and close it tightly immediately after taking the dose.

Change of 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 too much of this medicine increases the risk of bleeding. Seek immediate medical attention 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 clot formation after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Viatris at the usual time of day next day.
Do not take a double dose to make up for a missed dose.
Use in adults: prevention of blockage of blood vessels in the brain or the rest of the body due to the formation of blood clots that have developed following an irregular heartbeat and treatment of blood clots in the veins of the legs and lungs including prevention of the reformation of blood clots in the veins of the legs and lungs
Use in children: treatment of blood clots and prevention of the reformation of blood clots
The missed dose may still be taken up to 6 hours before the next dose.
If less than 6 hours remain until 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 because the risk of developing a blood clot may be higher if you stop treatment too soon. Contact your doctor if you experience stomach problems after taking Dabigatran etexilate Viatris.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Dabigatran etexilate Viatris acts on the blood coagulation system, therefore most of the side effects are
related to signs such as bruises or bleeding. Major or severe bleeding events may occur, which
constitute the most serious side effects, and which, regardless of location, can be disabling, life-
threatening or even lead to death. In some cases, these bleedings may not be evident.
If you experience any bleeding that does not resolve spontaneously or if you experience symptoms of
excessive bleeding (exceptional weakness, feeling of fatigue, paleness, dizziness, headache or
inexplicable swelling) consult your doctor immediately. Your doctor may decide to subject you to a
thorough check-up or change the treatment.
Immediately inform your doctor if you experience a serious allergic reaction causing difficulty
breathing or dizziness.
Possible side effects are listed below, grouped by the frequency with which they
occur.
Prevention of blood clot formation after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

• Reduction in the amount of hemoglobin 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, at the level of the stomach or intestines, from penis/vagina or
  from the urinary tract (including the presence of blood in the urine that colors it pink or red), from
  hemorrhoids, from the rectum, under the skin, in a joint, from a wound or after it, after a surgical
  intervention
• Formation of a hematoma or hematoma that occurs after surgery
• Presence of blood in the stool, detected by laboratory examination
• Reduction in the number of red blood cells in the blood
• Reduction in the proportion of blood cells
• Allergic reaction
• Vomiting
• Diarrhea with loose or liquid stools
• Feeling unwell
• Secretion from the wound (exudation of liquid 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, from the injection site or from the site of
  catheter insertion into a vein
• Bloody secretion from the catheter insertion site into a vein
• Coughing up blood or sputum stained with blood
• 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 breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Pain in the abdomen or stomach
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

Not known (frequency cannot be estimated based on available data):

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

Prevention of blockage of blood vessels in the brain or the rest of the body due to the
formation of blood clots developed following an altered heartbeat
Common (may affect up to 1 in 10 people):

• Bleeding that may occur from the nose, at the level of the stomach or intestines, from penis/vagina or
  from the urinary tract (including the presence of blood in the urine that colors it pink or red), or under
  the skin
• Reduction in the number of red blood cells in the blood
• Pain in the abdomen or stomach
• Indigestion
• Diarrhea with loose or liquid stools
• Feeling unwell

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

• Bleeding
• Bleeding that may occur from hemorrhoids, from the rectum or in the brain
• Formation of a hematoma
• Coughing up blood or sputum stained with blood
• Reduction in the number of platelets in the blood
• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• 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, from a wound, from the injection site or
  from the site of catheter insertion into a vein
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
• Reduction 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 based on available data):

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

In a clinical study, the percentage 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
reformation 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, at the level of the stomach or intestines, from the rectum, from
  penis/vagina or from the urinary tract (including the presence of blood in the urine that colors 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 hemorrhoids
• Reduction in the number of red blood cells in the blood
• Formation of a hematoma
• Coughing up blood or sputum stained with blood
• Allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Feeling unwell
• Vomiting
• Pain in the abdomen or stomach
• Diarrhea with loose or liquid 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 or from the injection site or from the site of catheter
  insertion into a vein or from the brain
• Reduction 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
• Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
• Difficulty swallowing

Not known (frequency cannot be estimated based on available data):

• Difficulty breathing or wheezing
• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Reduction in the proportion of blood cells
• Reduction 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 program, the percentage 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 the formation of new 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
• Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Formation of a hematoma
• Bleeding from the nose
• Reflux of gastric juices into the esophagus
• Vomiting
• Feeling unwell
• Diarrhea 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 at the level of the stomach or intestines, from the brain, from the rectum, from
  penis/vagina or from the urinary tract (including the presence of blood in the urine that colors it pink or
  red) or under the skin
• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Reduction in the proportion of blood cells
• Itching
• Coughing up blood or sputum stained with blood
• Pain in the abdomen or stomach
• Inflammation of the esophagus 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 based on 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, from a surgical incision, from the injection site or
  from the site of catheter insertion into a vein
• Bleeding that may occur from hemorrhoids
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Abnormal liver function test results

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the national reporting
system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can contribute to providing 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 package, 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 in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Package contents and other information

What Dabigatran etexilate Viatris contains

• The active ingredient is dabigatran etexilate. Each hard capsule contains dabigatran etexilate mesylate corresponding to 110 mg of dabigatran etexilate.
• The other ingredients 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 package contents
Dabigatran etexilate Viatris 110 mg capsules are hard capsules approximately 19 mm in length
with an opaque light blue cap and opaque light blue body, filled with pellets ranging in color from light
yellow to yellowish, with “VTRS” printed on “DC110” on the cap and body with 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 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 unit dose.
Dabigatran etexilate Viatris is also available in packs containing 100 or 180 capsules in
HDPE bottles with a child-resistant screw closure. 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

Dabigatran etexilate Viatris 150 mg hard capsules

dabigatran etexilate

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take Dabigatran etexilate Viatris
• 3. How to take Dabigatran etexilate Viatris
• 4. Possible side effects
• 5. How to store Dabigatran etexilate Viatris
• 6. Contents of the pack and other information

1. What is Dabigatran etexilate Viatris and what 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 present in the body
involved in the formation of blood clots.
Dabigatran etexilate Viatris is used in adults for:

• 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 blood clots from reforming 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 to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely impaired.
• if you have ongoing bleeding.
• if you have injuries to an organ that increase the risk of serious bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
• if you have an increased tendency to bleed. This can be congenital, due to an unknown cause or due to other medicines.
• if you are taking medicines to prevent blood clots from forming (e.g. warfarin, rivaroxaban, apixaban or heparin), except when you are switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and you are receiving heparin through it to keep it open, or when your heartbeat is restored to normal with a procedure called transcatheter ablation for atrial fibrillation.
• if you have severely impaired liver function or a liver disease that could in any way cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking oral cyclosporine, a medicine for the prevention of rejection episodes after organ transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heartbeat.
• if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C
• if you have had an artificial heart valve implanted that requires permanent use of anticoagulants.

Warnings and precautions
Talk to your doctor before taking Dabigatran etexilate Viatris. You may also need to
talk to your doctor during treatment with this medicine if you experience symptoms or if you need to
undergo surgery.

Tell your doctorif you suffer from or have suffered from any medical condition or illness, in particular one
of those included in the following list:

• if you have an increased risk of bleeding such as:
• if you have had recent bleeding.
• if you have undergone a biopsy (surgical removal of tissue) in the previous month.
• if you have experienced serious injuries (e.g. bone fracture, head injury or any injury that required surgery).
• if you suffer from inflammation of the esophagus or stomach.
• if you have problems with stomach acid reflux into the esophagus.
• 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 suffer from a heart infection (bacterial endocarditis).
• if you are aware that your kidney function is reduced or you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/foamy urine).
• if you are over 75 years of age.
• if you are an adult patient and weigh 50 kg or less.
• for use in children only: if the child has an infection around or inside the brain.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of developing a heart attack.
• if you suffer from a liver disease, associated with changes in blood tests. In this case, the use of this medicine is not recommended.

Be particularly careful with Dabigatran etexilate Viatris

• if you need to undergo surgery: In this case, Dabigatran etexilate Viatris will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the operation. It is very important

to take Dabigatran etexilate Viatris before and after the operation exactly at the time that your
doctor has told you.

• if an operation involves the presence of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take Dabigatran etexilate Viatris before and after the operation exactly at the time that your doctor has told you.
• immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has worn off, because urgent care is needed.
• if you fall or get injured during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may need to examine you because 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), tell your doctor, who will decide if you need to change your therapy.

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 tell your doctor before taking Dabigatran
etexilate Viatris if you are taking any of the medicines listed below:

• 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 they are only applied to the skin
• Medicines for treating altered heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may tell you to use a reduced dose of Dabigatran etexilate Viatris based on the condition for which it was prescribed to you. See section 3.
• Medicines to prevent rejection episodes after organ transplantation (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 for the treatment of 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)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

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

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

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 the capsules whole. For the treatment of children under 12 years of age, as soon as they are able to ingest soft food, other age-appropriate dosage forms are available.
Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor.

Take Dabigatran etexilate Viatris as recommended for the following conditions:
Prevention of blood vessel obstruction in the brain or the rest of the body due to the formation of blood clots that have developed following an altered heartbeat and treatment of blood clots in the legs and lungs including prevention of re-formation of blood clots in the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice a day.
If you are 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice a day.
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 a day, because the risk of bleeding may increase.
If you are potentially exposed to a higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice a day.
You can continue to take this medicine if your heartbeat needs to be restored to normal with a procedure called cardioversion or through a procedure called transcatheter ablation for atrial fibrillation. Take Dabigatran etexilate Viatris according to your doctor's instructions.
If a medical device (stent) has been inserted into a blood vessel to keep it open as part of a procedure called percutaneous coronary intervention with stent, you may be treated with Dabigatran etexilate Viatris after your doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate Viatris according to your doctor's instructions.
Treatment of blood clots and prevention of the formation of new blood clots in children.
Dabigatran etexilate Viatris must be taken twice a day, one dose in the morning and one in the evening, approximately at the same time each day. The administration interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. Continue to use all other medicines, unless your doctor tells you to stop taking any of them.
Table 1 shows the single and total daily doses of Dabigatran etexilate Viatris in milligrams (mg). The doses depend on the weight in kilograms (kg) and the age in years of the patient.
Table 1: Dosage 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 release at the gastric level. Do not break, chew, or remove the granules from the capsule as it may increase the risk of bleeding.

Instructions for opening the bottle

• The bottle opens by pressing and rotating the cap.
• After removing the capsule, reposition the cap on the bottle and close it tightly immediately after taking the dose.

Changing 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 too much of this medicine increases the risk of bleeding. Seek immediate medical attention if you have taken an excessive number of capsules. Specific treatment options are available.

If you forget to take Dabigatran etexilate Viatris
The forgotten dose can still be taken up to 6 hours before the next dose.
If less than 6 hours remain until the next dose, the forgotten dose should be skipped.

Do not double the dose to make up for forgetting the 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 because the risk of developing a blood clot may be higher if you stop treatment too soon. Contact your doctor if you experience stomach problems after taking Dabigatran etexilate Viatris.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Dabigatran etexilate Viatris acts on the blood coagulation system, therefore most of the side effects are
related to signs such as bruising or bleeding. Major or severe bleeding events may occur, which
constitute the most serious side effects, and which, regardless of location, can be disabling, life-
threatening or even lead to death. In some cases, these bleedings may not be evident.
If you experience any bleeding that does not resolve spontaneously or if you experience symptoms of
excessive bleeding (exceptional weakness, feeling of fatigue, paleness, dizziness, headache or
inexplicable swelling) consult your doctor immediately. The doctor may decide to subject you to a
thorough check-up or change the treatment.
Immediately inform your doctor if you experience a severe allergic reaction causing difficulty
breathing or dizziness.
The possible side effects are listed below, grouped by the frequency with which they
occur.
Prevention of blockage of blood vessels in the brain or the rest of the body due to the
formation of blood clots developed following an altered heartbeat
Common (may affect up to 1 in 10 people):

• Bleeding that may occur from the nose, at the level of the stomach or intestine, from penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red), or under the skin
• Reduction in the number of red blood cells in the blood
• Abdominal or stomach pain
• Indigestion
• Diarrhea with soft or liquid stools
• Feeling unwell

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

• Bleeding
• Bleeding that may occur from hemorrhoids, from the rectum or in the brain
• Bruising
• Coughing up blood or sputum stained with blood
• Reduction in the number of platelets in the blood
• Reduction in the amount of hemoglobin present in the blood (the substance contained in red blood cells)
• Allergic reaction
• Sudden change in the skin that alters its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• 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, from a wound, from the injection site or from the site of catheter insertion into a vein
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Significant skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Reduction in the proportion of blood cells
• Increased liver enzymes
• Yellowing of the skin or the white of the eyes, caused by problems with the liver or blood

Not known (frequency cannot be estimated based on available data):

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

In a clinical study, the percentage 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
reformation 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, at the level of the stomach or intestine, from the rectum, from penis/vagina or from the urinary tract (including the presence of blood in the urine which turns 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 hemorrhoids
• Reduction in the number of red blood cells in the blood
• Bruising
• Coughing up blood or sputum stained with blood
• Allergic reaction
• Sudden change in the skin that alters its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Feeling unwell
• Vomiting
• Abdominal or stomach pain
• Diarrhea with soft or liquid 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 or from the injection site or from the site of catheter insertion into a vein or from the brain
• Reduction 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
• Significant skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Difficulty swallowing

Not known (frequency cannot be estimated based on available data):

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

In the clinical study program, the percentage 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 the formation of new 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
• Significant skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that alters its color and appearance
• Bruising
• Nosebleeds
• Reflux of gastric juices into the esophagus
• Vomiting
• Feeling unwell
• Diarrhea with soft 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 at the level of the stomach or intestine, from the brain, from the rectum, from penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red) or under the skin
• Reduction in the amount of hemoglobin present in the blood (the substance contained in red blood cells)
• Reduction in the proportion of blood cells
• Itching
• Coughing up blood or sputum stained with blood
• Abdominal or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or the white of the eyes, caused by problems with the liver or blood

Not known (frequency cannot be estimated based on 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, from a surgical incision, from the injection site or from the site of catheter insertion into a vein
• Bleeding that may occur from hemorrhoids
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Abnormal liver function test results

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 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 in waste water. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Package contents and other information

What Dabigatran etexilate Viatris contains

• The active ingredient is dabigatran etexilate. Each hard capsule contains dabigatran etexilate mesylate corresponding to 150 mg of dabigatran etexilate.
• The other ingredients 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 package contents
Dabigatran etexilate Viatris 150 mg capsules are hard capsules approximately 21 mm in length
with a light blue opaque cap and a white opaque body, filled with pellets ranging in color from light
yellow to yellowish, with “VTRS” printed on “DC150” on the cap and body with black ink.
Dabigatran etexilate Viatris is available in packs containing 30, 60 or 180 capsules in blisters
of aluminum-OPA/aluminum/PVC.
Dabigatran etexilate Viatris is available in packs containing 10 x 1, 30 x 1, 60 x 1, 100 x 1
or 180 x 1 capsules in aluminum-OPA/aluminum/PVC blisters, divisible for unit dose.
Dabigatran etexilate Viatris is also available in packs containing 100 or 180 capsules in
HDPE bottles with a child-resistant screw closure. 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