DABIGATRAN 75 mg Hard Capsule

Содержание инструкции

1. Dabigatran Etexilate Adamed 75 mg hard capsules
   1. What is Dabigatran Etexilato Adamed and what is it used for
   2. What you need to know before taking Dabigatran Etexilate Adamed
   3. How to take Dabigatran Etexilate Adamed
   4. Possible side effects
   5. How to store Dabigatran Etexilate Adamed
   6. Contents of the pack and other information
2. Dabigatran Etexilate Adamed 110 mg hard capsules
   1. What is Dabigatran Etexilate Adamed and what is it used for
   2. What you need to know before taking Dabigatran Etexilate Adamed
   3. How to take Dabigatran Etexilate Adamed
   4. Possible side effects
   5. How to store Dabigatran Etexilato Adamed
   6. Contents of the pack and other information
3. Dabigatran Etexilate Adamed 150 mg hard capsules
   1. What is Dabigatran Etexilate Adamed and what is it used for
   2. What you need to know before you take
   3. How to take Dabigatran Etexilate Adamed
   4. Possible side effects
   5. How to store Dabigatran Etexilato Adamed
   6. Contents of the pack and other information

Dabigatran Etexilate Adamed 75 mg hard capsules

Generic medicine

Read this leaflet carefully before 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 they have the same symptoms as you, as it may 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 Adamed is and what it is used for
• 2. What you need to know before you take Dabigatran Etexilate Adamed
• 3. How to take Dabigatran Etexilate Adamed
• 4. Possible side effects
• 5. How to store Dabigatran Etexilate Adamed
• 6. Contents of the pack and other information

1. What is Dabigatran Etexilato Adamed and what is it used for

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

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

Dabigatran Etexilato Adamed is used in children 8 years of age and older for:

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

2. What you need to know before taking Dabigatran Etexilate Adamed

Do not take Dabigatran Etexilate Adamed

• 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 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 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 anticoagulation.

Warnings and precautions
Talk to your doctor before taking Dabigatran Etexilate Adamed. 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 Adamed” 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 urinating in reduced 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.
• only for use in children: if the child has an infection around the brain or inside it.
• 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 alterations in blood tests. In this case, the use of this medicine is not recommended.

Be particularly careful with Dabigatran Etexilate Adamed

• if you need to undergo surgery: in this case, Dabigatran Etexilate Adamed 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 Adamed 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 Adamed 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 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 to change your therapy.

Other medicines and Dabigatran Etexilate Adamed
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 Adamed 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 Adamed based on the condition for which it has been prescribed to you. 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 on pregnancy and the fetus are unknown. You should not take this
medicine if you are pregnant unless your doctor tells you that you can. If you are a woman of
childbearing potential, you should avoid pregnancy during treatment with Dabigatran Etexilate Adamed.
You should not breastfeed while taking Dabigatran Etexilate Adamed.

Driving and using machines
Dabigatran Etexilate Adamed has no known effects on the ability to drive vehicles and operate machinery.

3. How to take Dabigatran Etexilate Adamed

Dabigatran Etexilato Adamed capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole.
Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor.

Take Dabigatran Etexilato Adamed 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 are 75 years of age 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 Adamed 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 Etexilato Adamed within 1-4 hours after the end of the surgery, 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 Adamed within 1-4 hours after the end of the surgery, 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 Adamed 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 using any of them.
Table 1 shows the single and total daily doses of Dabigatran Etexilato Adamed 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 Adamed 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 Adamed
Dabigatran Etexilato Adamed can be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure release in the stomach. Do not break, chew or remove the granules from the capsule as it may increase the risk of bleeding.

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

If you take more Dabigatran Etexilato Adamed 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 Adamed
Prevention of blood clot formation after knee or hip replacement surgery.
If you forget to take a dose, continue with the remaining daily doses of Dabigatran Etexilato Adamed at the usual time the next day.
Do not take a double dose to make up for a missed dose.
Treatment of blood clots and prevention of the reformation of blood clots in children.
The missed dose can 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 Adamed
Take Dabigatran Etexilato Adamed 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 Adamed.
If you have any doubts about using 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 Etexilato Adamed 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, may be disabling, life-
threatening or even lead to death. In some cases, these bleedings may not be apparent.
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
inexplained 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 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 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 the penis/vagina or
  from the urinary tract (including the presence of blood in the urine which colors it pink or red), from
  hemorrhoids, from the rectum, under the skin, in a joint, from a wound or following it, after surgery
• Hematoma formation or hematoma occurring 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 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
• Stomach or intestinal ulcer (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

Treatment of blood clots and prevention of blood clot reformation 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
• Hematoma formation
• 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
  the penis/vagina or from the urinary tract (including the presence of blood in the urine which 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
• Stomach or intestinal ulcer (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 Adamed

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 pack or on the blister after
“Exp”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Store in the original packaging to protect the medicine from light and 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. Contents of the pack and other information

What Dabigatran Etexilate Adamed contains

• The active substance is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate (as mesylate).
• The other ingredients are tartaric acid, gum arabic, hypromellose, talc, dimethicone and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), water and hypromellose.
• The black printing ink contains shellac, black iron oxide (E172) and potassium hydroxide.

Description of the appearance of Dabigatran Etexilate Adamed and contents of the pack
Dabigatran Etexilate Adamed 75 mg is in the form of a hard capsule with an opaque white cap with
radial black “D75” printing and an opaque white body, containing a yellowish pellet.
This medicinal product is available in cardboard packs of 30 or 60 hard capsules in blisters of
Polyamide/Aluminum/PVC//Aluminum.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów Poland

Manufacturer
Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland

Dabigatran Etexilate Adamed 110 mg hard capsules

Generic medicine

Read this leaflet carefully before 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 they have the same symptoms as you, 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 Adamed is and what it is used for
• 2. What you need to know before you take Dabigatran Etexilate Adamed
• 3. How to take Dabigatran Etexilate Adamed
• 4. Possible side effects
• 5. How to store Dabigatran Etexilate Adamed
• 6. Contents of the pack and other information

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

Dabigatran Etexilate Adamed contains the active substance dabigatran etexilate and belongs to a
group of medicines called anticoagulants. This medicine blocks the action of a substance
present in the body involved in the formation of blood clots.
Dabigatran Etexilate Adamed 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 disorder 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 Adamed is used in children aged 8 years and older for:

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

2. What you need to know before taking Dabigatran Etexilate Adamed

Do not take Dabigatran Etexilate Adamed

• 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 caused by other medicines.
• if you are taking medicines to prevent the formation of blood clots (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 reduced 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 based on glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C
• if you have had an artificial heart valve implanted that requires the permanent use of anticoagulants.

Warnings and precautions
Talk to your doctor before taking Dabigatran Etexilate Adamed. 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 sustained 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 section “Other medicines and Dabigatran Etexilate Adamed” 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 reduced 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.
• only for use in children: if the child has an infection around the brain or inside it.
• 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.

Take particular care with Dabigatran Etexilate Adamed

• if you need to undergo surgery: in this case, Dabigatran Etexilate Adamed 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 Adamed 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 Adamed 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 ended, because urgent care is needed.
• if you fall or injure yourself 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 Adamed
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 Adamed 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 to treat fungal infections (e.g. ketoconazole, itraconazole) unless they are only applied to the skin
• Medicines to treat 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 Adamed 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-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 Adamed on pregnancy and the fetus are unknown. You should not take
this medicine if you are pregnant unless your doctor tells you that you can. If you are a woman of
childbearing potential, you should avoid pregnancy during treatment with Dabigatran Etexilate Adamed.
You should not breastfeed during treatment with Dabigatran Etexilate Adamed.

Driving and using machines
Dabigatran Etexilate Adamed has no known effects on the ability to drive and use machines.

3. How to take Dabigatran Etexilate Adamed

Dabigatran Etexilate Adamed capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole.
Take this medicine following the doctor’s instructions exactly. If you have any doubts, consult your
doctor.

Take Dabigatran Etexilate Adamed 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 are 75 years of age 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 Adamed 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 Adamed within 1-4 hours after the end of
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 Adamed within 1-4 hours after the end of
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 re-formation 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 of age 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
Adamed of 220 mg taken as one 110 mg capsule twice a day, because the risk of
bleeding may increase.
If you are potentially at 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. Take Dabigatran Etexilate Adamed
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 may be treated
with Dabigatran Etexilate Adamed after your doctor has determined that normal
blood coagulation control has been achieved. Take Dabigatran Etexilate Adamed according to your doctor’s instructions.
Treatment of blood clots and prevention of new blood clots in
children.

Dabigatran Etexilate Adamed 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 Adamed 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 Adamed 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 Adamed
Dabigatran Etexilate Adamed 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.

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

If you take more Dabigatran Etexilate Adamed 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 Adamed
Prevention of blood clot formation after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran Etexilate Adamed 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
re-formation of blood clots in the veins of the legs and lungs
Use in children: treatment of blood clots and prevention of re-formation of blood clots
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 must be skipped.
Do not double the dose to make up for a missed dose.

If you stop taking Dabigatran Etexilate Adamed
Take Dabigatran Etexilate Adamed 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 Etexilate Adamed.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dabigatran Etexilato Adamed 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 the 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 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. 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 according to 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 intestine, from penis/vagina or from the urinary tract (including blood in the urine that turns it pink or red), from hemorrhoids, from the rectum, under the skin, in a joint, from a wound or following it, after a surgical intervention
• Hematoma formation or hematoma occurring after an operation
• 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 1000 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 site of catheter insertion 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 an operation
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Noticeable skin rash due to the presence of 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 an operation

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
formation of blood clots developed following 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 blood in the urine that turns 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
• Hematoma formation
• 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 1000 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 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 Etexilato Adamed than with warfarin. The overall incidence was low.

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/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 blood in the urine that 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
• Hematoma formation
• 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 1000 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 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 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
  Etexilato Adamed 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 due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Hematoma formation
• Nosebleeds
• 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 turns 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 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 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 Etexilato Adamed

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 or blister after
“Exp”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Store in the original package to protect the medicine from light and 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. Contents of the pack and other information

What Dabigatran Etexilate Adamed contains

• The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
• The other ingredients are tartaric acid, gum arabic, hypromellose, dimethicone, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), indigo carmine (E132), water and hypromellose.
• The black printing ink contains shellac, black iron oxide (E172) and potassium hydroxide.

Description of the appearance of Dabigatran Etexilate Adamed and contents of the pack
Dabigatran Etexilate Adamed 110 mg is in the form of a hard capsule with an opaque blue cap with radial black “D110” printing and an opaque blue body, containing a yellowish pellet.
This medicine is available in cardboard packs of 10, 30, 60, 100 or 180 hard capsules in
blisters of Polyamide/Aluminum/PVC//Aluminum inserted in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, Poland

Manufacturer
Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland

Dabigatran Etexilate Adamed 150 mg hard capsules

Generic medicine

Read this leaflet carefully before 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 they have the same symptoms as you, 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 Adamed is and what it is used for
• 2. What you need to know before you take Dabigatran Etexilate Adamed
• 3. How to take Dabigatran Etexilate Adamed
• 4. Possible side effects
• 5. How to store Dabigatran Etexilate Adamed
• 6. Contents of the pack and other information

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

Dabigatran Etexilate Adamed contains the active substance dabigatran etexilate and belongs to a
group of medicines called anticoagulants. This medicine blocks the action of a substance
present in the body involved in the formation of blood clots.
Dabigatran Etexilate Adamed 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 Adamed is used in children aged 8 years and older for:

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

2. What you need to know before you take

Dabigatran Etexilate Adamed
Do not take Dabigatran Etexilate Adamed

• 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 unknown cause or caused by other medicines.
• if you are taking medicines to prevent the formation of blood clots (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 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 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 Adamed. 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 had 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 Adamed” 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 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.

Pay particular attention with Dabigatran Etexilate Adamed

• if you need to undergo surgery: in this case, Dabigatran Etexilate Adamed 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 Adamed 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 Adamed 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 ended, because urgent care is needed.
• if you fall or injure yourself 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 Adamed
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 Adamed if you are taking any of the medicines listed below:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumone, 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 Adamed 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-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 Adamed on pregnancy and the fetus are unknown. Do not take
this medicine if you are pregnant unless your doctor tells you that you can. If you are a woman of
childbearing potential, you should avoid pregnancy during treatment with Dabigatran Etexilate Adamed.
Do not breastfeed during treatment with Dabigatran Etexilate Adamed.

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

3. How to take Dabigatran Etexilate Adamed

Dabigatran Etexilate Adamed 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, Dabigatran Etexilate Adamed coated granules are available as soon as they are able to ingest soft food.
Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor.

Take Dabigatran Etexilate Adamed as recommended for the following conditions:
Prevention of blood vessel blockage in the brain or the rest of the body due to the formation of blood clots developed as a result of altered heartbeat and treatment of blood clots in the legs and lungs including the 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 of age 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 Adamed 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 Adamed 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 can be treated with Dabigatran Etexilate Adamed after your doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran Etexilate Adamed according to your doctor's instructions.
Treatment of blood clots and prevention of the formation of new blood clots in children.

Dabigatran Etexilate Adamed 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. Your doctor will establish the correct dose. Your 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 Adamed 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 Adamed 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 Adamed
Dabigatran Etexilate Adamed 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.

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

If you take more Dabigatran Etexilate Adamed 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 Adamed
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 the missed dose.

If you stop taking Dabigatran Etexilate Adamed
Take Dabigatran Etexilate Adamed 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 Adamed.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Dabigatran Etexilato Adamed 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, 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 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
a thorough check-up or change the treatment.
Immediately inform your doctor if you experience a severe allergic reaction causing breathing
difficulties or dizziness.
Possible side effects are listed below, grouped according to how frequently they occur.
Prevention of blood vessel blockage 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 the 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
• Decrease 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
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin present 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 ulcer of the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal results of liver function tests

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 breathing difficulties or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Notable skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Decrease in the proportion of blood cells
• Increase in 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
• Decrease 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 Etexilato
Adamed than with warfarin. The overall incidence was low.
Treatment of blood clots in the veins of the legs and lungs including the 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 the 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
• Decrease 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 modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including ulcer of the esophagus)
• 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 results of liver function tests
• Increase in 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
• Decrease in the number of platelets in the blood
• Severe allergic reaction causing breathing difficulties or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Notable 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
• Decrease in the amount of hemoglobin present 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 program, the percentage of heart attacks was higher with Dabigatran Etexilato Adamed 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):

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Notable skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Bruising
• Nose bleeding
• Reflux of gastric juices into the esophagus
• Vomiting
• Feeling unwell
• Diarrhea with soft or liquid stools
• Indigestion
• Hair loss
• Increase in 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 at the level of the stomach or intestines, from the brain, from the rectum, from the 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
• Decrease in the amount of hemoglobin present in the blood (the substance contained in red blood cells)
• Decrease 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 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 breathing difficulties 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 ulcer of the esophagus)
• Abnormal results of liver function tests

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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 Etexilato Adamed

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 or blister after
“Exp”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Store in the original package to protect the medicine from light and 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. Contents of the pack and other information

What Dabigatran Etexilate Adamed contains
The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as
mesylate).
The other ingredients are tartaric acid, gum arabic, hypromellose, dimethicone, talc and
hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), indigo
carmine (E132), water and hypromellose.
The black printing ink contains shellac, black iron oxide (E172) and potassium hydroxide.

Description of the appearance of Dabigatran Etexilate Adamed and contents of the pack
Dabigatran Etexilato Adamed 150 mg is in the form of a hard capsule with an opaque blue cap with a
radial black “D150” print and an opaque white body, containing a yellowish pellet.
This medicine is available in cardboard packs of 30, 60, 100 or 180 hard capsules in blisters
of Polyamide/Aluminum/PVC//Aluminum inserted in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, Poland

Manufacturer
Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland