DABIGATRAN 75 mg Капсулы Твердые

Содержание инструкции

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

Dabigatran etexilate Welding 75 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 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 Welding is and what it is used for
• 2. What you need to know before you take Dabigatran etexilate Welding
• 3. How to take Dabigatran etexilate Welding
• 4. Possible side effects
• 5. How to store Dabigatran etexilate Welding
• 6. Contents of the pack and other information

1. What is Dabigatran etexilato Welding and what it is used for

Dabigatran etexilato Welding 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 etexilato Welding is used in adults for:

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

Dabigatran etexilato Welding 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 Welding

taking Dabigatran etexilate Welding

• 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 unknown cause or due to other medicines.
• if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban or heparin), except when you are switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and

heparin is administered through it to keep it open or when your heartbeat is
restored to normal 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 ciclosporin, 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 Welding. 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 may increase the risk of bleeding. See section “Other medicines and Dabigatran etexilate Welding” 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)/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 Welding

• if you need to undergo surgery: In this case, Dabigatran etexilate Welding 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 Welding 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 Welding 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 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 it is necessary to change your therapy.

Other medicines and Dabigatran etexilate Welding
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 Welding 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 Welding 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, ciclosporin)
• 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 Welding 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 Welding.
You should not breastfeed during treatment with Dabigatran etexilate Welding.

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

3. How to take Dabigatran etexilate Welding

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

Take Dabigatran etexilate Welding 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 is decreasedby more than half, you must take a reduced dose of Dabigatran etexilate Welding of 75 mgbecause the risk of bleeding may increase.
For both surgeries, 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 Welding 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 etexilate Welding 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 etexilate Welding 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 Welding 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 Welding 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 Welding
Dabigatran etexilate Welding 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 blisters

Separate a unit of the blister from the whole blister along the perforated line

Lift the aluminum foil on the back and remove the capsule.

• Do not push the capsules through the aluminum foil of the blister.
• The aluminum foil of the blister should only be lifted when it is necessary to remove a capsule.

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

If you take more Dabigatran etexilate Welding 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 Welding
Prevention of blood clot formation after knee or hip replacement surgery Continue with the remaining daily doses of Dabigatran etexilate Welding at the usual time of day.
Do not take a double dose to make up for the missed dose.
Treatment of blood clots and prevention of re-formation 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 the missed dose.

If you stop taking Dabigatran etexilate Welding
Take Dabigatran etexilate Welding 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 Welding.
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 etexilato Welding 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 evident.
If you experience any bleeding that does not resolve spontaneously or if you experience symptoms
of excessive bleeding (exceptional weakness, feeling of fatigue, pallor, 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 serious allergic reaction causing
difficulty breathing or dizziness.
The 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 intestine, from 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 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 soft 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 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 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 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
• Nose bleeding
• 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 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 effectsIf 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 etexilato Welding

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 after Scad
or EXP. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
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 Welding contains

• The active ingredient is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate (as mesylate).
• The other ingredients are tartaric acid, gum arabic, hypromellose, dimethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide and hypromellose.
• The black printing ink contains shellac, black iron oxide and potassium hydroxide.

Description of the appearance of Dabigatran etexilate Welding and contents of the pack
Dabigatran etexilate Welding 75 mg is a hard capsule (approximately 18 × 6 mm) with an opaque white cap
and an opaque white body. “75” is printed on the body of the hard capsule.
This medicinal product is available in packs of 10 × 1, 30 × 1 or 60 × 1 hard capsules in blisters of
OPA/Al/PVC//Al
Unit dose blisters:
This medicinal product is available in packs containing 10 × 1, 30 × 1 or 60 × 1 hard capsules in
perforated and detachable OPA/Al/PVC//Al blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Welding GmbH & Co
KG
Esplanade 39
20354 Hamburg

Manufacturer
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
PLA 3000
Malta
or
Laboratori Fundacio Dau
C/c 12-14 Poligono Indutrial Zona
Franca De Barcelona
08040 Barcelona
Spain
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:

Dabigatran etexilate Welding 110 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 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 Welding is and what it is used for
• 2. What you need to know before you take Dabigatran etexilate Welding
• 3. How to take Dabigatran etexilate Welding
• 4. Possible side effects
• 5. How to store Dabigatran etexilate Welding
• 6. Contents of the pack and other information

1. What is Dabigatran etexilato Welding and what it is used for

Dabigatran etexilato Welding 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 etexilato Welding 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 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 etexilato Welding 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 Welding

Do not take Dabigatran etexilate Welding

• 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 brain surgery or

to the
eyes).

• if you have an increased tendency to bleed. This may be congenital, due to 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 reduced liver function or a liver disease that may somehow 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 the permanent use of anticoagulants.

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

Tell your doctorif you suffer from or have suffered from any medical condition or illness, especially
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 past 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 Welding” below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you suffer from a heart infection (bacterial endocarditis).
• if you know 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 Welding

• if you need to undergo surgery: In this case, Dabigatran etexilate Welding 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 Welding 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 Welding before and after the operation exactly at the time you have been told by your doctor.

immediately tell your doctor if you experience numbness or weakness in your legs or problems
with your bowels or bladder after the anesthesia has ended, as 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 it is necessary to change your therapy.

Other medicines and Dabigatran etexilate Welding
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 Welding 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 Welding 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 treating 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 breastfeedingThe effects of Dabigatran etexilate Welding 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 Welding.
You should not breastfeed during treatment with Dabigatran etexilate Welding.

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

3. How to take Dabigatran etexilate Welding

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

Take Dabigatran etexilate Welding 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 the function of your kidneys 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 is decreasedby more than half, you must take a reduced dose of Dabigatran etexilate Welding of 75 mgbecause the risk of bleeding may increase.
For both procedures, treatment should not be started in case of bleeding at the site of the operation. 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 Welding 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 Welding 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 the 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 Welding of
220 mg taken as one 110 mg capsule twice a day, because the risk of bleeding may increase.
If you are potentially at increased 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 Welding 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 Welding after your doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate Welding according to your doctor's instructions.
Treatment of blood clots and prevention of the formation of new blood clots in children.

Dabigatran etexilate Welding 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 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 Welding 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 Welding 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
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 Welding
Dabigatran etexilate Welding 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 blisters
The following images illustrate how to remove the Dabigatran etexilate Welding capsules from the blister

Separate a unit of the blister from the whole blister along the perforated line

Lift the aluminum foil located on the back and remove the capsule.

• Do not push the capsules through the aluminum foil of the blister.
• The aluminum foil of the blister should only be lifted when it is necessary to remove a capsule.

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

If you take more Dabigatran etexilate Welding 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 Welding
Prevention of blood clot formation after knee or hip replacement surgery Continue with the remaining daily doses of Dabigatran etexilate Welding at the usual time of day.
Do not take a double dose to make up for the 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 the 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 should be skipped. Do not double the dose to make up for the missed dose.

If you stop taking Dabigatran etexilate Welding
Take Dabigatran etexilate Welding 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 Welding.
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 Welding 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 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 serious allergic reaction causing
difficulty breathing or dizziness.
The 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, stomach or intestines, from the 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 surgery
• 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 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 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 alters 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 from 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, stomach or intestines, from the 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 alters 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
• 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 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 from 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 Welding 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, stomach or intestines, from the rectum, from the 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 from hemorrhoids, from the rectum or in the brain
• Hematoma formation
• Coughing up blood or sputum stained with blood
• Reduction in the number of red blood cells in the blood
• Prurito
• Ulcera dello stomaco o dell’intestino (compresa ulcera dell’esofago)
• 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 due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Difficulty swallowing Not known (frequency cannot be estimated from 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 Welding 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 alters its color and appearance
• Hematoma formation
• 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 in the stomach or intestines, in the brain, from the rectum, from the 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 from available data):

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding 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 effect, including those not listed in this leaflet, please
consult 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 Reporting side effects can help provide more information
about the safety of this medicine.

5. How to store Dabigatran etexilato Welding

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 box, blister after Scad
or EXP. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions
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. Contents of the pack and other information

What Dabigatran etexilate Welding contains

• The active ingredient is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesylate).
• The other ingredients are tartaric acid, gum arabic, hypromellose, dimethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine and hypromellose.
• The black printing ink contains shellac, black iron oxide and potassium hydroxide.

Description of the appearance of Dabigatran etexilate Welding and contents of the pack
Dabigatran etexilate Welding 110 mg are hard capsules (approximately 19 × 7 mm) with an opaque light blue cap and an opaque light blue body.
“110” is printed on the body of the hard capsule.
This medicinal product is available in packs of 10 × 1, 30 × 1, 60 × 1, 100 x 1 or 180 x 1 capsules
in multipacks of 3 packs of 60 × 1 capsules (180 capsules) or in multipacks of 2
packs of 50 × 1 capsules (100 capsules) in OPA/Al/PVC//Al blisters.
Unit dose blisters:
This medicinal product is available in packs containing 10 × 1, 30 × 1, 60 × 1, 100 × 1 or 180 × 1
capsules, in a multipack containing 3 packs of 60 x 1 capsules (180
capsules) or in a multipack containing 2 packs of 50 x 1 capsules (100
capsules) in perforated and detachable OPA/Al/PVC//Al blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Welding GmbH & Co KG
Esplanade 39
20354 Hamburg

Manufacturer
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
PLA 3000
Malta
or
Laboratori Fundacio Dau
C/c 12-14 Poligono Indutrial Zona
Franca De Barcelona
08040 Barcelona
Spain
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Dabigatran etexilate Welding 150 mg hard capsules

dabigatran etexilate
Generic medicine

Read this leaflet carefully before you start to take 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 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 Welding is and what it is used for
• 2. What you need to know before you take Dabigatran etexilate Welding
• 3. How to take Dabigatran etexilate Welding
• 4. Possible side effects
• 5. How to store Dabigatran etexilate Welding
• 6. Contents of the pack and other information

1. What is Dabigatran etexilato Welding and what is it used for

Dabigatran etexilato Welding 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 etexilato Welding 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 disturbance 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 etexilato Welding 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 Welding

Do not take Dabigatran etexilate Welding

• 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 due to 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 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 Welding. 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 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 Welding” 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 old.
• 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 Welding

• if you need to undergo surgery: In this case, Dabigatran etexilate Welding 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 Welding 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 Welding 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, 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 Welding
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 Welding 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 Welding 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 remedy for depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Welding 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 Welding.
You should not breastfeed during treatment with Dabigatran etexilate Welding.

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

3. How to take Dabigatran etexilate Welding

Dabigatran etexilate Welding 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 Welding 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 doubts, consult your doctor.

Take Dabigatran etexilate Welding as recommended for the following conditions:
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 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 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 Welding 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 Welding 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 Welding after your doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate Welding according to your doctor's instructions.
Treatment of blood clots and prevention of the formation of new blood clots in children.

Dabigatran etexilate Welding 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 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 Welding 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 Welding 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 or one 110 mg capsule plus two 75
mg
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule plus one 110 mg
150 mg: one 150 mg capsule or
two 75 mg capsules

How to take Dabigatran etexilate Welding
Dabigatran etexilate Welding 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 blisters
The following images illustrate how to remove the Dabigatran etexilate Welding capsules from the blister

Separate one unit of the blister from the entire blister along the perforated line

Lift the aluminum foil located on the back and remove the
capsule.

• Do not push the capsules through the aluminum foil of the blister.
• The aluminum foil of the blister should only be lifted when it is necessary to remove a capsule.

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

If you take more Dabigatran etexilate Welding 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 Welding
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 Welding
Take Dabigatran etexilate Welding exactly as prescribed. Do not stop taking
this medicine without talking to your doctor first 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 Welding.
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 everybody gets them.
Dabigatran etexilate Welding acts on the blood coagulation system, therefore most of the side
effects are related to signs such as bruises or bleeding. Major or serious 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
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
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 serious allergic reaction causing
difficulty breathing or dizziness.
The possible side effects are listed below, grouped by how frequently 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 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
• 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 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 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 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 to fight infections)
• Hair loss In a clinical study, the percentage of heart attacks was higher with Dabigatran etexilate Welding 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 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
• 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
• 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 to 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 Welding than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the incidence of heart attacks was observed compared with 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 modifies 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 to 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 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 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 to 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 ulcer of the esophagus)
• Abnormal results of liver function tests Reporting of side effectsIf you get any side effects, talk to your doctor or pharmacist. This includes any possible 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 Welding

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, blister after Scad or
EXP. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine via 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 contains Dabigatran etexilate Welding
• The active ingredient is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).
• The other ingredients are tartaric acid, gum arabic, hypromellose, dimethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine and hypromellose.
• The black printing ink contains shellac, black iron oxide and potassium hydroxide.

Description of the appearance of Dabigatran etexilate Welding and contents of the pack
Dabigatran Welding 150 mg is a hard capsule (approximately 22 × 8 mm) with an opaque light blue cap and an opaque white body. “150” is printed on the body of the hard capsule
This medicine is available in packs of 10 × 1, 30 × 1, 60 × 1, 100 x 1 or 180 x 1 hard capsules
in multipacks of 3 packs of 60 × 1 hard capsules (180 hard capsules) or in multipacks of 2
packs of 50 × 1 hard capsules (100 hard capsules) in OPA/AL/PVC//AL blisters.
Unit-dose blisters:
This medicine is available in packs containing 10 × 1, 30 × 1, 60 × 1, 100 × 1 or 180 × 1
hard capsules, in a multipack containing 3 packs of 60 x 1 hard capsules (180
hard capsules) or in a multipack containing 2 packs of 50 x 1 hard capsules (100
hard capsules) in perforated and detachable OPA/Al/PVC//Al blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Welding GmbH & Co
KG
Esplanade 39
20354 Hamburg

Manufacturer
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
PLA 3000
Malta
or
Laboratorios Fundacio Dau
C/c 12-14 Poligono Indutrial Zona
Franca De Barcelona
08040 Barcelona
Spain
For further information on this medicine, contact the local representative of the marketing authorisation holder: