DABIGATRAN 75 mg Hard Capsules

Зміст інструкції

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

Dabigatran etexilatoAccord 75 mg hard capsules

dabigatran etexilato

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet
• 1. What Dabigatran etexilato Accord is and what it is used for
• 2. What you need to know before you take Dabigatran etexilato Accord
• 3. How to take Dabigatran etexilato Accord
• 4. Possible side effects
• 5. How to store Dabigatran etexilato Accord
• 6. Contents of the pack and other information

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

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

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

Dabigatran etexilate Accord 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 etexilato Accord

Do not take Dabigatran etexilato Accord

• if you are allergic to dabigatran etexilato 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 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

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 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 permanent use of anticoagulants. Warnings and precautions

Talk to your doctor before taking Dabigatran etexilato Accord. 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
• 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 etexilato Accord” 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 etexilato Accord

• if you need to undergo surgery: In this case, Dabigatran etexilato Accord 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 etexilato Accord 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 etexilato Accord 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 end of anesthesia, 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 to change the therapy. Other medicines and Dabigatran etexilato Accord

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. In particular, tell your doctor before taking Dabigatran
etexilato Accord 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 etexilato Accord based on the condition for which it has been prescribed. See section 3
• Medicines to prevent rejection episodes after organ transplantation (e.g. tacrolimus, cyclosporine)
• A combination product based on 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 (Hypericum perforatum), 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 AIDS (e.g. ritonavir)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilato Accord on pregnancy and the fetus are unknown. Do 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 etexilato Accord.
Do not breastfeed during treatment with Dabigatran etexilato Accord.

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

Dabigatran etexilato Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially
“sodium-free”.

3. How to take Dabigatran etexilate Accord

Dabigatran etexilate Accord hard 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, other pharmaceutical forms such as 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 doubts, consult your doctor.

Take Dabigatran etexilate Accord 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 Accord 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 Accord 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 Accord 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 Accord should 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 doses of Dabigatran etexilate Accord in milligrams (mg). The doses depend on the weight in kilograms (kg) and the age in years of the patient:
Table 1: Dabigatran etexilate Accord capsule dosage table
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 Accord
Dabigatran etexilate Accord 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 Accord 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 Accord
Prevention of blood clot formation after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Accord at the usual time of the next day.
Do not take a double dose to make up for a missed dose.
Treatment of blood clots and prevention of the reformation of blood clots in children.
The missed dose may still be taken up to 6 hours before the next dose.
If less than 6 hours remain until the next dose, the missed dose should be skipped.
Do not double the dose to make up for a missed dose.

If you stop taking Dabigatran etexilate Accord

Take Dabigatran etexilate Accord 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 Accord.
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 everybody gets them.
Dabigatran etexilato Accord acts on the blood coagulation system, therefore most of the side effects are
related to signs such as bruising or bleeding. Major or severe bleeding events may occur, which
constitute the most serious side effects, and which, regardless of location, can be disabling, life-
threatening or even lead to death. In some cases, these bleedings may not be evident.
If you experience any bleeding that does not resolve spontaneously or if you experience symptoms of
excessive bleeding (exceptional weakness, feeling of fatigue, paleness, dizziness, headache or
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 in
breathing or dizziness.
The possible side effects are listed below, grouped by 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 results of liver function tests
Not common (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 that colors 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
­ Formation of a hematoma or hematoma that occurs 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 liquid from the surgical wound)
­ Increased liver enzymes
­ Yellowing of the skin or the white part of the eyes, caused by problems with the liver or
blood
Rare (may affect up to 1 in 1,000 people):
­ Bleeding
­ Bleeding that may occur in the brain, from a surgical incision, from the injection site
or from the site of catheter insertion into a vein
­ Bloody secretion from the 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
­ Significant skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
­ Sudden change in the skin that modifies its color and appearance
­ Itching
­ Ulcer of the stomach or intestine (including ulcer of the esophagus)
­ 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 from available data):
­ Difficulty breathing or wheezing
­ Reduction in the number or even absence of white blood cells (which help fight
infections)
­ Hair loss
Treatment of blood clots and prevention of 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
­ Significant skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
­ Sudden change in the skin that modifies its color and appearance
­ Formation of a hematoma
­ Nose bleeding
­ Reflux of gastric juices into the esophagus
­ Vomiting
­ Feeling unwell
­ Diarrhea with soft or liquid stools
­ Indigestion
­ Hair loss
­ Increased liver enzymes
Not common (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
that colors it pink or red) or under the skin
­ Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
­ Reduction in the proportion of blood cells
­ Itching
­ Coughing up blood or sputum stained with blood
­ Pain in the abdomen or stomach
­ Inflammation of the esophagus and stomach
­ Allergic reaction
­ Difficulty swallowing
­ Yellowing of the skin or the white part of the eyes, caused by problems with the liver or
blood
Not known (frequency cannot be estimated 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
­ 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
reported in Annex V. By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Dabigatran etexilato Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister and bottle after
Exp. The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
After first opening, the bottle can be used for up to 60 days.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Package contents and other information

What Dabigatran etexilate Accord contains

• The active ingredient is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate (as mesylate).
• The other ingredients are tartaric acid (E334), hypromellose (E464), talc (E553b), hydroxypropylcellulose (E463), sodium croscarmellose (E468) and magnesium stearate (E572) (see section 2).
• The capsule shell contains titanium dioxide (E171) and hypromellose (E464).
• The black printing ink contains shellac (E904), propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide (E525).

Description of Dabigatran etexilate Accord and package contents
Dabigatran etexilate Accord 75 mg hard capsules (approximately 18 x 6 mm) are size “2” hard capsules with an opaque white cap imprinted with “MD” and an opaque white body imprinted with “75” in black ink, containing a mixture of pellets ranging in colour from white to light yellow and light yellow granules.
Dabigatran etexilate Accord 75 mg hard capsules are available in packs containing blisters OPA/Alu/desiccant PE-PET/Alu/PE containing 10, 30 and 60 capsules in a carton.
Dabigatran etexilate Accord 75 mg hard capsules are available in packs containing unit dose blisters OPA/Alu/desiccant PE-PET/Alu/PE containing 10x1, 30x1 and 60x1 capsules in a carton.
Dabigatran etexilate Accord 75 mg hard capsules are available in packs containing a child-resistant closure polypropylene bottle containing 60 capsules in a carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6 Planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul.Lutomierska 50,
95-200, Pabianice, Poland
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht, Netherlands
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU /IE/ IS / IT / LT / LV / L U / MT /
NL / NO / PT / PL / RO / SE / SI / SK / UK(NI) / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica A. E.
Tel: : +30 210 7488 821
More detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu/.

Dabigatran etexilato Accord 110 mg hard capsules

dabigatran etexilate

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

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

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

Do not take Dabigatran etexilate Accord

• 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 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 heartbeats.
• if you are taking a combination product based on glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C
• if you have had an artificial heart valve implanted that requires permanent use of anticoagulants. Warnings and precautions

Talk to your doctor before taking Dabigatran etexilate Accord. 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 Accord” 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.

Take particular care with Dabigatran etexilate Accord

• if you need to undergo surgery: In this case, Dabigatran etexilate Accord 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 Accord 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 Accord before and after the operation exactly at the time you have been told by your doctor.
• immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has worn off, as urgent care is needed.
• if you fall or injure yourself during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may consider it necessary 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 Accord

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 Accord 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 heartbeats (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 Accord based on the condition for which it has been prescribed. See section 3.
• Medicines to prevent rejection episodes after organ transplantation (e.g. tacrolimus, cyclosporine)
• A combination product based on 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 (Hypericum perforatum), 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 AIDS (e.g. ritonavir)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin) Pregnancy and breastfeeding

The effects of Dabigatran etexilate Accord 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 Accord.
You should not breastfeed during treatment with Dabigatran etexilate Accord.

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

Dabigatran etexilate Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially
“sodium-free”.

3. How to take Dabigatran etexilate Accord

Dabigatran etexilate Accord hard capsules can be used in adults and in children aged 8 years or older who are able to swallow the capsules whole. For the treatment of children under 12 years of age as soon as they are able to swallow soft food, other pharmaceutical forms such as coated granules are available.
Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor.

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

150 mg once a day(taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function has decreasedby more than half, you must take a reduced dose of Dabigatran etexilate Accord 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 Accord 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 Accord 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.
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 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 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 Accord 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 Dabigatran etexilate Accord 220 mg taken as one 110 mg capsule twice a day.
You can continue to take this medicine if your heartbeat needs to be returned to normal with a procedure called cardioversion. Take Dabigatran etexilate Accord 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 Accord after your doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate Accord according to your doctor's instructions.
Treatment of blood clots and prevention of the formation of new blood clots in children.

Dabigatran etexilate Accord must be taken twice a day, one dose in the morning and one in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. 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 doses of Dabigatran etexilate Accord 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 Accord 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 Accord
Dabigatran etexilate Accord 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 Accord 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 Accord
Prevention of blood clot formation after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Accord 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 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 a missed dose.

If you stop taking Dabigatran etexilate Accord
Take Dabigatran etexilate Accord 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 Accord.
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 Accord 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 evident.
If you experience any bleeding that does not resolve spontaneously or if you experience symptoms of
excessive bleeding (exceptional weakness, feeling of fatigue, paleness, dizziness, headache or
inexplicable swelling) consult your doctor immediately. The doctor may decide to subject you to a
thorough check-up or change the treatment.
Immediately inform your doctor if you experience a serious allergic reaction causing difficulty
breathing or dizziness.
Possible side effects are listed below, grouped by the frequency with which they occur.
Prevention of blood clot formation after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):
­ Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
­ Abnormal liver function test results
Uncommon (may affect up to 1 in 100 people):
­ Bleeding that may occur from the nose, at the level of the stomach or 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 a surgical intervention
­ Formation of a hematoma or hematoma that occurs 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 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 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 an operation
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, 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), or under the skin
­ Reduction in the number of red blood cells in the blood
­ Pain in the abdomen or stomach
­ Indigestion
­ Diarrhea with loose or liquid stools
­ Feeling unwell
Uncommon (may affect up to 1 in 100 people):
­ Bleeding
­ Bleeding that may occur from hemorrhoids, from the rectum or in the brain
­ Formation of a hematoma
­ Coughing up blood or sputum stained with blood
­ Reduction in the number of platelets in the blood
­ Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
­ Allergic reaction
­ Sudden change in the skin that modifies its color and appearance
­ Itching
­ 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 with nodules, dark red, swollen, itchy caused by an allergic reaction
­ Reduction in the proportion of blood cells
­ Increased liver enzymes
­ Yellowing of the skin or the white part of the eyes, caused by problems with the liver or
blood
Not known (frequency cannot be estimated 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 etexilato
Accord 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 the presence of blood in the urine which colors it
pink or red) or under the skin
­ Indigestion
Uncommon (may affect up to 1 in 100 people):
­ Bleeding
­ Bleeding that may occur in a joint or from a wound
­ Bleeding that may occur from hemorrhoids
­ Reduction in the number of red blood cells in the blood
­ Formation of a hematoma
­ Coughing up blood or sputum stained with blood
­ Allergic reaction
­ Sudden change in the skin that modifies its color and appearance
­ Itching
­ Stomach or intestinal ulcer (including esophageal ulcer)
­ Inflammation of the esophagus and stomach
­ Reflux of gastric juices into the esophagus
­ Feeling unwell
­ Vomiting
­ Pain in the abdomen or stomach
­ Diarrhea with loose or liquid stools
­ Abnormal liver function test results
­ Increased liver enzymes
Rare (may affect up to 1 in 1,000 people):
­ Bleeding that may occur from a surgical incision or from the injection site or from the site of
catheter insertion into a vein or from the brain
­ Reduction in the number of platelets in the blood
­ Severe allergic reaction causing difficulty breathing or dizziness
­ Severe allergic reaction causing swelling of the face or throat
­ Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
­ Difficulty swallowing
Not known (frequency cannot be estimated 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 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 Accord than with warfarin. The overall incidence was low. In patients treated with dabigatran
no imbalance in the incidence of heart attacks was observed compared to patients treated with
placebo.
Treatment of blood clots and prevention of the formation of new blood clots in
children.
Common (may affect up to 1 in 10 people):
­ Reduction in the number of red blood cells in the blood
­ Reduction in the number of platelets in the blood
­ Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
­ Sudden change in the skin that modifies its color and appearance
­ Formation of a hematoma
­ 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 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 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 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 reported in Annex V. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Dabigatran etexilato Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister and bottle after
Exp. The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
After first opening, the bottle can be used for up to 60 days.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Package contents and other information

What Dabigatran etexilate Accord contains

• The active ingredient is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesylate).
• The other ingredients are tartaric acid (E334), hypromellose (E464), talc (E553b), hydroxypropylcellulose (E463), sodium croscarmellose (E468) and magnesium stearate (E572) (see section 2).
• The capsule shell contains titanium dioxide (E171) and hypromellose (E464).
• The black printing ink contains shellac (E904), propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide (E525).

Description of the appearance of Dabigatran etexilate Accord and package contents
Dabigatran etexilate Accord 110 mg hard capsules are size “1” hard capsules (approximately
19 x 7 mm) with an opaque white cap imprinted with “MD” and an opaque white body imprinted with
“110” in black ink, containing a mixture of pellets ranging in colour from white to light yellow and
light yellow granules.
Dabigatran etexilate Accord 110 mg hard capsules are available in packs containing divisible blisters
OPA/Alu/desiccant PE-PET/Alu/PE containing 10, 30, 60, 100 and 180 capsules in a carton.
Dabigatran etexilate Accord 110 mg hard capsules are available in packs containing unit dose divisible
blisters OPA/Alu/desiccant PE-PET/Alu/PE containing 10x1, 30x1, 60x1, 100x1 and
180x1 capsule in a carton.
Dabigatran etexilate Accord 110 mg hard capsules are available in packs containing a
polypropylene bottle with a child-resistant closure containing 60 capsules in a carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6 Planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul.Lutomierska 50,
95-200, Pabianice, Poland
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht, Netherlands
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU /IE/ IS / IT / LT / LV / L U / MT / NL /
NO / PT / PL / RO / SE / SI / SK / UK(NI) / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica A. E.
Tel: : +30 210 7488 821
More detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/.

Dabigatran etexilato Accord 150 mg hard capsules

dabigatran etexilate

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet
• 1. What Dabigatran etexilato Accord is and what it is used for
• 2. What you need to know before you take Dabigatran etexilato Accord
• 3. How to take Dabigatran etexilato Accord
• 4. Possible side effects
• 5. How to store Dabigatran etexilato Accord
• 6. Contents of the pack and other information

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

Dabigatran etexilate Accord contains the active ingredient dabigatran etexilate and belongs to a group
of medicines called anticoagulants. It blocks the action of a substance present in the body
involved in the formation of blood clots.
Dabigatran etexilate Accord 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 etexilate Accord 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 etexilato Accord

Do not take Dabigatran etexilato Accord

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

Warnings and precautions
Talk to your doctor before taking Dabigatran etexilato Accord. 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 etexilato Accord” below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you suffer from a heart infection (bacterial endocarditis).
• if you are aware that your kidney function is reduced or you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/frothy urine).
• if you are over 75 years of age.
• if you are an adult patient and weigh 50 kg or less.
• for use in children only: if the child has an infection around or inside the brain.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of developing a heart attack.
• if you suffer from a liver disease, associated with changes in blood tests. In this case, the use of this medicine is not recommended.

Be particularly careful with Dabigatran etexilato Accord

• if you need to undergo surgery: In this case, Dabigatran etexilato Accord 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 etexilato Accord before and after the operation exactly at the time
that your doctor has told you.

• if an operation involves the presence of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take Dabigatran etexilato Accord before and after the operation exactly at the time that your doctor has told you.
• immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has worn off, 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 whether it is necessary to change therapy.

Other medicines and Dabigatran etexilato Accord
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
etexilato Accord 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 etexilato Accord 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)
• A combination product containing 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 (Hypericum perforatum), 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 AIDS (e.g. ritonavir)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilato Accord on pregnancy and the fetus are unknown. Do 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 etexilato Accord.
Do not breastfeed during treatment with Dabigatran etexilato Accord.

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

Dabigatran etexilato Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially
“sodium-free”.

3. How to take Dabigatran etexilate Accord

Dabigatran etexilate Accord hard 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, other pharmaceutical forms such as coated granules are available as soon as they are able to ingest soft food.
Take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor.

Take Dabigatran etexilate Accord 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 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 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 Accord 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 Dabigatran etexilate Accord 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 Accord 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 Accord after the doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate Accord according to your doctor's instructions.
Treatment of blood clots and prevention of the formation of new blood clots in children.

Dabigatran etexilate Accord 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 Accord 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 Accord 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 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 Accord
Dabigatran etexilate Accord 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 Accord 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 Accord
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 etexilate Accord
Take Dabigatran etexilate Accord exactly as prescribed. Do not stop taking this medicine without talking to your doctor first, 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 Accord.
If you have any questions about using this medicine, ask your doctor or pharmacist.

blood clot may be higher if you stop the treatment too early. Contact your doctor if you experience stomach problems after taking Dabigatran etexilate Accord.
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 everybody gets them.
Dabigatran etexilato Accord 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 the 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 the symptoms of
excessive bleeding (exceptional weakness, feeling of fatigue, paleness, dizziness, headache or
inexplained 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 breathing
difficulty or dizziness.
The possible side effects are listed below, grouped by the frequency with which they
occur.
Prevention of blockage of blood vessels in the brain or the rest of the body due to
the formation of blood clots developed following altered heartbeat
Common (may affect up to 1 in 10 people):
­ Bleeding that may occur from the nose, at the level of the stomach or intestine, from
penis/vagina or from the urinary tract (including the presence of blood in the urine which colors it pink or
red), or under the skin
­ Reduction in the number of red blood cells in the blood
­ Stomach or abdominal 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 esophageal ulcer)
­ 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 difficulty or dizziness
­ Severe allergic reaction causing swelling of the face or throat
­ Significant skin rash due to the presence of nodules, dark red, swollen, itchy
caused by an allergic reaction
­ Reduction in the proportion of blood cells
­ Increased liver enzymes
­ Yellowing of the skin or the white of the eyes, caused by problems with the liver or
blood
Not known (the frequency cannot be estimated from the 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 etexilato
Accord 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 intestine, 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
­ 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 esophageal ulcer)
­ Inflammation of the esophagus and stomach
­ Reflux of gastric juices into the esophagus
­ Feeling unwell
­ Vomiting
­ Stomach or abdominal 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
insertion of the catheter into a vein or from the brain
­ Reduction in the number of platelets in the blood
­ Severe allergic reaction causing breathing difficulty 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 (the frequency cannot be estimated from the 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 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 Accord than with warfarin. The overall incidence was low. In patients treated with dabigatran
no imbalance in the incidence of heart attacks was observed compared to patients treated with
placebo.
Treatment of blood clots and prevention of the formation of new blood clots in
children.
Common (may affect up to 1 in 10 people):
­ Reduction in the number of red blood cells in the blood
­ Reduction in the number of platelets in the blood
­ Significant skin rash due to the presence of nodules, dark red, swollen, itchy
caused by an allergic reaction
­ Sudden change in the skin that 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 the presence of blood in the urine which 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
­ Stomach or abdominal pain
­ Inflammation of the esophagus and stomach
­ Allergic reaction
­ Difficulty swallowing
­ Yellowing of the skin or the white of the eyes, caused by problems with the liver or
blood
Not known (the frequency cannot be estimated from the available data):
­ Absence of white blood cells (which help to fight infections)
­ Severe allergic reaction causing breathing difficulty 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
insertion of the catheter into a vein
­ Bleeding that may occur from hemorrhoids
­ Ulcer of the stomach or intestine (including esophageal ulcer)
­ Abnormal results of liver function tests

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 listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dabigatran etexilato Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister and bottle after
Exp. The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
After first opening, the bottle can be used for up to 60 days.
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 Accord contains

• The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).
• The other ingredients are tartaric acid (E334), hypromellose (E464), talc (E553b), hydroxypropylcellulose (E463), sodium croscarmellose (E468) and magnesium stearate (E572) (see section 2).
• The capsule shell contains titanium dioxide (E171) and hypromellose (E464).
• The black printing ink contains shellac (E904), propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide (E525). Description of the appearance of Dabigatran etexilate Accord and contents of the pack

Dabigatran etexilate Accord 150 mg hard capsules are hard capsules size “0” (approximately 22
x 8 mm) with an opaque white cap imprinted with “MD” and an opaque white body imprinted with
“150” in black ink, containing a mixture of pellets from white to light yellow in colour and granules
of light yellow colour.
Dabigatran etexilate Accord 150 mg hard capsules are available in packs containing blisters
OPA/Alu/desiccant PE-PET/Alu/PE containing 10, 30, 60 and 180 capsules in a carton.
Dabigatran etexilate Accord 150 mg hard capsules are available in packs containing divisible blisters
for unit dose OPA/Alu/desiccant PE-PET/Alu/PE containing 10x1, 30x1, 60x1 and 180x1
capsules in a carton.
Dabigatran etexilate Accord 150 mg hard capsules are available in packs containing a
polypropylene bottle with child-resistant closure containing 60 capsules in a carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6a Planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul.Lutomierska 50,
95-200, Pabianice, Poland
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht, The Netherlands
For further information on this medicine, contact the local representative of the marketing
authorisation holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE/IS / IT / LT / LV / L U / MT /
NL / NO / PT / PL / RO / SE / SI / SK / UK(NI) / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica A. E.
Tel: : +30 210 7488 821
More detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu.

PATIENT ALERT CARD
(Accord logo)
Dabigatran etexilate Accorddabigatran etexilate

• This card must always accompany you/the person assisting the patient
• Ensure you always use the latest version (xxxx 202x)

Dear Patient/Person assisting a paediatric patient,
Your doctor has prescribed/has prescribed for the child a treatment with Dabigatran etexilate Accord. To
use Dabigatran etexilate Accord safely, consider the important information provided
As this card contains important information regarding your/the child’s treatment, it must always
accompany you/the child, to inform healthcare professionals about the treatment with Dabigatran
etexilate Accord.

Dabigatran etexilate Accord Information for the patient/for those assisting paediatric patients
Regarding your/the child’s treatment

• Dabigatran etexilate Accord thins the blood. It is used to treat existing blood clots or to prevent the formation of dangerous blood clots.
• When taking Dabigatran etexilate Accord, follow your doctor’s/the child’s doctor’s instructions. Never skip a dose or stop taking Dabigatran etexilate Accord without talking to your doctor/the child’s doctor.
• Inform your doctor/the child’s doctor about all the medicines you/the child are taking.
• Before any surgery or invasive procedures, inform your doctor/the child’s doctor about taking Dabigatran etexilate Accord.
• Dabigatran etexilate Accord capsules can be taken with or without food. The capsule must be swallowed whole with a glass of water. The capsule must not be broken or chewed and the granules must not be removed from the capsule. When to consult the doctor
• Taking Dabigatran etexilate Accord may increase the risk of bleeding. Contact your doctor/the child’s doctor immediately if you/the child experience any of the possible signs and symptoms of bleeding: unusual swelling, discomfort, pain or headache, dizziness, paleness, weakness, unusual bruising, nosebleeds, gum bleeding, cuts that bleed unusually long, abnormal menstrual flow or vaginal bleeding, blood in the urine which may be pink or brown, red/black stools, coughing up blood, vomiting blood or material that looks like coffee grounds.
• In case of falls or injuries, especially if you hit your head, seek urgent medical attention.
• Do not stop taking Dabigatran etexilate Accord without talking to your doctor/the child’s doctor if you/the child experience heartburn, nausea, vomiting, stomach discomfort, bloating or upper abdominal pain.

Dabigatran etexilate Accord Information for healthcare professionals

• Dabigatran etexilate Accord is an oral anticoagulant (direct thrombin inhibitor).
• It may be necessary to interrupt Dabigatran etexilate Accord before surgery or invasive procedures.
• In case of major bleeding, the administration of Dabigatran etexilate Accord must be stopped immediately.
• For adult patients, a specific reversal agent (idarucizumab) is available. The efficacy and safety of the specific reversal agent idarucizumab have not been established in paediatric patients. For details and recommendations on how to reverse the anticoagulant effect of Dabigatran etexilate Accord, refer to the summary of product characteristics of Dabigatran etexilate Accord and idarucizumab.
• Dabigatran etexilate Accord is primarily eliminated by the kidneys; adequate diuresis must be maintained. Dabigatran etexilate Accord is dialyzable.

Complete this section or ask your doctor/the child’s doctor to do so.
Patient Information
________________________________
Patient Name
_________________________________
Date of Birth
_________________________________
Indication for which the anticoagulant is used
_________________________________
Dose of Dabigatran etexilate Accord