Dabigatran etexilate Accord: detailed information

Patient Information Leaflet

Dabigatran etexilate Accord 75 mg hard capsules

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet
1. What Dabigatran etexilate Accord is 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 etexilate Accord
6. Contents of the pack and other information

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

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

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

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

Warnings and precautions

Talk to your doctor before taking Dabigatran etexilate Accord. You may also need to consult your doctor during treatment with this medicine if you develop symptoms or need to undergo surgery.
Tell your doctor if you have or have had any medical condition or illness, especially any of the following:

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

Take special care with Dabigatran etexilate Accord

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

Other medicines and Dabigatran etexilate Accord

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

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

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

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

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 children aged 8 years and older who are able to swallow the capsules whole.
For the treatment of children under 12 years of age, as soon as they are able to swallow soft food, other pharmaceutical forms such as coated granules are available.
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
Take Dabigatran etexilate Accord as recommended for the following conditions:
Prevention of blood clots after knee or hip replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you must take a reduced dose of Dabigatran etexilate Accord of 75 mg, because the risk of bleeding may increase.
For both types of surgery, treatment must not be started if there is bleeding at the surgical site. If treatment cannot be started until the day after surgery, administration should begin with a dose of 2 capsules once daily.
After knee replacement surgery
You should start treatment with Dabigatran etexilate Accord within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 10 days.
After hip replacement surgery
You should start treatment with Dabigatran etexilate Accord within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.
Treatment of blood clots and prevention of new blood clots in children.
Dabigatran etexilate Accord should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.
Table 1 shows the single and total doses of Dabigatran etexilate Accord in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years:
Table 1: Dabigatran etexilate Accord capsule dosing table

Weight/age combinations		Single dose in mg	Total daily dose in mg
Weight in kg	Age in years	Single dose in mg	Total daily dose in mg
From 11 to less than 13 kg	From 8 to less than 9 years	75	150
From 13 to less than 16 kg	From 8 to less than 11 years	110	220
From 16 to less than 21 kg	From 8 to less than 14 years	110	220
From 21 to less than 26 kg	From 8 to less than 16 years	150	300
From 26 to less than 31 kg	From 8 to less than 18 years	150	300
From 31 to less than 41 kg	From 8 to less than 18 years	185	370
From 41 to less than 51 kg	From 8 to less than 18 years	220	440
From 51 to less than 61 kg	From 8 to less than 18 years	260	520
From 61 to less than 71 kg	From 8 to less than 18 years	300	600
From 71 to less than 81 kg	From 8 to less than 18 years	300	600
81 kg or more	From 10 to less than 18 years	300	600

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 gastric release. Do not break, chew, or remove the granules from the capsule, as this may increase the risk of bleeding.

Switching anticoagulant treatment
Do not change your anticoagulant treatment without first 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 clots after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Accord at the usual time the next day.
Do not take a double dose to make up for the missed dose.

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

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

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

4. Possible side effects

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

Prevention of blood clots after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):
- Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
- Abnormal liver function test results

Uncommon (may affect up to 1 in 100 people):
- Bleeding that may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or after wound closure, following surgery
- Formation of a haematoma or haematoma occurring after surgery
- Presence of blood in the stool, detected by laboratory testing
- Decrease in the number of red blood cells in the blood
- Decrease in the proportion of blood cells
- Allergic reaction
- Vomiting
- Diarrhoea with loose or liquid stools
- Feeling unwell
- Discharge from the wound (leakage of fluid from the surgical wound)
- Increased liver enzymes
- Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Rare (may affect up to 1 in 1,000 people):
- Bleeding
- Bleeding that may occur in the brain, from a surgical incision, injection site, or catheter insertion site in a vein
- Blood-stained discharge from the catheter insertion site in a vein
- Coughing up blood or blood-stained sputum
- Decrease in the number of platelets in the blood
- Decrease in the number of red blood cells after surgery
- Severe allergic reaction causing difficulty in breathing or dizziness
- Severe allergic reaction causing swelling of the face or throat
- Pronounced skin rash with dark red, swollen, itchy lumps due to an allergic reaction
- Sudden skin changes altering its colour and appearance
- Itching
- Stomach or intestinal ulcer (including oesophageal ulcer)
- Inflammation of the oesophagus and stomach
- Reflux of gastric juices into the oesophagus
- Abdominal or stomach pain
- Indigestion
- Difficulty swallowing
- Fluid leaking from a wound
- Fluid leaking from a wound after surgery

Not known (frequency cannot be estimated from the available data):
- Difficulty breathing or wheezing
- Decrease in the number or even absence of white blood cells (which help fight infections)
- Hair loss

Treatment of blood clots and prevention of recurrence of blood clots in children
Common (may affect up to 1 in 10 people):
- Decrease in the number of red blood cells in the blood
- Decrease in the number of platelets in the blood
- Pronounced skin rash with dark red, swollen, itchy lumps due to an allergic reaction
- Sudden skin changes altering its colour and appearance
- Haematoma formation
- Nosebleeds
- Reflux of gastric juices into the oesophagus
- Vomiting
- Feeling unwell
- Diarrhoea with loose or liquid stools
- Indigestion
- Hair loss
- Increased liver enzymes

Uncommon (may affect up to 1 in 100 people):
- Decrease in the number of white blood cells (which help fight infections)
- Bleeding that may occur in the stomach or intestine, brain, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
- Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
- Decrease in the proportion of blood cells
- Itching
- Coughing up blood or blood-stained sputum
- Abdominal or stomach pain
- Inflammation of the oesophagus and stomach
- Allergic reaction
- Difficulty swallowing
- Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the available data):
- Absence of white blood cells (which help fight infections)
- Severe allergic reaction causing difficulty in breathing or dizziness
- Severe allergic reaction causing swelling of the face or throat
- Difficulty breathing or wheezing
- Bleeding
- Bleeding that may occur in a joint or from a wound, surgical incision, injection site, or catheter insertion site in a vein
- Bleeding that may occur from haemorrhoids
- Stomach or intestinal ulcer (including oesophageal ulcer)
- Abnormal liver function test results

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dabigatran etexilate 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 below 30 °C.
After first opening, the bottle can be used for up to 60 days.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no
longer required. This will help protect the environment.

6. Package contents and other information

What Dabigatran etexilate Accord contains

The active substance is dabigatran. Each hard capsule contains 75 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), iron oxide black (E172) and potassium hydroxide (E525).

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

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6th Floor,
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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / 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 medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

Package leaflet: information for the patient

Dabigatran etexilate Accord 110 mg hard capsules

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

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

Contents of this leaflet

What Dabigatran etexilate Accord is and what it is used for
What you need to know before taking Dabigatran etexilate Accord
How to take Dabigatran etexilate Accord
Possible side effects
How to store Dabigatran etexilate Accord
Contents of the pack and other information

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

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

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

Dabigatran etexilato Accord is used in children for:

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

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

Warnings and precautions

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

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

Take special care with Dabigatran etexilato Accord

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

Other medicines and Dabigatran etexilato Accord

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

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines for treating fungal infections (e.g. ketoconazole, itraconazole), unless applied only topically to the skin
Medicines for treating irregular heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a reduced dose of Dabigatran etexilato Accord depending on the condition for which it has been prescribed. See section 3.
Medicines to prevent organ transplant rejection (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 used to treat depression
Antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)
Rifampicin or clarithromycin (two antibiotics)
Certain antiepileptic medicines (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding

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

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

Dabigatran etexilato 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 etexilato Accord

Dabigatran etexilato Accord hard capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 12 years of age as soon as they are able to swallow soft food, other pharmaceutical forms such as coated granules are available.

Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor.

Take Dabigatran etexilato Accord as recommended for the following conditions:

Prevention of blood clots after knee or hip replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).

If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).

If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).

If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you must take a reduced dose of Dabigatran etexilato Accord of 75 mg, because the risk of bleeding may increase.

For both surgeries, treatment must not be started if there is 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 daily.

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

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

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots caused by irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.

If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.

If you are taking medicines containing verapamil, you must take a reduced dose of Dabigatran etexilato Accord of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.

If you are potentially at higher risk of bleeding, your doctor may decide to prescribe you a dose of Dabigatran etexilato Accord of 220 mg taken as one 110 mg capsule twice daily.

You may continue taking this medicine if your heart rhythm needs to be restored to normal through a procedure called cardioversion. Take Dabigatran etexilato Accord according to your doctor’s instructions.

If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stent placement, you may be treated with Dabigatran etexilato Accord after your doctor has determined that normal control of blood coagulation has been achieved. Take Dabigatran etexilato Accord according to your doctor’s instructions.

Treatment and prevention of new blood clots in children

Dabigatran etexilato Accord should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.

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

Table 1 shows the single and total doses of Dabigatran etexilato Accord in milligrams (mg). The doses depend on the patient’s weight in kilograms (kg) and age in years.

Table 1: Dosing table for Dabigatran etexilato Accord capsules

Weight/age combinations		Single dose in mg	Total daily dose in mg
Weight in kg	Age in years	Single dose in mg	Total daily dose in mg
From 11 to less than 13 kg	From 8 to less than 9 years	75	150
From 13 to less than 16 kg	From 8 to less than 11 years	110	220
From 16 to less than 21 kg	From 8 to less than 14 years	110	220
From 21 to less than 26 kg	From 8 to less than 16 years	150	300
From 26 to less than 31 kg	From 8 to less than 18 years	150	300
From 31 to less than 41 kg	From 8 to less than 18 years	185	370
From 41 to less than 51 kg	From 8 to less than 18 years	220	440
From 51 to less than 61 kg	From 8 to less than 18 years	260	520
From 61 to less than 71 kg	From 8 to less than 18 years	300	600
From 71 to less than 81 kg	From 8 to less than 18 years	300	600
81 kg or more	From 10 to less than 18 years	300	600

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 gastric release. Do not break, chew, or remove granules from the capsule, as this may increase the risk of bleeding.

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

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not 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 serious bleeding events may occur, which represent the most serious side effects and, regardless of their location, may be disabling, life-threatening, or even fatal. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to perform a thorough check-up or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.
The possible side effects are listed below, grouped by frequency of occurrence.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In a clinical study, the rate of heart attacks was higher with Dabigatran 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 recurrence 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 intestine, rectum, penis/vagina, urinary tract (including blood in urine turning it pink or red), or under the skin
Indigestion

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

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

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

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

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

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

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

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

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

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

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

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system 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 etexilate Accord

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

6. Package contents and other information

What Dabigatran etexilate Accord contains

The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
The other components 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 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 hard capsules of size “1” (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 white to pale yellow pellets and pale 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 box.
Dabigatran etexilate Accord 110 mg hard capsules are available in packs containing divisible unit-dose blisters OPA/Alu/desiccant PE-PET/Alu/PE containing 10x1, 30x1, 60x1, 100x1 and 180x1 capsules in a box.
Dabigatran etexilate Accord 110 mg hard capsules are available in packs containing a polypropylene bottle with child-resistant closure containing 60 capsules in a box.
Not all pack sizes may be marketed.

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / 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 medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

Patient information leaflet

Dabigatran etexilate Accord 150 mg hard capsules

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

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

Contents of this leaflet

What Dabigatran etexilate Accord is and what it is used for
What you need to know before taking Dabigatran etexilate Accord
How to take Dabigatran etexilate Accord
Possible side effects
How to store Dabigatran etexilate Accord
Contents of the pack and other information

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

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

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

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

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

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

Take special care with Dabigatran etexilate Accord

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

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

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless applied only topically to the skin
Medicines to treat irregular heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may advise you to use a lower dose of Dabigatran etexilate Accord depending on the condition for which it was prescribed. See section 3.
Medicines to prevent transplant rejection (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 used to treat depression
Antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)
Rifampicin or clarithromycin (two antibiotics)
Certain antiepileptic medicines (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Accord during pregnancy and on the unborn child are unknown. You must not take
this medicine during pregnancy unless your doctor tells you it is safe to do so. If you are a woman of childbearing age, you must avoid pregnancy while being treated with Dabigatran etexilate Accord.
You must not breastfeed while being treated with Dabigatran etexilate Accord.
Driving and using machines
Dabigatran etexilate Accord has no known effect on the ability to drive or operate machinery.
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 children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 12 years of age, as soon as they are able to swallow soft food, other pharmaceutical forms such as coated granules are available.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Take Dabigatran etexilate Accord as recommended for the following conditions:
Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots forming as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs.
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of Dabigatran etexilate Accord of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at higher risk of bleeding, your doctor may decide to prescribe you a dose of Dabigatran etexilate Accord of 220 mg taken as one 110 mg capsule twice daily.
You may continue taking this medicine if your heart rhythm needs to be restored to normal through a procedure called cardioversion or via a procedure called catheter ablation for atrial fibrillation. Take Dabigatran etexilate Accord as directed by your doctor.
If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Dabigatran etexilate Accord after your doctor has determined that normal control of blood coagulation has been achieved. Take Dabigatran etexilate Accord as directed by your doctor.
Treatment of blood clots and prevention of formation of new blood clots in children.
Dabigatran etexilate Accord should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.
Table 1 shows the individual and total daily doses of Dabigatran etexilate Accord in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.
Table 1: Dosing table for Dabigatran etexilate Accord capsules

Weight/age combinations		Single dose in mg	Total daily dose in mg
Weight in kg	Age in years	Single dose in mg	Total daily dose in mg
From 11 to less than 13 kg	From 8 to less than 9 years	75	150
From 13 to less than 16 kg	From 8 to less than 11 years	110	220
From 16 to less than 21 kg	From 8 to less than 14 years	110	220
From 21 to less than 26 kg	From 8 to less than 16 years	150	300
From 26 to less than 31 kg	From 8 to less than 18 years	150	300
From 31 to less than 41 kg	From 8 to less than 18 years	185	370
From 41 to less than 51 kg	From 8 to less than 18 years	220	440
From 51 to less than 61 kg	From 8 to less than 18 years	260	520
From 61 to less than 71 kg	From 8 to less than 18 years	300	600
From 71 to less than 81 kg	From 8 to less than 18 years	300	600
81 kg or more	From 10 to less than 18 years	300	600

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 gastric release. Do not break, chew, or remove the granules from the capsule, as this may increase the risk of bleeding.

Switching 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 an excessive amount of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

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

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

4. Possible side effects

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

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots developing as a result of irregular heartbeat
Common (may affect up to 1 in 10 people):
- Bleeding that may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including presence of blood in urine turning it pink or red), or under the skin
- Decrease in the number of red blood cells in the blood
- Abdominal or stomach pain
- Indigestion
- Diarrhoea with loose or liquid stools
- Feeling unwell

Uncommon (may affect up to 1 in 100 people):
- Bleeding
- Bleeding that may occur from haemorrhoids, rectum, or brain
- Formation of haematoma
- Coughing up blood or sputum containing blood
- Decrease in the number of platelets in the blood
- Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
- Allergic reaction
- Sudden skin changes altering its colour and appearance
- Itching
- Stomach or intestinal ulcer (including oesophageal ulcer)
- Inflammation of the oesophagus and stomach
- Gastric acid reflux into the oesophagus
- Vomiting
- Difficulty swallowing
- Abnormal liver function test results

Rare (may affect up to 1 in 1,000 people):
- Bleeding that may occur in a joint, from a surgical incision, wound, injection site, or catheter insertion site in a vein
- Severe allergic reaction causing difficulty breathing or dizziness
- Severe allergic reaction causing swelling of the face or throat
- Pronounced skin rash with lumps, dark red in colour, swollen and itchy, caused by an allergic reaction
- Decrease in proportion of blood cells
- Increase in liver enzymes
- Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from available data):
- Difficulty breathing or wheezing
- Decrease in number or even absence of white blood cells (which help fight infections)
- Hair loss

In a clinical study, the rate of heart attacks was higher with Dabigatran 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 re-formation of blood clots in the veins of the legs and/or lungs
Common (may affect up to 1 in 10 people):
- Bleeding that may occur from the nose, stomach or intestine, rectum, penis/vagina, or urinary tract (including presence of blood in urine turning it pink or red), or under the skin
- Indigestion

Uncommon (may affect up to 1 in 100 people):
- Bleeding
- Bleeding that may occur in a joint or from a wound
- Bleeding that may occur from haemorrhoids
- Decrease in the number of red blood cells in the blood
- Formation of haematoma
- Coughing up blood or sputum containing blood
- Allergic reaction
- Sudden skin changes altering its colour and appearance
- Itching
- Stomach or intestinal ulcer (including oesophageal ulcer)
- Inflammation of the oesophagus and stomach
- Gastric acid reflux into the oesophagus
- Feeling unwell
- Vomiting
- Abdominal or stomach pain
- Diarrhoea with loose or liquid stools
- Abnormal liver function test results
- Increase in liver enzymes

Rare (may affect up to 1 in 1,000 people):
- Bleeding that may occur from a surgical incision, injection site, catheter insertion site in a vein, or brain
- Decrease in the number of platelets in the blood
- Severe allergic reaction causing difficulty breathing or dizziness
- Severe allergic reaction causing swelling of the face or throat
- Pronounced skin rash with lumps, dark red in colour, swollen and itchy, caused by an allergic reaction
- Difficulty swallowing

Not known (frequency cannot be estimated from available data):
- Difficulty breathing or wheezing
- Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
- Decrease in proportion of blood cells
- Decrease in number or even absence of white blood cells (which help fight infections)
- Yellowing of the skin or whites of the eyes, caused by liver or blood problems
- Hair loss

In the clinical study programme, the rate of heart attacks was higher with Dabigatran 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 formation of new blood clots in children
Common (may affect up to 1 in 10 people):
- Decrease in the number of red blood cells in the blood
- Decrease in the number of platelets in the blood
- Pronounced skin rash with lumps, dark red in colour, swollen and itchy, caused by an allergic reaction
- Sudden skin changes altering its colour and appearance
- Formation of haematoma
- Nosebleed
- Gastric acid reflux into the oesophagus
- Vomiting
- Feeling unwell
- Diarrhoea with loose or liquid stools
- Indigestion
- Hair loss
- Increase in liver enzymes

Uncommon (may affect up to 1 in 100 people):
- Decrease in the number of white blood cells (which help fight infections)
- Bleeding that may occur in the stomach or intestine, brain, rectum, penis/vagina, urinary tract (including presence of blood in urine turning it pink or red), or under the skin
- Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
- Decrease in proportion of blood cells
- Itching
- Coughing up blood or sputum containing blood
- Abdominal or stomach pain
- Inflammation of the oesophagus and stomach
- Allergic reaction
- Difficulty swallowing
- Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

5. How to store Dabigatran etexilate Accord

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

6. Package contents and other information

What Dabigatran etexilato Accord contains

The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).
The other components 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 printing black ink contains shellac (E904), propylene glycol (E1520), iron oxide black (E172) and potassium hydroxide (E525).

Description of the appearance of Dabigatran etexilato Accord and contents of the pack

Dabigatran etexilato Accord 150 mg hard capsules are size “0” hard capsules (approximately 22 x 8 mm) with an opaque white cap printed with "MD" and an opaque white body printed with "150" in black ink, containing a mixture of white to pale yellow pellets and pale yellow granules.
Dabigatran etexilato Accord 150 mg hard capsules are available in packs containing OPA/Alu/desiccant PE-PET/Alu/PE blisters with 10, 30, 60 and 180 capsules in a carton.
Dabigatran etexilato Accord 150 mg hard capsules are available in packs containing unit-dose divisible blisters OPA/Alu/desiccant PE-PET/Alu/PE with 10x1, 30x1, 60x1 and 180x1 capsules in a carton.
Dabigatran etexilato 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 Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6th Floor,
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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / 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 medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.

PATIENT MEDICAL ALERT CARD

(logo Accord)
Dabigatran etexilato Accord
dabigatran etexilate

This card must always accompany you/the person caring for the pediatric patient
Make sure to always use the latest version (xxxx 202x)

Dear Patient/Person caring for a pediatric patient,
Your doctor has prescribed you/has prescribed the child a treatment with Dabigatran etexilato Accord. To use Dabigatran etexilato Accord safely, consider the important information provided in the package leaflet.
Since this card contains important information regarding your treatment/the child's treatment, it must always accompany you/the child, to inform healthcare professionals about the treatment with Dabigatran etexilato Accord.

Dabigatran etexilato Accord Information for the patient/for caregivers of pediatric patients
Regarding your treatment/the child's treatment

Dabigatran etexilato Accord thins the blood. It is used to treat existing blood clots or to prevent the formation of dangerous blood clots.
When taking Dabigatran etexilato Accord, follow your doctor's/your child's doctor's instructions. Never skip a dose or stop taking Dabigatran etexilato Accord without talking to your doctor/your child's doctor.
Inform your doctor/your child's doctor about all medicines you/your child are taking.
Before any surgery or invasive procedures, inform your doctor/your child's doctor that you/your child are taking Dabigatran etexilato Accord.
Dabigatran etexilato 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 contact the doctor

Taking Dabigatran etexilato Accord may increase the risk of bleeding. Seek immediate medical attention from your doctor/your child's doctor if you/your child experience any of the following possible signs and symptoms of bleeding: swelling, discomfort, pain or unusual headache, dizziness, paleness, weakness, unusual bruising, nosebleeds, bleeding gums, cuts that bleed unusually long, abnormal menstrual flow or vaginal bleeding, blood in urine which may appear pink or brown, red/black stools, coughing up blood, vomiting blood or material resembling coffee grounds.
In case of falls or injuries, especially if you/your child receive a blow to the head, consult a doctor urgently.
Do not stop taking Dabigatran etexilato Accord without talking to your doctor/your child's doctor if you/your child experience heartburn, nausea, vomiting, stomach discomfort, bloating or upper abdominal pain.

Dabigatran etexilato Accord Information for healthcare professionals

Dabigatran etexilato Accord is an oral anticoagulant (direct thrombin inhibitor).
Dabigatran etexilato Accord may need to be discontinued prior to surgery or invasive procedures.
In case of major bleeding, treatment with Dabigatran etexilato Accord must be stopped immediately.
A specific reversal agent (idarucizumab) is available for adult patients. The efficacy and safety of the specific reversal agent idarucizumab have not been established in pediatric patients. For details and recommendations on how to reverse the anticoagulant effect of Dabigatran etexilato Accord, refer to the Summary of Product Characteristics of Dabigatran etexilato Accord and idarucizumab.
Dabigatran etexilato Accord is primarily eliminated via the renal route; adequate diuresis must be maintained. Dabigatran etexilato Accord is dialyzable.

Complete this section or ask your doctor/your child's doctor to do so.
Patient information

Patient's name

Date of birth

Indication for which the anticoagulant is used

Dose of Dabigatran etexilato Accord