Daroxomb: detailed information

Package leaflet: Information for the

patient
Daroxomb 75 mg hard capsules
dabigatran etexilate
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, because it contains
important information for you.

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

Contents of this leaflet:

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

1. What Daroxomb is and what it is used for

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

preventing the formation of blood clots in the veins after a surgical replacement of the knee or hip joint.

Daroxomb is used in children for:

treating blood clots and preventing recurrence of blood clots.

2. What you need to know before taking Daroxomb

Do not take Daroxomb

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 bleeding.
if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g. gastric ulcer, lesion 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 clotting (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching anticoagulant treatment, while

you have a venous or arterial catheter and are receiving heparin through this catheter to keep it
open or while heart rhythm 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 lead to death.
if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
if you are taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation.
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 received a mechanical heart valve requiring permanent blood thinning.

Warnings and precautions
Talk to your doctor before taking Daroxomb. You may also need to speak with your doctor
during treatment with Daroxomb if symptoms occur or if you need to undergo surgery.
Tell your doctor if you have or have had medical conditions or diseases, particularly any of the
following:

if you have an increased risk of bleeding, such as:
- if you have recently bled.
- if you have undergone surgical removal of tissue (biopsy) within the last month.
- if you have suffered a serious injury (e.g. a bone fracture, head trauma, or any injury requiring surgical treatment).
- if you suffer from inflammation of the oesophagus or stomach.
- if you have gastroesophageal reflux (stomach acid flowing back into the oesophagus).
- if you are taking medicines that could increase the risk of bleeding. See "Other medicines and Daroxomb" below.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you suffer from an infection of the heart (bacterial endocarditis).
- if you know you have reduced kidney function or if you suffer from dehydration (symptoms include feeling thirsty and reduced urination of dark-coloured (concentrated)/foamy urine).
- if you are over 75 years old.
- if you are an adult weighing 50 kg or less.
- only when used in children: 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 having a heart attack.
if you have liver disease associated with changes in blood tests. Use of this medicine is not recommended in this case.

Take special care with Daroxomb

If you are scheduled for surgery: In this case, Daroxomb will need to be temporarily stopped due to an increased risk of bleeding during and immediately after surgery. It is very important to take Daroxomb before and after surgery exactly at the times instructed by your doctor.
If surgery involves a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or pain relief):
it is very important to take Daroxomb before and after surgery exactly at the times instructed by your doctor.
Inform your doctor immediately if you experience numbness or weakness in the legs or problems with the bowel or bladder after the end of anaesthesia, as urgent medical care is required.
- if you fall or injure yourself during treatment, especially if you hit your head. Call a doctor urgently. A medical check-up may be necessary, as you may be at increased 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 your treatment needs to be changed.

Other medicines and Daroxomb
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 Daroxomb if you are
taking any of the following medicines:

Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines to treat fungal infections (e.g. ketoconazole, itraconazolo), unless applied only to the skin
Medicines to treat abnormal heart rhythms (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 Daroxomb depending on the condition for which it has been prescribed. See also section 3.
Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)
A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
St. John’s wort, a herbal medicine for 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)
Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Daroxomb on pregnancy and the unborn child are unknown. You must not take
Daroxomb if you are pregnant unless your doctor advises that it is safe to do so. If you are a woman of childbearing age, you must avoid becoming pregnant while taking Daroxomb. You must not breastfeed while taking Daroxomb.
You must not breastfeed while taking Daroxomb.
Driving and using machines
Daroxomb has no known effects on the ability to drive vehicles or operate machinery.

3. How to take Daroxomb

Daroxomb capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. There are other age-appropriate dosage forms available for the treatment of children under 8 years of age.
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Take Daroxomb as recommended for the following conditions:
Prevention of blood clot formation 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 Daroxomb of 75 mg, as the risk of bleeding may increase.
For both types of surgical procedures, treatment must not be started if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, administration should begin with 2 capsules once daily.
After knee replacement surgery
You should start treatment with Daroxomb 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 Daroxomb 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
Daroxomb should be taken twice daily, one dose in the morning and one dose 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 body weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose as treatment progresses. Continue taking all other medicines unless your doctor tells you to stop them.
Table 1 shows the single and total daily doses of Daroxomb in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.
Table 1: Dosing table for Daroxomb

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 above	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 Daroxomb
Daroxomb can be taken with or without food. The capsule should 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.

Instructions for opening the blister packs
The following image illustrates how to remove Daroxomb capsules from the blister

Two-step diagram showing how to separate a pill strip by bending it and how to lift the top paper or foil lid

Separate one unit of the blister from the entire strip along the perforated line.
Lift the foil from the back and remove the capsule.

Do not push the capsules through the foil backing of the blister.
Do not peel off the foil until a capsule is needed.

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

If you take more Daroxomb than you should
Taking too much Daroxomb 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 Daroxomb
Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of Daroxomb at your usual time the next day. Do not take a double dose to make up for a forgotten dose.

Treatment of blood clots and prevention of recurrence of blood clots in children
A missed dose may still be taken up to 6 hours before the next scheduled dose.
A missed dose should be omitted if less than 6 hours remain before the next dose.
Do not take a double dose to make up for a missed dose.

Contact your doctor if you experience indigestion after taking Daroxomb.
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 everyone gets them.

Daroxomb affects blood clotting, so most of the side effects are related to signs such as bruising or bleeding.

Major or severe bleeding may occur, which are the most serious side effects; regardless of location, these bleedings can become disabling, life-threatening, or even lead to death. In some cases, such bleedings may not be obvious.

If you experience any bleeding that does not stop on its own, or if you develop signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to monitor you closely or adjust your treatment.

Inform your doctor immediately if you experience a severe allergic reaction causing breathing difficulties or dizziness.

The possible side effects are listed below, grouped according to how frequently 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)
Unusual results in liver function laboratory tests

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

Bleeding may occur from the nose, stomach or intestine, from the penis/vagina or urinary tract (including blood in urine which may turn the urine pink or red), from haemorrhoids, from the rectum, under the skin, in a joint, or from or after an injury or surgery
Development of haematoma or bruising after surgery
Blood detected in stool by laboratory test
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 watery stools
Feeling unwell
Wound discharge (fluid leaking from the surgical wound)
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood

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

Bleeding
Bleeding may occur in the brain, from a surgical incision, from the site of an injection, or from the site where a venous catheter is inserted
Blood-stained discharge from the site where a venous catheter is inserted
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 breathing difficulties or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash with raised, itchy, dark red bumps due to an allergic reaction
Sudden change in the skin altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juice 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):

Breathing difficulties 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
Skin rash with raised, itchy, dark red bumps due to an allergic reaction
Sudden change in the skin altering its colour and appearance
Formation of haematoma
Nosebleeds
Reflux of gastric juice into the oesophagus
Vomiting
Feeling unwell
Diarrhoea with loose or watery 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 may occur in the stomach or intestine, from the brain, from the rectum, from the penis/vagina or urinary tract (including blood in urine which may turn the urine 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 percentage 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 problems with the liver or blood

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

Absence of white blood cells (which help fight infections)
Severe allergic reaction causing breathing difficulties or dizziness
Severe allergic reaction causing swelling of the face or throat
Breathing difficulties or wheezing
Bleeding
Bleeding may occur in a joint or from an injury, from a surgical incision, or from the site of an injection or venous catheter insertion
Bleeding from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Unusual results in liver function laboratory tests

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Daroxomb

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after "Exp.". The expiry date refers to the last day of the month.
Do not store above 30 °C.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Daroxomb contains
The active substance is dabigatran. Each hard capsule contains 86.48 mg of dabigatran etexilate (as
mesilate), equivalent to 75 mg of dabigatran etexilate.
The excipients are tartaric acid, arabic gum, hypromellose 2910, dimethicone 350, talc and
hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171) and
hypromellose 2910.
Description of the appearance of Daroxomb and package contents
Daroxomb 75 mg are hard capsules filled with granules of whitish to pale yellow colour, in white to off-white hard capsules of size 2.
This medicinal product is available in packaging containing:
10 x 1, 30 x 1 or 60 x 1 hard capsules in single-dose blisters made of Aluminium / OPA-ALU-PVC perforated.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan
Italy
Manufacturers:
Galenicum Health, S.L.U.
Sant Gabriel, 50
08950 – Esplugues de Llobregat
Barcelona – Spain
and
SAG Manufacturing S.L.U
Linea. N-I, Km 36
28750 San Agustín de Guadalix,
Madrid – Spain
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
Daroxomb 110 mg hard capsules
dabigatran etexilate
Equivalent medicine
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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Daroxomb is and what it is used for

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

preventing the formation of blood clots in the veins after a surgical replacement of the knee or hip joint.
preventing the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat 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.

Daroxomb is used in children for:

treating blood clots and preventing the recurrence of blood clots.

2. What you should know before taking Daroxomb

Do not take Daroxomb

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 bleeding.
if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g. gastric ulcer, lesion 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 clotting (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment, while you have a venous or arterial catheter and are receiving heparin through this catheter to keep it open, or while heart rhythm is being restored to normal via a procedure called trans-catheter ablation for atrial fibrillation.
if you have severely reduced liver function or liver disease that could lead to death.
if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
if you are taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation.
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 received an artificial heart valve requiring permanent blood thinning.

Warnings and precautions
Talk to your doctor before taking Daroxomb. You may also need to speak with your doctor during treatment with Daroxomb if you develop symptoms or if you need to undergo surgery.
Tell your doctor if you have or have had any medical conditions or diseases, particularly any of the following:

if you have an increased risk of bleeding, such as:
- if you have recently bled.
- if you have undergone surgical tissue removal (biopsy) within the last month.
- if you have sustained a serious injury (e.g. bone fracture, head trauma, or any injury requiring surgical treatment).
- 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 could increase the risk of bleeding. See "Other medicines and Daroxomb" below.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you suffer from an infection of the heart (bacterial endocarditis).
- if you know you have reduced kidney function or if you suffer from dehydration (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 when used in children: 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 having a heart attack.
if you have liver disease associated with changes in blood tests. Use of this medicine is not recommended in this case.

Take special care with Daroxomb

If you need to undergo surgery: In this case, Daroxomb will need to be temporarily stopped due to an increased risk of bleeding during and immediately after surgery. It is very important to take Daroxomb exactly at the times prescribed by your doctor, both before and after surgery.
If surgery involves a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or pain relief):
- it is very important to take Daroxomb exactly at the times prescribed by your doctor, both before and after surgery.
- 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 care is required.
if you fall or injure yourself during treatment, especially if you hit your head. Call a doctor urgently. You may need to be examined by a doctor, as you may be at increased 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 your treatment needs to be changed.

Other medicines and Daroxomb
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 Daroxomb if you are taking any of the following medicines:

Medicines to 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 abnormal heart rhythms (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 Daroxomb depending on the condition for which it has been prescribed. See section 3.
Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)
A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
St. John’s wort, a herbal medicine used for 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).
Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
The effects of Daroxomb on pregnancy and the unborn child are unknown. You must not take Daroxomb if you are pregnant unless your doctor advises that it is safe to do so. If you are a woman of childbearing potential, you must avoid becoming pregnant while taking Daroxomb.
You must not breastfeed while taking Daroxomb.
Driving and using machines
Daroxomb has no known effects on the ability to drive or operate machinery.

3. How to take Daroxomb

Take Daroxomb 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 have reduced kidney function (by more than half), you should be treated with a reduced dose of 75 mg of Daroxomb, 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 2 capsules once daily.

After knee replacement surgery
You should start treatment with Daroxomb within 1–4 hours after the end 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 Daroxomb within 1–4 hours after the end of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.

Prevention of brain or systemic vessel blockage due to blood clots arising from abnormal heartbeats, and treatment of blood clots in the leg and lung veins, including prevention of recurrence of venous blood clots in 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 of Daroxomb is 220 mg, taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you should be treated with a reduced dose of 220 mg, taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you have a potentially higher risk of bleeding, your doctor may decide to prescribe a dose of 220 mg, taken as one 110 mg capsule twice daily.

You may continue taking Daroxomb if your heartbeat needs to be restored to normal through a procedure called cardioversion. Take Daroxomb exactly as your doctor has instructed.

If a medical device (stent) has been placed in a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Daroxomb after your doctor has determined that normal blood clotting control has been achieved. Take Daroxomb exactly as your doctor has instructed.

Treatment and prevention of recurrence of blood clots in children
Daroxomb 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 body weight and age. Your doctor will determine the correct dose and may adjust it as treatment progresses. Continue taking all other medicines unless your doctor tells you to stop.

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

Table 1: Dosage table for Daroxomb

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 above	From 10 to less than 18 years	300	600

How to take Daroxomb
Daroxomb can be taken with or without food. The capsule should 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.

Instructions for opening blister packs
The following image illustrates how to remove Daroxomb capsules from the blister pack:

Two-step diagram showing how to separate two sheets of flexible material using dashed lines and curved directional arrows

Separate one unit of the blister from the entire blister along the perforated line.
Lift the foil from the back and remove the capsule.

Do not push the capsules through the foil backing of the blister.
Do not peel off the blister foil until a capsule is needed.

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

If you take more Daroxomb than you should
Taking too much Daroxomb increases the risk of bleeding. Contact your doctor immediately if you have taken too many Daroxomb capsules. Specific treatment options are available.

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

Use in adults: Prevention of brain or systemic vessel blockage due to blood clots arising from irregular heartbeats, 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.

A missed dose may still be taken up to 6 hours before the next scheduled dose.
A missed dose should be omitted if less than 6 hours remain before the next dose.
Do not take a double dose to make up for a missed dose.

If you stop taking Daroxomb
Take Daroxomb exactly as prescribed. Do not stop taking Daroxomb without first talking to your doctor, as the risk of developing a blood clot may be higher if you stop treatment too early.
Contact your doctor if you experience indigestion after taking Daroxomb.
If you have any doubts about using 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.
Daroxomb affects blood clotting, so most side effects are related to signs such as bruising or bleeding.
Major or severe bleeding may occur, which are the most serious side effects, and regardless of location, may become disabling, life-threatening, or even lead to death. In some cases, this bleeding may not be obvious.
If you experience any bleeding that does not stop on its own, or if you develop signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to keep you under close observation or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing breathing difficulties or dizziness.

The possible side effects are listed below, grouped according to how frequently 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)
Unusual results in laboratory tests of liver function

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

Bleeding from the nose, stomach or intestines, penis/vagina or urinary tract (including blood in urine which may turn urine pink or red), from haemorrhoids, rectum, under the skin, in a joint, from or after an injury or after surgery
Formation of haematoma or bruising occurring after surgery
Blood detected in faeces by laboratory test
Decrease in the number of red blood cells in the blood
A decrease in the proportion of blood cells
Allergic reaction
Vomiting
Diarrhoea with loose or liquid stools
Feeling unwell
Wound secretion (fluid leaking from the surgical wound)
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood

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

Bleeding
Bleeding may occur in the brain, from a surgical incision, from the site of an injection, or from the site of a venous catheter
Blood-stained discharge from the site of a venous catheter
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 breathing difficulties or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash characterized by dark red, raised, itchy bumps caused by an allergic reaction
Sudden change in the skin altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juice 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):

Breathing difficulties or wheezing
Decrease in number or even absence of white blood cells (which help fight infections)
Hair loss

Prevention of brain or body vessel blockage due to blood clots developing after abnormal heartbeats

Common (may affect up to 1 in 10 people):

Bleeding from the nose, stomach or intestines, penis/vagina or urinary tract (including blood in urine which may turn urine 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 may occur from haemorrhoids, rectum, or in the 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 change in the skin altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juice into the oesophagus
Vomiting
Difficulty swallowing
Unusual results in laboratory tests of liver function

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

Bleeding may occur in a joint, from a surgical incision, from an injury, from the site of an injection, or from the site of a venous catheter
Severe allergic reaction causing breathing difficulties or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash characterized by dark red, raised, itchy bumps caused by an allergic reaction
A decrease in the percentage of blood cells
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood

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

Breathing difficulties 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 with dabigatran etexilate was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the legs and lungs, including prevention of recurrence of blood clots in the legs and/or lungs

Common (may affect up to 1 in 10 people):

Bleeding from the nose, stomach or intestines, rectum, penis/vagina or urinary tract (including blood in urine which may turn urine pink or red), or under the skin
Indigestion

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

Bleeding
Bleeding may occur in a joint or from an injury
Bleeding 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 change in the skin altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juice into the oesophagus
Feeling unwell
Vomiting
Abdominal or stomach pain
Diarrhoea with loose or liquid stools
Unusual results in laboratory tests of liver function
Increased liver enzymes

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

Bleeding may occur from a surgical incision, or from the site of an injection or from the site of a venous catheter or in the brain
Decrease in the number of platelets in the blood
Severe allergic reaction causing breathing difficulties or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash characterized by dark red, raised, itchy bumps caused by an allergic reaction
Difficulty swallowing

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

Breathing difficulties or wheezing
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
A decrease in the 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 problems with the liver or blood
Hair loss

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

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
Skin rash characterized by dark red, raised, itchy bumps caused by an allergic reaction
Sudden change in the skin altering its colour and appearance
Formation of haematoma
Nosebleeds
Reflux of gastric juice 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 may occur in the stomach or intestines, from the brain, rectum, penis/vagina or urinary tract (including blood in urine which may turn urine pink or red), or under the skin
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
A decrease in the percentage 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 problems with the liver or blood

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

Absence of white blood cells (which help fight infections)
Severe allergic reaction causing breathing difficulties or dizziness
Severe allergic reaction causing swelling of the face or throat
Breathing difficulties or wheezing
Bleeding
Bleeding may occur in a joint or from an injury, from a surgical incision, or from the site of an injection or from the site of a venous catheter
Bleeding may occur from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Unusual results in laboratory tests of liver function

Reporting of side effects
If you experience any side effects, 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Daroxomb

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after "Exp.". The expiry date refers to the last day of the month.
Do not store above 30 °C.
Keep in the original packaging to protect the medicine from moisture.
For bottles only:
Use within 4 months after first opening the bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Daroxomb contains

The active substance is dabigatran. Each hard capsule contains 126.83 mg of dabigatran etexilate (as mesilate), equivalent to 110 mg of dabigatran etexilate.
The excipients are tartaric acid, acacia gum, hypromellose 2910, simethicone 350, talc, and hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), hypromellose 2910, and FD&C Blue No. 2/indigo carmine (E-132).

Description of the appearance of Daroxomb and contents of the pack
Daroxomb 110 mg are hard capsules filled with whitish to pale yellow granules, contained in size 1 blue hard capsules.
This medicinal product is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in single-dose blisters made of Aluminium / OPA-ALU-PVC perforated film.
A multiple pack containing 3 packs of 60 hard capsules x 1 (180 hard capsules) or a multiple pack containing 2 packs of 50 hard capsules x 1 (100 hard capsules) in single-dose blisters made of perforated aluminium/OPA-ALU-PVC.
60 hard capsules in an HDPE bottle with child-resistant cap and desiccant included inside the cap.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano, Italy

Manufacturers:
Galenicum Health, S.L.U.
Sant Gabriel, 50
08950 – Esplugues de Llobregat
Barcelona – Spain
and
SAG Manufacturing S.L.U
Linea N-I, Km 36
28750 San Agustín de Guadalix,
Madrid – Spain

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
Daroxomb 150 mg hard capsules
dabigatran etexilate
Generic medicine
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 side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

What is in this package leaflet

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

1. What Daroxomb is and what it is used for

Daroxomb contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body that is involved in blood clotting.
Daroxomb is used in adults for:

Preventing the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat 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 recurrence of blood clots in the veins of the legs and lungs.

Daroxomb is used in children for:

treating blood clots and preventing recurrence of blood clots.

2. What you should know before taking Daroxomb

Do not take Daroxomb

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 bleeding.
if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, lesion 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 clotting (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching anticoagulant treatment, while you have a venous or arterial catheter and are receiving heparin through this catheter to keep it open, or while your heartbeat is being restored to normal via a procedure called transcateter ablation for atrial fibrillation.
if you have severely reduced liver function or a liver disease that could lead to death.
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 rejection after transplantation.
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 received an artificial heart valve requiring permanent blood thinning.

Warnings and precautions
Talk to your doctor before taking Daroxomb. You may also need to speak with your doctor during treatment with Daroxomb if you experience symptoms or if you need to undergo surgery.
Tell your doctor if you have or have had medical conditions or diseases, especially any of the following:

if you have an increased risk of bleeding, such as:
- if you have recently bled.
- if you underwent surgical removal of tissue (biopsy) within the last month.
- if you have suffered a severe injury (e.g. bone fracture, head trauma, or any injury requiring surgical treatment).
- 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 could increase the risk of bleeding. See 'Other medicines and Daroxomb' below.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you suffer from an infection of the heart (bacterial endocarditis).
- if you know you have reduced kidney function or if you suffer from dehydration (symptoms include feeling thirsty and reduced urination of dark-colored (concentrated) /foamy urine).
- if you are over 75 years old.
- if you are an adult patient weighing 50 kg or less.
- only if used in children: 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 have a liver disease associated with changes in blood tests. Use of this medicine is not recommended in this case.

Take special care with Daroxomb

If you need to undergo surgery: In this case, Daroxomb will need to be temporarily stopped due to an increased risk of bleeding during and immediately after surgery. It is very important to take Daroxomb before and after surgery exactly at the times indicated by your doctor.
If surgery involves a catheter or injection into the spinal column (e.g. for epidural or spinal anaesthesia or pain relief):
- it is very important to take Daroxomb before and after surgery exactly at the times indicated by your doctor.
- Inform your doctor immediately if you experience numbness or weakness in the legs or problems with the bowel or bladder after the anaesthesia wears off, as urgent medical care is required.
if you fall or injure yourself during treatment, especially if you hit your head. Call a doctor urgently. You may need to be checked by a doctor, as you may be at increased 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 treatment needs to be modified.

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

Medicines to 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 abnormal heart rhythms (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may instruct you to use a reduced dose of Daroxomb depending on the condition for which it has been prescribed. See section 3.
Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)
A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
St. John’s wort, a herbal medicine for 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 used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Daroxomb on pregnancy and the unborn child are unknown. You must not take Daroxomb if you are pregnant unless your doctor advises you that it is safe to do so. If you are a woman of childbearing age, you must avoid becoming pregnant while taking Daroxomb.
You must not breastfeed while taking Daroxomb.

Driving and using machines
Daroxomb has no known effects on the ability to drive vehicles or operate machinery.

3. How to take Daroxomb

Daroxomb capsules can be used in adults and children aged 8 years and older who are able to swallow capsules whole. There are other age-appropriate dosage forms available for the treatment of children under 8 years of age.
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Take Daroxomb as recommended for the following conditions:
Prevention of blockage in the brain or blood vessels due to blood clots that develop after abnormal heartbeats, 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 should be treated with a reduced dose of Daroxomb of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you have a potentially higher risk of bleeding, your doctor may decide to prescribe a Daroxomb dose of 220 mg taken as one 110 mg capsule twice daily.
You may continue taking this medicine if your heartbeat needs to be restored to normal through a procedure called cardioversion or a procedure called trans-catheter ablation for atrial fibrillation. Take Daroxomb exactly as directed by your doctor.
If a medical device (stent) has been placed in a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Daroxomb after your doctor has determined that normal blood clotting control has been achieved. Take Daroxomb exactly as directed by your doctor.
Treatment of blood clots and prevention of recurrence of blood clots in children
Daroxomb should be taken twice daily, one dose in the morning and one dose 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 body weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose as treatment progresses. Continue taking all other medicines unless your doctor tells you to stop.
Table 1 shows the individual and total daily doses of Daroxomb in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.
Table 1: Dosage table for Daroxomb

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 Daroxomb
Daroxomb can be taken with or without food. The capsule should 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.

Instructions for opening the blister packs
The following image illustrates how to remove Daroxomb capsules from the blister

Two-step diagram showing how to separate a tablet strip and how to gently lift the upper protective sheet

Separate one unit of the blister from the entire blister along the perforated line.
Lift the foil from the back of the blister and remove the capsule.

Do not push the capsules through the foil backing of the blister.
Do not peel off the blister foil until a capsule is needed.

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

If you forget to take Daroxomb
A missed dose may still be taken if it is within 6 hours before the next scheduled dose.
A missed dose should be omitted if less than 6 hours remain before the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Daroxomb
Take Daroxomb exactly as prescribed. Do not stop taking Daroxomb 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 indigestion after taking Daroxomb.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Daroxomb affects blood clotting, so most side effects are related to signs such as bruising or bleeding.
Major or severe bleeding may occur, which represent the most serious side effects and, regardless of location, may become disabling, life-threatening, or even lead to death. In some cases, this bleeding may not be obvious.
If you experience any hemorrhagic bleeding that does not stop on its own, or if you develop signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to monitor you closely or adjust your treatment.
Contact your doctor immediately if you experience a severe allergic reaction causing breathing difficulties or dizziness.

The possible side effects are listed below, grouped according to how frequently they occur.

Prevention of blockage in the brain or blood vessels due to blood clots developing after abnormal heartbeats

Common (may affect up to 1 in 10 people):

Bleeding may occur from the nose, in the stomach or intestines, from the penis/vagina, or from the 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
Diarrhea with loose or watery stools
Feeling unwell

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

Bleeding
Bleeding may occur from hemorrhoids, from the rectum, or in the brain
Bruising (hematoma formation)
Coughing up blood or bloody sputum
Decrease in the number of platelets in the blood
Decrease in hemoglobin levels in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden change in the skin altering its color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulcer)
Inflammation of the esophagus and stomach
Gastric acid reflux into the esophagus
Vomiting
Difficulty swallowing
Unusual results in liver function laboratory tests

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

Bleeding may occur in a joint, from a surgical incision, from an injury, from the site of an injection, or from the site of a venous catheter insertion
Severe allergic reaction causing breathing difficulties or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash characterized by dark red, raised, itchy bumps due to an allergic reaction
Decrease in the proportion of blood cells
Increased 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):

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

In a clinical study, the rate of heart attacks with dabigatran etexilate was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the leg veins and lungs, including prevention of recurrence of blood clots in the leg veins and/or lungs

Common (may affect up to 1 in 10 people):

Bleeding may occur from the nose, in the stomach or intestines, from the rectum, from the penis/vagina, or from the 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 may occur in a joint or from an injury
Bleeding may occur from hemorrhoids
Decrease in the number of red blood cells in the blood
Bruising (hematoma formation)
Coughing up blood or bloody sputum
Allergic reaction
Sudden change in the skin altering its color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulcer)
Inflammation of the esophagus and stomach
Gastric acid reflux into the esophagus
Feeling unwell
Vomiting
Abdominal or stomach pain
Diarrhea with loose or watery stools
Unusual results in liver function laboratory tests
Increased liver enzymes

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

Bleeding may occur from a surgical incision, or from the site of an injection, from the site of a venous catheter insertion, or in the brain
Decrease in the number of platelets in the blood
Severe allergic reaction causing breathing difficulties or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash characterized by dark red, raised, itchy bumps due to an allergic reaction
Difficulty swallowing

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

Breathing difficulties or wheezing
Decrease in hemoglobin levels in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
Decrease in the number of, 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 trial program, the rate of heart attacks with dabigatran etexilate was higher than with warfarin. The overall incidence was low. No imbalance in the rate of heart attacks was observed in patients treated with dabigatran compared to those treated with placebo.

Treatment 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
Skin rash characterized by dark red, raised, itchy bumps due to an allergic reaction
Sudden change in the skin altering its color and appearance
Bruising (hematoma formation)
Nosebleeds
Gastric acid reflux into the esophagus
Vomiting
Feeling unwell
Diarrhea with loose or watery 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 may occur in the stomach or intestines, in the brain, from the rectum, from the penis/vagina, or from the urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in hemoglobin levels in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
Itching
Coughing up blood or bloody sputum
Abdominal or stomach pain
Inflammation of the esophagus 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 breathing difficulties or dizziness
Severe allergic reaction causing swelling of the face or throat
Breathing difficulties or wheezing
Bleeding
Bleeding may occur in a joint or from an injury, from a surgical incision, or from the site of an injection or from the site of a venous catheter insertion
Bleeding may occur from hemorrhoids
Stomach or intestinal ulcer (including esophageal ulcer)
Unusual results in liver function laboratory tests

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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Daroxomb

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after "Exp.". The expiry date refers to the last day of the month.
Do not store above 30 ºC.
Keep in the original packaging to protect the medicine from moisture.
For bottles only:
Use within 4 months after first opening the bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Daroxomb contains
The active substance is dabigatran. Each hard capsule contains 172.95 mg of dabigatran etexilate
(as mesilate), equivalent to 150 mg of dabigatran etexilate.

The excipients are tartaric acid, arabic gum, hypromellose 2910, dimethicone 350, talc and hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), hypromellose 2910 and FD&C Blue No. 2/indigo carmine (E-132).

Description of the appearance of Daroxomb and contents of the pack
Daroxomb 150 mg are hard capsules filled with white to pale yellow granules, in size 0 capsules with a blue cap and a white to whitish body.
This medicine is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in single-dose blisters made of perforated Al/OPA-ALU-PVC.
A multiple pack containing 3 packs of 60 hard capsules x 1 (180 hard capsules) or a multiple pack containing 2 packs of 50 hard capsules x 1 (100 hard capsules) in single-dose blisters made of perforated Al/OPA-ALU-PVC.
60 hard capsules in an HDPE bottle with child-resistant cap and desiccant included inside the cap.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano, Italy

Manufacturers:
Galenicum Health, S.L.U.
Sant Gabriel, 50
08950 – Esplugues de Llobregat
Barcelona – Spain

and
SAG Manufacturing S.L.U
Linea N-I, Km 36
28750 San Agustín de Guadalix,
Madrid – Spain

More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.