DabigatrÁn etexilato pensa 110… leaflet – Spain

How to use DabigatrÁn etexilato pensa 110 mg cÁpsulas duras efg

Introduction

Package Insert: Information for the Patient

Dabigatrán etexilate pensa 110 mg Hard Capsules EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

Keep this package insert, as you may need to refer to it again.
If you have any questions, consult your doctor or pharmacist.
This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Dabigatrán etexilato pensa and how is it used

Dabigatrán etexilato pensa contains the active ingredient dabigatrán etexilato and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in the formation of blood clots.

Dabigatrán etexilato is used in adults for:

preventing the formation of blood clots in veins after knee or hip replacement surgery.
preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body if you have a type of irregular heart rhythm called non-valvular atrial fibrillation and have at least one additional risk factor.
treating blood clots in the veins of your legs and lungs and to prevent them from coming back.

Dabigatrán etexilato is used in children for:

treating blood clots and preventing them from coming back.

2. What you need to know before starting to take Dabigatran etexilate

Do not take Dabigatrán etexilato pensa if you think

you are allergic to dabigatrán etexilato or any of the other ingredients of this medicine (listed in section 6).
your kidney function is severely reduced.
you are currently experiencing bleeding.
you have any disease in an organ of the body that increases the risk of severe bleeding (e.g., stomach ulcer, head injury or bleeding, recent brain or eye surgery).
you are prone to bleeding. This tendency may be of birth, unknown cause, or caused by other medicines.
you are taking medicines to prevent blood clotting in the blood (e.g., warfarin, rivaroxabán, apixabán, or heparin), except when changing anticoagulant treatment, while having a venous or arterial catheter, and heparin is administered through this catheter to keep it open, or while your normal heart rhythm is being restored by a procedure called catheter ablation for atrial fibrillation.
your liver function is severely reduced or you have any liver disease that may be fatal.
you are taking ketoconazol oral or itraconazol, medicines used in the treatment of fungal infections.
you are taking ciclosporina oral, a medicine used to prevent organ rejection after a transplant.
you are taking dronedarona, a medicine used to treat abnormal heart rhythm.
you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
you have had a heart valve artificial implanted that requires permanent anticoagulant treatment.

Warnings and precautions

Consult your doctor before starting to take this medicine. During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you are to undergo surgery.

Inform your doctorif you have or have had any disorder or disease, especially any of the following:

If you have an increased risk of bleeding, for example:
- if you have recently experienced bleeding.
- if you have had a surgical tissue extraction (biopsy) in the last month.
- if you have had a severe injury (e.g., a bone fracture, a head injury, or any injury that required surgical treatment).
- if you have an inflammation of the esophagus or stomach.
- if you have problems with reflux of stomach juice into the esophagus.
- if you are taking medicines that may increase the risk of bleeding. See “Other medicines and Dabigatrán etexilato pensa” below.
- if you are taking anti-inflammatory medicines such as diclofenaco, ibuprofen, or piroxicam.
- if you have a bacterial infection of the heart (endocarditis).
- if you know that your kidney function is reduced or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark-colored, concentrated urine with foam).
- if you are over 75 years old.
- if you are an adult and weigh 50 kg or less.
- only if used in children: if the child has an infection in the brain or around it.

if you have had a heart attack or if you have been diagnosed with diseases that increase the risk of having a heart attack.

if you have a liver disease associated with changes in blood tests. The use of this medicine is not recommended in this case.

Be especially careful with Dabigatrán etexilato pensa

if you are to undergo surgery:

In this case, dabigatrán etexilato must be temporarily interrupted due to an increased risk of bleeding during and shortly after surgery. It is very important that you take this medicine exactly as instructed by your doctor before and after surgery.

if a surgical procedure requires the placement of a catheter or injection in the spine (e.g., for epidural or spinal anesthesia or for pain relief):

It is very important that you take this medicine exactly as instructed by your doctor before and after surgery.
Inform your doctor immediately if you experience numbness or weakness in your legs or intestinal or urinary problems after the end of anesthesia, as this situation requires urgent attention.

if you fall or are injured during treatment, especially if you hit your head. Seek urgent medical attention. You may need a doctor to examine you, as you may have an increased risk of bleeding.

if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), inform your doctor so that they can decide if your treatment needs to be modified.

Other medicines and Dabigatrán etexilato pensa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.Particularly, inform your doctor before taking this medicine if you are taking any of the following medicines:

Medicines to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxabán, acetylsalicylic acid).
Medicines used in the treatment of fungal infections (e.g., ketoconazol, itraconazol), except when applied to the skin.
Medicines used in the treatment of abnormal heart rhythm (e.g., amiodarona, dronedarona, quinidina, verapamilo).

If you are taking medicines that contain amiodarona, quinidina, or verapamilo, your doctor may instruct you to use a reduced dose of dabigatrán etexilato according to the disease for which you have been prescribed it. See section 3.

Medicines used to prevent organ rejection after a transplant (e.g., tacrolimus, ciclosporina).
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, diclofenaco).
St. John's Wort, a medicinal plant for depression.
Antidepressant medicines called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors.
Rifampicin or claritromicina (two antibiotics).
Antiviral medicines for HIV (e.g., ritonavir).
Certain medicines used to treat epilepsy (e.g., carbamazepina, phenitoína).

Pregnancy and breastfeeding

The effects of this medicine on pregnancy and the fetus are unknown. Do not use this medicine if you are pregnant unless your doctor tells you it is safe to do so. If you are of childbearing age, avoid becoming pregnant during treatment with dabigatrán etexilato.

It is not recommended to breastfeed naturally during treatment with this medicine.

Driving and operating machines

Dabigatrán etexilato has no known effects on the ability to drive and operate machines.

Dabigatrán etexilato pensa contains sodium

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

3. How to take Dabigatrán etexilate pensa

Dabigatran etexilate capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. Other appropriate pharmaceutical forms are available for children under 12 years of age who are able to swallow soft foods.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Take dabigatran etexilate as recommended for the following situations:

Prevention of blood clot formation after knee or hip arthroplasty

The recommended dose is 220 mg once a day (administered as 2 capsules of 110 mg).

If your renal function is decreased by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once a day (administered as 2 capsules of 75 mg).

If you are taking medications containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once a day (administered as 2 capsules of 75 mg).

If you are taking medications containing verapamil and your renal function is decreased by more than half, you should be indicated a reduced dose of dabigatran etexilate of 75 mg, as your risk of bleeding may increase.

In both types of surgery, treatment should not be initiated if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, dosing should be initiated with 2 capsules once a day.

After knee arthroplasty

Initiate treatment with dabigatran etexilate 1-4 hours after surgery, taking a single capsule. Then, take 2 capsules once a day for a total of 10 days.

After hip arthroplasty

Initiate treatment with dabigatran etexilate 1-4 hours after surgery, taking a single capsule. Then, take 2 capsules once a day for a total of 28-35 days.

Prevention of cerebral or systemic vascular occlusion due to blood clot formation developed after abnormal heart rhythm and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of blood clots in the veins of your legs and lungs

The recommended dose is 300 mg administered as 1 capsule of 150 mg twice a day.

If you are 80 years of age or older, the recommended dose is 220 mg administered as 1 capsule of 110 mg twice a day.

If you are taking medications containing verapamil, you should be indicated a reduced dose of dabigatran etexilate of 220 mg taken as 1 capsule of 110 mg twice a day, as your 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 administered as 1 capsule of 110 mg twice a day.

You can continue taking this medication if necessary to restore your normal heart rhythm by a procedure called cardioversion. Take this medication as your doctor has instructed.

If you have had a medical device (vascular endoprosthesis) placed in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with vascular endoprosthesis placement, you can receive treatment with this medication once your doctor has decided that normal blood coagulation has been achieved. Take this medication as your doctor has instructed.

Treatment of blood clots and prevention of recurrence of blood clots in children

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

The recommended dose depends on weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Follow all other medications unless your doctor tells you to stop using one.

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

Table 1:Table of posology for dabigatran etexilate capsules

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

Single doses that require combinations of more than one capsule:

300 mg:two capsules of 150 mg or

four capsules of 75 mg

260 mg:one capsule of 110 mg plus one capsule of 150 mg or

one capsule of 110 mg plus two capsules of 75 mg

220 mg:two capsules of 110 mg

185 mg:one capsule of 75 mg plus one capsule of 110 mg

150 mg:one capsule of 150 mg or

two capsules of 75 mg

How to take Dabigatran etexilate pensa

Dabigatran etexilate can be taken with or without food. The capsule should be swallowed whole with a glass of water, to ensure release in the stomach. Do not break, chew, or open the capsule to take only its contents, as this may increase the risk of bleeding.

Change of anticoagulant treatment

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

If you take more Dabigatran etexilate pensa than you should

Taking too much of this medication increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. There are specific treatment options available.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Dabigatran etexilate pensa

Prevention of blood clot formation after knee or hip arthroplasty

Take the remaining daily doses of this medication at the same time the next day.

Do not take a double dose to compensate for the missed doses.

Use in adults: Prevention of cerebral or systemic vascular occlusion due to blood clot formation developed after abnormal heart rhythm and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of blood clots in the veins of your legs and lungs.

Use in children: Treatment of blood clots and prevention of recurrence of blood clots

A missed dose can be taken up to 6 hours before the next dose.

A missed dose should be omitted if the remaining time before the next dose is less than 6 hours. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Dabigatran etexilate pensa

Take dabigatran etexilate exactly as prescribed. Do not interrupt your treatment with this medication without consulting your doctor first, as the risk of developing a blood clot may be higher if you interrupt treatment too soon. Contact your doctor if you experience indigestion after taking this medication.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Dabigatrán etexilate acts on blood coagulation; therefore, most side effects are related to signs such as bruising or bleeding. Severe or life-threatening bleeding episodes, which can cause disability, may occur, regardless of their location. In some cases, these bleeding episodes may not be evident.

If you experience any bleeding episode that does not stop on its own or if you experience signs of excessive bleeding (exceptional 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 medication.

Inform your doctor immediately if you experience a severe allergic reaction that causes difficulty breathing or dizziness.

The possible side effects are detailed below, grouped by frequency of occurrence.

Prevention of blood clot formation after knee or hip replacement surgery

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

Decreased blood hemoglobin levels (the substance present in red blood cells)
Anomalies in liver function tests

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

Bleeding may occur through the nose, stomach, or intestines, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), hemorrhoids, rectum, under the skin, joint, or after an injury or surgery
Formation of hematomas or bruising after surgery
Blood detected in stool in a laboratory test
Decreased red blood cell count in the blood
Decreased proportion of blood cells
Allergic reaction
Vomiting
Frequent loose or liquid stools
Feeling like vomiting
Suppuration of wounds (secretion of liquid from a surgical wound)
Increased liver enzymes
Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems

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

Bleeding
Bleeding may occur in the brain, at the site of a surgical incision, at the site of an injection, or at the site of a catheter in a vein
Bleeding from a catheter in a vein with pus
Coughing up blood or sputum with blood spots
Decreased platelet count in blood
Decreased red blood cell count in blood after surgery
Severe allergic reaction that causes difficulty breathing or dizziness
Severe allergic reaction that causes swelling of the face or throat
Hives with dark, prominent, and itchy red bumps, caused by an allergic reaction
Change in skin color and appearance
Itching
Ulcer in the stomach or intestines (including ulcer in the esophagus)
Inflammation of the esophagus and stomach
Reflux of stomach juice into the esophagus
Abdominal pain or stomach pain
Indigestion
Difficulty swallowing
Liquid leaking from a wound
Liquid leaking from a wound after surgery

Unknown frequency (frequency cannot be estimated from available data):

Difficulty breathing or wheezing
Decreased white blood cell count (which helps fight infections)
Hair loss

Prevention of cerebral or systemic blood clot formation developed after abnormal heart rhythm

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

Bleeding may occur through the nose, stomach, or intestines, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin
Decreased red blood cell count in blood
Abdominal pain or stomach pain
Indigestion
Frequent loose or liquid stools
Feeling like vomiting

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

Bleeding
Bleeding may occur from hemorrhoids, rectum, or brain
Formation of hematomas
Coughing up blood or sputum with blood spots
Decreased platelet count in blood
Decreased hemoglobin levels in blood (the substance present in red blood cells)
Allergic reaction
Change in skin color and appearance
Itching
Ulcer in the stomach or intestines (including ulcer in the esophagus)
Inflammation of the esophagus and stomach
Reflux of stomach juice into the esophagus
Vomiting
Difficulty swallowing
Anomalies in liver function tests

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

Bleeding may occur in a joint, at the site of a surgical incision, in a wound, at the site of an injection, or at the site of a catheter in a vein
Decreased platelet count in blood
Severe allergic reaction that causes difficulty breathing or dizziness
Severe allergic reaction that causes swelling of the face or throat
Hives with dark, prominent, and itchy red bumps, caused by an allergic reaction
Decreased proportion of blood cells
Increased liver enzymes
Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems

Unknown frequency (frequency cannot be estimated from available data):

Difficulty breathing or wheezing
Decreased white blood cell count (which helps fight infections)
Hair loss

In a clinical trial, the index of heart attacks with dabigatrán etexilate was numerically higher than with warfarin. The global incidence was low.

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

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

Bleeding may occur through the nose, stomach, or intestines, rectum, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin
Indigestion

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

Bleeding
Bleeding may occur in a joint or in a wound
Bleeding may occur from hemorrhoids
Decreased red blood cell count in blood
Formation of hematomas
Coughing up blood or sputum with blood spots
Allergic reaction
Change in skin color and appearance
Itching
Ulcer in the stomach or intestines (including ulcer in the esophagus)
Inflammation of the esophagus and stomach
Reflux of stomach juice into the esophagus
Feeling like vomiting
Vomiting
Abdominal pain or stomach pain
Frequent loose or liquid stools
Anomalies in liver function tests
Increased liver enzymes

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

Bleeding may occur at the site of a surgical incision, at the site of an injection, at the site of a catheter in a vein, or from the brain
Decreased platelet count in blood
Severe allergic reaction that causes difficulty breathing or dizziness
Severe allergic reaction that causes swelling of the face or throat
Hives with dark, prominent, and itchy red bumps, caused by an allergic reaction
Difficulty swallowing

Unknown frequency (frequency cannot be estimated from available data):

Difficulty breathing or wheezing
Decreased hemoglobin levels in blood (the substance present in red blood cells)
Decreased proportion of blood cells
Decreased white blood cell count (which helps fight infections)
Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems
Hair loss

In the clinical trial program, the index of heart attacks with dabigatrán etexilate was higher than with warfarin. The global incidence was low. No imbalance in the index of heart attacks was observed in patients treated with dabigatrán compared to patients treated with placebo.

Treatment of blood clots and prevention of recurrence of blood clots in children

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

Decreased red blood cell count in blood
Decreased platelet count in blood
Hives with dark, prominent, and itchy red bumps, caused by an allergic reaction
Change in skin color and appearance
Formation of hematomas
Nasal bleeding
Reflux of stomach juice into the esophagus
Vomiting
Feeling like vomiting
Frequent loose or liquid stools
Indigestion
Hair loss
Increased liver enzymes

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

Decreased white blood cell count (which helps fight infections)
Bleeding may occur in the stomach or intestines, brain, rectum, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin
Decreased hemoglobin levels in blood (the substance present in red blood cells)
Decreased proportion of blood cells
Itching
Coughing up blood or sputum with blood spots
Abdominal pain or stomach pain
Inflammation of the esophagus and stomach
Allergic reaction
Difficulty swallowing
Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems

Unknown frequency (frequency cannot be estimated from available data):

Decreased white blood cell count (which helps fight infections)
Severe allergic reaction that causes difficulty breathing or dizziness
Severe allergic reaction that causes swelling of the face or throat
Difficulty breathing or wheezing
Bleeding
Bleeding may occur in a joint or in a wound, at the site of a surgical incision, at the site of an injection, or at the site of a catheter in a vein
Bleeding may occur from hemorrhoids
Ulcer in the stomach or intestines (including ulcer in the esophagus)
Anomalies in liver function tests

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.Medicating the reporting of side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Dabigatrán etexilate

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box or blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and the medication that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and the medication that you no longer need. By doing so, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Dabigatrán etexilato pensa

The active ingredient is dabigatrán etexilato. Each hard capsule contains 110 mg of dabigatrán etexilato (in the form of mesilato).
Other components are microcrystalline cellulose, sodium croscarmellose, crospovidone, tartaric acid, hydroxypropyl cellulose, mannitol (E-421), talc, and magnesium stearate.
The capsule coating contains iron oxide red (E-172), titanium dioxide (E-171), and hypromellose.
The black printing ink contains shellac, propylene glycol (E-1520), iron oxide black (E-172), and potassium hydroxide.

Appearance of the product and contents of the packaging

Dabigatrán etexilato pensa 110 mg are hard capsules (approximately 22 mm in length) with opaque pink-colored caps and bodies bearing the imprint “DA110”.

Dabigatrán etexilato pensa is available in perforated aluminum/aluminum blisters with desiccant, in carton containers containing 10, 30, and 60 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

TOWA Pharmaceutical Europe, S.L.

Calle de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

PLA 3000, Paola

Malta

Last approval date of this prospectus: March 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

How much does DabigatrÁn etexilato pensa 110 mg cÁpsulas duras efg cost in Spain in 2025?

The average price of DabigatrÁn etexilato pensa 110 mg cÁpsulas duras efg in July, 2025 is around 16.53 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.