Patient Information Leaflet: Package Insert

Dabigatrán etexilate pensa 150 mg hard capsules EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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 the brain (stroke) and in other blood vessels of the body if you have a type of irregular heart rhythm called non-valvular atrial fibrillation and have at least one additional risk factor.
• treat blood clots in the veins of your legs and lungs and to prevent new blood clots from forming in the veins of your legs and lungs.

Dabigatrán etexilato is used in children for:

• treat blood clots and to prevent new blood clots from forming.

Do not take Dabigatrán etexilato pensa if you

• are allergic to dabigatrán etexilato or any of the other ingredients of this medicine (listed in section 6).
• have severely reduced kidney function.
• are currently experiencing bleeding.
• 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).
• are prone to bleeding. This may be a birth defect, of unknown cause, or caused by other medicines.
• are taking medicines to prevent blood clotting in the blood (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when changing from one anticoagulant treatment to another, 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.
• have severely reduced liver function or have any liver disease that may be fatal.
• are taking ketoconazole oral or itraconazole, medicines used in the treatment of fungal infections.
• are taking ciclosporin oral, a medicine used to prevent organ rejection after a transplant.
• are taking dronedarone, a medicine used to treat abnormal heart rhythm.
• are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• have had a heart valve 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 inflammation of the esophagus or stomach.
  • if you have problems with reflux of stomach acid 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 diclofenac, ibuprofen, or piroxicam.
  • if you have a bacterial infection of the heart (endocarditis).
  • if you know that you have reduced kidney function 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 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 should be temporarily discontinued 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 surgery requires the placement of a catheter or injection into 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 requires urgent attention.

• if you fall or are injured during treatment, especially if you hit your head. Seek urgent medical attention. You may need to be examined by a doctor, 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, rivaroxaban, acetylsalicylic acid)
• Medicines for the treatment of fungal infections (e.g., ketoconazole, itraconazole), except when applied to the skin
• Medicines used in the treatment of abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil)

If you are taking medicines that contain verapamil, your doctor may instruct you to use a reduced dose of this medicine according to the disease for which it was prescribed. See section 3.

• Medicines to prevent organ rejection after a transplant (e.g., tacrolimus, ciclosporin)
• 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 medicinal herb for depression
• Antidepressants called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)

• Antiviral medicines for HIV/AIDS (e.g., ritonavir)
• Certain medicines for the treatment of epilepsy (e.g., carbamazepine, phenytoin)

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.

Do not 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”.

Dabigatran etexilate capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. There are other appropriate pharmaceutical forms for children under 8 years old.

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 vascular or systemic thrombosis developed after abnormal heart rhythm and treatment of blood clots in the veins of your legs and lungs, including prevention of blood clots from reforming in the veins of your legs and lungs

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

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

If you are using medications containing verapamil, you should be indicated a reduced dose of Dabigatran etexilate of 220 mg taken as one capsule of 110 mg twice a day, as your risk of bleeding may increase.

If you have a potentially greater risk of bleeding, your doctor may decide to prescribe a dose of 220 mg administered as one 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 or by a procedure called catheter ablation for atrial fibrillation.Take Dabigatran etexilate 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 endoprosthesis placement, you can receive treatment with Dabigatran etexilate once your doctor has decided that normal blood coagulation has been achieved.Take dabigatran as your doctor has instructed.

Treatment of blood clots and prevention of blood clots from reforming 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 administration 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. Continue using 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:Dosing table for Dabigatran etexilate

Single doses requiring 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

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 in anticoagulant treatment

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

If you take more Dabigatran etexilate 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 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dabigatran etexilate

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 missed doses.

If you interrupt treatment with Dabigatran etexilate

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

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

Like all medicines, this medicine may 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 are the most serious side effects, may occur, regardless of their location, and may cause disability, be potentially fatal, or even cause death. In some cases, these bleeding episodes may not be apparent.

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 cerebral or systemic vascular occlusion by blood clot formation developed after abnormal heart rhythmdeveloped after abnormal heart rhythm

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

• Bleeding may occur from 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 number of red blood cells in the 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 number of platelets in the blood
• Decreased hemoglobin in the blood (the substance present in red blood cells)
• Allergic reaction
• Sudden change in skin that affects color and physical appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of stomach acid into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormalities in liver function tests
• Increased liver enzymes

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

• Bleeding may occur in a joint, surgical incision site, wound, injection site, or venous catheter site
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes facial or throat swelling
• Urticaria 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 number or even absence of leukocytes (which help fight infections)
• Hair loss

In a clinical trial, the incidence 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 from 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 wound
• Bleeding may occur from hemorrhoids
• Decreased number of red blood cells in the blood
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Allergic reaction
• Sudden change in skin that affects color and physical appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of stomach acid into the esophagus
• Feeling like vomiting
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormalities in liver function tests
• Increased liver enzymes

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

• Bleeding may occur in a surgical incision site, injection site, or venous catheter site, or from the brain
• Decreased number of platelets in the blood
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes facial or throat swelling
• Urticaria 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 in the blood (the substance present in red blood cells)
• Decreased proportion of blood cells
• Decreased number or even absence of leukocytes (which help 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 incidence of heart attacks with Dabigatrán etexilate was higher than with warfarin.The global incidence was low. No imbalance in the incidence 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 number of red blood cells in the blood
• Decreased number of platelets in the blood
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction
• Sudden change in skin that affects color and physical appearance
• Formation of hematomas
• Nasal bleeding
• Reflux of stomach acid 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 number of leukocytes (which help fight infections)
• Bleeding may occur from 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 in the 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 leukocytes (which help fight infections)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or wound, surgical incision site, injection site, or venous catheter site
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Abnormalities 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications 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 medications you no longer need. By doing so, you will help protect the environment.

Composition of Dabigatrán etexilato pensa

• The active ingredient is dabigatrán. Each hard capsule contains 150 mg of dabigatrán etexilato (in the form of mesilato).
• The other components are microcrystalline cellulose, sodium croscarmellose (E-468), crospovidone (type A), 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, iron oxide black (E-172), and potassium hydroxide.

Appearance of the product and content of the packaging

Dabigatrán etexilato pensa 150 mg are hard capsules (approx 23.4 mm in length) with opaque pink-colored caps and bodies that carry the imprint "DA150".

Dabigatrán etexilato pensa is available in packaging containing 60 hard capsules in perforated aluminum/aluminum blisters.

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.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

O

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park Paola

PLA 3000

Malta

Last approval date of this prospectus: May 2023

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/