Leaflet: information for the patient

Dabigatrán etexilate Krka 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, and you must 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.

1.What Dabigatrán etexilate Krka is and what it is used for

2.What you need to know before you start taking Dabigatrán etexilate Krka

3.How to take Dabigatrán etexilate Krka

4.Possible side effects

5.Storage of Dabigatrán etexilate Krka

6.Contents of the pack and additional information

This medicine 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 form 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 Krka

• if you are allergic to dabigatrán etexilato or any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you currently have bleeding.
• if you have any disease in an organ of the body that increases the risk of severe bleeding (e.g., stomach ulcer, injury or cerebral hemorrhage, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be congenital, of unknown cause, or caused by other medicines.
• if 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.
• if your liver function is severely reduced or if you have any liver disease that may be fatal.
• if you are taking ketoconazol oral or itraconazol, medicines used in the treatment of fungal infections.
• if you are taking ciclosporina oral, a medicine used to prevent organ rejection after a transplant.
• if you are taking dronedarona, a medicine used to treat abnormal heart rhythm.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had an artificial 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 had bleeding.
• if you have had a recent surgical tissue extraction (biopsy) in the last month.
• if you have had a severe injury (e.g., a bone fracture, head injury, or any injury that required surgical treatment).
• if you have inflammation of the esophagus or stomach.
• if you have problems with acid reflux in the esophagus.
• if you are taking medicines that may increase the risk of bleeding. See “Other medicines and Dabigatrán etexilato Krka” below.
• if you are taking anti-inflammatory medicines such as diclofenaco, ibuprofeno, or piroxicam.
• if you have a bacterial heart infection (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 this medicine

• if you are to undergo surgery:

In this case, this medicine 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 a surgical procedure requires the placement of a catheter or injection in the spinal column (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 Krka

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 takingdabigatrán etexilato if you are taking any of the following medicines:

• Medicines to reduce blood clotting (e.g., warfarin, fenprocumón, acenocumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxabán, ácido acetilsalicílico).
• 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 verapamilo, your doctor may instruct you to use a reduced dose of this medicine, depending on the disease for which you were prescribed it. See section 3.

• Medicines used to prevent organ rejection after a transplant (e.g., tacrólimus, ciclosporina).
• A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• Anti-inflammatory and pain-relieving medicines (e.g., ácido acetilsalicílico, ibuprofeno, diclofenaco).
• St. John's Wort, a medicinal plant for depression.
• Antidepressant medicines called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors.
• Rifampicina or claritromicina (two antibiotics).
• Antiviral medicines for HIV/AIDS (e.g., ritonavir).
• Certain medicines used to treat epilepsy (e.g., carbamazepina, fenitoína).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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 this medicine.

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

Driving and operating machines

This medicine has no known effects on the ability to drive and operate machines.

This medication may be used in adults and children 8 years of age or older who are able to swallow the capsules whole. There are other appropriate pharmaceutical forms available for the treatment of children under 8 years of age.

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 obstruction by blood clot formation developed after abnormal heart rhythm and treatment of blood clots in the veins of your legs and lungs, including prevention of blood clots in the veins of your legs and lungs from recurring

The recommended dose is 300 mg administered in the form of one 150 mg capsule twice a day.

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

If you are taking medications containing verapamil, you should be instructed on a reduced dose of dabigatran etexilate of 220 mg taken in the form of one 110 mg capsule 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 in the form of one 110 mg capsule twice a day.

You may continue taking this medication as needed to restore your normal heart rhythm through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Take this medication as instructed by your doctor.

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 may receive treatment with this medication once your doctor has decided that normal blood clotting control has been achieved. Take this medication as instructed by your doctor.

Treatment of blood clots and prevention of blood clots in children

This medication 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 your 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 this medication in milligrams (mg) based on your weight in kilograms (kg) and age in years:

Table 1: Dosing table for dabigatran etexilate capsules

Single doses requiring combinations of more than one capsule:

300 mg: two 150 mg capsules or four 75 mg capsules

260 mg: one 110 mg capsule plus one 150 mg capsule or one 110 mg capsule plus two 75 mg capsules

220 mg: two 110 mg capsules

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

150 mg: one 150 mg capsule or two 75 mg capsules

How to take Dabigatran etexilate Krka

This medication may 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.

Instructions for opening the blisters

The following images illustrate how to remove the capsules from this medication from the blister:

To remove the capsule from the blister:

1. Hold the blister by the edges and separate one unit from the rest of the blister by gently tearing along the perforated line that delimits it.
2. Pull the edge of the sheet until it is completely separated.
3. Let the capsule fall onto your hand.
4. Swallow the capsules whole with a glass of water.

• Do not press the capsules through the blister sheet.
• Do not remove the sheet from the blister until the capsule is needed.

Change in anticoagulant treatment

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

If you take more Dabigatran etexilate Krka 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 or pharmacist immediately or call the Toxicology Information Service, phone: 915620420, indicating the medication and the amount ingested.

If you forgot to take Dabigatran etexilate Krka

A missed dose may 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 Krka

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 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.

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

Severe side effects

This medicine affects blood clotting; therefore, most side effects are related to signs such as petechiae or bleeding.

Bleeding episodes, major or severe, are the most severe side effects and, regardless of their location, can 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, pallor, 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.

Other side effects

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

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

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

• Bleeding may be 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

Poorly frequent (may affect up to 1 in 100 people):

• Bleeding
• Bleeding may be 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 level 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
• Anomalies in liver function tests
• Increased liver enzymes

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

• Bleeding may be 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

Frequency unknown (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 this medicine 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 be 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

Poorly frequent (may affect up to 1 in 100 people):

• Bleeding
• Bleeding may be in a joint or wound
• Bleeding may be 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
• Anomalies in liver function tests
• Increased liver enzymes

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

• Bleeding may be 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

Frequency unknown (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decreased hemoglobin level 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 this medicine was higher than with warfarin. The global incidence was low. No imbalance in the incidence 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

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

Poorly frequent (may affect up to 1 in 100 people):

• Decreased number of leukocytes (which help fight infections)
• Bleeding may be 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 level 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

Frequency unknown (frequency cannot be estimated from available data):

• Decreased number or even absence of 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 be in a joint or wound, surgical incision site, injection site, or venous catheter site
• Bleeding may be from hemorrhoids
• Ulcer in the stomach or intestines (including esophageal ulcer)
• 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://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 packaging and on the aluminum blister after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Dabigatran etexilate Krka

• The active ingredient is dabigatran etexilate. Each hard capsule contains 150mg of dabigatran etexilate (as dabigatran etexilate mesilate).
• The other components are tartaric acid, hypromellose, hydroxypropylcellulose, and talc inside the capsule.
• The capsule components are titanium dioxide (E171), indigo carmine (E132), carrageenan, potassium chloride, and hypromellose.
• The black printing ink contains shellac, iron oxide black (E172), and potassium hydroxide.

Appearance of the product and contents of the packaging

Hard capsules (capsules): The capsule cap is blue and the body is white or almost white with the mark “150” printed in black longitudinally. The capsule size is 0 and the approximate length is 24 mm.

Dabigatran etexilate Krka is available in boxes containing:

• 60x1 hard capsule in blister packs.

Holder of the marketing authorization and responsible for manufacturing

KKRA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicine, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

Last approval date of this leaflet: February 2024

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