Leaflet: information for the patient

Dabigatrán etexilate Krka 110mg 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, consult 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 is Dabigatrán etexilate Krka and what it is used for

2.What you need to know before starting to take 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 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 new blood clots from forming in the veins of your legs and lungs.

Dabigatrán etexilato is used in children for:

• treating blood clots and preventing 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 are currently experiencing bleeding.
• if 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).
• if you are prone to bleeding. This tendency may be congenital, unknown, or caused by other medications.
• if you are taking medications to prevent blood clotting in the blood (e.g., warfarin, rivaroxaban, apixaban, 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 through 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 ketoconazole oral or itraconazole, medications used in the treatment of fungal infections.
• if you are taking oral ciclosporin, a medication used to prevent organ rejection after a transplant.
• if you are taking dronedarone, a medication used to treat abnormal heart rhythm.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medication 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 experienced bleeding.
• if you have recently undergone a tissue extraction procedure (biopsy) in the last month.
• if you have suffered 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 acid reflux in the esophagus.
• if you are taking medications that may increase the risk of bleeding. See “Other medicines and Dabigatrán etexilato Krka” below.
• if you are taking anti-inflammatory medications 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 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 Krka

• if you need to undergo surgery:

In this case, this medicine must 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 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 get 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, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines used in 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 amiodarone, quinidine, or verapamil, your doctor may instruct you to use a reduced dose of this medicine 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, ciclosporin).
• A combination product of glecaprevir and pibrentasvir (an antiviral medication used to treat hepatitis C).
• Anti-inflammatory and pain-relieving medications (e.g., acetylsalicylic acid, ibuprofen, diclofenac).
• St. John's Wort, a medicinal plant for depression.
• Antidepressants called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (two antibiotics).
• Antiviral medications for HIV/AIDS (e.g., ritonavir).
• Certain medications used to treat epilepsy (e.g., carbamazepine, phenytoin).

Pregnancy and breastfeeding

Inform your doctor or pharmacist if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant 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 can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. There are other suitable pharmaceutical forms for the treatment of children under 8 years old.

Follow exactly the administration instructions of 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 replacement surgery

The recommended dose is 220 mg once a day (administered in the form of 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 a day (administered in the form of 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 in the form of 2 capsules of 75 mg).

If you are taking medications containing verapamil and your kidney function is reduced by more than half, you should be instructed to take a reduced dose of this medication 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 replacement surgery

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

After hip replacement surgery

Start treatment with this medication 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 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 recurrence of blood clots in the veins of your legs and lungs

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

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

If you are taking medications containing verapamil, you should be instructed to take a reduced dose of this medication of 220 mg taken in the form of one 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 in the form of 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. 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 vascular endoprosthesis placement, you can 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 recurrence 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 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 this medication 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 capsules

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 Krka

This medication 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.

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 forget to take Dabigatran etexilate Krka

Prevention of blood clot formation after knee or hip replacement surgery

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 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 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 Krka

Take this medication 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.

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 hemorrhages. Severe bleeding episodes, which are the most severe side effects, can 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 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, 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 blood clot formation after knee or hip arthroplasty

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 can 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 petechiae 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 can occur in the brain, at the site of a surgical incision, at the site of an injection, or at the site of a venous catheter
• Suppurative venous catheter site
• 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 facial or throat swelling
• Urticaria 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 esophageal ulcer)
• Esophageal and gastric inflammation
• Reflex of gastric juice into the esophagus
• Abdominal pain or stomach pain
• Indigestion
• Dysphagia
• 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 or absence of leukocytes (which help fight infections)
• Hair loss

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 can 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 can 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 esophageal ulcer)
• Esophageal and gastric inflammation
• Reflex of gastric juice into the esophagus
• Vomiting
• Dysphagia
• Anomalies in liver function tests

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

• Bleeding can 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 venous catheter
• Decreased platelet count in 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
• 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 or 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 overall 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 can 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 can occur in a joint or in a wound
• Bleeding can 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 esophageal ulcer)
• Esophageal and gastric inflammation
• Reflex of gastric juice into the esophagus
• 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 can occur at the site of a surgical incision, at the site of an injection, at the site of a venous catheter, or from the brain
• Decreased platelet count in 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
• Dysphagia

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 or 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. 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 red blood cell count in blood
• Decreased platelet count in blood
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction
• Change in skin color and appearance
• Formation of hematomas
• Nasal bleeding
• Reflex of gastric 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 leukocyte count (which help fight infections)
• Bleeding can 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
• Esophageal and gastric inflammation
• Allergic reaction
• Dysphagia
• 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 leukocyte count (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 can 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 venous catheter
• Bleeding can occur 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 of 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. Deposit 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. By doing so, you will help protect the environment.

Composition of Dabigatran etexilate Krka

• The active ingredient is dabigatran etexilate. Each hard capsule contains 110mg 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 also blue with the mark “110” printed in black longitudinally. The capsule size is 1 and the approximate length is19 mm.

Dabigatran etexilate Krka is available in boxes containing:

• 10x1, 30x1, 60x1 hard capsules in blister packs.

cap with desiccant included.

Marketing authorization holder and responsible manufacturer

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

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

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

Last approval date of this leaflet: February 2024

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/.