Dabigatran etexilate Krka 150 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dabigatran etexilate Krka 150 mg hard capsules EFG

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

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

Contents of the leaflet

1. What Dabigatran etexilate Krka is and what it is used for
2. What you need to know before taking Dabigatran etexilate Krka
3. How to take Dabigatran etexilate Krka
4. Possible side effects
5. How to store Dabigatran etexilate Krka
6. Contents of the pack and other information

1. What Dabigatran Etexilate Krka is and what it is used for

This medicine contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in blood clot formation.

Dabigatran etexilate is used in adults for:

• preventing the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation and have at least one additional risk factor.

• treating blood clots in the veins of your legs and lungs and to prevent recurrence of blood clots in the veins of your legs and lungs.

Dabigatran etexilate is used in children for:

• treating blood clots and preventing them from reoccurring.

2. What you need to know before starting to take Dabigatrán etexilato Krka

Do not take Dabigatrán etexilato Krka

• if you are allergic to dabigatran etexilate or to any of the other components of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you are currently experiencing bleeding.
• if you have any organ disease that increases the risk of serious bleeding (e.g., stomach ulcer, brain injury or 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 clots (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching between anticoagulant treatments, while you have 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 you have a liver disease that could be life-threatening.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had an artificial heart valve implanted that requires lifelong anticoagulant treatment.

Warnings and precautions

Talk to 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 need to undergo surgery.

Tell your doctor if you have or have had any disorder or illness, 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 removal (biopsy) within the last month.

• if you have suffered a serious injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment).

• if you have inflammation of the esophagus or stomach.

• if you have gastroesophageal reflux disease (acid reflux into the esophagus).

• if you are receiving medicines that may increase the risk of bleeding. See “Other medicines and Dabigatrán etexilato Krka” below.

• if you are using anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam.

• if you have an infection in the heart (bacterial endocarditis).

• if you know you have reduced kidney function or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark [concentrated]/foamy urine).

• if you are over 75 years old.

• if you are an adult weighing 50 kg or less.

• only if used in children: if the child has an infection in or around the brain.

• If you have had a heart attack or have been diagnosed with conditions that increase the risk of having a heart attack.

• If you have a liver disease associated with changes in blood test results. The use of this medicine is not recommended in such cases.

Take special care with this medicine

• If you need 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 before and after surgery exactly as directed by your doctor.

• If surgery requires the placement of a catheter or an injection into the spine (e.g., for epidural or spinal anesthesia or for pain relief):

• It is very important that you take this medicine before and after surgery exactly as directed by your doctor.

• Inform your doctor immediately if you experience numbness or weakness in the legs or bowel or bladder problems after anesthesia wears off, as this situation requires urgent medical attention.

• If you fall or get injured during treatment, especially if you hit your head. Seek urgent medical help. You may need to be examined by a doctor, as you may have an increased risk of bleeding.

• If you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether your treatment needs to be adjusted.

Other medicines and Dabigatrán etexilato Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, you must inform your doctor before taking dabigatran etexilate if you are taking any of the following medicines:

• Medicines to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines to treat fungal infections (e.g., ketoconazole, itraconazole), except when applied only to the skin.
• Medicines used to treat abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil).

If you are taking medicines containing verapamil, your doctor may advise you to use a reduced dose of this medicine, depending on the condition for which it has been prescribed. See section 3.

• Medicines used to prevent organ rejection after transplantation (e.g., tacrolimus, cyclosporine).
• A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• Anti-inflammatory and pain-relieving medicines (e.g., acetylsalicylic acid, ibuprofen, diclofenac).
• St. John’s wort, a herbal remedy for depression.
• Antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (two antibiotics).
• Antiviral medicines for HIV (e.g., ritonavir).
• Certain medicines used to treat epilepsy (e.g., carbamazepine, phenytoin).

Pregnancy and breastfeeding

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

The effects of this medicine on pregnancy and the fetus are unknown. You should 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, you should avoid becoming pregnant during treatment with this medicine.

Breastfeeding is not recommended during treatment with this medicine.

Driving and using machines

This medicine has no known effects on the ability to drive or operate machinery.

3. How to take Dabigatran etexilate Krka

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

Always follow exactly the dosing instructions given by your doctor. If you are unsure, please consult your doctor again.

Take dabigatran etexilate as recommended for the following conditions:

Prevention of stroke or systemic embolism caused by blood clots due to irregular heartbeat, and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of such clots

The recommended dose is 300 mg administered as one 150 mg capsule twice daily.

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

If you are taking medicines containing verapamil, you will be prescribed a reduced dose of dabigatran etexilate of 220 mg taken as one 110 mg capsule twice daily, because your risk of bleeding may be increased.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg administered as one 110 mg capsule twice daily.

You may continue taking this medicine if your normal heart rhythm is restored by a procedure called cardioversion or by a procedure called catheter ablation for atrial fibrillation. Take this medicine exactly as directed by your doctor.

If you have had a medical device (vascular stent) placed in a blood vessel to keep it open during a procedure known as percutaneous coronary intervention with stent placement, you may be treated with this medicine once your doctor has determined that normal blood coagulation control has been achieved. Take this medicine exactly as directed by your doctor.

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

This medicine should be taken twice daily, one dose in the morning and one dose in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.

The recommended dose depends on body weight and age. Your doctor will determine the correct dose. Your doctor may adjust your dose during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.

Table 1 shows the single doses and total daily doses of this medicine in milligrams (mg) according to body weight in kilograms (kg) and patient 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 medicine can be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure release in the stomach. Do not break, chew, or open the capsule and take only its contents, as this may increase the risk of bleeding.

Instructions for opening the blister packs

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

To remove the capsule from the blister:

1. Hold the blister at the edges and separate one unit from the rest of the blister by gently tearing along the perforated line marking that unit.
2. Pull the edge of the foil until it is completely detached.
3. Allow the capsule to fall into your hand.
4. Swallow the capsules whole with a glass of water.

• Do not press the capsules through the blister foil.
• Do not peel back the foil until the capsule is needed.

Switching 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 medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 915620420, indicating the medicine and the amount ingested.

If you forget to take Dabigatran etexilate Krka

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

A missed dose should be omitted if less than 6 hours remain before the next dose.

Do not take a double dose to make up for forgotten doses.

If you stop taking Dabigatran etexilate Krka

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

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

4. Possible adverse effects

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

Serious adverse effects

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

Major or severe episodes of bleeding may occur, which constitute the most serious adverse effects and, regardless of their location, may lead to disability, may be potentially fatal, or even result in death. In some cases, this bleeding may not be obvious.

If you experience any episode of bleeding that does not stop on its own, or if you experience signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to keep you under close observation or change your medication.

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

Other adverse effects

The possible adverse effects are listed below, grouped according to their frequency of occurrence.

Prevention of cerebrovascular or systemic vascular obstruction due to blood clot formation following abnormal heart rhythm

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

• Bleeding may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Feeling nauseous

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

• Bleeding
• Bleeding may occur from hemorrhoids, rectum, or brain
• Bruising
• Coughing up blood or sputum with blood streaks
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function tests

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

• Bleeding may occur in a joint, at a surgical incision site, in a wound, at the site of an injection, or at the site of a venous catheter insertion
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with dark red, raised, itchy bumps caused by an allergic reaction
• Decrease in the proportion of blood cells
• Increase in liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Frequency not known (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Hair loss

In a clinical trial, the rate 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

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

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

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

• Bleeding
• Bleeding may occur in a joint or wound
• Bleeding may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Bruising
• Coughing up blood or sputum with blood streaks
• Allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Feeling nauseous
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormal liver function tests
• Increase in liver enzymes

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

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

Frequency not known (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the proportion of blood cells
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems
• Hair loss

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

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

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

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Skin rash with dark red, raised, itchy bumps caused by an allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Bruising
• Nosebleeds
• Gastric juice reflux into the esophagus
• Vomiting
• Feeling nauseous
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increase in liver enzymes

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur in the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the proportion of blood cells
• Itching
• Coughing up blood or sputum with blood streaks
• Abdominal pain or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Frequency not known (frequency cannot be estimated from available data):

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or wound, at a surgical incision site, at the site of an injection, or at the site of a venous catheter insertion
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Abnormal liver function tests

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dabigatran etexilate Krka

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the aluminium blister after EXP. The expiry date refers to 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 via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dabigatran etexilate Krka

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

Appearance of the product and contents of the pack

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:

• 60 x 1 hard capsules in single-dose blisters.

Marketing Authorization Holder and 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, Oficina 1, 28108 Alcobendas, Madrid, Spain

Date of the most recent approval of this package leaflet: February 2024

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