DABIGATRAN ETEXILATE KRKA 75 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dabigatran Etexilate Krka 75 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Dabigatran Etexilate Krka and what is it 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 the formation of blood clots.

Dabigatran etexilate is used in adults to:

• prevent the formation of blood clots in the veins after knee or hip replacement surgery.

Dabigatran etexilate is used in children to:

• treat blood clots and prevent them from forming again.

2. What you need to know before you take Dabigatran Etexilate Krka

Do not take Dabigatran Etexilate Krka

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you are currently 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 bleeding in the brain, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be inherited, of unknown cause, or caused by other medicines.
• if you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, while having a venous or arterial catheter and being given heparin 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 you have a life-threatening liver disease.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral ciclosporin, a medicine used to prevent organ rejection after a transplant.
• if you are taking dronedarone, a medicine used to treat irregular heart rhythm.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have been implanted with an artificial heart valve that requires permanent anticoagulant treatment.

Warnings and precautions

Talk to your doctor before you start taking this medicine. During treatment with this medicine, you may also need to talk to your doctor if you experience any symptoms or if you need to have surgery.

Tell 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 surgical removal of tissue (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 acid reflux from the stomach into the esophagus.
• if you are taking medicines that may increase the risk of bleeding. See "Other medicines and Dabigatran Etexilate Krka" below.
• if you are using anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam.
• if you have a heart infection (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-colored urine/concentrated urine with foam).
• if you are over 75 years old.
• if you are an adult patient and weigh 50 kg or less.
• only if used in children: if the child has an infection in the brain or around the brain.

• 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 careful with this medicine

• If you need to have surgery:

In this case, this medicine should be temporarily stopped 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 at the times indicated by your doctor.

• If surgery requires the insertion of a catheter or injection into the spinal column (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 at the times indicated by your doctor.
• Tell your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the anesthesia has ended, as this situation requires urgent attention.

• If you fall or injure yourself during treatment, especially if you hit your head. Seek urgent medical attention. You may need a doctor to examine you, as you may have a higher risk of bleeding.
• If you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), tell your doctor so that they can decide if it may be necessary to modify the treatment.

Other medicines and Dabigatran Etexilate Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must tell 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 for the treatment of fungal infections (e.g. ketoconazole, itraconazole), except if they are only applied to the skin.
• Medicines used to treat irregular heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil).
• If you are using medicines that contain amiodarone, quinidine, or verapamil, your doctor may tell you to use a reduced dose of this medicine depending on the disease for which it has been prescribed. See also section 3.
• Medicines for the prevention of 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 herbal medicine for depression.
• Antidepressant medicines called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (two antibiotics).
• Antiviral medicines for HIV (e.g. ritonavir).
• Certain medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The effects of this medicine on pregnancy and the fetus are not known. You should not take this medicine if you are pregnant unless your doctor advises you to. 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 use machines.

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 pharmaceutical forms suitable for the treatment of children under 8 years.

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, 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 as 2 capsules of 110 mg).

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

If you are using medicines that contain amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once a day(administered as 2 capsules of 75 mg).

If you are using medicines that contain verapamil and your kidney function is reducedby more than half, you should be given a reduced dose of this medicine of 75 mgbecause your risk of bleeding may increase.

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

After knee replacement surgery

Treatment with this medicine should be started 1-4 hours after surgery, taking a single capsule. After that, 2 capsules should be taken once a day for a total of 10 days.

After hip replacement surgery

Treatment with this medicine should be started 1-4 hours after surgery, taking a single capsule. After that, 2 capsules should be taken once a day for a total of 28-35 days.

Treatment of blood clots and prevention of blood clots in children

This medicine 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 to 12 hours as possible.

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 medicines unless your doctor tells you to stop using them.

Table 1 shows the single and total daily doses of this medicine in milligrams (mg) based on the patient's weight in kilograms (kg) and age in years:

Table 1: Dosing table for dabigatran etexilate capsules

Doses that require combinations of one or more capsules:

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 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 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 marks the unit.
2. Pull the edge of the foil until it is completely separated.
3. Let the capsule 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 remove the foil from the blister until the capsule is needed.

Changing 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. 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, telephone: 915620420, indicating the medicine 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 medicine at the same time the next day.

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

Treatment of blood clots and prevention of blood clots in children

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

A forgotten dose should be omitted if the time before the next dose is less than 6 hours.

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 your treatment with this medicine without first consulting your doctor, as the risk of developing a blood clot may be higher if you stop treatment too soon. Contact your doctor if you experience indigestion after taking this medicine.

If you have any other 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 all people suffer from them.

Severe Adverse Effects

This medicine acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding.

Episodes of major or severe bleeding may occur, which are the most severe adverse effects and, regardless of their location, can cause disability, be potentially life-threatening, or even cause death. In some cases, these bleedings may not be apparent.

If you experience any episode of bleeding that does not stop by itself 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.

Other Adverse Effects

Possible adverse effects are detailed below, grouped according to their frequency of occurrence.

Prevention of blood clot formation after knee or hip arthroplasty

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

• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Anomalies in liver function tests

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

• Bleeding may occur in the nose, stomach, or intestine, from the penis/vagina or urinary tract (including blood in the urine that stains the urine pink or red), from hemorrhoids, rectum, under the skin, from a joint, or after an injury or surgery
• Formation of hematomas or bruising after surgery
• Detection of blood in stool in a laboratory test
• Decrease in the number of red blood cells in the blood
• Decrease in the proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Feeling like vomiting
• Purulent discharge from a wound (secretion of fluid from a surgical wound)
• Increased liver enzymes
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems

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

• Bleeding
• Bleeding may occur in the brain, at the site of a surgical incision, at the site of injection, or at the site of a catheter entry in a vein
• Purulent discharge from the site of a catheter entry in a vein
• Coughing up blood or sputum with blood spots
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgery
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

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

Treatment of blood clots and prevention of blood clot formation in children

Frequent (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, prominent, and itchy bumps, caused by an allergic reaction
• Sudden change in skin color and physical appearance
• Formation of hematomas
• Nosebleeds
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling like vomiting
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased 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 stains 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 spots
• Abdominal pain or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowish discoloration 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 that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or wound, in a surgical incision, at the site of injection, or at the site of a catheter entry in a vein
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Anomalies in liver function tests

Reporting Adverse Effects

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

5. Storage of Dabigatran Etexilate Krka

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

Do not use this medicine after the expiration date stated 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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Dabigatran Etexilate Krka

• The active ingredient is dabigatran etexilate. Each hard capsule contains 75 mg of dabigatran etexilate (as dabigatran etexilate mesilate).
• The other ingredients are tartaric acid, hypromellose, hydroxypropylcellulose, and talc inside the capsule.
• The capsule ingredients are titanium dioxide (E171), carrageenan, potassium chloride, and hypromellose.
• The black printing ink contains shellac, iron oxide black (E172), and potassium hydroxide.

Appearance of the Product and Package Contents

Hard capsules (capsules): The capsule cap is white or almost white, the capsule body is white or almost white with the mark "75" printed longitudinally. The capsule size is 2 and the length is approximately 18 mm.

Dabigatran Etexilate Krka is available in boxes containing:

• 30 x 1 or 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

You can request more information about this medicine by contacting 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 Last Approval of this Leaflet: February 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/