Patient Information Leaflet

Dabigatrán etexilate Stadafarma 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.

• Consult your doctor or pharmacist if you experience any side effects, even if they are not listed in this leaflet. See section 4.

This medicationcontains the active ingredient dabigatrán etexilato and belongs to a group of medications called anticoagulants. It works by blocking a substance in the body involved in the formation of blood clots.

Dabigatrán etexilatois used in adults for:

• to prevent 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.

• to 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 etexilatois used in children for:

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

Do not takeDabigatrán etexilate Stadafarma

• if you are allergic to dabigatrán 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 experiencing 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 medications.
• if you are taking medications to prevent blood clotting in the blood (e.g.,warfarin, rivaroxaban, apixaban, or heparin), except when changing from one anticoagulant treatment to another, 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 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 ciclosporin oral, 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 a heart valve implanted that requires permanent anticoagulant treatment.

Warnings and precautions

Consult your doctor before starting to takeDabigatrán etexilate Stadafarma.During treatment withthis medicineyou may also need to consult your doctor if you experience any symptoms or if you are to undergo surgery.

Inform your doctorif you have or have had any disorder or disease, especially any of the following:

• If you have an increased risk of bleeding, for example:
• • if you have recently experienced bleeding.
  • if you have had a surgical tissue extraction (biopsy) in the last month.
  • if you have 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 andDabigatrán etexilate Stadafarma” below.
  • if you are taking anti-inflammatory medications such as diclofenac, ibuprofen, or piroxicam.
  • if you have a heart infection (bacterial 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)/foamy urine).
  • 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 ofthis medicineis not recommended in this case.

Be especially careful withDabigatrán etexilate Stadafarma

• If you are to undergo surgery:

In this case,dabigatrán etexilatemust be temporarily discontinued due to an increased risk of bleeding during and shortly after surgery. It is very important that you takedabigatrán etexilateexactly at the times indicated by your doctor before and after surgery.

• If surgery requires the placement 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 takedabigatrán etexilateexactly at the times indicated by your doctor before and after surgery.

• 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 andDabigatrán etexilate Stadafarma

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.Particularly, you must inform your doctor before takingdabigatrán etexilateif you are taking any of the following medicines:

• Medicines to reduce blood clotting (e.g., warfarin, phenprocoumon,acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines for the treatment of fungal infections (e.g., ketoconazole, itraconazole),except when applied to the skin
• Medicines used in the treatment of abnormal heart rhythm (e.g., amiodarone,dronedarone, quinidine, verapamil).If you are taking medicines that contain amiodarone, quinidine, or verapamil, your doctor may instruct you to use a reduced dose ofdabigatrán etexilateaccording to the disease for which you have been prescribed it. See section 3.
• Medicines 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 herb for depression
• Antidepressant medications 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 for the treatment of epilepsy (e.g., carbamazepine, phenytoin)

Pregnancy and breastfeeding

The effects ofdabigatrán etexilateon pregnancy and the fetus are unknown. Do not usethis medicineif you are pregnant unless your doctor tells you it is safe to do so. If you are fertile, avoid becoming pregnant during treatment withdabigatrán etexilate.

Breastfeeding is not recommended during treatment withdabigatrán etexilate.

Driving and operating machines

Dabigatrán etexilatehas no known effects on the ability to drive and operate machines.

Dabigatran etexilatecan be used in adults and children aged 8 years or older who are able to swallow the capsules whole. There are other appropriate pharmaceutical forms for children under 8 years 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 ofone 150 mg capsule twice a day.

If you are80 years of age or older, the recommended dose ofdabigatran etexilateis 220 mg administered in the form ofone 110 mg capsule twice a day.

If you are usingmedicines containing verapamil, you should be told to take a reduced dose ofdabigatran etexilateof 220 mg taken in the form ofone 110 mg capsule twice a day, as your risk of bleeding may increase.

If you have apotentially higher risk of bleeding, your doctor may decide to prescribe a dose of 220 mg ofdabigatran etexilateadministered in the form ofone 110 mg capsule twice a day.

You can continue to takedabigatran etexilateif necessary to restore your normal heart rhythm by a procedure called cardioversion or by a procedure called catheter ablation for atrial fibrillation. Takedabigatran etexilateas your doctor has instructed you.

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 withdabigatran etexilateonce your doctor has decided that normal blood coagulation control has been achieved. Takedabigatran etexilateas your doctor has instructed you.

Treatment of blood clots and prevention of blood clots in children

Dabigatran etexilateshould 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 the age and weight of the child. Your doctor will determine the correct dose. It is possible that your doctor will adjust the dose during treatment. Continue to use all other medications unless your doctor tells you to stop using one.

Single dose ofdabigatran etexilateto administer twice a day in milligrams (mg) based on the weight in kilograms (kg) and age in years of the patient:

How to takeDabigatran etexilate Stadafarma

Dabigatran etexilatecan be taken with or without food. The capsule should be swallowed whole with a glass of water to ensure release in the stomach. Do not break, chew, or open the capsule to take only its contents, as this may increase the risk of bleeding.

Change in anticoagulant treatment

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

If you take moreDabigatran etexilate Stadafarmathan you should

Taking too muchdabigatran etexilateincreases the risk of bleeding. If you have taken too much or accidentally ingested the medication, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingestedofdabigatran etexilate. There are available specific treatment options.

If you forgot to takeDabigatran etexilate Stadafarma

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

A missed dose should be omitted if the time remaining before the next dose is less than 6 hours. Do not take a double dose to compensate for missed doses.

If you interrupt treatment withDabigatran etexilate Stadafarma

Takedabigatran etexilateexactly as prescribed. Do not interrupt your treatment withdabigatran etexilatewithout 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 takingdabigatran etexilate.

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.

Dabigatrán etexilate acts on blood coagulation; therefore, most side effects are related to signs such as bruising or bleeding.

Bleeding episodes, major or severe, are the most serious 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.

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

Prevention of cerebral or systemic vascular occlusion due to 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
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Feeling like vomiting

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

• Bleeding
• Bleeding may be from hemorrhoids, rectum, or brain.
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• 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 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 or from the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction that causes difficulty breathing or dizziness

• Severe allergic reaction that causes facial or throat swelling
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction
• Difficulty swallowing

Unknown frequency (frequency cannot be estimated from available data):

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

In a clinical trial, the index of heart attacks withdabigatrán etexilatewas 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

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

• Bleeding
• Bleeding may be in a joint or wound
• Bleeding may be from hemorrhoids
• Decrease in the 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
• Decrease in the number of platelets in the blood
• Severe allergic reaction that causes difficulty breathing or dizziness

• Severe allergic reaction that causes facial or throat swelling
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction
• Difficulty swallowing

Unknown frequency (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• 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 leukocytes (which help fight infections)
• Yellowing of the skin or white of the eyes, caused by liver or blood problems
• Hair loss

In the clinical trial program, the index of heart attacks withdabigatrán etexilatewas higher than with warfarin. The global incidence was low. No imbalance was observed in the index of heart attacks in patients treated with dabigatrán compared to patients treated with placebo.

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

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

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction
• Sudden change in skin that affects color and physical appearance
• Formation of hematomas
• Nasal bleeding
• Reflux of stomach acid into the esophagus
• Vomiting
• Feeling like vomiting
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the 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
• 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
• Yellowing of the skin or white of the eyes, caused by liver or blood problems

Unknown frequency (frequency cannot be estimated from available data):

• Decrease in 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 adverse effects

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

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

Do not use this medication after the expiration date that appears on the box or blister packafter “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C

Store in the original packaging to protect it from humidity.

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

Composition ofDabigatrán etexilato Stadafarma

• The active ingredient isdabigatrán.Each hard capsule contains150 mg dabigatrán etexilato (in the form of mesilato).
• The other components are tartaric acid,gum arabic,hypromellose, dimethicone 350, talc, andhydroxypropylcellulose.
• The capsule coating contains carrageenan,potassium chloride, titanium dioxide(E-171),hypromellose, and indigo carmine (E-132).

Appearance of the product and contents of the package

Dabigatrán etexilato Stadafarma 150 mg are hard capsules with a blue-colored cap and a white or off-white body, size 0, containing pale yellowish-white pellets.

Dabigatrán etexilato Stadafarmais available in packages containing1 x 10, 3 x 10, or 6 x 10hard capsules, a multiple pack containing 3 packs of 1 x 60 hard capsules (180 hard capsules) or a multiple pack containing 2 packs of 1 x 50 hard capsules (100 hard capsules) in perforated blisters ofAluminum/OPA-ALU-PVC.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 – Barcelona

Spain

or

SAG Manufacturing S.L.U

Crta. N-I, Km 36

28750 San Agustín de Guadalix,

Madrid

Spain

or

STADA Arzneimittel AG

Stadastr. 2-18

61118 Bad Vilbel

Germany

or

Pharmadox Healthcare Limited

Kkw46 Kordin Industrial Park, Paola, PLA 3000,

Malta

Last review date of this leaflet:June 2023

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