Patient Information Leaflet

Dabigatrán etexilate Stadafarma 110 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. Do not give it to others even if they have similar symptoms to 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 veins after knee or hip replacement surgery.

• to prevent 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.

• to treat blood clots in the veins of your legs and lungs and to prevent them from coming back.

Dabigatrán etexilatois used in children for:

• to treat blood clots and prevent them from forming again.

Do not take Dabigatrán etexilato Stadafarma

• If you are allergic to dabigatrán etexilato or any of the other ingredients of this medication (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 severe bleeding (e.g., stomach ulcer, head or eye injury, 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 you have any liver disease that may be fatal.
• If you are taking ketoconazole oral or itraconazole, medications used to treat 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 glecaprevir and pibrentasvir combination product, an antiviral medication used to treat hepatitis C.
• If you have had a heart valve artificial implanted that requires permanent anticoagulant treatment.

Warnings and precautions

Consult your doctor before starting to take Dabigatrán etexilato Stadafarma.During treatment with this medication, 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 had a tissue extraction surgery (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 an inflammation of the esophagus or stomach.
  • if you have gastroesophageal reflux disease.
  • if you are taking medications that may increase the risk of bleeding. See “Other medications and Dabigatrán etexilato 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, 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 medication is not recommended in this case.

Be especially careful with Dabigatrán etexilato Stadafarma

• If you need to undergo surgery:

In this case, dabigatrán etexilato must be temporarily discontinued due to an increased risk of bleeding during and shortly after surgery. It is very important that you take dabigatrán etexilato exactly as instructed by your doctor before and after surgery.

• If a surgical procedure 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 take dabigatrán etexilato exactly as instructed 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 condition 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 medications and Dabigatrán etexilato Stadafarma

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.Particularly, you must inform your doctor before taking dabigatrán etexilato if you are taking any of the following medications:

• Medications to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medications for the treatment of fungal infections (e.g., ketoconazole, itraconazole),except when applied to the skinonly.
• Medications used to treat abnormal heart rhythm (e.g., amiodarone,dronedarone, quinidine, verapamil).If you are taking medications that contain amiodarone, quinidine, or verapamil, your doctor may instruct you to use a reduced dose of dabigatrán etexilato according to the disease for which it was prescribed. See section 3.
• Medications 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 of dabigatrán etexilato on pregnancy and the fetus are unknown. Do not use this medication 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 dabigatrán etexilato.

Do not breastfeed during treatment with dabigatrán etexilato.

Driving and operating machines

Dabigatrán etexilato has 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 old.

Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, consult your doctor again.

Takedabigatran etexilateas 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 yourrenal function is decreased by more than half or if you are 75 years old or more, the recommended dose is 150 mg once a day(administered in the form of 2 capsules of 75 mg).

If you are taking medications containingamiodarone, 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 takingmedications containing verapamil and your renal function is decreased by more than half, you should be indicated a reduced dose ofdabigatran etexilateof 75 mg because 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

You should initiate treatment withdabigatran etexilate1-4 hours after the operation, taking a single capsule. Then, 2 capsules should be taken once a day for a total of 10 days

After hip replacement surgery

You should initiate treatment withdabigatran etexilate1-4 hours after the operation, taking a single capsule. Then, 2 capsules should be taken once a day for a total of 28-35 days

Prevention of cerebral or systemic vascular obstruction or 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 ofone capsule of 150 mg twice a day.

If you are 80 years old or more, the recommended dose ofdabigatran etexilateis 220 mg administered in the form ofone capsule of 110 mg twice a day.

If you are takingmedications containing verapamil, you should be indicated a reduced dose ofdabigatran etexilateof 220 mg taken in the form ofone capsule of 110 mg 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 capsule of 110 mg twice a day.

You can continue takingdabigatran etexilateif necessary to restore your normal heart rhythm by a procedure called cardioversion. Takedabigatran etexilateas your doctor has instructed

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

Treatment of blood clots and prevention of recurrence 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 age and weight. 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.

Single dose ofdabigatran etexilateto administer twice a day in milligrams (mg) according to 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 content, as this may increase the risk of bleeding.

Change of 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. In case of overdose or accidental ingestion, 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

Prevention of blood clot formation after knee or hip replacement surgery

Take the remaining daily doses ofdabigatran etexilateat 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 or 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 withDabigatran etexilate Stadafarma

Takedabigatran etexilateexactly as your doctor has 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 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, 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.

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)
• Abnormalities in liver function tests

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

• Bleeding may occur from the nose, stomach, or intestines, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), from hemorrhoids, rectum, under the skin, from a joint, from a wound, or after surgery
• Formation of hematomas or bruising 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
• Wound supuration (exudate 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 may 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 that affects appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Esophageal and stomach inflammation
• Reflex of stomach juice into the esophagus
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• 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 white blood cell count (which helps 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 may occur from the nose, stomach, or intestines, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin
• Decreased red blood cell count 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 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 the blood (the substance present in red blood cells)
• Allergic reaction
• Change in skin color that affects appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Esophageal and stomach inflammation
• Reflex of stomach juice into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormalities in liver function tests

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

• Bleeding may occur from a joint, surgical incision, wound, injection site, or venous catheter site, 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
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decreased hemoglobin levels in the blood (the substance present in red blood cells)
• Decreased proportion of blood cells
• Decreased white blood cell count (which helps fight infections)
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems
• Hair loss

In a clinical trial, the index of heart attacks with dabigatrán etexilate was numerically higher than with warfarin. The global incidence was low.

Treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and/or lungs

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

• Bleeding may occur 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 occur from a joint or wound
• Bleeding may occur from hemorrhoids
• Decreased red blood cell count in the blood
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Allergic reaction
• Change in skin color that affects appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Esophageal and stomach inflammation
• Reflex of stomach juice into the esophagus
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormalities in liver function tests
• Increased liver enzymes

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

• Bleeding may occur from a surgical incision, injection site, venous catheter site, 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
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decreased hemoglobin levels in the blood (the substance present in red blood cells)
• Decreased proportion of blood cells
• Decreased white blood cell count (which helps 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 index of heart attacks with dabigatrán etexilate was higher than with warfarin. The global incidence was low. No imbalance in the index of heart attacks was observed 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):

• Decreased red blood cell count in the blood
• Decreased platelet count in blood
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction
• Change in skin color that affects appearance
• Formation of hematomas
• Nasal bleeding
• Reflex of stomach 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 white blood cell count (which helps fight infections)
• Bleeding may occur from the stomach or intestines, brain, rectum, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin
• Decreased hemoglobin levels in the blood (the substance present in red blood cells)
• Decreased proportion of blood cells
• Itching
• Coughing up blood or sputum with blood spots
• Abdominal pain or stomach pain
• Esophageal and stomach inflammation
• Allergic reaction
• Difficulty swallowing
• 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 white blood cell count (which helps 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 occur from a joint or wound, surgical incision, injection site, or venous catheter site
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Abnormalities 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 leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: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 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 contains110 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 110 mg are hard blue capsules, size 1, containing white to pale yellow 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 ofAluminio/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/