Patient Information Leaflet: Information for the Patient

Dabigatrán etexilate Stadafarma 75 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 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:

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

Dabigatrán etexilatois used in children for:

• treat blood clots and prevent the formation of new blood clots.

Do not take Dabigatrán etexilato Stadafarma

• if you are allergic to dabigatrán etexilato or any of the other ingredients of this medicine (listed in section 6)
• if your kidney function is severely reduced
• if you currently have 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 congenital, of unknown cause, or caused by other medicines
• if you are taking medicines to prevent the formation of blood clots in the blood (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when changing from one anticoagulant treatment to another, 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 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, medicines used in the treatment of fungal infections
• if you are taking ciclosporin oral, a medicine used to prevent organ rejection after a transplant
• 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 a heart valve implanted that requires permanent anticoagulant treatment

Warnings and precautions

Consult your doctor before starting to take Dabigatrán etexilato Stadafarma.During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you are to undergo surgery.

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

• If you have an increased risk of bleeding, for example:
• • if you have recently had bleeding
  • if you have had a surgical tissue extraction (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 reflux of stomach acid into the esophagus
  • if you are taking medicines that may increase the risk of bleeding. See “Other medicines and Dabigatrán etexilato Stadafarma” below
  • if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam
  • if you have a bacterial infection of the heart (bacterial endocarditis)
  • if you know that your kidney function is reduced or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark-colored (concentrated) urine with foam)
  • if you are over 75 years old
  • if you are an adult and weigh 50 kg or less
  • only if used in children: if the child has an infection in the brain or around it

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

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

Be especially careful with Dabigatrán etexilato Stadafarma

• If you have to undergo surgery:

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

• If a surgical procedure requires the placement of a catheter or an injection in the spine (e.g., for epidural or spinal anesthesia or for pain relief):
• • It is very important that you take dabigatrán etexilato exactly at the times indicated by your doctor before and after surgery

• If you fall or injure yourself during treatment, especially if you hit your head. Seek urgent medical assistance. You may need a doctor to examine you, as you may have an increased risk of bleeding.

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

Other medicines and Dabigatrán etexilato 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 taking dabigatrán etexilato if you are taking any of the following medicines:

• Medicines to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines used in the treatment of fungal infections (e.g., ketoconazole, itraconazole), except when applied to the skin
• Medicines used in the treatment of abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines that contain amiodarone, quinidine, or verapamil, your doctor may instruct you to use a reduced dose of dabigatrán etexilato according to the disease for which it has been prescribed. See section 3
• Medicines used to prevent organ rejection after a transplant (e.g., tacrolimus, ciclosporin)
• A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medicines (e.g., acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's Wort, a medicinal herb 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 used to treat epilepsy (e.g., carbamazepine, phenytoin)

Pregnancy and breastfeeding

The effects of dabigatrán etexilato on pregnancy and the fetus are unknown. Do not use this medicine if you are pregnant unless your doctor tells you it is safe to do so. If you are of childbearing age, avoid becoming pregnant during treatment with 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 is220 mg once a day(administered in the form of 2 capsules of 110 mg).

If yourrenal function is decreasedby more than half or if you are75 years of age or older, the recommended dose is150 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 is150 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 decreasedby more than half, you should be instructed on a reduced dose ofdabigatran etexilateof75 mgbecause 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 start treatment withdabigatran etexilate1-4 hours after surgery, 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 start treatment withdabigatran etexilate1-4 hours after surgery, taking a single capsule. Then, 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

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 taking one.

Single dose ofdabigatran etexilateto administer twice a day in milligrams (mg) based on 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 etexilateorincreases the risk of bleeding.If you have taken too much or have ingested an accidental overdose, 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.Specific treatment options are available.

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.

Treatment of blood clots and prevention of blood clots in children

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 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 medications, this medication may cause side effects, although not everyone will experience them. Dabigatrán etexilateacts on blood coagulation; therefore, most side effects are related to signs such as bruising or bleeding.

Severe or life-threatening bleeding episodes, which are the most serious side effects, may occur, regardless of their location, and may cause disability, be potentially fatal, or even cause death. In some cases, these bleeding episodes may not be evident.

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

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

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 hemoglobin levels in the blood (the substance present in red blood cells)
• Abnormal liver function test results

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), 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 (exudation of liquid from a surgical wound)
• Increased liver enzymes
• Yellowing 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 catheter in a vein
• Suppurative bleeding from the site of a catheter in a vein
• Coughing up blood or sputum with blood spots
• Decreased platelet count in the blood
• Decreased red blood cell count in the blood after surgery
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes facial or throat swelling
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction
• Change in skin color and appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Esophageal and stomach inflammation
• Reflux 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 or absence of leukocytes (which help fight infections)
• Hair loss

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

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

• Decreased red blood cell count in the blood
• Decreased platelet count in the blood
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction
• Change in skin color and appearance
• Formation of hematomas
• Nasal bleeding
• Reflux 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 leukocyte count (which help 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
• Yellowing of the skin or white of the eyes, caused by liver or blood problems

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

• Leukocyte deficiency (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 occur in a joint or wound, at the site of a surgical incision, at the site of an injection, or at the site of a catheter in a vein
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Abnormal liver function test results

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through 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 medication.

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 moisture.

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

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Composition of Dabigatrán etexilato Stadafarma

• The active ingredient isdabigatrán.Each hard capsule contains75 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), andhypromellose.

Appearance of the product and content of the container

Dabigatrán etexilato Stadafarma 75 mg are hard capsules of white to off-white color, size 2, containing pale yellowish white pellets.

Dabigatrán etexilato Stadafarmais available in containers containing1 x 10, 3 x 10, or 6 x 10hard capsules in perforated blisters of Aluminio/OPA-ALU-PVC.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorio STADA, 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 Agustin 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 leafletJune 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/