Label: information for the patient

Dabigatrán Etexilate TecniGen 150 mg hard capsules EFG

Read this label carefully before starting to take this medication,

because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. 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 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.

• 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:

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

Do not take Dabigatrán Etexilato TecniGen

• 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 cerebral hemorrhage, recent surgical intervention of the brain or eyes).
• 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 the formation of blood clots 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 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 take dabigatrán etexilato.You may also need to consult your doctor if you experience any symptoms or if you are to undergo surgery during treatment with this medicine.

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 recently undergone a tissue extraction procedure (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 medications that may increase the risk of bleeding. See “Other medications and Dabigatrán Etexilato TecniGen” below.
• if you are taking anti-inflammatory medications 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.
• ifyou are an adult andweigh50kgor 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 tests. The use of this medicine is not recommended in this case.

Be especially careful with dabigatrán etexilato

• If you need 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 as instructed 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 take dabigatrán etexilato exactly as instructed by your doctor before and after surgery.
• Inform your doctor immediately if you experience numbness or weakness in your legs or intestinal or urinary problems after the end of anesthesia, as this requires urgent attention.

• 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 medications and Dabigatrán Etexilato TecniGen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.Particularly, 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 only to the skin.
• Medications used in the treatment of abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil).If you are taking medications that contain verapamil, your doctor may instruct you to use a reduced dose of dabigatrán etexilato according to the disease for which you have been prescribed it. See section 3.
• Medications for the prevention of 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 medications and pain relievers (e.g., acetylsalicylic acid, ibuprofen, diclofenac).
• St. John's Wort, a medicinal plant 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 (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 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.

It is not recommended to 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 etexilate capsules can 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.

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

If you are usingmedicines containing verapamil, you should be indicated a reduced dose of dabigatran etexilate of 220 mg taken in the form ofone capsule of 110 mg twice a day, as your risk of bleeding may increase.

If you have apotential higher risk of bleeding, your doctor may decide to prescribe a dose of dabigatran etexilate 220 mg administered in the form ofone capsule of 110 mg twice a day.

You can continue taking this medication if necessary to restore your normal heart rhythm by a procedure called cardioversion or by a procedure calledablation with a catheter for atrial fibrillation. Take dabigatran etexilate as your doctor has indicated.

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 endoprosthesis placement, you can receive treatment with dabigatran etexilate once your doctor has decided that normal blood coagulation control has been achieved. Take dabigatran etexilate as your doctor has indicated.

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

Dabigatran etexilate 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 as possible to 12 hours.

The recommended dose depends on weight and age. 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.

The table 1 shows the single doses and total daily doses of dabigatran etexilate in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.

Table1:Table of posology for dabigatran etexilate capsules

Single doses that require combinations of more than one capsule:

300 mg: two capsules of 150 mg or four capsules of 75 mg

260 mg:one capsule of 110 mg plus one capsule of 150 mg or one capsule of 110 mg plus two capsules of 75 mg

220 mg:two capsules of 110 mg

185 mg:one capsule of 75 mg plus one capsule of 110 mg

150 mg:one capsule of 150 mg or two capsules of 75 mg

How to take Dabigatran Etexilate TecniGen

Dabigatran etexilate 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.

Change of anticoagulant treatment

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

If you take more Dabigatran Etexilate TecniGen than you should

Taking too much dabigatran etexilate 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, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeDabigatran Etexilate TecniGen

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 missed doses.

If you interrupt treatment with Dabigatran Etexilate TecniGen

Takedabigatran etexilateexactly as prescribed. Do not interrupt your treatment withdabigatran etexilate without 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.

Severe or life-threatening bleeding episodes, which are the most serious side effects, can occur regardless of their location and may cause disability or 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 listed 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 occur through 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 level in 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.
• Reflex of gastric juice 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 occur in a joint, surgical incision site, 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.
• Decreased proportion of blood cells.
• Increased liver enzymes.
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood disorders.

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

• Difficulty breathing or wheezing.
• Decreased white blood cell count (which helps fight infections).
• Hair loss.

In a clinical trial, the incidence of heart attacks with dabigatrán etexilate was numerically higher than with warfarin. The overall 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 through 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 in 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.
• Sudden change in skin that affects color and physical appearance.
• Itching.
• Ulcer in the stomach or intestines.
• Inflammation of the esophagus and stomach.
• Reflex of gastric juice 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 occur in a surgical incision site, 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 level in 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 disorders.
• Hair loss.

In the clinical trial program, the incidence of heart attacks with dabigatrán etexilate was higher than with warfarin. The overall incidence was low. No imbalance in the incidence 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.
• Sudden change in skin that affects color and physical appearance.
• Formation of hematomas.
• Nasal bleeding.
• Reflex of gastric 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 in 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 level in 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.
• Inflammation of the esophagus and stomach.
• Allergic reaction.
• Difficulty swallowing.
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood disorders.

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 in a joint or wound, surgical incision site, injection site, or venous catheter site.
• Bleeding may occur from hemorrhoids.
• Ulcer in the stomach or intestines (including esophageal ulcer).
• Anomalies 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 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 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 pack after “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 containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Dabigatrán Etexilato TecniGen

• The active ingredient isdabigatrán.Each hard capsule contains150 mg of dabigatrán etexilato (in the form of mesilato).
• The other components are tartaric acid, gum arabic, hypromellose 2910, dimethicone 350, talc, and hydroxypropylcellulose.
• The capsule coating contains carrageenan, potassium chloride, titanium dioxide (E-171), hypromellose 2910, andcarmine (E-132).

Appearance of the product and contents of the packaging

Dabigatrán Etexilato TecniGen 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 TecniGenis available in packagingthat contains 6 x 10hard capsulesin perforated or non-perforated blisters ofAluminum/OPA-AL-PVC.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Responsible manufacturer:

Galenicum Health, S.L.

Avda.Cornellá 144, 7th-1st floor. Edificio LEKLA,

08950 – Esplugues de Llobregat (Barcelona)

Spain

Or

SAG Manufacturing S.L.U

Crta.N-I, Km 36

28750 San Agustin de Guadalix,

Madrid

Spain

Or

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2 Abrunheira, 11

2710-089 Sintra

Portugal

Last review date of this leaflet:January 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/