Label: information for the patient

Dabigatrán Etexilate TecniGen 110 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 etexilato is used in adults for:

• preventing the formation of blood clots in veins after knee or hip replacement surgery.
• 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.
• treating blood clots in the veins of your legs and lungs and to prevent them from coming back.

Dabigatrán etexilato is used in children for:

• treat blood clots and to prevent them from coming back.

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 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 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 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 medications that may increase the risk of bleeding. See “Other medicines 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 (concentrated) or foamy urine).
• 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 situation 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 medicines and Dabigatrán Etexilato TecniGen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.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 amiodarone, quinidine, or 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 and pain-relieving medications (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.

Do not breastfeed naturally 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 can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. Other appropriate pharmaceutical forms are available for the treatment of children under 8 years of age.

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

Takedabigatran 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 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 is 150 mg once a day(administered in the form of 2 capsules of 75 mg).

If you are taking medications containingamiodarone, quinidine, or verapamilthe 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 decreasedby more than half, you should be instructed on a reduced dose ofdabigatran etexilateof 75 mgdue to an increased risk of bleeding.

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

Start treatment with dabigatran etexilate 1-4 hours after surgery, taking a single capsule. After that, take 2 capsules once a day for 10 days in total.

After hip replacement surgery

Start treatment with dabigatran etexilate 1-4 hours after surgery, taking a single capsule. After that, take 2 capsules once a day for 28-35 days in total.

Prevention of cerebral or systemic vascular obstruction due to blood clot formation developed after abnormal heart rhythm andtreatment 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 of dabigatran etexilate is 220 mg administered in the form ofone capsule of 110 mg twice a day.

If you are takingmedications containing verapamil, you should be instructed on 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 apotentially higher risk of bleeding, your doctor may decide to prescribe a dose of 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 through a procedure called cardioversion. Take dabigatran etexilate as instructed by your doctor.

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 with dabigatran etexilate once your doctor has decided that normal blood clotting has been achieved. Take dabigatran etexilate as instructed by your doctor.

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 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 taking 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 of Dabigatran Etexilate.

If you forget to takeDabigatran Etexilate TecniGen

Prevention of blood clot formation after knee or hip replacement surgery

Take the remaining daily doses of dabigatran etexilate at 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 due to blood clot formation developed after abnormal heart rhythm andtreatment 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 with Dabigatran Etexilate TecniGen

Take dabigatran etexilate exactly as prescribed. Do not interrupt your treatment with dabigatran 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 taking dabigatran 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, may occur, regardless of their location, and may cause disability or even 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 replacement surgery

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

• Decreased blood hemoglobin levels (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), under the skin, from hemorrhoids, from the rectum, from an injury, 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.
• Suppuration of wounds (secretion of liquid 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 catheter insertion in a vein.
• Bleeding from a catheter insertion 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 swelling of the face or throat.
• 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).
• Inflammation of the esophagus and stomach.
• Gastroesophageal reflux.
• Abdominal pain or stomach pain.
• Indigestion.
• Dysphagia.
• 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 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 the blood.
• Decreased hemoglobin levels in the blood (the substance present in red blood cells).
• Allergic reaction.
• Change in skin color and appearance.
• Itching.
• Ulcer in the stomach or intestines (including esophageal ulcer).
• Inflammation of the esophagus and stomach.
• Gastroesophageal reflux.
• Vomiting.
• Dysphagia.
• Abnormal liver function test results.

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

• Bleeding may occur in an articulation, surgical incision, wound, injection site, or catheter insertion in a vein.
• Decreased platelet count in the blood.
• Severe allergic reaction that causes difficulty breathing or dizziness.
• Severe allergic reaction that causes swelling of the face or throat.
• 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 problems.

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 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 your legs and lungs, including prevention of their recurrence

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 in an articulation 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 and appearance.
• Itching.
• Ulcer in the stomach or intestines (including esophageal ulcer).
• Inflammation of the esophagus and stomach.
• Gastroesophageal reflux.
• Feeling like vomiting.
• Vomiting.
• Abdominal pain or stomach pain.
• Frequent loose or liquid stools.
• Abnormal liver function test results.
• Increased liver enzymes

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

• Bleeding may occur in a surgical incision, injection site, or catheter insertion in a vein, or from the brain.
• Decreased platelet count in the blood.
• Severe allergic reaction that causes difficulty breathing or dizziness.
• Severe allergic reaction that causes swelling of the face or throat.
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction.
• Dysphagia.

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 their recurrence 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.
• Gastroesophageal reflux.
• 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.
• Inflammation of the esophagus and stomach.
• Allergic reaction.
• Dysphagia.
• 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 swelling of the face or throat.
• Difficulty breathing or wheezing.
• Bleeding.
• Bleeding may occur in an articulation or wound, surgical incision, injection site, or catheter insertion 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 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. Deposit containers and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. By doing so, you will help protect the environment.

Composition of Dabigatrán Etexilato TecniGen

• The active ingredient isdabigatrán.Each hard capsule contains110 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 content of the container

Dabigatrán Etexilato TecniGen 110 mg are hard blue capsules, size 1,containing white to pale yellow pellets.

Dabigatrán Etexilato TecniGenis available in containers that contain3x10 or 6x10hard capsules in perforated or non-perforated aluminized PVC/OPA-AL blisters.

Only some container sizes 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. Arroyo de la Vega Industrial Estate,

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

National Highway 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,

2710-089 Sintra

Portugal

Last review date of this leaflet:January 2023

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