Prospecto:Information for the Patient

Bigetra 110 mg Hard Capsules EFG

dabigatrán etexilate

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.

- If you have any doubts, consult yourdoctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you, as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

1.What Bigetra is and for what it is used

2.What you need to knowbeforestarting totake Bigetra

3.How to take Bigetra

4.Possible adverse effects

5Storage of Bigetra

6.Contents of the package and additional information

Bigetra contains the active ingredient dabigatran etexilate 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.

Dabigatran etexilate is used in adults for:

- preventing the formation of blood clots in the 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.

Dabigatran etexilate is used in children 8 years of age or older for:

- treating blood clots and preventing them from forming again.

Do not take Bigetra

- if you are allergic to dabigatran etexilate or any of the components of this medication (listed in section 6).

- if your renal function is severely reduced.

- if you currently have bleeding.

- if you have any organ disease in the body that increases the risk of severe bleeding (e.g., stomach ulcer, recent surgery or cerebral hemorrhage, 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 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 can 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 rejection of organs 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 artificial implanted that requires permanent anticoagulant treatment.

Warnings and precautions

Consult your doctor before starting to take this medication. During treatment with this medication, you may also need to consult your doctor if you experience any side effects 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 tissue biopsy in the last month.
• if you have had a severe injury (e.g., a fracture, a head injury or any injury that required surgical treatment).

• if you have an inflammation of the esophagus or stomach.
• if you have problems with reflux of stomach acid into the esophagus.
• if you are taking medications that may increase the risk of bleeding. See “Other medications and Bigetra” below.

• if you are taking anti-inflammatory medications such as diclofenac, ibuprofen or piroxicam.

• if you have an infection in the heart (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 urine [concentrated]/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 tests. The use of this medication is not recommended in this case.

Be especially careful with Bigetra

• If you have to undergo surgery:

In this case, dabigatran etexilate must be temporarily interrupted due to a higher risk of bleeding during and shortly after surgery. It is very important that you take dabigatran etexilate 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 spinal column (e.g., for epidural or spinal anesthesia or for pain relief):

• It is very important that you take dabigatran etexilate exactly at the times indicated by your doctor before and after surgery.
• Inform your doctor immediately if you experience numbness or weakness in the 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 assistance. You may need a doctor to examine you, as you may have a higher 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 Bigetra

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 dabigatran etexilateif you are taking any of the following medications::

• Medications to reduce blood clotting (e.g., warfarin, fenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)

• Medications used in the treatment of fungal infections (e.g., ketoconazole, itraconazole), except if only applied 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 indicate that you use a reduced dose of this medicationdepending on the disease for which you have been prescribed it. See section 3.

• Medications used to prevent rejection of organs 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/AIDS (e.g., ritonavir)
• Certain medications used in the treatment of epilepsy (e.g., carbamazepine, phenytoin)

Pregnancy and breastfeeding

The effects of dabigatran etexilate on pregnancy and the fetus are unknown. Do not use this medication if you are pregnant unless your doctor indicates that it is safe to do so. If you are fertile, avoid becoming pregnant during treatment with dabigatran etexilate.

Do not breastfeed during treatment with dabigatran etexilate.

Driving and operating machines

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

Dabigatran etexilatecapsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole.

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

Take Bigetra as recommended for the following situations:

Prevention of the formation of blood clots after a 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 your renal function is decreased by more than half or if you are 75 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 that contain amiodarone, 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 taking medications that contain verapamil and your renal function is decreased by more than half, you should be indicated a reduced dose of dabigatran etexilate of 75 mg, as 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 a knee replacement surgery

Initiate treatment with dabigatran etexilate 1-4 hours after the surgery, taking a single capsule. After that, 2 capsules should be taken once a day for a total of 10 days.

After a hip replacement surgery

Initiate treatment with dabigatran etexilate 1-4 hours after the surgery, taking a single capsule. After that, 2 capsules should be taken once a day for a total of 28-35 days.

Prevention of cerebral or systemic vascular occlusion or the formation of blood clots developed after an abnormal heart rhythm and treatment of blood clots in the veins of your legs and lungs, including prevention of blood clots in the veins of your legs and lungs from recurring

The recommended dose is 300 mg administered in the form of one capsule of 150 mg twice a day.

If you are 80 years of age or older, the recommended dose is 220 mg administered in the form of one capsule of 110 mg twice a day.

If you are taking medications that contain verapamil, you should be indicated a reduced dose of dabigatran etexilate of 220 mg taken in the form of one capsule of 110 mg twice a day, as your risk of bleeding may increase.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe a dose of 220 mg administered in the form of one 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 your doctor has instructed.

If you have had a pacemaker (endovascular stent) placed in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with endovascular stent placement, you can receive treatment with dabigatran etexilate once your doctor has decided that normal coagulation has been achieved. Take dabigatran etexilate as your doctor has instructed.

Treatment of blood clots and prevention of blood clots from recurring in children

Dabigatran etexilate should be taken twice a day, one dose in the morning and one dose at night, approximately at the same time every day. The dosing interval should be the maximum possible 12 hours apart.

The recommended dose depends on weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue to use all other medications unless your doctor tells you to stop using one.

The table below shows the unique 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.

Table 1: Dosing table for dabigatran etexilate capsules

Unique 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 Bigetra

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 in anticoagulant treatment

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

If you take too much Bigetra

Taking too much of this medication increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. There are available specific treatment options.

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 ingested.

If you forget to take Bigetra

Prevention of the formation of blood clots after a 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 occlusion or the formation of blood clots developed after an abnormal heart rhythm and treatment of blood clots in the veins of your legs and lungs, including prevention of blood clots in the veins of your legs and lungs from recurring

Use in children: Treatment of blood clots and prevention of blood clots from recurring

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 Bigetra

Take dabigatran etexilate exactly as prescribed. Do not interrupt your treatment with this medication 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.

Dabigatran etexilateactson the blood's coagulation; therefore, the majority of 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 lead to 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 detailed 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 hemoglobin levels in the blood (the substance present in red blood cells)
• Anomalies in liver function tests

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

• Bleeding can occur through the nose, stomach, or intestines, the penis/vagina, or the urinary tract (including blood in the urine that turns the urine pink or red), hemorrhoids, the rectum, under the skin, after a lesion, 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 watery stools
• Feeling like vomiting
• Suppuration of wounds (exudation of liquid from a surgical wound)
• Increased liver enzymes
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood disorders

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

• Bleeding
• Bleeding can occur in the brain, at the site of a surgical incision, at the site of injection, or at the site of a catheter in a vein
• Sanguineous suppuration at 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 ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric 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 sibilant breathing
• Decreased or even absence of leukocytes (which help fight infections)
• Hair loss

Prevention of cerebral or systemic vascular occlusion or formation of blood clots

developed after abnormal heart rhythm

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

• Bleeding can occur through the nose, stomach, or intestines, the penis/vagina, or the 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 watery stools
• Feeling like vomiting

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

• Bleeding
• Bleeding can occur in an articulation, at the site of a surgical incision, in a wound, at the site of injection, or at the site of a catheter in a vein
• Bleeding can occur in hemorrhoids
• 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 ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Anomalies in liver function tests
• Increased liver enzymes

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

• Bleeding can occur in an articulation, at the site of a surgical incision, in a wound, at the site of injection, or at the site of a catheter 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 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 sibilant breathing
• Decreased or even absence of leukocytes (which help fight infections)

• Hair loss

In a clinical trial, theindex of heart attacks with dabigatran etexilatewas numerically higher than with warfarin. The global incidence was low.

Treatment of blood clots in the veins of your legs and lungs, including

prevention of them from recurring in the veins of your legs and/or

lungs

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

• Bleeding can occur through the nose, stomach, or intestines, the rectum, the penis/vagina, or the urinary tract (including blood in the urine that turns the urine pink or red), or under the skin
• Indigestion

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

• Bleeding
• Bleeding can occur in an articulation or in a wound
• Bleeding can occur in hemorrhoids
• Decreased red blood cell count in the blood
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Decreased platelet count in the blood
• Allergic reaction
• Change in skin color and appearance
• Itching
• Ulcer in the stomach or intestines (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Anomalies in liver function tests
• Increased liver enzymes

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

• Bleeding can occur in an articulation, at the site of a surgical incision, in a wound, at the site of injection, or at the site of a catheter 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 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 sibilant breathing
• Decreased or even absence of leukocytes (which help fight infections)

• Decreased hemoglobin levels in the blood (the substance present in red blood cells)
• Decreased proportion of blood cells
• Decreased platelet count in the blood
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood disorders
• Hair loss

In the clinical trial program, theindex of heart attacks with dabigatran etexilatewas higher than with warfarin. The global incidence was low. No imbalance was observed in theindex of heart attacks in patients treated with dabigatran 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
• Reflux of gastric juice into the esophagus
• Vomiting
• Frequent loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decreased leukocyte count (which help fight infections)
• Bleeding can occur in the stomach or intestines, the brain, the rectum, the penis/vagina, or the 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
• Reflux of gastric juice into the esophagus
• Vomiting
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Anomalies in liver function tests

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

• Decreased leukocyte count (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 sibilant breathing
• Bleeding
• Bleeding can occur in an articulation, in a wound, at the site of a surgical incision, at the site of injection, or at the site of a catheter in a vein
• Bleeding can occur in hemorrhoids
• Ulcer in the stomach or intestines (including ulcer in the esophagus)
• 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 the Spanish System of Pharmacovigilance of Medicines for Human Usehttps://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 the blister 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 light and humidity.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. In this way, you will help protect the environment.

Composition of Bigetra

The active ingredient is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (in the form of mesilate).

The other components are tartaric acid, xanthan gum, hypromellose, dimethicone, talc, and hydroxypropylcellulose.

The capsule coating contains carrageenan, potassium chloride, titanium dioxide (E171),indigo carmine (E132), water, and hypromellose.

The black printing ink contains shellac, iron oxide black (E172), and potassium hydroxide.

Appearance of the product and contents of the package

Bigetra 110 mg is presented in the form of hard capsules with a blue opaque cap with "D110" printed in black and a blue opaque body, containing yellowish granules.

This medication is presented in carton boxes containing 10, 30, 60, 100, or 180 hard capsules in Poliamida/Aluminio/PVC//Aluminio blisters.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Madrid

Spain

Responsible for manufacturing

Adamed Pharma S.A.

Ul. Marszalka Jósefa Pilsudskiego 5

95-200 Pabianice, Lodzkie

Poland

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of thisleaflet: February 2024

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