Prospecto:Information for the Patient

Bigetra 150 mg Hard Capsules

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 known as 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 brain (stroke) and other blood vessels of the body if you have a form of irregular heart rhythm called atrial fibrillation non-valvular and have at least one additional risk factor.

- treating blood clots in the veins of your legs and lungs and to prevent blood clots from recurring in the veins of your legs and lungs.

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

- treating blood clots and preventing the formation of new blood clots.

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 are currently experiencing 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 receiving heparin 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 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 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 symptoms or if you are to undergo surgery.

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

- If you have an increased risk of bleeding, for example:

• if you have recently experienced bleeding.
• if you have had a tissue biopsy (e.g., a liver or bone marrow biopsy) in the last month.
• if you have had a severe injury (e.g., a fracture or a head injury) that required surgical treatment.

• if you have inflammation of the esophagus or stomach.
• if you have gastroesophageal reflux disease.
• if you are taking medications that may increase the risk of bleeding. See “Other medications and Bigetra” below.

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

• if you have a bacterial endocarditis infection in the heart.
• if you know that you have reduced kidney function, or if you are dehydrated (symptoms include feeling thirsty and passing dark, concentrated urine with foam).

• if you are over 75 years old.
• if you are an adult and weigh 50 kg or less.
• only 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 need to undergo surgery:

In this case, dabigatran etexilate should be temporarily discontinued due to an increased risk of bleeding during and shortly after surgery. It is very important that you take dabigatran etexilate exactly as instructed 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 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 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 condition called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), inform your doctor so that they can decide if your treatment needs to be modified.

Other medications and 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 etexilate if you are taking any of the following medications:

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

• Medications used in the treatment of fungal infections (e.g., ketoconazole, itraconazole), except when 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 verapamil, your doctor may instruct you to use a reduced dose of this medication based on your disease.

• 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., aspirin, ibuprofen, diclofenac).
• St. John's Wort, a medicinal plant for depression.
• Antidepressants 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 to treat 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 tells you 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 etexilate has 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 ischemic stroke or systemic embolism by 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 asone capsule of 150 mg twice a day.

If you are80 years of age or older,the recommended dose is 220 mg administered asone capsule of 110 mg twice a day.

If you are takingmedicines containing verapamil,you should be instructed to take a reduced dose of dabigatran etexilateof 220 mg taken asone 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 asone 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 or through a procedure called catheter ablation for atrial fibrillation. Take dabigatran etexilateas your doctor has instructed you.

If you have had amedical device (vascular stent) placed in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with

placement of a vascular stent, you can receive treatment with dabigatran etexilateonce your doctor has decided that normal blood clotting has been achieved. Take dabigatran etexilateas your doctor has instructed you.

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 the maximum possible at 12 hours.

The recommended dose depends on weight and age. Your doctor will determine the correct dose. It is possible that your doctor will adjust the dose during treatment. Continue to use all other

medicines unless your doctor tells you to stop using one.

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

Table 1: Dosing table for dabigatran etexilatecapsules

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 Bigetra

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 of anticoagulant treatment

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

If you take more Bigetra than you should

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 forgot to take Bigetra

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 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.

Dabigatrán 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 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 inexplicable 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 cerebral or systemic vascular occlusion due to blood clot formation developed after an abnormal heart beat

developed after an abnormal heart beat

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

• Bleeding may be 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 number of red blood cells 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 be from hemorrhoids, rectum, or brain
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Decreased number of platelets in the blood
• Decreased hemoglobin level in the 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 stomach acid 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 be in a joint, surgical incision site, wound, injection site, or venous catheter site

• 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
• Yellowing of the skin or white of the eyes, caused by liver or blood problems

Frequency unknown (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decreased number or even absence of leukocytes (which help fight infections)

• Hair loss

In a clinical trial, the incidence of heart attacks with dabigatrán 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 blood clots from reforming in the veins of your legs and/or

lungs

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

• Bleeding may be 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 be in a joint or wound
• Bleeding may be from hemorrhoids
• Decreased number of red blood cells 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 (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflex of stomach acid 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 be in a surgical incision site, injection site, or venous catheter site, or from the brain

• Decreased number of platelets 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

Frequency unknown (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decreased hemoglobin level in the blood (the substance present in red blood cells)
• Decreased proportion of blood cells
• Decreased number or even absence of leukocytes (which help fight infections)
• Yellowing of the skin or white of the eyes, caused by liver or blood problems
• Hair loss

In the clinical trial program, the incidence of heart attacks with dabigatrán etexilatewas higher than with warfarin. 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 blood clots from reforming in newborns

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

• Decreased number of red blood cells in the blood
• Decreased number of platelets in the 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 stomach acid 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 number of leukocytes (which help fight infections)
• Bleeding may be from the stomach, 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 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
• Difficulty swallowing
• Yellowing of the skin or white of the eyes, caused by liver or blood problems

Frequency unknown (frequency cannot be estimated from available data):

• Decreased leukocytes (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 be in a joint or wound, surgical incision site, injection site, or venous catheter site
• Bleeding may be 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 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 thrown away through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Bigetra

The active ingredient is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (in the form of mesilate).

The other components are tartaric acid, arabic 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 150 mg is presented in the form of hard capsules with a blue opaque cap with "D150" printed in black and a white opaque body, containing yellowish granules.

This medication is presented in carton boxes containing 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 this prospectus: 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/)