Package Insert: Information for the Patient

Dabigatrán etexilate Tevagen75 mg Hard Capsules EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, 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 who 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 package insert. See section 4.

Dabigatrán etexilato Tevagen contains the active ingredient dabigatrán etexilato and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in the formation of blood clots.

Dabigatrán etexilato is used in adults to:

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

Dabigatrán etexilato is used in children to:

• treat blood clots and prevent them from reforming.

Do not take Dabigatrán etexilato Tevagen

• 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, head injury or bleeding, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be congenital, of unknown cause, or caused by other medicines.
• if you are taking medicines to prevent blood clotting in the blood (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when changing from one anticoagulant treatment to another, while you have a venous or arterial catheter and heparin is administered through this catheter to keep it open, or while your normal heart rhythm is being restored by a procedure called catheter ablation for atrial fibrillation.
• if your liver function is severely reduced or if you have any liver disease that may be fatal.
• if you are taking ketoconazole oral or itraconazole, medicines used in the treatment of fungal infections.
• if you are taking ciclosporin oral, a medicine used to prevent organ rejection after a transplant.
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had a heart valve implanted that requires permanent anticoagulant treatment.

Warnings and precautions

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

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

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

• if you have recently had bleeding.
• if you have had a surgical tissue extraction (biopsy) in the last month.
• if you have had a severe injury (e.g., a bone fracture, a head injury, or any injury that required surgical treatment).
• if you have inflammation of the esophagus or stomach.
• if you have problems with acid reflux in the esophagus.
• if you are taking medicines that may increase the risk of bleeding. See “Other medicines and Dabigatrán etexilato Tevagen” below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam.
• if you have a bacterial infection of the heart (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 (concentrated)/foamy urine).
• 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 medicine is not recommended in this case.

Be especially careful with Dabigatrán etexilato Tevagen

• if you need to undergo surgery:

In this case, dabigatrán etexilato should 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 in the spine (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 Tevagen

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 takingdabigatrán etexilatoif you are taking any of the following medicines:

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

Pregnancy and breastfeeding

The effects of dabigatrán etexilato on pregnancy and the fetus are unknown. Do not use this medicine if you are pregnant unless your doctor tells you it is safe to do so. If you are of childbearing age, avoid becoming pregnant during treatment with dabigatrán etexilato.

Do not breastfeed during treatment with dabigatrán etexilato.

Driving and operating machines

Dabigatrán etexilato has no known effects on the ability to drive and operate machines.

Dabigatran etexilate 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 the treatment of 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 blood clot formation after knee or hip replacement surgery

The recommended dose is220 mg once a day(administered in the form of 2 capsules of 110 mg).

If yourrenal function is decreasedby more than half or if you are75 years of age or older, the recommended dose is150 mg once a day(administered in the form of 2 capsules of 75 mg).

If you are taking medications containingamiodarone, quinidine, or verapamil, the recommended dose is150 mg once a day(administered in the form of 2 capsules of 75 mg).

If you are takingmedications containing verapamil and your renal function is decreasedby more than half, you should be instructed on a reduced dose ofdabigatran etexilateof75 mgbecause your risk of bleeding may increase.

In both types of surgery, treatment should not be initiated if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, dosing should be initiated with 2 capsules once a day.

After knee replacement surgery

Initiate treatment withdabigatran etexilate1-4 hours after surgery, taking a single capsule. After that, take 2 capsules once a day for a total of 10 days.

After hip replacement surgery

Initiate treatment withdabigatran etexilate1-4 hours after surgery, taking a single capsule. After that, take 2 capsules once a day for a total of 28-35 days.

Treatment of blood clots and prevention 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 taking one.

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.

Table 1: Dosage table for dabigatran etexilate

Single doses requiring 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 Tevagen

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.

Instructions for opening the blisters

The following images illustrate how to extract the dabigatran etexilate capsules from the blister:

Separate an individual blister from the blister strip through the perforated line.

Remove the rear sheet and extract the capsule

• Do not press the capsules through the blister sheet.
• Do not remove the blister sheet until the capsule is needed.

Change in anticoagulant treatment

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

If you take more Dabigatran etexilate Tevagen 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 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 take Dabigatran etexilate Tevagen

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.

Treatment of blood clots and prevention of blood clots in children

A missed dose can be taken up to 6 hours before the next dose.

A missed dose should be omitted if the remaining time before the next dose is less than 6 hours. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Dabigatran etexilate Tevagen

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 medications, this medication may cause side effects, although not everyone will experience them.

Dabigatran 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, be potentially fatal, or even cause death. In some cases, these bleeding episodes may not be evident.

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

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

The possible side effects are listed below, grouped by frequency of occurrence.

Prevention of blood clot formation after knee or hip arthroplasty

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

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

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

• Bleeding may occur from the nose, stomach, or intestines, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), hemorrhoids, rectum, under the skin, from a joint, from a wound, or after surgery
• Formation of hematomas or bruising after surgery
• Blood detected in stool in a laboratory test
• Decreased red blood cell count in the blood
• Decreased proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Discomfort
• Wound supuration (exudation of liquid from a surgical wound)
• Increased liver enzymes
• Yellowing of the skin or white of the eyes, caused by liver or blood problems

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

• Bleeding
• Bleeding may occur in the brain, at the site of a surgical incision, at the site of an injection, or at the site of a catheter insertion in a vein
• Suppurative bleeding from a catheter insertion site 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, raised, and itchy bumps, caused by an allergic reaction
• Change in skin color and appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Esophageal and stomach inflammation
• Reflex of stomach juice into the esophagus
• Abdominal pain or stomach pain
• Indigestion
• Dysphagia
• Liquid oozing from a wound
• Liquid oozing from a wound after surgery

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

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

Treatment of blood clots and prevention of blood clot formation 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, raised, and itchy bumps, caused by an allergic reaction
• Change in skin color and appearance
• Formation of hematomas
• Nasal bleeding
• Reflex of stomach juice into the esophagus
• Vomiting
• Discomfort
• 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
• Esophageal and stomach inflammation
• Allergic reaction
• Dysphagia
• 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 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, at a surgical incision site, at the site of an injection, or at the site of a 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 the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging or 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 moisture.

Medicines should not be thrown down the drains or in the trash.Deposit the packaging and medicines that you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Dabigatrán etexilato Tevagen

The active ingredient is dabigatrán. Each hard capsule contains 86.48 mg of dabigatrán etexilato (in the form of mesilato) equivalent to 75 mg of dabigatrán etexilato.

The other components are tartaric acid, arabic gum, hypromellose 2910, dimethicone 350, talc, and hydroxypropylcellulose.

The capsule coating contains carrageenan, potassium chloride, titanium dioxide (E-171), and hypromellose 2910.

Appearance of the product and contents of the packaging

Dabigatrán etexilato Tevagen 75 mg are hard, white to off-white, size 2 capsules filled with pale yellow to off-white granules.

This medication is available in blister packs of aluminum/OPA-AL-PVC of 10 x 1, 30 x 1, 60 x 1 hard capsules.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 - Edificio Albatros B, 1st floor.

28108, Alcobendas (Madrid)

Spain

Responsible for manufacturing:

Galenicum Health, S.L.U.

Avda. Cornella, 144

08950 – Esplugues de Llobregat (Barcelona)

Spain

or

SAG Manufacturing S.L.U

Crta. N-I, Km 36

28750 San Agustin de Guadalix,

Madrid, Spain

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

Spain: Dabigatrán etexilato Tevagen 75 mg hard capsules EFG

Malta: Dabigatran etexilate SAG 75 hard capsules

Date of the last review of this leaflet: December 2023

The 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/