Package Insert: Information for the Patient

Privenax 110 mg Hard Capsules EFG

dabigatrán etexilate

Read this package insert carefully before you start taking this medicine, because 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 medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

This medication contains the active ingredient dabigatrán 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.

Dabigatrán 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 recurring in the veins of your legs and lungs.

Dabigatrán is used in children for:

• treating blood clots and preventing them from reforming.

Do not take Privenax

• if you are allergic to dabigatrán etexilato or any of the other components of this medication (listed in section 6).
• if your kidney 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, head injury or bleeding, 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 blood clotting in the blood (e.g., warfarin, rivaroxabán, apixabán, 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 through a procedure called catheter ablation for atrial fibrillation.
• if your liver function is severely reduced or you have any liver disease that may be fatal.
• if you are taking ketoconazol oral or itraconazol, medications used in the treatment of fungal infections.
• if you are taking ciclosporina oral, a medication used to prevent organ rejection after a transplant.
• if you are taking dronedarona, 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. 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 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 an inflammation of the esophagus or stomach.
  • if you have problems with acid reflux in the esophagus.
  • if you are taking medications that may increase the risk of bleeding. See “Other medications and dabigatrán” below.
  • if you are taking anti-inflammatory medications such as diclofenaco, ibuprofeno, or piroxicam.
  • if you have a bacterial infection in the heart (endocarditis).
  • if you know that your kidney function is reduced or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark-colored, concentrated urine with foam).
  • if you are over 75 years old.
  • 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 dabigatrán is not recommended in this case.

Be especially careful with dabigatrán

• if you need to undergo surgery:

In this case, dabigatrán should be temporarily interrupted due to an increased risk of bleeding during and shortly after surgery. It is very important that you take this medication exactly as instructed by your doctor before and after surgery.

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

• if you fall or get injured during treatment, especially if you hit your head. Seek urgent medical attention. You may need a doctor to examine you, as you may have an increased risk of bleeding.

• if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), inform your doctor so that they can decide if your treatment needs to be modified.

Other medications and dabigatrán

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.Particularly, inform your doctor before taking dabigatrán if you are taking any of the following medications:

• Medications to reduce blood clotting (e.g., warfarin, fenprocumón, acenocumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxabán, or acetylsalicylic acid).
• Medications used in the treatment of fungal infections (e.g., ketoconazol, itraconazol), except when applied to the skin.
• Medications used in the treatment of abnormal heart rhythm (e.g., amiodarona, dronedarona, quinidina, verapamilo).

If you are taking medications that contain amiodarona, quinidina, or verapamilo, your doctor may instruct you to use a reduced dose of dabigatrán according to the disease for which you were prescribed it. See section 3.

• Medications used to prevent organ rejection after a transplant (e.g., tacrólimus, ciclosporina).
• 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, ibuprofeno, diclofenaco).
• St. John's Wort, a medicinal plant for depression.
• Antidepressant medications called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors.
• Rifampicina or claritromicina (two antibiotics).
• Antiviral medications for HIV (e.g., ritonavir).
• Certain medications used to treat epilepsy (e.g., carbamazepina, fenitoína).

Pregnancy and breastfeeding

The effects of dabigatrán on pregnancy and the fetus are unknown. Do not use dabigatrán 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 this medication.

Do not breastfeed naturally during treatment with dabigatrán.

Driving and operating machinery

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

Privenax capsules 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 this medication 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 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 using medications containingamiodarone, 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 usingmedications containing verapamil and your renal function is decreased by more than half, you should be instructed on a reduced dose of dabigatran 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 knee replacement surgery

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

Prevention of cerebral or systemic vascular obstruction due to blood clot formation developed after abnormal heart rhythm and treatment of blood clots in the veins ofyour 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 are 80 years of age or older, the recommended dose of dabigatran is 220 mg administered in the form ofone capsule of 110 mg twice a day.

If you are usingmedications containing verapamil, you should be instructed on a reduced dose of dabigatran 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 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 once your doctor has decided that normal blood clotting control has been achieved. Take this medication as instructed by your doctor.

Treatment of blood clots and prevention of recurrence of blood clots inchildren

Dabigatran 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 dosing interval should be as close as possible to 12 hours.

The recommended dose depends on age and weight. Your doctor will determine the correct dose. It is possible that your doctor will adjust the dose during treatment. Follow all other medications unless your doctor tells you to stop using one.

Table 1 shows the single doses and total daily doses of Privenax in milligrams (mg). The doses depend on weight in kilograms (kg) and age in years of the patient.

Table 1: Dosage table for Privenax 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 Privenax

Privenax 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 capsules of Privenax from the blister:

1

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

2

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 Privenax than you should

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

Incaseofsobredosisoringestiónaccidental,consultyourdoctoror pharmacistimmediatelyorcalltheToxicological Information Service,phone:915620420, indicating the medication and the amount ingested.

If you forget to take Privenax

Prevention of blood clot formation after knee or hip replacement surgery

Take the remaining daily doses of dabigatran 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 and treatment of blood clots in the veins ofyour 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 Privenax

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

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 acts on blood clotting; therefore, most side effects are related to signs such as bruising or bleeding. Severe or life-threatening bleeding episodes, which can cause disability, be potentially fatal, or even lead to death, can occur. In some cases, these bleeding episodes may not be apparent.

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

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

The possible side effects are 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)
• Abnormalities in liver function tests

Poorly frequent (may affect up to 1 in 100 people):

• Bleeding can occur through 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 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
• 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 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 suppurative infection at the site of a catheter in a vein
• Coughing up blood or sputum with blood spots
• Decreased platelet count in blood
• Decreased red blood cell count in 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)
• Esophageal and stomach inflammation
• Gastroesophageal reflux
• 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 wheezing
• Decreased white blood cell count (which helps fight infections)
• Hair loss

Prevention of cerebral or systemic vascular occlusion by blood clot formation developed after abnormal heart rhythm

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

• Bleeding can occur through the nose, stomach, or intestines, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin
• Decreased red blood cell count in blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Feeling like vomiting

Poorly frequent (may affect up to 1 in 100 people):

• Bleeding
• Bleeding can occur from hemorrhoids, rectum, or brain
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Decreased platelet count in 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)
• Esophageal and stomach inflammation
• Gastroesophageal reflux
• Vomiting
• Difficulty swallowing
• Abnormalities in liver function tests

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

• Bleeding can occur in a joint, 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
• 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
• Yellowing 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 incidence of heart attacks with dabigatran was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of blood clots in the veins of your legs and/or lungs

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

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

Poorly frequent (may affect up to 1 in 100 people):

• Bleeding
• Bleeding can occur in a joint or in a wound
• Bleeding can occur from hemorrhoids
• Decreased red blood cell count in 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)
• Esophageal and stomach inflammation
• Gastroesophageal reflux
• Vomiting
• Difficulty swallowing
• Abnormalities in liver function tests
• Increased liver enzymes

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

• Bleeding can occur at the site of a surgical incision, at the site of injection, at the site of a catheter in a vein, or from the brain
• Decreased platelet count in 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
• Difficulty swallowing

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)
• 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 dabigatran was higher than with warfarin. The overall incidence was low. No imbalance in the incidence of heart attacks was observed in patients treated with dabigatran compared to patients treated with placebo.

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

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

• Decreased red blood cell count in blood
• Decreased platelet count in 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

Poorly frequent (may affect up to 1 in 100 people):

• Decreased white blood cell count (which helps fight infections)
• Bleeding can occur in the stomach or intestines, brain, rectum, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin
• Decreased hemoglobin 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
• Difficulty swallowing
• Yellowing 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 can occur in a joint or in a wound, in a surgical incision, at the site of injection, or at the site of a catheter in a vein
• Bleeding can occur from hemorrhoids
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Abnormalities 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 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 above 86°F (30°C)

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Privenax

• The active ingredient is dabigatrán. Each hard capsule contains 110 mg of dabigatrán etexilate (in the form of mesilate).
• 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, and blue FD&C 2/indigo carmine (E-132).

Appearance of the product and content of the container

Privenax 110 mg are pale yellowish white pellets inside hard blue size 1 capsules.

Privenax is presented in containers containing 10 x 1, 30 x 1, or 60 x 1 hard capsules in perforated aluminum/OPA-AL-PVC blister packs.

Only some container sizes may be commercially available.

Marketing Authorization Holder

Kern Pharma S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Galenicum Health, S.L.U.

Sant Gabriel, 50

08950 – Esplugues de Llobregat (Barcelona)

Spain

or

Galenicum Health, S.L.

Avenida Cornella, 144 Edificio LEKLA

08950 – Esplugues de Llobregat (Barcelona)

Spain

or

SAG Manufacturing S.L.U

Crta. N-I, Km 36

28750 San Agustin de Guadalix,

Madrid – Spain

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

Malta – Privenax 110 mg hard capsules

Portugal – Dabigatrano etexilato Pharmakern 110 mg capsules

Spain – Privenax 110 mg hard capsules EFG

Last review date of this leaflet: June 2024

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