Package Insert: Information for the Patient

Privenax 75 mg Hard Capsules EFG

dabigatrán etexilate

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 refer to 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 may 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.

This medication contains the active ingredient dabigatrán 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.

Dabigatrán is used in adults for:

• to prevent the formation of blood clots in veins after knee or hip arthroplasty.

Dabigatrán is used in children for:

• to treat blood clots and prevent the formation of new blood clots.

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 disease in an organ of the body that increases the risk of severe bleeding (e.g., stomach ulcer, injury or cerebral hemorrhage, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be congenital, unknown cause, 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 artificial 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 reflux of stomach juice into 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 (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-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 your doctor has instructed you 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 your doctor has instructed you 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 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, 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 recommend breastfeeding during treatment with dabigatrán.

Driving and operating machinery

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

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

Follow exactly the dabigatran administration instructions 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 is220 mg once a day(administered as 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 as 2 capsules of 75 mg).

If you are taking medications containingamiodarone, quinidine, or verapamil, the recommended dose is150 mg once a day(administered as 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 dabigatran dose of75 mgas 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. Then, 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. Then, 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 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 age and weight. 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.

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

Table 1: Dosing 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 Privenax capsules 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 too much dabigatran

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

Incaseofsobredosisoringestiónaccidental,consultyourdoctororpharmacistimmediatelyorcalltheToxicological 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 make up 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 make up 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, may occur, regardless of their location. 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 listed below, grouped by frequency of occurrence.

Prevention of blood clot formation after knee or hip replacement surgery

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

• Decreased 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 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, a joint, or after an injury or 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
• Wound supuration (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 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 injection, or at the site of a venous catheter
• Sanguineous supuration at the site of a venous catheter
• 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
• Acute skin change that affects color and physical appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Esophageal and stomach inflammation
• Gastroesophageal reflux
• Abdominal pain or stomach pain
• Indigestion
• Dysphagia
• Liquid leaking from a wound
• Liquid leaking from a wound after surgery

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

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

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, prominent, and itchy red bumps, caused by an allergic reaction
• Acute skin change that affects color and physical appearance
• Formation of hematomas
• Nasal bleeding
• Gastroesophageal reflux
• Vomiting
• Feeling like vomiting
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decreased white blood cell count (which helps fight infections)
• Bleeding may occur 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
• Dysphagia
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems

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

• Decreased white blood cell count (which helps fight infections)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or wound, at the site of a surgical incision, at the site of injection, or at the site of a venous catheter
• 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 leaflet.You can also report them directly through the Spanish System for the Vigilance of Medicinal Products 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 medications you no longer need. By doing so, you will help protect the environment.

Composition of Privenax

• The active ingredient is dabigatrán. Each hard capsule contains 75 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), and hypromellose 2910.

Appearance of the product and contents of the packaging

Privenax 75 mg are pale yellow to white pellets inside hard white to off-white size 2 capsules.

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

Only some packaging 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 75 mg hard capsules

Portugal – Dabigatrano etexilato Pharmakern 75 mg capsules

Spain – Privenax 75 mg hard capsules

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 /.