APIXABAN KERN PHARMA 2.5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet: Information for the Patient

Apixaban Kern Pharma 2.5 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Apixaban Kern Pharma and what is it used for
2. What you need to know before taking Apixaban Kern Pharma
3. How to take Apixaban Kern Pharma
4. Possible side effects
5. Storage of Apixaban Kern Pharma
6. Package contents and additional information

1. What is Apixaban Kern Pharma and what is it used for

This medication contains the active substance apixaban and belongs to a group of medications called anticoagulants. This medication helps prevent the formation of blood clots by blocking Factor Xa, an important element in blood coagulation.

Apixaban is used in adults:

• to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After hip or knee replacement surgery, you may have a higher risk of developing blood clots in the veins of your legs. This can cause swelling in your legs, with or without pain. If a blood clot travels from your leg to your lungs, it can block blood flow, causing difficulty breathing, with or without chest pain. This medical condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.

• to prevent the formation of a blood clot in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose, move to the brain, and cause a stroke, or move to other organs, preventing proper irrigation (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.

• to treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent these blood clots from recurring in the blood vessels of the legs and/or lungs.

2. What you need to know before taking Apixaban Kern Pharma

Do not take Apixaban Kern Pharma if:

• you are allergicto apixaban or any of the other components of this medication (listed in section 6);
• you have excessive bleeding;
• you have a disease in an organ of the body that increases the risk of severe bleeding (such as an active or recent stomach or intestinal ulcer, or recent cerebral hemorrhage);
• you have a liver disease that increases the risk of bleeding (hepatic coagulopathy);
• you are taking medications to prevent blood coagulation (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when changing anticoagulant treatment, while having an arterial or venous line and being treated with heparin to keep the line open, or when a tube is inserted into a blood vessel (catheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions

Tell your doctor, pharmacist, or nurse before taking this medication if you have any of the following conditions:

• an increased risk of bleeding, such as:

• bleeding disorders, including situations that result in a decrease in platelet activity;
• very high blood pressure, not controlled by medical treatment;
• you are over 75 years old;
• you weigh 60 kg or less;

• a severe kidney disease or if you are on dialysis;
• a liver problem or history of liver problems;
• • This medication will be used with caution in patients with signs of altered liver function
• you have had a catheter or received an injection in the spine(for anesthesia or pain relief), your doctor will indicate that you should wait at least 5 hours after removing the catheter before taking this medication;
• you have a heart valve prosthesis;
• if your doctor determines that your blood pressure is unstable or you are scheduled to receive another treatment or undergo surgery to remove the blood clot from your lungs.

Be careful with apixaban

• if you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), inform your doctor to decide if it may be necessary to modify the treatment.

If you need to undergo surgery or a procedure that may cause bleeding, your doctor will indicate that you should temporarily stop taking this medication for a period of time. If you are unsure whether a procedure may cause bleeding, consult your doctor.

Children and adolescents

This medication is not recommended for use in children and adolescents under 18 years of age.

Other medications and Apixaban Kern Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take other medications.

Some medications may increase the effects of apixaban, and other medications may decrease its effects. Your doctor will decide if you should be treated with apixaban if you are taking these medications and if you should be closely monitored.

The following medications may increase the effects of apixaban and increase the risk of unwanted bleeding:

• some antifungal medications(e.g., ketoconazole, etc.);
• some antiviral medications for HIV/AIDS(e.g., ritonavir);
• other medications to reduce blood coagulation(e.g., enoxaparin, etc.);
• anti-inflammatory medicationsor medications for pain relief(e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years old and taking acetylsalicylic acid, there is a higher likelihood of bleeding;
• medications for high blood pressure or heart problems(e.g., diltiazem);
• antidepressantscalled selective serotonin reuptake inhibitorsor serotonin-norepinephrine reuptake inhibitors.

The following medications may reduce the ability of apixaban to prevent blood clot formation.

• medications for the treatment of epilepsy or convulsions(e.g., phenytoin, etc.);
• St. John's Wort(a herbal medication for the treatment of depression);
• medications for the treatment of tuberculosisor other infections(e.g., rifampicin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medication.

Pregnancy

The effects of apixaban on pregnancy and the fetus are unknown. You should not take this medication if you are pregnant. Inform your doctor, pharmacist, or nurse immediatelyif you become pregnant while taking this medication.

Breastfeeding

It is unknown if apixaban is excreted in human milk. Ask your doctor or pharmacist before taking this medication during breastfeeding. They will indicate whether you should interrupt breastfeeding or whether you should stop taking or not start taking this medication.

Driving and using machines

This medication has no influence on the ability to drive or use machines.

Apixaban Kern Pharma contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Apixaban Kern Pharma

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor, pharmacist, or nurse again.

Dosage

Take the tablet with water. This medication can be taken with or without food.

Try to take the tablets at the same time each day to achieve a better treatment effect.

If you have difficulty swallowing the tablet whole, talk to your doctor about other possible ways to take this medication. The tablet can be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before taking it.

Instructions for crushing:

• Crush the tablets with a mortar.
• Transfer all the powder carefully into a suitable container, mixing the powder with a small amount, for example, 30 ml (2 tablespoons), of water or any of the other liquids mentioned to make the mixture.
• Take the mixture.
• Rinse the mortar and the mortar's hand that were used to crush the tablet and the container with a small amount of water or one of the other liquids (e.g., 30 ml), and take that liquid.

If necessary, your doctor may also administer the crushed apixaban tablet mixed in 60 ml of water or 5% glucose in water through a nasogastric tube.

Take Apixaban Kern Pharma according to the following recommendations:

To prevent the formation of blood clots in hip or knee replacement surgery.

The recommended dose is one tablet of apixaban 2.5 mgtwice a day. For example, take one tablet in the morning and one in the evening.

You should take the first tablet between 12 and 24 hours after surgery.

If you have undergone major hipsurgery, you will generally take the tablets for a period of 32 to 38 days.

If you have undergone major kneesurgery, you will generally take the tablets for a period of 10 to 14 days.

To prevent the formation of a blood clot in the heart in patients with an irregular heartbeat and at least one additional risk factor.

The recommended dose is one tablet of apixaban 5 mgtwice a day.

The recommended dose is one tablet of apixaban 2.5 mgtwice a day if:

• you have severely decreased kidney function;
• two or more of the following factors apply to you:
• • your blood test results suggest poor kidney function (the creatinine serum value is 1.5 mg/dl (133 micromoles/l) or higher);
  • you are 80 years old or older;
  • your weight is 60 kg or less

The recommended dose is one tablet twice a day, for example, take one tablet in the morning and one in the evening.

Your doctor will indicate how long you should continue treatment.

To treat blood clots in the veins of the legs and in the blood vessels of the lungs

The recommended dose is two tabletsof apixaban 5 mgtwice a day for the first 7 days, for example, two tablets in the morning and two tablets in the evening.

After 7 days, the recommended dose is one tabletof apixaban 5 mgtwice a day, for example, one tablet in the morning and one in the evening.

To prevent blood clots from recurring after 6 months of treatment

The recommended dose is one tablet of apixaban 2.5 mgtwice a day, for example, one tablet in the morning and one in the evening.

Your doctor will indicate how long you should continue treatment.

Your doctor may change your anticoagulant treatment as follows:

• Changing from apixaban to other anticoagulant medications

Stop taking this medication. Start treatment with other anticoagulant medications (e.g., heparin) at the time you would take the next tablet.

• Changing from other anticoagulant medications to apixaban

Stop taking other anticoagulant medications. Start treatment with apixaban at the time you would take the next dose of the other anticoagulant medication, and then continue as usual.

• Changing from a treatment with anticoagulants that contain vitamin K antagonists (e.g., warfarin) to apixaban

Stop taking the medication that contains a vitamin K antagonist. Your doctor will need to perform blood tests and indicate when to start taking apixaban.

• Changing from apixaban to a treatment with anticoagulants that contain vitamin K antagonists (e.g., warfarin)

If your doctor indicates that you should start taking a medication that contains a vitamin K antagonist, continue taking apixaban for at least 2 days after your first dose of the medication that contains a vitamin K antagonist. Your doctor will need to perform blood tests and indicate when to stop taking apixaban.

Patients undergoing cardioversion

If your heartbeat needs to be restored through a process called cardioversion, take this medication at the times indicated by your doctor to prevent blood clots in the blood vessels of the brain and other blood vessels in the body.

If you take more Apixaban Kern Pharma than you should

Inform your doctor immediatelyif you have taken a higher dose of this medication than prescribed. Bring the medication package to your doctor, even if there are no tablets left.

If you take more apixaban than the recommended dose, you may increase the risk of bleeding. If bleeding occurs, surgery, blood transfusions, or other treatments that can reverse anti-factor Xa activity may be necessary.

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 forget to take Apixaban Kern Pharma

• Take the dose as soon as you remember and:
• • take the next dose of apixaban at the usual time
  • then continue taking the medication as usual

If you have doubts about what to do or if you forget to take more than one dose,ask your doctor, pharmacist, or nurse.

If you interrupt treatment with Apixaban Kern Pharma

Do not interrupt treatment with this medication without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is interrupted too soon.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Apixaban can be administered in three different diseases. The known adverse effects and the frequency with which they occur may be different and are therefore indicated separately below. For these conditions, the most frequent adverse effect of this medicine is bleeding, which can endanger the patient's life and requires immediate medical attention.

The following adverse effects have been reported when taking apixaban to prevent the formation of blood clots after hip or knee replacement surgery.

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Anemia, which can cause fatigue or paleness;
• Bleeding, including:
• • hematoma and swelling;

• Nausea (feeling of discomfort).

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Decrease in the number of platelets in the blood (which can affect coagulation);
• Bleeding:
• • after your operation, including hematoma and swelling, bleeding or fluid discharge from the wound/surgical incision (suppuration), or at the injection site;
  • from the stomach, intestine, or bright/red blood in the stool;
  • blood in the urine;
  • from the nose;
  • vaginal;

• Low blood pressure, which can cause fainting or a faster heartbeat;
• Blood tests may show:
• • abnormal liver function;
  • increase in some liver enzymes;
  • increase in bilirubin, a byproduct of red blood cells, which can cause yellowing of the skin and eyes;

• Itching.

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

• Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. Tell your doctor immediatelyif you experience any of these symptoms.
• Bleeding:
• • in a muscle;
  • in the eyes;
  • from the gums and coughing up blood;
  • from the rectum;

• Hair loss.

Frequency Not Known (cannot be estimated from available data)

• Bleeding:
• • in the brain or spinal cord;
  • in the lungs or throat;
  • in the mouth;
  • in the abdomen or the space behind the abdominal cavity;
  • hemorrhoidal;
  • tests showing blood in the stool or urine;

• Skin rash that can form blisters and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around) (erythema multiforme);
• Inflammation of the blood vessels (vasculitis) that can cause skin rash, appearance of red, round, and smooth spots under the skin surface or hematomas.
• Bleeding in the kidney, sometimes with blood in the urine, which can cause the kidneys to fail to function properly (anticoagulant-related nephropathy).

The following adverse effects have been reported when taking apixaban to prevent the formation of blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Bleeding, including:
• • in the eyes;
  • in the stomach or intestine;
  • from the rectum;
  • blood in the urine;
  • from the nose;
  • from the gums;
  • hematoma and swelling;

• Anemia, which can cause fatigue or paleness;
• Low blood pressure, which can cause fainting or a faster heartbeat;
• Nausea (general discomfort);
• Blood tests may show:
• • an increase in gamma glutamyl transferase (GGT).

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Bleeding:
• • in the brain or spinal cord;
  • in the mouth or coughing up blood;
  • in the abdomen or vagina;
  • bright/red blood in the stool;
  • bleeding after your operation, including hematoma and swelling, bleeding or fluid discharge from the wound/surgical incision (suppuration), or at the injection site;
  • hemorrhoidal;
  • tests showing blood in the stool or urine;
• Decrease in the number of platelets in the blood (which can affect coagulation);
• Blood tests may show:
• • • abnormal liver function;
    • increase in some liver enzymes;
    • increase in bilirubin, a byproduct of red blood cells, which can cause yellowing of the skin and eyes;
  • Skin rash;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. Tell your doctor immediatelyif you experience any of these symptoms.

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

• Bleeding:
• • in the lungs or throat;
  • within the space behind the abdominal cavity;
  • in a muscle.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

• Skin rash that can form blisters and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around) (erythema multiforme).

Frequency Not Known (cannot be estimated from available data)

• Inflammation of the blood vessels (vasculitis) that can cause skin rash, appearance of red, round, and smooth spots under the skin surface or hematomas.
• Bleeding in the kidney, sometimes with blood in the urine, which can cause the kidneys to fail to function properly (anticoagulant-related nephropathy).

The following adverse effects have been reported when taking apixaban to treat or prevent blood clots from recurring in the veins of the legs and in the blood vessels of the lungs.

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Bleeding, including:
• • • from the nose;
    • from the gums;
    • blood in the urine;
    • hematoma and swelling;
    • from the stomach, intestine, or rectum;
    • in the mouth;
    • vaginal;
  • Anemia, which can cause fatigue or paleness;
  • Decrease in the number of platelets in the blood (which can affect coagulation);
  • Nausea (general discomfort);
  • Skin rash;
  • • Blood tests may show:
    • • an increase in gamma glutamyl transferase (GGT) or alanine aminotransferase (ALT).

  Uncommon Adverse Effects (may affect up to 1 in 100 people)

  • Low blood pressure, which can cause fainting or a faster heartbeat;
  • Bleeding:
  • • in the eyes;
    • in the mouth or coughing up blood;
    • bright/red blood in the stool;
    • tests showing blood in the stool or urine;
    • bleeding after your operation, including hematoma and swelling, bleeding or fluid discharge from the wound/surgical incision (suppuration); or at the injection site;
    • hemorrhoidal;
    • in a muscle;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. Contact your doctor immediatelyif you experience any of these symptoms.
  • Blood tests may show:
  • • abnormal liver function;
    • increase in some liver enzymes;
    • increase in bilirubin, a byproduct of red blood cells, which can cause yellowing of the skin and eyes.

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

  • Bleeding:
  • • in the brain or spinal cord;
    • in the lungs.

  Frequency Not Known (cannot be estimated from available data)

  • Bleeding:
  • • in the abdomen or the space behind the abdominal cavity.
  • Skin rash that can form blisters and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around) (erythema multiforme);
  • Inflammation of the blood vessels (vasculitis) that can cause skin rash, appearance of red, round, and smooth spots under the skin surface or hematomas.
  • Bleeding in the kidney, sometimes with blood in the urine, which can cause the kidneys to fail to function properly (anticoagulant-related nephropathy).

  Reporting of Adverse Effects

  If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

  5. Storage of Apixaban Kern Pharma

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

  Do not use this medicine after the expiration date that appears on the blister pack and on the carton after CAD. The expiration date is the last day of the month indicated.

  This medicine does not require special storage conditions.

  Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

  6. Package Contents and Additional Information

  Composition of Apixaban Kern Pharma

  The active ingredientis apixaban.

  Apixaban Kern Pharma 2.5 mg: each tablet contains 2.5 mg of apixaban.

  The other ingredientsare:

  • Core of the tablet: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, sodium lauryl sulfate, and sodium stearyl fumarate
  • Coating: lactose monohydrate, hypromellose, titanium dioxide (E-171), triacetin, and yellow iron oxide (E-172).

  Appearance of the Product and Package Contents

  The film-coated tablets are round (approximately 6 mm in diameter) and yellow, containing 2.5 mg of the active ingredient apixaban.

  • They are presented in PVC/PVDC aluminum blisters within cartons containing 20 and 60 film-coated tablets.

  Patient Information Card: Information Management

  Inside the packaging of this medicine, along with the leaflet, you will find a Patient Information Card or your doctor may give you a similar card.

  This Patient Information Card includes useful information for you and will alert other doctors that you are being treated with apixaban. You should keep this card with you at all times.

  1. Take the card.
  2. Complete the following sections or ask your doctor to complete them:
     • Name:
     • Date of birth:
     • Indication:
     • Dose: ........mg twice a day
     • Doctor's name:
     • Doctor's phone number:
  3. Fold the card and carry it with you at all times.

  Marketing Authorization Holder

  Kern Pharma, S.L.

  Venus, 72 - Pol. Ind. Colón II

  08228 Terrassa - Barcelona

  Spain

  Manufacturer

  Pharmadox Healthcare Ltd.

  KW20A Kordin Industrial Park,

  Paola PLA 3000,

  Malta

  or

  Adalvo Limited

  Malta Life Sciences Park,

  Building 1, Level 4, Sir Temi Zammit Buildings,

  San Gwann, SGN 3000

  Malta

  Date of the Last Revision of this Leaflet: April 2025

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