ELIBAX 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Elibax 2.5 mg film-coated tablets EFG

apixaban

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

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

• Keep this package 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 package leaflet. See section 4.

Contents of the package leaflet

1. What is Elibax and what is it used for
2. What you need to know before taking Elibax
3. How to take Elibax
4. Possible side effects
5. Storage of Elibax
6. Contents of the pack and further information

1. What is Elibax and what is it used for

Elibax 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.

Apixaban is used in children from 28 days to less than 18 years of age to treat blood clots and to prevent these blood clots from recurring in the veins and blood vessels of the lungs.

For the recommended dose appropriate for body weight, see section 3.

2. What you need to know before taking Elibax

Do not takeElibaxif

• you are allergicto apixaban or any of the other ingredients of this medication (listed in section 6);

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• you have a disease in an organof the body that increases the risk of severe bleeding (such as

a recent or active stomach or intestinal ulcer, or recent brain hemorrhage);

• you have a liver diseasethat increases the risk of bleeding (hepatic coagulopathy);
• you are taking medications to prevent blood coagulation(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching to 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 these conditions:

• a 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 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 (an immune system disorder 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

The use of this medication is not recommended in children and adolescents with a body weight below 35 kg.

Other medications and Elibax

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or may need to use other medications.

Some medications may increase the effects of apixaban, and some 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 kept under closer observation.

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

• some medications for fungal infections(e.g., ketoconazole, etc.);
• some antiviral medications for HIV/AIDS(e.g., ritonavir);
• other medications to reduce blood coagulation(e.g., enoxaparin, etc.);
• anti-inflammatoryor 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);

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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 seizures(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.

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

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

Driving and using machines

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

Excipients

Elibax 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; this is, essentially "sodium-free".

3. How to take Elibax

Follow the instructions for administration of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor, pharmacist, or nurse.

Dosage

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

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

If you have difficulty swallowing the tablet whole, talk to your doctor about other possible ways to take apixaban. 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, e.g., 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 have been 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 Elibax according to the following recommendations:

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

The recommended dose of apixaban is one 2.5 mg tablet twice 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 of apixaban is one 5 mgtablet twice a day.

The recommended dose is one apixaban 2.5 mgtablet twice a day if:

• you have severely decreased kidney function;
• you have two or more of the following factors:
• your blood test results suggest poor kidney function (the serum creatinine 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 the treatment.

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

The recommended dose is twoapixaban 5 mgtablets twice a day for the first 7 days, for example, two tablets in the morning and two in the evening.

After 7 days, the recommended dose is oneapixaban 5 mgtablet twice 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 apixaban 2.5 mgtablet twice a day, for example, one tablet in the morning and one in the evening.

Your doctor will indicate how long you should continue the treatment.

Use in children and adolescents

For the treatment of blood clots and to prevent these blood clots from recurring in the veins and blood vessels of the lungs.

Follow the instructions for administration of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor, pharmacist, or nurse.

Try to take or administer the dose at the same time each day to achieve a better effect of the treatment.

The dose of apixaban depends on body weight and will be calculated by your doctor.

The recommended dose for children and adolescents with a weight of at least 35 kg is fourapixaban 2.5 mgtablets twice a day for the first 7 days, for example, four tablets in the morning and four in the evening.

After 7 days, the recommended dose is twoapixaban 2.5 mgtablets twice a day, for example, two tablets in the morning and two in the evening.

For parents and caregivers: observe the child to ensure they take the complete dose.

It is essential to respect scheduled visits to the doctor, as it may be necessary to adjust the dose based on changes in weight.

Your doctor may change your anticoagulant treatment as follows:

• Switching from apixaban to anticoagulant medications

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

• Switching from anticoagulant medications to apixaban

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

• Switching 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.

• Switching 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.

Patient 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 Elibax than you should

Tell your doctor immediatelyif you have taken a higher dose of this medication than prescribed. Bring the medication packaging 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 call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Elibax

Take the dose as soon as you remember and

• take the next apixaban dose 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 Elibax

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 side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. Apixaban can be administered for three different diseases. The known side effects and their frequency may be different, and therefore, they are indicated separately below. For these conditions, the most common side effect of this medication is bleeding, which can be life-threatening and requires immediate medical attention.

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

Common side effects (may affect up to 1 in 10 people)

• Anemia, which can cause fatigue or paleness;
• Bleeding, including:
• • hematoma and swelling;
• Nausea (general discomfort).

Adverse effects rarely occurring (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, blood or fluid secretion 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 that 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.

Adverse effects rarely occurring (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. Inform 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 the 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 round and smooth red 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 blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common 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 that can cause fainting or a faster heartbeat;
• Nausea (general discomfort);
• Blood tests may show:
• • an increase in gamma glutamyl transferase (GGT).

Adverse effects rarely occurring (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 surgery, including hematoma and swelling, blood or fluid secretion 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. Inform your doctor immediatelyif you experience any of these symptoms.

Adverse effects rarely occurring (may affect up to 1 in 1,000 people)

• Bleeding:
• • in the lungs or throat;
  • 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 the available data)

• Inflammation of the blood vessels (vasculitis) that can cause skin rash, appearance of round and smooth red 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).

Adverse effects in children and adolescents

Inform the child's doctor immediatelyif you observe any of these symptoms:

• Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. These adverse effects are common (may affect up to 1 in 10 people).

In general, the adverse effects observed in children and adolescents treated with apixaban were similar to those observed in adults and were mainly mild to moderate in intensity. The most frequently observed adverse effects in children and adolescents were nosebleeds and abnormal vaginal bleeding.

Very common adverse effects (may affect more than 1 in 10 people)

• Bleeding, including:
• • vaginal;
  • nasal.

Common adverse effects (may affect up to 1 in 10 people)

• Bleeding, including:
• • from the gums;
  • blood in the urine;
  • hematoma and swelling;
  • from the intestine or rectum;
  • bright/red blood in the stool;
  • bleeding after surgery, including hematoma and swelling, blood or fluid secretion from the wound/surgical incision (suppuration), or at the injection site;
• Hair loss;
• Anemia, which can cause fatigue or paleness;
• Decrease in the number of platelets in the child's blood (which can affect coagulation);
• Nausea (general discomfort);
• Skin rash;
• Itching;
• Low blood pressure that can cause fainting or a faster heartbeat in the child;
• Blood tests may show:
• • abnormal liver function;
  • increase in some liver enzymes;
  • increase in alanine aminotransferase (GPT).

Frequency not known (cannot be estimated from the available data)

• Bleeding:
• • in the abdomen or the space behind the abdominal cavity;
  • in the stomach;
  • in the eyes;
  • in the mouth;
  • hemorrhoidal;
  • in the mouth or coughing up blood;
  • in the brain or spinal cord;
  • in the lungs;
  • in a muscle;
• 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 round and smooth red spots under the skin surface, or hematomas.
• Blood tests may show:
• • an increase in gamma glutamyl transferase (GGT);
  • tests showing blood in the stool or urine.
• 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 is not listed 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 Elibax

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

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

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition ofElibax

The active ingredientis apixaban.

Elibax 2.5 mg: each tablet contains 2.5 mg of apixaban.

Other ingredientsare:

• Core of the tablet: anhydrous lactose(see section 2 "Elibax contains lactose and sodium"), microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate (see section 2 "Elibax contains lactose and sodium"), and magnesium stearate.
• Coating: lactose monohydrate(see section 2 "Elibax contains lactose and sodium"), hypromellose, calcium carbonate, triacetin, yellow iron oxide (E172), black iron oxide (E172), and red iron oxide (E172).

Appearance and package contents

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

They are available in PVC/PVDC aluminum blister packs in cartons containing 20 and 60 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 and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

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.