ELIBAX 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Elibax 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, ask 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, ask 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 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 suitable 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 components of this medication (listed in section 6);

-

• 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 cerebral hemorrhage);

a recent or active stomach or intestinal ulcer, or recent cerebral 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 having a tube 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 decreased 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 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 tell you to temporarily stop taking this medication for a while. If you are unsure whether a procedure may cause bleeding, ask your doctor.

Children and adolescents

This medication is not recommended for use 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 pain-relieving medications(e.g., acetylsalicylic acid or naproxen). Especially 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);

-

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 to treat 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, ask 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 immediatelyif you become pregnant while taking this medication.

It is unknown if apixaban is excreted in human milk. Ask your doctor, pharmacist, or nurse before taking this medication during breastfeeding. They will tell you whether to interrupt breastfeeding or whether to stop 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 exactly as indicated by your doctor or pharmacist. If you are unsure, ask 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 treatment effect.

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 liquids mentioned for making 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 Elibax according to the following recommendations:

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 mg tablet twice a day.

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

-

• 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 tell you 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 two apixaban 5 mg tablets twice 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 apixaban 5 mg tablet twice a day, for example, one tablet in the morning and one tablet in the evening.

To prevent blood clots from recurring after 6 months of treatment, the recommended dose is one apixaban 2.5 mg tablet twice a day, for example, one tablet in the morning and one tablet in the evening.

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

Use in children and adolescents

To treat 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 exactly as indicated by your doctor or pharmacist. If you are unsure, ask your doctor, pharmacist, or nurse.

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

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 two apixaban 5 mg tablets twice 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 apixaban 5 mg tablet twice a day, for example, one tablet in the morning and one tablet 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 treatment with apixaban to a treatment with anticoagulants that contain vitamin K antagonists (e.g., warfarin)

If your doctor tells you to 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 Elibax than you should

Tell your doctor immediatelyif you have taken a dose greater than the prescribed dose of this medication. 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 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 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 Elibax

Do not interrupt treatment with this medication without talking to your doctor first, as the risk of developing a blood clot may be greater 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 gets them. 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 blood clot formation in the heart in patients with an irregular heartbeat and at least one additional risk factor.

Common side 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;
  • bruising 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 side 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 surgery, including bruising and swelling, discharge of blood or fluid from the wound/incision or injection site (suppuration) or place of injection;
  • hemorrhoidal;
  • tests that show blood in the stool or urine;
• Decreased number of platelets in the blood (which can affect coagulation);
• Blood tests may show:
• • abnormal liver function;
  • increased liver enzymes;
  • increased bilirubin, a product derived from 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 side effects (may affect up to 1 in 1,000 people)

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

Very rare side 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)

• Vascular inflammation (vasculitis) that can cause skin rash, appearance of round and smooth red spots under the skin surface or bruises.
• Bleeding in the kidney, sometimes with blood in the urine, which causes 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.

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

• Bleeding including:
• • from the nose;
  • from the gums;
  • blood in the urine;
  • bruising 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 (GPT).

Uncommon adverse effects (may affect up to 1 in 100 people)

• Low blood pressure that 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 an operation that includes bruising and swelling, discharge of blood or fluid from the wound/surgical incision (suppuration) or 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;
  • an increase in some liver enzymes;
  • an 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 the 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);
• Vascular inflammation (vasculitis) that can cause skin rash, appearance of round and smooth red spots under the skin surface or bruises.
• Bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to fail to function properly (anticoagulant-related nephropathy).

Additional adverse effects in children and adolescents

Report immediately to the child's doctorif 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 mainly of mild to moderate 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;
  • bruising and swelling;
  • from the intestine or rectum;
  • bright red blood in the stool;
  • bleeding after an operation that includes bruising and swelling, discharge of blood or fluid from the wound/surgical incision (suppuration) or 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 in the child or a faster heartbeat
• Blood tests may show:
• • abnormal liver function;
  • an increase in some liver enzymes;
  • an 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);
• Vascular inflammation (vasculitis) that can cause skin rash, appearance of round and smooth red spots under the skin surface or;
• 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 causes 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 prospectus. 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 that appears on the blister pack and on the box 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 through 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 ofElibax

The active ingredientis apixaban.

Elibax 5 mg: each tablet contains 5 mg of apixaban.

The 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, red iron oxide (E172).

Appearance of the product and package contents

The film-coated tablets are oval (9.5 mm x 5 mm), pink, containing 5 mg of the active ingredient apixaban.

They are presented in PVC/PVDC aluminum blisters within cardboard boxes containing 60 tablets.

Patient Information Card: information management

Inside the packaging of this medicine, along with the prospectus, 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 prospectus: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.