APIXABAN AUROVITAS 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Apixaban Aurovitas 2.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Apixaban Aurovitas and what is it used for

This medicine contains the active substance apixaban, which belongs to a group of medicines called anticoagulants. This medicine helps to prevent the formation of blood clots by blocking Factor Xa, an important element in the blood clotting process.

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 forming 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 the flow of blood, 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 potentially fatal 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 happening again 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 happening again 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 you take Apixaban Aurovitas

Do not take Apixaban Aurovitas if:

• you are allergic to apixaban or any of the other ingredients of this medicine (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 medicines to prevent blood clotting (such as warfarin, rivaroxaban, dabigatran, or heparin), except when switching 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 medicine if you have any of these 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;
• • severe kidney disease or if you are on dialysis;
  • a liver problem or history of liver problems.

Apixaban Aurovitas will be used with caution in patients with signs of liver function alteration

• you had a catheter or received an injection in the spine (for anesthesia or pain relief), your doctor will tell you to wait at least 5 hours after removing the catheter before taking Apixaban Aurovitas;
• if 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 Aurovitas

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 have surgery or a procedure that may cause bleeding, your doctor will tell you to temporarily stop taking this medicine for a while. If you are not sure if a procedure may cause bleeding, consult your doctor.

Children and adolescents

Apixaban Aurovitas is not recommended for use in children and adolescentswith a body weight below 35 kg.

Other medicines and Apixaban Aurovitas

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use other medicines.

Some medicines may increase the effects of apixaban and some medicines may decrease its effects. Your doctor will decide if you should be treated with apixaban if you are taking these medicines and if you should be kept under closer observation.

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

• some medicines for fungal infections (such as ketoconazole, etc.);
• some antiviral medicines for HIV/AIDS (such as ritonavir);
• other medicines to reduce blood clotting (such as enoxaparin, etc.);
• anti-inflammatory or pain-relieving medicines (such as acetylsalicylic acid or naproxen). Especially if you are over 75 years old and taking acetylsalicylic acid, there is a higher likelihood of bleeding;
• medicines for high blood pressure or heart problems (such as diltiazem);
• antidepressants called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.

The following medicines may reduce the ability of apixaban to prevent blood clot formation:

• medicines to prevent epilepsy or seizures (such as phenytoin, etc.);
• St. John's Wort (a herbal medicine for the treatment of depression);
• medicines to treat tuberculosis or other infections (such as rifampicin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The effects of Apixaban Aurovitas on pregnancy and the fetus are not known. You should not take this medicine if you are pregnant. Inform your doctor immediately if you become pregnant while taking this medicine.

It is not known whether apixaban is excreted in human milk. Ask your doctor or pharmacist before taking this medicine during breastfeeding. They will tell you whether to stop breastfeeding or whether to stop or not start taking this medicine.

Driving and using machines

Apixaban Aurovitas has not been shown to affect your ability to drive or use machines.

Apixaban Aurovitas contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Apixaban Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Apixaban Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are not sure, consult your doctor, pharmacist, or nurse.

Dosage

Take the tablet with water. This medicine 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, then mix the powder with a small amount, for example, 30 ml (2 tablespoons), of water or any of the other liquids mentioned above 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 (for example, 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 this medicine according to the following recommendations:

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

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

For example, take one tablet in the morning and one in the evening.

You should take the first tablet between 12 to 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 5mgtwice a day.

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

• you have severely reduced 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 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 tabletsof apixaban 5mgtwice 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 5mgtwice a day, for example, one tablet in the morning and one in the evening.

To prevent blood clots from happening again after 6 months of treatment

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

Your doctor will tell you 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 happening again in the veins and blood vessels of the lungs.

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are not sure, 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 the doctor.

The recommended dose for children and adolescents with a weight of at least 35 kg is four tabletsof apixaban 2.5mgtwice 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 two tabletsof apixaban 2.5 mg 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 important to respect scheduled visits to the doctor, as it may be necessary to adjust the dose based on weight changes.

Your doctor may change your anticoagulant treatment as follows:

• Switching from apixaban to anticoagulant medicines

Stop taking apixaban. Start treatment with anticoagulant medicines (such as heparin) at the time you would take the next apixaban tablet.

• Switching from anticoagulant medicines to apixaban

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

• Switching from treatment with anticoagulants that contain Vitamin K antagonists (such as warfarin) to apixaban

Stop taking the medicine that contains a Vitamin K antagonist. Your doctor will need to perform blood tests and tell you when to start taking apixaban.

• Switching from apixaban to treatment with anticoagulants that contain Vitamin K antagonists (such as warfarin).

If your doctor tells you to start taking a medicine that contains a Vitamin K antagonist, continue taking apixaban for at least 2 days after your first dose of the medicine that contains a Vitamin K antagonist. Your doctor will need to perform blood tests and tell you when to stop taking Apixaban Aurovitas.

Patients undergoing cardioversion

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

If you take more Apixaban Aurovitas than you should

Tell your doctor immediatelyif you have taken a dose higher than the prescribed dose of apixaban. Bring the medicine pack 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 the anti-factor Xa activity may be necessary.

In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Apixaban Aurovitas

• If you forget a morning dose, take it as soon as you remember and you can take it with the evening dose.
• If you forget an evening dose, you can only take it during that same night. Do not take two doses the next morning, continue taking the medicine the next day, as usual, twice a day as recommended.

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 stop taking Apixaban Aurovitas

Do not stop taking apixaban without talking to your doctor first, because the risk of developing a blood clot may be higher if you stop the treatment too soon.

If you have any doubts about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, apixaban 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 at which they occur may be different and are therefore indicated separately below. For these conditions, the most frequent adverse effect of apixaban 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 surgery, including hematoma and swelling, bleeding or fluid secretion from the wound/surgical incision (suppuration), or 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 heart rate;
• 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 produce: 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.

Unknown Frequency(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 that show 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 the formation of blood clots in the heart in patients with irregular heart rhythm 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 that can cause fainting or a faster heart rate;
• Nausea (general discomfort);
• Blood tests may show:

• anincrease 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 surgery, including hematoma and swelling, bleeding or fluid secretion from the wound/surgical incision (suppuration), or injection site;
  • hemorrhoidal;
  • in a muscle.

• 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 produce: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. Inform your doctor immediately if 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).

Unknown Frequency(cannot be estimated from 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).

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 (feeling of discomfort);
• Skin rash;
• Blood tests may show:
• • anincrease in gamma glutamyl transferase (GGT) or alanine aminotransferase (ALT).

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

• Low blood pressure that can cause fainting or a faster heart rate;
• Bleeding:
• • in the eyes;
  • in the mouth or coughing up blood;
  • bright red blood in the stool;
  • tests that show blood in the stool or urine;

• bleeding after surgery, including hematoma and swelling, bleeding or fluid secretion from the wound/surgical incision (suppuration), or injection site;
  • hemorrhoidal;
  • in a muscle.

• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) that can produce: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. Contact your doctor immediately if 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.

Unknown Frequency(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 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).

Additional Adverse Effects in Children and Adolescents

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

• Allergic reactions (hypersensitivity) that can produce: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. These adverse effects are frequent (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 frequent adverse effects observed in children and adolescents were nosebleeds and abnormal vaginal bleeding.

Very Frequent Adverse Effects(may affect more than 1 in 10 people)

• Bleeding that includes:

• vaginal;
• nasal.

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

• Bleeding that includes:

• 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, bleeding or fluid secretion 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 heart rate;
• Blood tests may show:

• abnormal liver function;
• increase in some liver enzymes;
• increase in alanine aminotransferase (GPT).

Unknown Frequency(cannot be estimated from 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 that show 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Apixaban Aurovitas

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

Do not use this medicine after the expiration date that appears on the packaging and blister 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 thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGREpoint of the pharmacy. 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 Aurovitas

• The active ingredient is apixaban. Each film-coated tablet contains 2.5 mg of apixaban.

• The other components (excipients) are:

• Core of the tablet:lactose, microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate.

• Coating of the tablet:lactose monohydrate, hypromellose 2910 (6 cps), triacetin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

Appearance of the Product and Package Contents

Film-coated tablet, biconvex, light yellow to yellow in color, round, engraved with 'N' on one side and '2.5' on the other.

It is presented in blisters and PEAD jars.

Package sizes:

Blister packs: 10, 14, 20, 28, 56, 60, 100, 168, and 200 film-coated tablets.

PEAD jars: 60, 100, 200, 250, and 500 (250 and 500 only for clinical use) film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid,

Spain

Manufacturer:

APL Swift Services (Malta) Ltd,

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000,

Malta

Or

Generis Farmacêutica S.A., Portugal

Rua de João de Deus, nº 19,

Venda Nova. Amadora

2700-487,

Portugal

Or

Arrow Generiques

26 Avenue Tony Garnier,

69007, Lyon,

France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Apixaban PUREN 2.5 mg film-coated tablets

Belgium: Apixaban AB 2.5 mg film-coated tablets

Apixaban AB 2.5 mg coated tablets

Apixaban AB 2.5 mg film-coated tablets

Spain: Apixaban Aurovitas 2.5 mg film-coated tablets EFG

France: Apixaban Arrow 2.5 mg, film-coated tablet

Netherlands: Apixaban Aurobindo 2.5 mg, film-coated tablets

Poland: Apixaban Aurovitas

Portugal: Apixabano Generis

Date of the last revision of this prospectus:July 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)