APIXABAN AUROVITAS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Apixaban Aurovitas 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. Storing 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 component of blood clotting.

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 and travel to the brain, leading to a stroke, or to other organs and block normal blood flow to that organ (also known as systemic embolism). A stroke can be potentially fatal and requires immediate medical treatment.

• 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 brain 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 through this line to keep it 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 will be used with caution in patients with signs of liver function impairment

• if you have a heart valve replacement;
• if your doctor determines that your blood pressure is unstable or you are scheduled to receive other 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), tell 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, ask 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 risk 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). In particular, if you are over 75 years old and take 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-norepinephrine reuptake inhibitors.

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

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

It is not known if apixaban is excreted in human milk. Ask your doctor or pharmacist for advice 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 the 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 instructions of administration of this medicine given by your doctor or pharmacist. If you are in doubt, ask your doctor, pharmacist, or nurse again.

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.
• rinsing 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 a blood clot in the heart of 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 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 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 instructions of administration of this medicine given by your doctor or pharmacist, or the child's doctor or pharmacist. If you are in doubt, ask the 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 two tabletsof apixaban 5mgtwice 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 one tabletof apixaban 5mgtwice a day, for example, one tablet in the morning and one in the evening.

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

It is important 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 medicines

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

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 greater than the prescribed dose of Apixaban Aurovitas. Take the medicine 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, 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 miss a morning dose, take it as soon as you remember and you can take it with the evening dose.
• If you miss 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 miss more than one dose, ask your doctor, pharmacist, or nurse.

If you stop taking Apixaban Aurovitas

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

If you have 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. The most frequent adverse effect of apixaban is bleeding, which can put the patient's life at risk and requires immediate medical attention.

The following adverse effects have been reported when taking apixaban for the prevention of blood clot formation 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;
• bruising and swelling;

• Anemia, which can cause fatigue or paleness;
• Low blood pressure that can cause fainting or a faster heart rate;
• Nausea (feeling of discomfort);
• Blood tests may show:

• an increase in gamma glutamyltransferase (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 that includes bruising and swelling, bleeding or fluid discharge from the wound/surgical incision (suppuration) or injection site;
• hemorrhoidal;
• tests that show 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.

Rare Adverse 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 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 bruising.
• 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 that includes:

• from the nose;
• from the gums;
• blood in the urine;
• bruising and swelling;
• in 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 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 that includes bruising and swelling, bleeding or fluid discharge 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. Inform 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 bruising.
• 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 your 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 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;
  • bruising and swelling;
  • from the intestine or rectum;
  • bright red blood in the stool;
  • bleeding after surgery that includes bruising and swelling, bleeding or fluid discharge 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 or a faster heart rate 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 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 red, round, and smooth spots under the skin surface or bruising;
• 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 of 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 leaflet. 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 disposed of through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that 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 5 mg of apixaban.

• The other ingredients (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 pink to pink, oval, engraved with 'N' on one side and '5' on the other.

Available in blisters and PEAD bottles.

Package sizes:

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

PEAD bottles: 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.

Avda. 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 5 mg Filmtabletten

Belgium: Apixaban AB 5 mg filmomhulde tabletten

Apixaban AB 5 mg comprimés pelliculés

Apixaban AB 5 mg Filmtabletten

Spain: Apixabán Aurovitas 5 mg film-coated tablets EFG

France: Apixaban Arrow 5 mg, comprimé pelliculé

Netherlands: Apixaban Aurobindo 5 mg, filmomhulde tabletten

Poland: Apixaban Aurovitas

Portugal: Apixabano Generis

Date of the last revision of this leaflet: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)