APIXABAN FARMALIDER 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

Apixaban Farmalider 5 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medicationbecauseit contains important information foryou.

• 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 should not be given 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 thepackage leaflet:

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

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

Apixaban Farmalider 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 Farmalider 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.

2. What you need to know before taking Apixaban Farmalider

Do not takeApixaban Farmalider

• if you are allergic to apixaban or any of the other components of this medication

(listed in section 6);

• if you bleed excessively;
• if 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);
• if you have a liver disease that increases the risk of bleeding (hepatic coagulopathy);
• if 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 andprecautions

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

• an increased risk of bleeding, such as:
• bleeding disorders, including situations that result in a decrease in platelet activity;
• very high blood pressure, not controlled by medical treatment;
• you are over 75 years old;
• you weigh 60 kg or less;
• severe kidney disease or if you are on dialysis;
• a liver problem or history of liver problems;

This medication will be used with caution in patients with signs of altered liver function

• you have a cardiac 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 period. If you are unsure whether a procedure may cause bleeding, consult your doctor.

Children andadolescents

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

Using Apixaban Farmalider with othermedications

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 monitored more closely.

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-inflammatory or pain-relieving medications (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);
• antidepressants called selective serotonin reuptake inhibitors or 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 tuberculosis or other infections (e.g., rifampicin).

Pregnancy andbreastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist 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.

Inform your doctor 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 or not start taking this medication.

Driving and usingmachines

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

Apixaban Farmalider contains lactose (a type of sugar) andsodium.

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

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

3. How to take Apixaban Farmalider

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in 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 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.

Crushing instructions:

? Crush the tablets with a mortar.

? Carefully transfer all the powder to a suitable container, mixing the powder with a small amount, e.g., 30 ml (2 tablespoons), of water or any of the liquids mentioned to make the mixture.

? Take the mixture.

? Rinse the mortar and the mortar's hand that were used to crush the tablet and the container with a small amount of water or one of the other liquids (e.g., 30 ml), and take that liquid.

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

Take Apixaban Farmalider according to the followingrecommendations:

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 2.5 mg tablet twice a day if:

• you have severely decreased kidney function;
• two or more of the following factors apply:
• your blood test results suggest poor kidney function (serum creatinine value of 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, e.g., take one tablet in the morning and one in the evening.

Your doctor will indicate how long you should continue treatment.

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

The recommended dose is two 5 mg tablets of apixaban twice a day for the first 7 days, e.g., two tablets in the morning and two tablets in the evening.

After 7 days, the recommended dose is one 5 mg tablet of apixaban twice a day, e.g., 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 2.5 mg tablet of apixaban twice a day, e.g., one tablet in the morning and one tablet in the evening.

Your doctor will indicate how long you should continue treatment.

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 a Vitamin K antagonist (e.g., warfarin).

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

Patients undergoingcardioversion

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

If you take more Apixaban Farmalider than youshould

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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.

If you forget to takeApixaban Farmalider

• 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 withApixaban Farmalider

Do not interrupt treatment with this medication without first talking to your doctor, 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 Adverse Effects

Like all medicines, apixaban can cause adverse effects, although not all people suffer from them. The most frequent adverse effect of this medication 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 to prevent the formation of blood clots in the heart in patients with irregular heartbeats 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 heartbeat;
• Nausea (general discomfort);
• Blood tests may show:
• an increase in gamma glutamyl transferase (GGT).

Infrequent 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 bruising and swelling, discharge of blood or fluid from the wound/surgical incision (suppuration) or 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;
• 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.
• 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 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 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;
• 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).

Infrequent 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 surgery, including 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 available data)

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

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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Apixaban Farmalider

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and on each blister, after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Apixaban Farmalider

• The active ingredient is apixaban. Each tablet contains 5 mg of apixaban.
• The other components are:
  • Core of the tablet: lactose (see section 2 "Apixaban Farmalider contains lactose (a type of sugar) and sodium"), microcrystalline cellulose, croscarmellose sodium (see section 2 "Apixaban Farmalider contains lactose (a type of sugar) and sodium"), lauryl sulfate sodium, magnesium stearate;
  • Coating: lactose monohydrate, (see section 2 "Apixaban Farmalider contains lactose (a type of sugar) and sodium") hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172).

Appearance of the Product and Package Contents

The film-coated tablets are oval, pink, and have "I2" engraved on one side, with a length of approximately 9.9 mm and a width of 5.3 mm.

Apixaban Farmalider 5 mg film-coated tablets are presented in blisters within packages containing 28, 60, and 100 (clinical packaging) film-coated tablets.

Patient Information Card: Handling of Information

Inside the Apixaban Farmalider packaging, 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 must keep this card with you at all times.

1. Take the card.
2. Separate the language you need (this is facilitated through the perforated ends).
3. 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:

1. Fold the card and carry it with you at all times.

Marketing Authorization Holder

Farmalider S.A.

C/ La Granja, 1

28108 Alcobendas – Madrid

Spain

Manufacturers

Farmalider S.A.

C/ Aragoneses, 2

28108 Alcobendas – Madrid

Spain

Date of the Last Revision of this Prospectus: April 2025

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