APIXABAN FARMAPROJECTS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Apixaban Farmaprojects contains the active substance apixaban and 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 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, travel to the brain, and cause a stroke, or travel to other organs and prevent proper irrigation of that organ (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 happening again in the blood vessels of the legs and/or lungs.

2. What you need to know before you take Apixaban Farmaprojects

Notice

• you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6);
• you have excessive bleeding;
• you have a disease in an organof 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 diseasethat increases the risk of bleeding (hepatic coagulopathy);
• you are taking medicines to prevent blood clotting(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching treatment, while having an arterial or venous line and being treated with heparin to keep that line open, or when having a tube inserted into a blood vessel (catheter ablation) to treat an irregular heartbeat (arrhythmia).

Warningsandprecautions

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;
• a severe kidney disease or if you are on dialysis;
• a liver problem or history of liver problems;
• • This medicine will be used with caution in patients with signs of altered liver function
• you have a heart valve replacement;
• 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 have surgery or a procedure that may cause bleeding, your doctor will tell you to temporarily stop taking this medicine for a period of time. If you are not sure if a procedure may cause bleeding, consult your doctor.

Childrenandadolescents

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

Useofothermedicines

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(e.g., ketoconazole, etc.);
• some antiviral medicines for HIV/AIDS(e.g., ritonavir);
• other medicines to reduce blood clotting(e.g., enoxaparin, etc.);
• anti-inflammatoryor pain-relieving medicines(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;
• medicines for high blood pressure or heart problems(e.g., diltiazem);
• antidepressants called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors

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

• medicines for the treatment of epilepsy or seizures(e.g., phenytoin, etc.);
• St. John's Wort(a herbal medicine for the treatment of depression);
• medicines for the treatment of tuberculosisor other infections(e.g., rifampicin).

Pregnancyandbreast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking 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 immediatelyif you become pregnant while taking this medicine.

It is not known if Apixaban is excreted in human milk. Ask your doctor, pharmacist, or nurse before taking this medicine during breast-feeding. They will tell you whether to stop breast-feeding or to stop or not start taking this medicine.

Drivingandusingmachines

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

ApixabanFarmaprojectscontainslactoseandsodium

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

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

3. How to take Apixaban Farmaprojects

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, 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 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.

Instructionsforcrushing:

• Crush the tablets with a mortar.
• Transfer all the powder carefully into a suitable container, mixing the powder with a small amount, e.g., 30 ml (2 tablespoons), of water or any of the other liquids mentioned to make the mixture.
• Take the mixture.
• Flush the mortar and pestle 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.

TakingApixabanFarmaprojects

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 Apixaban 5 mgtablet twice a day.

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

-

• two or more of the following factors apply to you:
• • 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 twoApixaban 5 mgtablets 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 oneApixaban 5 mgtablet twice a day, for example, one tablet in the morning and one tablet in the evening.

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

The recommended dose is one Apixaban 2.5 mgtablet twice a day, for example, one tablet in the morning and one tablet in the evening.

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

Your doctor may change your anticoagulant treatment as follows:

Switching from Apixaban to other anticoagulant medicines

Stop taking Apixaban. Start treatment with other anticoagulant medicines (e.g., heparin) at the time you would have taken the next Apixaban tablet.

Switching from other anticoagulant medicines to Apixaban

Stop taking other anticoagulant medicines. Start Apixaban treatment at the time you would have taken the next dose of the other anticoagulant medicine, and then continue as usual.

Switching from treatment with anticoagulants that contain vitamin K antagonists (e.g., warfarin) to Apixaban

Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and tell you when to start taking Apixaban.

Switching from Apixaban treatment to treatment with anticoagulants that contain vitamin K antagonists (e.g., 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 vitamin K antagonist medicine. Your doctor will need to perform blood tests and tell you when to stop taking Apixaban.

Patientsundergoingcardioversion

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

Specialinstructions

Tell your doctor immediatelyif you have taken a higher dose of Apixaban than prescribed. Take the package of the medicine 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, consult your doctor or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

Misseddose

• Take the dose as soon as you remember and
• • take the next dose of Apixaban at the usual time;
  • then continue taking the medicine as usual.

If you are not sure what to do or if you have missed more than one dose,ask your doctor, pharmacist, or nurse.

Stoppingtreatment

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effect of this medicine 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 that includes:
• • 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).

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 that includes bruising and swelling, discharge of blood or fluid from the wound/surgical incision (purulent discharge) 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 blood clotting);
• Blood tests may show:
• • abnormal liver function;
  • increase in some liver enzymes;
  • increase in 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)

• 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 side effects have been reported when taking Apixaban to treat or prevent blood clots from happening again 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 pallor;
• 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 heart rate;
• 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, including hematoma 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;
  • increased liver enzymes;
  • increased 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);
• 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 malfunction (nephropathy related to anticoagulants).

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 it 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 medication.

5. Storage of Apixaban Farmaprojects

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

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

This medication does not require special storage conditions.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need at the Sigre point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Apixaban Farmaprojects

• The active ingredient is apixaban. Each tablet contains 5 mg of apixaban.
• The other components are:
• • Tablet core: mannitol, microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate;
  • Film coating: hypromellose 2910/6, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Appearance of the product and package contents

Film-coated tablets are oblong, biconvex, and pink in color.

Al/PVC/PVDC blister packs. Boxes of 14, 20, 28, 56, 60, 168, or 200 film-coated tablets.

Only some package sizes may be marketed.

Patient information card: handling of information

Inside the Apixaban 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 this medication. You must carry 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:
4. Fold the card and carry it with you at all times.

Marketing authorization holder

Farmaprojects, S.A.U.

Carrer Provença 392, 6th floor

08025 Barcelona

Spain

Manufacturer

Zaklady Farmaceutyczne POLPHARMA S.A.

ul. Pelplinska 19, 83-200 Starogard Gdanski

Poland

Date of the last revision of this prospectus05/2025

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