APIXABAN FARMAPROJECTS 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Apixaban Farmaprojects 2.5 mg Film-Coated Tablets EFG

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.
• If you have any questions, consult 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, consult 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 Apixaban Farmaprojects and what is it used for
2. What you need to know before taking Apixaban Farmaprojects
3. How to take Apixaban Farmaprojects
4. Possible side effects
5. Storage of Apixaban Farmaprojects
6. Contents of the pack and further 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 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 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 developing blood clots in the veins of your legs. This can cause swelling in the legs, with or without pain. If a blood clot travels from the leg to the lungs, it can block blood flow, 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 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 Farmaprojects

Notice

• you are allergicto apixaban or any of the other components of this medication (listed in section 6);
• you bleed excessively;
• 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 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 a tube is inserted into a blood vessel (catheter ablation) to treat an irregular heartbeat (arrhythmia).

Warningsandprecautions

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

• you had a catheter or received an injection in the spine(for anesthesia or pain relief), your doctor will indicate that you should wait at least 5 hours after removing the catheter before taking this medication;
• 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 indicate that you should temporarily stop taking this medication for a period of time. If you are unsure whether a procedure may cause bleeding, consult your doctor.

Childrenandadolescents

The use of this medication is not recommended in children and adolescents under 18 years of age.

Use of Apixaban Farmaprojects

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 medications for pain relief(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);
• 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 convulsions(e.g., phenytoin, etc.);
• St. John's Wort(a herbal medicine for the treatment of depression);
• medications for the treatment of tuberculosisor other infections(e.g., rifampicin).

Pregnancyandbreastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult 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. Inform your doctor, pharmacist, or nurse immediatelyif you become pregnant while taking this medication.

It is unknown if 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.

Drivingandusingmachines

Apixaban does not have any influence on the ability to drive or use machines.

Apixaban Farmaprojects contains lactose and sodium

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 Farmaprojects

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage

Take the tablet with water. Apixaban can be taken with or without food.

Try to take the tablets at the same time every 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.

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.
• Clear 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 (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.

Taking Apixaban Farmaprojects

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

The recommended dose is one Apixaban 2.5 mg tablet twice a day. For example, take one tablet in the morning and one in the evening.

You should take the first tablet between 12 and 24 hours after surgery.

If you have undergone hipreplacement surgery, you will usually take the tablets for a period of 32 to 38 days.

If you have undergone kneereplacement surgery, you will usually 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 Apixaban 5 mgtablet twice a day.

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

-

• 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 indicate 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 in the evening.

To prevent blood clots from recurring 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 in the evening.

Your doctor will indicate how long you should continue the 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 vitamin K antagonists (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 the 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.

Special warnings

Inform your doctor immediatelyif you have taken a higher dose of this medication than prescribed. Bring the medication packaging 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Special precautions

Take the dose as soon as you remember and:

• take the next Apixaban dose at the usual time
• then, continue taking the medication as usual.

If you have doubts about what to do or if you have forgotten to take more than one dose, ask your doctor, pharmacist, or nurse.

Stopping treatment

Do not interrupt treatment with this medication without first talking to your doctor, as the risk of developing a blood clot may be higher 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 will experience them. Apixaban can be administered for three different diseases. The known side effects and their frequency may be different, and therefore, they are indicated separately below. For these conditions, 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 the formation of blood clots after hip or knee replacement surgery.

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

• Anemia, which can cause fatigue or paleness;
• Bleeding, including hematoma and swelling;
• Nausea (general discomfort).

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

• Decreased number of platelets in the blood (which can affect coagulation);
• Bleeding:
• • after surgery, including hematoma and swelling, secretion of blood or fluid from the wound/surgical incision (suppuration), or at the injection site;
  • from the stomach, intestine, or bright red blood in the stool;
  • blood in the urine;
  • from the nose;
  • vaginal;
• Low blood pressure, which can cause fainting or a faster heartbeat;
• 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;
• Itching.

Rare side effects (may affect up to 1 in 1,000 people)

• 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.
• Bleeding:
• • in a muscle;
  • in the eyes;
  • from the gums and coughing up blood;
  • from the rectum;
• Hair loss.

Frequency not known (cannot be estimated from the 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 showing 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 causes the kidneys to fail to function properly (anticoagulant-related nephropathy).

The following adverse effects have been reported when taking Apixaban to prevent blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.

Common 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 faster heart rate;
• Nausea (general discomfort);
• Blood tests may show:
• • an increase 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, secretion of blood or fluid from the wound/surgical incision (suppuration) or at the 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;
  • 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;
  • 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).

Frequency not known (cannot be estimated from the 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 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;
  • 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 (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 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 surgery, including hematoma and swelling, secretion of blood or fluid from the wound/surgical incision (suppuration); or at the 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;
  • 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 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 round and smooth red spots under the skin surface or hematomas.
• 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 Apixaban Farmaprojects

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and blister, after "CAD/EXP". 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 you no longer need at the Sigre collection point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines 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 2.5 mg of apixaban.
• The other ingredients are:
• • Core of the tablet: 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).

Appearance of the product and package contents

Round, biconvex, film-coated tablets, yellow in color.

Al/PVC/PVDC blister packs. Boxes of 10, 20, 60, 168, or 200 film-coated tablets.

Not all pack sizes may be marketed.

Patient Information Card: handling of information

Inside the packaging of Apixaban Farmaprojects, 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 medicine. 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 prospectus

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