APIXABAN TEVAGEN 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

This medication contains the active ingredient apixaban and belongs to a group of medications called anticoagulants. Apixaban 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 your legs, with or without pain. If a blood clot travels from your leg to your 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 Tevagen

Do not take Apixaban Tevagen

• if you are allergicto apixaban or any of the other ingredients of this medication (listed in section 6)
• if you have excessive bleeding
• if you have an organ diseasethat 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 diseasethat 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 treatment, while having an arterial or venous line and being treated with heparin to keep the line open, or when having a tube 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 medication if you have any of the following conditions:

• increased risk of bleeding, such as:

• bleeding disorders, including situations that result in decreased 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
• liver disease 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 tell you to wait at least 5 hours after removing the catheter before taking this medication.

• you have a heart valve prosthesis
• 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 Tevagen

• 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 treatment modification is necessary.

If you need 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 if a procedure may cause bleeding, consult your doctor.

Children and Adolescents

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

Other Medications and Apixaban Tevagen

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or may take other medications.

Some medications may increase the effects of apixaban, and other 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 closely monitored.

The following medications may increase the effects of apixaban and increase the risk of unwanted bleeding:

• some antifungal medications(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 medicationsor 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)
• antidepressantscalled selective serotonin reuptake inhibitorsor 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 for the treatment of tuberculosis or other infections(e.g., rifampicin)

Pregnancy and Breastfeeding

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. Tell your doctor immediately if 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 tell you whether to interrupt breastfeeding or whether to stop or not start taking this medication.

Driving and Using Machines

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

Apixaban Tevagen contains lactose (a type of sugar) 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 Tevagen

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor, pharmacist, or nurse again.

Dosage

Take the tablet with water. This medication 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 this medication. 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.
• Transfer all the powder carefully into a suitable container, mixing the powder with a small amount, for example, 30 ml (2 tablespoons), of water or any of the mentioned liquids 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 Tevagen according to the following recommendations:

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

The recommended dose is one 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 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 5 mgtablet twice a day.

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

• you have severely impaired kidney function
• two or more of the following factors apply to you:

• your blood test results indicate 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, for example, take one tablet in the morning and one in the evening. Your doctor will tell you 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 tabletstwice 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 5 mg tablettwice 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 2.5 mgtablet twice a day, for example, one tablet in the morning and one in the evening.

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

Your doctor may change your anticoagulant treatment as follows:

• Switching from Apixaban Tevagen to other anticoagulant medications

Stop taking this medication. Start treatment with other anticoagulant medications (e.g., heparin) at the time you would take the next dose of Apixaban Tevagen.

• Switching from other anticoagulant medications to Apixaban Tevagen

Stop taking other anticoagulant medications. Start treatment with apixaban at the time you would take the next dose of the other anticoagulant medication, and then continue as usual.

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

Stop taking the medication 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 Tevagen to treatment with anticoagulants that contain Vitamin K antagonists (e.g., warfarin)

If your doctor tells you to 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 tell you when to stop taking apixaban.

Patient 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.

If you take more Apixaban Tevagen than you should

Tell your doctor immediatelyif you have taken a dose higher than the prescribed dose of this medication. Bring the medication 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Apixaban Tevagen

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 with Apixaban Tevagen

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 Adverse Effects

Like all medicines, apixaban can cause adverse effects, although not all people suffer from them. This medicine can be administered for three different diseases. The known adverse effects and the frequency with which they occur may be different and are therefore indicated separately below. For these conditions, the most frequent adverse effect of this medicine 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 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, blood or fluid secretion from the wound/surgical incision (suppuration), or at the injection site
• in 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 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 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

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 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 spots under the skin surface, or hematomas.
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney failure (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, which can cause fainting or a 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, blood or fluid secretion 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).

Unknown Frequency (frequency cannot be estimated from available data)

• Inflammation of the blood vessels (vasculitis) that can cause skin rash, appearance of round and smooth spots under the skin surface, or hematomas.
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney failure (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:

• 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, which 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 surgery, including hematoma and swelling, blood or fluid secretion 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

Unknown Frequency (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 spots under the skin surface, or hematomas.
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney failure (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 Tevagen

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

Do not use this medicine after the expiration date stated on the carton, blister/pack after "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 via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Apixaban Tevagen

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

• The other ingredients are:
• Core of the tablet: lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate (vegetable).

• Coating: lactose monohydrate, hypromellose 2910 (15mPa), titanium dioxide (E171), triacetin, yellow iron oxide (E172).

See Section 2 "Apixaban Tevagen contains lactose (a type of sugar) and sodium"

Appearance of the Product and Package Contents

Apixaban Tevagen are film-coated tablets, yellow, round, biconvex, 6 mm in diameter, and 3 mm in thickness.

Apixaban Tevagen is available in the following package sizes:

Blister packs of 10, 20, 21, 60, 63, 100, 168, and 200 film-coated tablets.

Single-dose blister packs: 10x1, 20x1, 60x1, 100x1, 168x1 film-coated tablets.

Bottles with child-resistant caps containing 60 film-coated tablets.

Not all package sizes may be marketed.

Patient Information Card: Handling of Information

Inside the package of this medicine, along with the leaflet, 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 (it is attached to the inside of the carton)
2. Separate your language (it is facilitated by the perforated edge)
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 and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

Alcobendas 28108

Madrid (Spain)

Manufacturer

Combino Pharm Malta, Ltd.

HF60 Hal Far Industrial Estate

Hal Far BBG3000

Malta

Date of the Last Revision of this Leaflet:

June 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