APIXABAN TEVA 2.5 mg FILM-COATED TABLETS

2. What you need to know before taking Apixaban Teva

Do not take Apixaban Teva

• if you are allergicto apixaban or any of the other ingredients of this medication (listed in section 6)
• if you bleed excessively
• if 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)
• if you have a liver diseasethat increases the risk of bleeding (hepatic coagulopathy)
• if you are taking medications to prevent blood coagulation(such as warfarin, rivaroxaban, dabigatran, or heparin), except when switching to another anticoagulant 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 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 your 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.
• if you have a prosthetic heart valve
• 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 Teva

• 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 medication for a while. If you are not sure if a procedure may cause bleeding, consult your doctor.

Children and adolescents

The use of this medication is not recommended in children and adolescents with a body weight below 35 kg.

Other medications and Apixaban Teva

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might 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 monitored more closely.

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

• some medications for fungal infections(such as ketoconazole, etc.),
• some antiviral medications for HIV/AIDS(such as ritonavir),
• other medications to reduce blood coagulation(such as enoxaparin, etc.),

• anti-inflammatory medicationsor medications for pain relief(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,

• medications for high blood pressure or heart problems(such as diltiazem),
• antidepressantscalled selective serotonin reuptake inhibitorsor serotonin-norepinephrine reuptake inhibitors.

The following medications may reduce the ability of apixaban to prevent blood clots.

• medications for the treatment of epilepsy or seizures(such as phenytoin, etc.),
• St. John's Wort(a herbal medication for the treatment of depression),
• medications 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, 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. 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 Teva 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 Teva

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 whole tablet, 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 other liquids mentioned to make the mixture.
• Take the mixture.
• Rinse the mortar and pestle 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 Apixaban Teva 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 another in the evening.

You should take the first tablet between 12 to 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 decreased kidney function
• 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 of age 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 another 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 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 another in the evening.

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

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

Your doctor will indicate 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 administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor, pharmacist, or nurse.

Try to take or administer the dose at the same time every day to achieve a better treatment effect.

The dose of apixaban depends on body weight and will be calculated by your doctor. The recommended dose for children and adolescents with a weight of at least 35 kg is four 2.5 mg apixaban tabletstwice a day for the first 7 days, for example, four tablets in the morning and four in the evening.

After 7 days, the recommended dose is two 2.5 mg apixaban tabletstwice a day, for example, two tablets in the morning and two in the evening.

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

It is essential to respect scheduled visits to the doctor, as it may be necessary to adjust the dose based on weight changes.

Your doctor may change your anticoagulant treatment as follows:

• Changing from Apixaban Teva to anticoagulant medications

Stop taking this medication. Start treatment with anticoagulant medications (for example, heparin) at the time you would take the next tablet.

• Changing from anticoagulant medications to Apixaban Teva

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

• Changing from a treatment with anticoagulants that contain Vitamin K antagonists (for example, warfarin) to Apixaban Teva

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.

• Changing from Apixaban Teva to a treatment with anticoagulants that contain a Vitamin K antagonist (for example, 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 heart rhythm 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 Teva than you should

Inform your doctor immediatelyif you have taken a dose greater than the prescribed dose of this medication.

Take 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 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 Teva

• If you forget a morning dose, take it as soon as you remember and you can take it with the evening dose.
• If you forget an evening dose, you can only take it during that same night. Do not take two doses the next morning, but instead, continue taking the medication the next day as usual, twice a day as recommended.

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 Teva

DO NOT interrupt treatment with this medication without first talking to your doctor, because the risk of developing a blood clot may be greater if you interrupt treatment too soon.

If you have any other doubts 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 their frequency may be different and are therefore indicated separately below. For these conditions, the most frequent adverse effect of this medicine is bleeding, which can endanger the patient's life and requires immediate medical attention.

The following adverse effects have been reported when taking apixaban for the preventionof the formationof 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 injection site
• in the stomach, intestine, or bright red blood in the stool
• blood in the urine
• from the nose
• vaginal

• Low blood pressure that 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 that show 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 can cause the kidneys to fail to function properly (anticoagulant-related nephropathy).

The following adverse effects have been reported when taking apixaban to prevent the formationof 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 that 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 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
• inside 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 (cannot be estimated from 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 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 the recurrence of blood clots 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 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, including hematoma and swelling, blood or fluid secretion 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
• 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 (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 red spots under the skin surface, or hematomas.
• 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, including:
• • Vaginal
  • Nasal

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Bleeding, including:
• • from the gums;
  • blood in the urine;
  • hematoma and swelling;
  • from the intestine or rectum;
  • bright red blood in the stool;
  • bleeding after surgery, including hematoma and swelling, blood or fluid secretion 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 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).

Unknown Frequency (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 round and smooth red spots under the skin surface, or hematomas;
• 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 Medicines and Healthcare Products Agency's (AEMPS) online system: 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 Teva

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, and bottle 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. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Apixaban Teva

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

The other ingredients are:

• Core of the tablet: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.

• Coating: lactose monohydrate (see section 2), hypromellose (E464), titanium dioxide (E171), macrogol 3350, triacetin, red iron oxide (E172), yellow iron oxide (E172).

Appearance of the Product and Package Contents

The tablets are light yellow, film-coated, round, with "TV" engraved on one side and "G1" on the other side. Dimensions: 5.9 - 6.5 mm in diameter, 3.0 - 3.6 mm in thickness.

They are available in:

• Single-dose blisters containing 10 x 1, 14 x 1, 20 x 1, 30 x 1, 56 x 1, 60 x 1, 100 x 1, 120 x 1, 168 x 1, 200 x 1 film-coated tablets.

• Bottles containing 180, 200, and 500 film-coated tablets.

• Bottles containing 180, 200, and 500 film-coated tablets, including cotton.

Not all pack sizes may be marketed.

Patient Information Card: Managing 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

1. 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

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitsa, 2600.

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria:

Apixaban ratiopharm 2.5 mg Filmtabletten

Belgium:

Apixaban Teva 2.5 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten

Bulgaria:

????????? ???? 2,5 mg ????????? ????????

Czech Republic:

Apixaban Teva

Germany:

Apixaban-ratiopharm 2.5 mg Filmtabletten

Denmark:

Apixaban Teva

Estonia:

Apixaban Teva

Spain:

Apixaban Teva 2.5 mg comprimidos recubiertos con película EFG

Finland:

Apixaban ratiopharm 2.5 mg tabletti, kalvopäällysteinen

France:

Apixaban TEVA 2.5 mg, comprimé pelliculé

Croatia:

Apiksaban Teva 2.5 mg filmom obložene tablete

Hungary:

Apixaban-Teva 2.5 mg filmtabletta

Ireland:

Apixaban Teva 2.5 mg Filmcoated Tablets

Iceland:

Apixaban Teva

Italy:

APIXABAN TEVA

Lithuania:

Apixaban Teva 2,5 mg plevele dengtos tabletes

Latvia:

Apixaban Teva 2,5 mg apvalkotas tablets

Luxembourg:

Apixaban-ratiopharm 2.5 mg Filmtabletten

Netherlands:

Apixaban Teva 2,5 mg, filmomhulde tabletten Teva B.V.

Norway:

Apixaban Teva

Poland:

Apixaban Teva

Romania:

Apixaban Teva BV 2,5 mg comprimate filmate

Sweden:

Apixaban Teva 2,5mg filmdragerade tabletter

Slovenia:

Apiksaban Teva 2,5 mg filmsko obložene tablete

Slovakia:

Apixaban Teva 2,5 mg

United Kingdom:

Apixaban Teva 2.5 mg Filmcoated Tablets

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 Healthcare Products (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85787/P_85787.html