APIXABAN VIATRIS 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Apixaban Viatris 2.5 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask 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, ask 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 Viatris and what is it used for
2. What you need to know before taking Apixaban Viatris
3. How to take Apixaban Viatris
4. Possible side effects
5. Storage of Apixaban Viatris
6. Package contents and additional information

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

Apixaban Viatris 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 Viatris 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 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 Viatris

Do not take Apixaban Viatris

• 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 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

Inform 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 diseases that result in decreased platelet activity
• uncontrolled high blood pressure
• 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 have 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
• 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 Viatris

• 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 to undergo surgery or a procedure that may cause bleeding, your doctor will tell you to temporarily stop taking this medication for a short time. If you are unsure if a procedure may cause bleeding, ask 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 Viatris

Inform your doctor, pharmacist, or nurse if you are using, have recently used, or may need to use any other medication.

Some medications may increase the effects of apixaban, and others 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 and norepinephrine reuptake inhibitors

The following medications may reduce the ability of apixaban to prevent blood clot formation:

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor, pharmacist, or nurse before taking this medication.

The effects of apixaban Viatris on pregnancy and the fetus are unknown. You should not take this medication if you are pregnant. Inform your doctor immediatelyif you become pregnant while taking this medication.

It is unknown if apixaban is excreted in breast milk. Ask your doctor, pharmacist, or nurse 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 not been shown to alter the ability to drive or use machines.

Apixaban Viatris 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 Viatris

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, ask your doctor, pharmacist, or nurse.

Dosage

Take the tablet with water. Apixaban Viatris 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.

Instructions for crushing:

• 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 for 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 (e.g., 30 ml), and take that liquid.

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

Take Apixaban Viatris according to the following recommendations:

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

The recommended dose is one Apixaban Viatris 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 apixaban 5mgtablet twice a day.

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

• you have severely decreased kidney function
• you have two or more of the following factors:

• your blood test results suggest poor kidney function (creatinine serum 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 treatment.

To Treat Blood Clots in the Veins of the Legs and in the Blood Vessels of the Lungs

The recommended dose is twoapixaban 5mgtablets 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 5mgtablet 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 2.5mgtablet 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 Viatris to anticoagulant medications

Stop taking Apixaban Viatris. Start treatment with anticoagulant medications (e.g., heparin) at the time you would take the next Apixaban Viatris tablet.

• Switching from anticoagulant medications to Apixaban Viatris

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

• Switching from treatment with anticoagulants containing vitamin K antagonists (e.g., warfarin) to Apixaban Viatris

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

• Switching from Apixaban Viatris to anticoagulant treatment containing vitamin K antagonists (e.g., warfarin)

If your doctor tells you to start taking a medication containing a vitamin K antagonist, continue taking Apixaban Viatris for at least 2 days after your first dose of the medication containing a vitamin K antagonist. Your doctor will need to perform blood tests and tell you when to stop taking apixaban.

Patients Undergoing Cardioversion

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

If You Take More Apixaban Viatris Than You Should

Inform your doctor immediatelyif you have taken a dose greater 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 call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Apixaban Viatris

Do not take a double dose to make up for forgotten tablets.

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 Viatris

Do not interrupt treatment with this medication without first talking to your doctor, as the risk of developing a blood clot may be greater if treatment is interrupted too soon.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible 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 they are indicated separately below. For these diseases, 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 blood clot formation in hip or knee replacement surgeries.

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 platelet count in blood (which can affect coagulation)
• Bleeding:

• after surgery, including hematoma and swelling, bleeding or fluid from the wound/incision, or at the injection site
• from the stomach, intestine, or blood in the stool
• blood in the urine
• from the nose
• vaginal

• Low blood pressure, which can cause fainting or 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 small, round, and smooth red spots under the skin surface or hematomas.

The following adverse effects have been reported when taking Apixaban Viatris to prevent the formation of 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 and coughing up blood
• in the abdomen or vagina
• bright red blood in the stool
• bleeding after surgery, including hematoma and swelling, discharge 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 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. 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 small, round, and smooth red spots under the skin surface or hematomas.

The following adverse effects have been reported when taking Apixaban Viatris 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 and coughing up blood
• bright red blood in the stool
• tests showing blood in the stool or urine
• bleeding after surgery, including hematoma and swelling, discharge 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. Inform 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 product derived from 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 small, round, and smooth red spots under the skin surface or hematomas.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an 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 Viatris

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

Do not use this medicine after the expiration date stated on the carton and on each blister, 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. Deposit the containers and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Contents of Apixaban Viatris

• The active ingredient is apixaban. Each tablet contains 2.5 mg of apixaban.
• The other ingredients are:
• • Core of the tablet: , microcrystalline cellulose (E-460), sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (E-470b).
  • Coating: , hypromellose (E-464), titanium dioxide (E-171), triacetin, yellow iron oxide (E-172).

Appearance of the product and package contents

The film-coated tablets are yellow, round (approximately 6 mm wide), biconvex (curved surfaces on both sides), and are marked with "IU1" on one side and smooth on the other.

Apixaban Viatris is available in:

• blister packs in cartons containing 10, 20, 56, 60, 100, 168, and 200 tablets or
• unit-dose blister packs in cartons of 10x1, 20x1, 56x1, 60x1, 100x1, 168x1, or 200x1 tablets or
• bottles with 60, 120, 180, or 1,000 tablets. The 60-tablet bottles have a child-resistant screw cap.

Not all pack sizes may be marketed.

Patient information card: information management

This leaflet contains a Patient Information Card. This Patient Information Card includes useful information for you and will inform other doctors that you are being treated with Apixaban Viatris. You must keep this card with you at all times.

Cut out the card from the leaflet and 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:

Carry this card with you at all times.

Marketing authorization holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturers

McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Or

Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352, Germany.

Or

Mylan Hungary Kft.

2900 Komárom

Mylan utca 1

Hungary

This medicine has been authorized in the EEA member states with the following names:

Germany Apixaban Mylan 2.5 mg Filmtabletten

Austria Apixaban Mylan 2.5 mg Filmtabletten

Belgium Apixaban Mylan 2.5 mg filmomhulde tabletten

Bulgaria Apixaban Mylan 2.5 mg film-coated tablets

Cyprus Apixaban / Mylan 2.5 mg film-coated tablets

Denmark Apixaban Mylan

Spain Apixabán Viatris 2.5 mg film-coated tablets EFG

Estonia Apixaban Mylan

Finland Apixaban Mylan

France Apixaban Viatris 2.5 mg film-coated tablets

Greece Apixaban / Mylan 2.5 mg film-coated tablets

Hungary Apixaban 2.5 mg filmtabletta

Ireland Apixaban Mylan 2.5 mg film-coated tablets

Iceland Apixaban Mylan

Italy Apixaban Mylan

Latvia Apixaban Mylan 2.5 mg apvalkotas tabletes

Lithuania Apixaban Mylan 2.5 mg plevele dengtos tabletės

Luxembourg Apixaban Mylan 2.5 mg comprimés pelliculés

Malta Apixaban Mylan 2.5 mg film-coated tablets

Norway Apixaban Mylan

Netherlands Apixaban Mylan 2.5 mg, filmomhulde tabletten

Portugal Apixabano Mylan

Czech Republic Apixaban Mylan

Slovakia Apixaban Mylan 2.5 mg

Sweden Apixaban Mylan

United Kingdom (Northern Ireland) Apixaban Mylan 2.5 mg film-coated tablets

Date of last revision of this leaflet:April 2022.

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