APIXABAN 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Apixaban Aurovitas, 5 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
3. What Apixaban Aurovitas is and What it is Used for
4. Important Information Before Taking Apixaban Aurovitas
   1. When Not to Take Apixaban Aurovitas:
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Apixaban Aurovitas and Other Medications
   5. Pregnancy and Breastfeeding
   6. Driving and Using Machines
   7. Apixaban Aurovitas Contains Lactose
   8. Apixaban Aurovitas Contains Sodium
5. How to Take Apixaban Aurovitas
   1. Dose
   2. Instructions for Crushing Tablets:
   3. Apixaban Aurovitas Should be Taken as Follows in the Following Indications:
   4. Your Doctor May Switch Your Anticoagulant Treatment as Follows:
   5. Patients Undergoing Cardioversion
   6. Taking More than the Recommended Dose of Apixaban Aurovitas
   7. Missing a Dose of Apixaban Aurovitas
   8. If You Have Any Further Questions on the Use of This Medication or If You Have Missed More Than One Dose
   9. Stopping Apixaban Aurovitas Treatment
6. Possible Side Effects
   1. Frequency Not Known
   2. Very Common Side Effects(may affect more than 1 in 10 people)
   3. Frequency Not Known
   4. Reporting Side Effects
7. How to Store Apixaban Aurovitas
8. Contents of the Package and Other Information
   1. What Apixaban Aurovitas Contains
   2. What Apixaban Aurovitas Looks Like and Contents of the Package
   3. Marketing Authorization Holder and Manufacturer/Importer
   4. Marketing Authorization Holder:
   5. Manufacturer/Importer:
   6. This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:
   7. Date of Last Revision of the Package Leaflet: 03/2025

Package Leaflet: Information for the User

Apixaban Aurovitas, 5 mg, Film-Coated Tablets

Apixaban

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medication has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What Apixaban Aurovitas is and What it is Used for
• 2. Important Information Before Taking Apixaban Aurovitas
• 3. How to Take Apixaban Aurovitas
• 4. Possible Side Effects
• 5. How to Store Apixaban Aurovitas
• 6. Contents of the Package and Other Information

1. What Apixaban Aurovitas is and What it is Used for

Apixaban Aurovitas contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medication helps prevent blood clots by blocking factor Xa, which is an important factor in blood clotting.

Apixaban Aurovitas is used in adults:

• to prevent blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and travel to the brain, causing a stroke, or to other organs, reducing blood flow to those organs (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), as well as to prevent the recurrence of blood clots in the veins of the legs and/or lungs.

Apixaban Aurovitas is used in children from 28 days to less than 18 years of age to treat and prevent the recurrence of blood clots in the veins or lungs.

2. Important Information Before Taking Apixaban Aurovitas

When Not to Take Apixaban Aurovitas:

• if you are allergic to apixaban or any of the other ingredients of this medication (listed in section 6);
• if you have excessive bleeding;
• if you have a condition that increases the risk of major bleeding (such as an active or recently diagnosed stomach or intestinal ulcer, or recent bleeding in the brain);
• if you have liver disease that leads to an increased risk of bleeding (hepatic coagulopathy);
• if you are taking medications that prevent blood clotting (such as warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the treatment is being switched, when a venous or arterial access line has been inserted and heparin is being administered through this line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into a vein) due to irregular heart rhythm (arrhythmia).

Warnings and Precautions

Before starting treatment, discuss with your doctor, pharmacist, or nurse if you have any of the following conditions:

• increased risk of bleeding, such as:
• bleeding disorders, including conditions that result in reduced platelet activity;
• very high blood pressure, uncontrolled by medication;
• if you are over 75 years old;
• if you weigh 60 kg or less;
• severe kidney disease or if you are on dialysis;
• liver problems or a history of liver problems;
• Apixaban Aurovitas should be used with caution in patients with signs of liver dysfunction.
• if you have a prosthetic heart valve;
• if your doctor determines that your blood pressure is unstable or if you are scheduled for another treatment or surgery to remove a blood clot from your lungs.

When to Exercise Particular Caution When Taking Apixaban Aurovitas

If you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

If you need to undergo surgery or a procedure that may be associated with bleeding, your doctor may ask you to temporarily stop taking this medication for a short period. If you are unsure whether a procedure may be associated with bleeding, you should ask your doctor.

Children and Adolescents

Apixaban Aurovitas is not recommended for children and adolescents weighing less than 35 kg.

Apixaban Aurovitas and Other Medications

Tell your doctor, pharmacist, or nurse about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

Some medications may enhance the effect of Apixaban Aurovitas, while others may reduce its effect. Your doctor will decide whether you should receive Apixaban Aurovitas while taking other medications and how closely you should be monitored.

The following medications may enhance the effect of Apixaban Aurovitas and increase the risk of unwanted bleeding:

• certain antifungal medications(such as ketoconazole and others);
• certain antiviral medications used to treat HIV/AIDS(such as ritonavir);
• other medications used to reduce blood clotting(such as enoxaparin and others);
• anti-inflammatory or pain-relieving medications(such as acetylsalicylic acid or naproxen). Especially if you are over 75 years old and taking acetylsalicylic acid, you may be at increased risk of unwanted bleeding;
• medications used to treat high blood pressure or heart problems(such as diltiazem);
• antidepressant medications known as selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs).

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

• medications used to prevent seizures or fits(such as phenytoin and others);
• St. John's Wort(a herbal supplement used for depression);
• medications used to treat tuberculosis or other infections(such as rifampicin).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medication.

The effect of Apixaban Aurovitas on pregnancy and the unborn child is unknown. You should not take this medication during pregnancy. If you become pregnant while taking this medication, you should contact your doctor immediately.

It is not known whether Apixaban Aurovitas passes into breast milk. Before taking this medication while breastfeeding, ask your doctor, pharmacist, or nurse for advice. You may be advised to stop breastfeeding, stop, or not start taking this medication.

Driving and Using Machines

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

Apixaban Aurovitas Contains Lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medication.

Apixaban Aurovitas Contains Sodium

This medication contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially 'sodium-free'.

3. How to Take Apixaban Aurovitas

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor, pharmacist, or nurse.

Dose

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

To achieve the best effect, try to take the tablets at the same time every day.

If you have difficulty swallowing the tablets whole, talk to your doctor about other ways to take Apixaban Aurovitas. The tablet can be crushed and mixed with water or 5% glucose solution, juice, or apple puree just before taking.

Instructions for Crushing Tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the powder to a suitable container and mix it with a small amount (e.g., 30 mL or 2 tablespoons) of water or another liquid mentioned above to prepare a mixture.
• Swallow the mixture.
• Rinse the pestle and mortar used to crush the tablets and the container with a small amount of water or another liquid (e.g., 30 mL) and swallow the rinse.

Your doctor may administer a crushed Apixaban Aurovitas tablet mixed with 60 mL of water or 5% glucose solution through a nasogastric tube if necessary.

Apixaban Aurovitas Should be Taken as Follows in the Following Indications:

Prevention of blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor

The recommended dose is one 5 mg apixaban tablet twice daily.

The recommended dose is one 2.5 mg apixaban tablet twice daily if:

• you have severe kidney problems;
• two or more of the following conditions are met:
• your blood test results indicate reduced kidney function (serum creatinine level of 1.5 mg/dL or more);
• you are 80 years old or more;
• your body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one tablet in the morning and one in the evening. Your doctor will decide how long you should continue treatment.

Treatment of blood clots in the veins of the legs and blood clots in the lungs

The recommended dose is two 5 mg Apixaban Aurovitas tablets twice daily for the first 7 days, for example, two tablets in the morning and two in the evening.

After 7 days, the recommended dose is one 5 mg Apixaban Aurovitas tablet twice daily, for example, one tablet in the morning and one in the evening.

Prevention of recurrence of blood clots after completing 6 months of treatment

The recommended dose is one 2.5 mg Apixaban Aurovitas tablet twice daily, for example, one tablet in the morning and one in the evening.

Your doctor will decide how long you should continue treatment.

Use in Children and Adolescents

Treatment and prevention of recurrence of blood clots in the veins or lungs.

Always take or administer this medication exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor, pharmacist, or nurse.

To achieve the best effect, try to take or administer the dose at the same time every day.

The dose of Apixaban Aurovitas is based on body weight and will be calculated by your doctor.

The recommended dose for children and adolescents weighing 35 kg or more is two 5 mg Apixaban Aurovitas tablets twice daily for the first 7 days, for example, two in the morning and two in the evening. After 7 days, the recommended dose is one 5 mg Apixaban Aurovitas tablet twice daily, for example, one in the morning and one in the evening.

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

It is essential to follow the scheduled doctor's visits, as the dose may need to be adjusted with changes in the patient's body weight.

Your Doctor May Switch Your Anticoagulant Treatment as Follows:

• Switching from Apixaban Aurovitas to other anticoagulantsStop taking Apixaban Aurovitas. Start treatment with other anticoagulants (such as heparin) at the time of the next scheduled dose.
• Switching from other anticoagulants to Apixaban AurovitasStop taking other anticoagulants. Start Apixaban Aurovitas treatment at the time of the next scheduled dose of the other anticoagulant, and then continue with the usual dosing schedule.
• Switching from treatment with a vitamin K antagonist (such as warfarin) to Apixaban AurovitasStop taking the vitamin K antagonist. Your doctor will perform blood tests and inform you when to start taking Apixaban Aurovitas.
• Switching from Apixaban Aurovitas to treatment with a vitamin K antagonist (such as warfarin)If your doctor tells you to start taking a vitamin K antagonist, you should continue taking Apixaban Aurovitas for at least 2 days after taking the first dose of the vitamin K antagonist. Your doctor will perform blood tests and inform you when to stop taking Apixaban Aurovitas.

Patients Undergoing Cardioversion

Patients who require cardioversion to restore a normal heart rhythm should take Apixaban Aurovitas at the times specified by their doctor to prevent the formation of blood clots in the blood vessels of the brain and other parts of the body.

Taking More than the Recommended Dose of Apixaban Aurovitas

If you take more Apixaban Aurovitas than you should, contact your doctor immediately. Take the package leaflet and any remaining tablets with you.

If you take more Apixaban Aurovitas than you should, you may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatments to reverse the effect of factor Xa inhibition may be necessary.

Missing a Dose of Apixaban Aurovitas

• If you miss a morning dose, take it as soon as you remember and take the evening dose as scheduled.
• If you miss an evening dose, you can take it only on the same evening. Do not take two doses on the next morning; instead, continue with the next scheduled dose.

If You Have Any Further Questions on the Use of This Medication or If You Have Missed More Than One Dose

contact your doctor, pharmacist, or nurse.

Stopping Apixaban Aurovitas Treatment

Do not stop taking Apixaban Aurovitas without consulting your doctor, as the risk of blood clots may be higher if treatment is stopped prematurely.

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

4. Possible Side Effects

Like all medications, Apixaban Aurovitas can cause side effects, although not everybody gets them.

The most common side effect of Apixaban Aurovitas is bleeding, which can be life-threatening and may require immediate medical attention.

The following side effects may occur when taking Apixaban Aurovitas to prevent blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.

Common Side Effects(may affect up to 1 in 10 people)

• Bleeding, including:
• in the eye;
• in the stomach or intestine;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• bruising and swelling;
• Anemia, which can cause tiredness or pale skin;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Nausea (feeling sick);
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity.

Uncommon Side Effects(may affect up to 1 in 100 people)

• Bleeding:
• in the brain or spinal cord;
• in the mouth or coughing up blood;
• in the abdomen or retroperitoneal space;
• from hemorrhoids;
• blood in the stool or urine detected in laboratory tests;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• Reduced platelet count (which can affect blood clotting);
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a breakdown product of red blood cells that can cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. If you notice any of these symptoms, contact your doctor immediately.

Rare Side Effects(may affect up to 1 in 1,000 people)

• Bleeding:
• in the lungs or throat;
• in the retroperitoneal space;
• in the muscles.

Very Rare Side Effects(may affect up to 1 in 10,000 people)

• A skin rash with blisters, which looks like targets (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

Frequency Not Known

• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin or bruising.

The following side effects may occur when taking Apixaban Aurovitas to treat or prevent the recurrence of blood clots in the veins of the legs and lungs.

Common Side Effects(may affect up to 1 in 10 people)

• Bleeding, including:
• from the nose;
• from the gums;
• blood in the urine;
• bruising and swelling;
• in the stomach, intestine, or rectum;
• in the mouth;
• from the vagina;
• Anemia, which can cause tiredness or pale skin;
• Reduced platelet count (which can affect blood clotting);
• Nausea (feeling sick);
• Skin rash;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT) activity.

Uncommon Side Effects(may affect up to 1 in 100 people)

• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Bleeding:
• in the eyes;
• in the mouth or coughing up blood;
• blood in the stool;
• blood in the urine detected in laboratory tests;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• from hemorrhoids;
• in the muscles;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. If you notice any of these symptoms, contact your doctor immediately;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a breakdown product of red blood cells that can cause yellowing of the skin and eyes.

Rare Side Effects(may affect up to 1 in 1,000 people)

• Bleeding:
• in the brain or spinal cord;
• in the lungs.

Frequency Not Known

• Bleeding:
• in the abdomen or retroperitoneal space;
• A skin rash with blisters, which looks like targets (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin or bruising.

Additional Side Effects in Children and Adolescents

If you notice any of the following symptoms, contact your doctor immediately:

• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. The frequency of these side effects is "common" (may affect up to 1 in 10 people).

Generally, side effects reported in children and adolescents treated with apixaban were similar to those seen in adults and were mostly mild or moderate in severity.

Side effects that were more common in children and adolescents were nosebleeds and abnormal vaginal bleeding.

Very Common Side Effects(may affect more than 1 in 10 people)

• Bleeding, including:
• from the vagina;
• from the nose.

Common Side Effects(may affect up to 1 in 10 people)

• Bleeding, including:
• from the gums;
• blood in the urine;
• bruising and swelling;
• in the intestine or rectum;
• blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• Hair loss;
• Anemia, which can cause tiredness or pale skin;
• Reduced platelet count (which can affect blood clotting);
• Nausea (feeling sick);
• Skin rash;
• Itching;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased alanine aminotransferase (ALT) activity.

Frequency Not Known

• Bleeding:
• in the abdomen or retroperitoneal space;
• in the stomach;
• in the eyes;
• in the mouth or coughing up blood;
• in the brain or spinal cord;
• in the lungs;
• in the muscles;
• A skin rash with blisters, which looks like targets (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin or bruising;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• blood in the stool or urine.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Apixaban Aurovitas

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

Do not use this medication after the expiry date stated on the carton, bottle, and blister after EXP. The expiry date refers to the last day of that month.

There are no special storage instructions for this medication.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Apixaban Aurovitas Contains

The active substance is apixaban. Each film-coated tablet contains 5 mg of apixaban.

The other ingredients are:

Tablet core:lactose, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate.

Tablet coating:lactose monohydrate, hypromellose 2910 (6 cps), triacetin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Apixaban Aurovitas Looks Like and Contents of the Package

Film-coated tablet.

Pale pink to pink, oval, biconvex film-coated tablets with "N" embossed on one side and "5" on the other side.

Apixaban Aurovitas film-coated tablets are available in blisters and HDPE bottles in a carton.

Package sizes:

Blisters: 14, 20, 28, 56, 60, 100, 168, and 200 film-coated tablets.

HDPE bottles: 60, 100, 200, 250, and 500 (packages of 250 and 500 are for hospital use only and for pharmacies that dispense doses) film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer/Importer

Marketing Authorization Holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warsaw

e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Generis Farmacêutica, S.A.

Rua João de Deus 19, Venda Nova

2700-487 Amadora

Portugal

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

Belgium:

Apixaban AB 5 mg filmomhulde tabletten

Apixaban AB 5 mg comprimés pelliculés

Apixaban AB 5 mg Filmtabletten

Germany:

Apixaban PUREN 5 mg Filmtabletten

France:

Apixaban Arrow 5 mg, comprimé pelliculé

Netherlands:

Apixaban Aurobindo 5 mg, filmomhulde tabletten

Poland:

Apixaban Aurovitas

Portugal:

Apixabano Generis

Spain:

Apixabán Aurovitas 5 mg comprimidos recubiertos con película EFG

Date of Last Revision of the Package Leaflet: 03/2025