Apixaban Aurovitas

Package Leaflet: Information for the User

Apixaban Aurovitas, 2.5 mg, film-coated tablets

Apixaban

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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 pack 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. It helps prevent blood clots from forming by blocking factor Xa, which is an important factor in blood clotting.

Apixaban Aurovitas is used in adults to:

• prevent blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, you may be at increased risk of blood clots in the veins of your legs. This can lead to swelling of your legs, with or without pain. If a blood clot breaks loose from your leg, it can travel to your lungs, which can block the flow of blood in your lungs and cause shortness of breath, chest pain, or even death.
• 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.
• treat blood clots in the veins of your legs (deep vein thrombosis) and blood clots in the blood vessels of your lungs (pulmonary embolism), as well as prevent new blood clots from forming in your legs and/or lungs.

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

2. Important information before taking Apixaban Aurovitas

When not to take Apixaban Aurovitas:

• If you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6);
• If you have excessive bleeding;
• If you have a condition that increases the risk of major bleeding(such as active or recent stomach or intestinal ulcers, recent bleeding in the brain);
• If you have liver diseasethat increases the risk of bleeding (hepatic coagulopathy);
• If you are taking other anticoagulant medicines(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the treatment is being switched, when a patient has a venous or arterial line 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 their vein) for irregular heart rhythm (arrhythmia).

Warnings and precautions

Before taking Apixaban Aurovitas, 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 lead to reduced platelet activity;
• Very high blood pressurethat is not controlled with 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 had a tube (catheter) or injection into your spine, your doctor will advise you to take Apixaban Aurovitas at least 5 hours after the catheter is removed;
• If you have a heart valve replacement;
• 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 be extra careful 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 have surgery or a procedure that may cause bleeding, your doctor may ask you to stop taking Apixaban Aurovitas for a short time. If you are unsure whether a procedure may cause 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 medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or might take.

Some medicines may increase the effect of Apixaban Aurovitas and increase the risk of unwanted bleeding. Your doctor will decide whether you should take Apixaban Aurovitas while taking other medicines and how closely you should be monitored.

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

• Some antifungal medicines(e.g., ketoconazole and others);
• Some antiviral medicines used to treat HIV/AIDS(e.g., ritonavir);
• Other anticoagulant medicines(e.g., enoxaparin and others);
• Anti-inflammatory or pain-relieving medicines(e.g., 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;
• Medicines used to treat high blood pressure or heart problems(e.g., diltiazem);
• Antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs).

The following medicines may reduce the ability of Apixaban Aurovitas to prevent blood clots:

• Medicines used to treat epilepsy or seizures(e.g., phenytoin and others);
• St. John's Wort (a herbal supplement used to treat depression);
• Medicines used to treat tuberculosis or other infections(e.g., 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 medicine.

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

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

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 by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Apixaban Aurovitas contains sodium

This medicine 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 medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

Dose

Swallow the tablet with water. Apixaban Aurovitas can be taken with or without food. To get 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, 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 make 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 or 2 tablespoons) and swallow the rinse liquid.

If necessary, your doctor may give you a crushed Apixaban Aurovitas tablet mixed with 60 mL of water or 5% glucose solution through a nasogastric tube.

Apixaban Aurovitas should be taken as follows in the following indications:

Prevention of blood clots after hip or knee replacement surgery.

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.

The first tablet should be taken 12 to 24 hours after surgery.

If you have had major hip surgery, you will usually take the tablets for 32 to 38 days.

If you have had major knee surgery, you will usually take the tablets for 10 to 14 days.

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;
• you meet two or more of the following conditions:
• 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 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 new 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 blood clots in the veins or lungs.

This medicine should always be taken or given exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

To get the best effect, try to take or give the tablets at the same time every day.

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

The recommended dose for children and adolescents weighing 35 kg or more is four 2.5 mg Apixaban Aurovitas tablets twice daily 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 Aurovitas tablets twice daily, for example, two tablets in the morning and two in the evening.

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

It is important 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 taking other anticoagulants (e.g., heparin) when the next Apixaban Aurovitas tablet is due.
• Switching from other anticoagulants to Apixaban AurovitasStop taking other anticoagulants. Start taking Apixaban Aurovitas when the next dose of the other anticoagulant is due, and then continue with the usual intake.
• Switching from vitamin K antagonist therapy (e.g., 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 vitamin K antagonist therapy (e.g., 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 need to undergo a procedure to restore a normal heart rhythm (cardioversion) should take Apixaban Aurovitas at the times specified by their doctor to prevent blood clots from forming in the blood vessels of the brain and other parts of the body.

What to do if you take more Apixaban Aurovitas than you should

If you take more Apixaban Aurovitas than you should, contact your doctor immediately. Take the package with you, even if it is empty.

If you take more Apixaban Aurovitas than you should, you may be at increased risk of bleeding, which can be life-threatening and may require surgical intervention, blood transfusion, or other treatment to reverse the effect of apixaban.

What to do if you miss a dose of Apixaban Aurovitas

• If you miss a morning dose, take it as soon as you remember and take the evening dose as usual. You can take the missed morning dose at the same time as the evening dose.
• If you miss an evening dose, you can take it the same evening. Do not take two doses the next morning, instead, continue with your normal schedule of two doses a day.

If you have any further questions on the use of this product or if you have missed more than one dose

ask your doctor, pharmacist, or nurse.

Stopping Apixaban Aurovitas

Do not stop taking Apixaban Aurovitas without talking to your doctor first, as stopping treatment too early may increase the risk of blood clots.

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

4. Possible side effects

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

Apixaban Aurovitas can be used in three different medical conditions. The known side effects and their frequency may vary in each of these conditions and are listed separately below. In these conditions, the most common overall 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 after hip or knee replacement surgery.

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

• Anemia, which can cause tiredness or pale skin;
• Bleeding, including:
• -bruising and swelling;
• Nausea (feeling sick).

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

• Reduced platelet count (which can affect blood clotting);
• Bleeding:
• after surgery, including bruising and swelling, bleeding or fluid leakage from the wound/incision or injection site;
• from the stomach or intestines, or black stools;
• blood in the urine;
• from the nose;
• from the vagina;
• Low blood pressure, which can cause dizziness or fainting;
• Blood test results may indicate:
• liver problems;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, 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), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.
• Bleeding:
• into the muscle;
• into the eyes;
• from the gums and coughing up blood;
• from the anus;
• Hair loss.

Frequency not known(cannot be estimated from the available data)

• Bleeding:
• into the brain or spinal cord;
• into the lungs or throat;
• into the abdominal cavity or the space behind the abdominal cavity;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• A skin rash that may form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, 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.

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

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

• Bleeding, including:
• into the eye;
• from the stomach or intestines;
• from the anus;
• 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 cause dizziness or fainting;
• 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:
• into the brain or spinal cord;
• into the mouth or coughing up blood;
• into the abdominal cavity or the space behind the abdominal cavity;
• black stools;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the wound/incision or injection site;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• Reduced platelet count (which can affect blood clotting);
• Blood test results may indicate:
• liver problems;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which 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, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.

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

• Bleeding:
• into the lungs or throat;
• into the abdominal cavity or the space behind the abdominal cavity;
• into the muscle.

Very rare side effects(may affect up to 1 in 10,000 people)

• A skin rash that may form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme).

Frequency not known(cannot be estimated from the available data)

• 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 blood clots in 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;
• from the stomach or intestines, or from the anus;
• from 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 cause dizziness or fainting;
• Bleeding:
• into the eyes;
• into the mouth or coughing up blood;
• black stools;
• blood test results indicating blood in the stool or urine;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the wound/incision or injection site;
• from hemorrhoids;
• into the muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.
• Blood test results may indicate:
• liver problems;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes.

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

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

Frequency not known(cannot be estimated from the available data)

• Bleeding:
• into the abdominal cavity or the space behind the abdominal cavity.
• A skin rash that may form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, 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 experience 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, and difficulty breathing. The frequency of these side effects is "common" (may affect up to 1 in 10 people).

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

The following side effects were seen more frequently in children and adolescents:

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;
• from the intestines or anus;
• black stools;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the wound/incision 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 cause dizziness or fainting;
• Blood test results may indicate:
• liver problems;
• increased activity of certain liver enzymes;
• increased alanine aminotransferase (ALT) activity.

Frequency not known (cannot be estimated from the available data)

• Bleeding:
• into the abdominal cavity or the space behind the abdominal cavity;
• into the stomach;
• into the eyes;
• into the mouth or coughing up blood;
• from hemorrhoids;
• into the brain or spinal cord;
• into the lungs;
• into the muscle;
• A skin rash that may form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, 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 of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Side effects can be reported to the national reporting system listed below.

You can also report side effects directly via the national reporting system.

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

5. How to store Apixaban Aurovitas

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

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

No special storage precautions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Apixaban Aurovitas contains

The active substance is apixaban. Each film-coated tablet contains 2.5 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 pack

Film-coated tablet.

Light yellow to yellow, round, biconvex film-coated tablet, with "N" engraved on one side and "2.5" on the other side.

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

Pack sizes:

Blisters: 10, 14, 20, 28, 56, 60, 100, 168, and 200 film-coated tablets.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warszawa

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:

Apixaban AB 2.5 mg filmomhulde tabletten

Apixaban AB 2.5 mg comprimés pelliculés

Apixaban AB 2.5 mg Filmtabletten

Germany:

Apixaban PUREN 2.5 mg Filmtabletten

France:

Apixaban Arrow 2.5 mg, comprimé pelliculé

Netherlands:

Apixaban Aurobindo 2.5 mg, filmomhulde tabletten

Poland:

Apixaban Aurovitas

Portugal:

Apixabano Generis

Spain:

Apixabán Aurovitas 2.5 mg comprimidos recubiertos con película EFG

Date of last revision of the package leaflet: 03/2025