Aboxoma

Package Leaflet: Information for the User

Aboxoma, 2.5 mg, film-coated tablets

Apixaban

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

• You should keep this leaflet, as 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 experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet

• 1. What Aboxoma is and what it is used for
• 2. Important information before taking Aboxoma
• 3. How to take Aboxoma
• 4. Possible side effects
• 5. How to store Aboxoma
• 6. Contents of the pack and other information

1. What Aboxoma is and what it is used for

Aboxoma contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots from forming by blocking factor Xa, which is an important factor in blood clotting.
Aboxoma is used in adults:

• to prevent blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, the patient is at increased risk of blood clots in the legs. This can lead to swelling of the legs, with or without pain. If a blood clot travels from the leg to the lungs, it can block blood flow to the lungs, causing shortness of breath with chest pain or without. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
• 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 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 legs and/or lungs.

Aboxoma is used in children from 28 days to less than 18 years of age to treat and prevent blood clots in the veins or blood vessels of the lungs.
Information on body weight and recommended dose can be found in section 3.

2. Important information before taking Aboxoma

When not to take Aboxoma

• 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 an organ diseasethat increases the risk of serious bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recent brain bleeding),
• If you have liver diseasethat increases the risk of bleeding (liver coagulopathy),
• If you are taking anticoagulant medicines(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the treatment is changed, when a venous or arterial access line is inserted in the patient and heparin is administered through this line to maintain its patency or when the patient is undergoing catheter ablation (a catheter is inserted into his 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 those that result in decreased 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 disease or a history of liver disease.
• Aboxoma should be used with caution in patients with signs of liver function changes.
• Tube (catheter) or injection into the spine(anesthetic or pain reliever), in which case the doctor will recommend taking Aboxoma after 5 or more 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 other treatment or surgery is planned to remove a blood clot from the lungs.

When taking Aboxoma, be careful 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 medicine for a short time. If you are unsure whether a given procedure may be associated with bleeding, you should ask your doctor.

Children and adolescents

Aboxoma is not recommended for children and adolescents with a body weight below 35 kg.

Aboxoma and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may increase the effect of Aboxoma, and some may reduce its effect. Your doctor will decide whether you should receive Aboxoma while taking other medicines and how closely you should be monitored.
The following medicines may increase the effect of Aboxoma 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 medicines used to reduce blood clotting(e.g., enoxaparin and others);
• Pain relievers or anti-inflammatory 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 disease(e.g., diltiazem);
• Antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin and norepinephrine reuptake inhibitors.

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

• Medicines used to treat epilepsy or seizures(e.g., phenytoin and others);
• St. John's Wort(a herbal supplement used for depression);
• Medicines used 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 have a child, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
The effect of Aboxoma on pregnancy and the unborn child is not known. You should not take Aboxoma during pregnancy. If you become pregnant while taking Aboxoma, you should contact your doctor immediately.
It is not known whether Aboxoma passes into breast milk. Before taking this medicine while breastfeeding, ask your doctor, pharmacist, or nurse for advice. You may be advised to stop breastfeeding or not to start taking this medicine.

Driving and using machines

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

Aboxoma contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially 'sodium-free'.

3. How to take Aboxoma

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. Aboxoma 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 problems swallowing the tablets whole, talk to your doctor about other ways to take Aboxoma. 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, then mix it with a small amount, e.g., 30 mL (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) and swallow the rinse liquid.

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

Aboxoma should be taken as recommended in the following indications:

Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one Aboxoma 2.5 mg tablet twice a day. For example, one tablet in the morning and one in the evening.
Take the first tablet 12 to 24 hours after surgery.
If you have had major hip replacement surgery, you will usually take the tablets for 32 to 38 days.
If you have had major knee replacement 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 and at least one additional risk factor
The recommended dose is one Aboxoma 5 mg tablet twice a day.
The recommended dose is one Aboxoma 2.5 mg tablet twice a day if:

• you have severe kidney problems,
• two or more of the following conditions are met:
• -your blood test results suggest decreased kidney function (serum creatinine level of 1.5 mg/dL (133 micromole/L) or higher),
• -you are 80 years old or older,
• -your body weight is 60 kg or less.

The recommended dose is one tablet twice a day, for example, one tablet in the morning and one in the evening. Your doctor will decide how long to continue treatment.
Treatment of blood clots in the legs and blood vessels of the lungs
The recommended dose is twoAboxoma 5 mg tablets twice a day for the first 7 days, for example, two tablets in the morning and two in the evening.
After 7 days, the recommended dose is oneAboxoma 5 mg tablet twice a day, 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 Aboxoma 2.5 mg tablet twice a day, for example, one tablet in the morning and one in the evening. Your doctor will decide how long to continue treatment.
Use in children and adolescents
Treatment and prevention of blood clots in the veins or blood vessels of the lungs.
This medicine should always be taken or given as directed by your doctor or pharmacist. 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 depends on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents weighing 35 kg or more is fourAboxoma 2.5 mg tablets, given twice a day for the first 7 days, for example, four in the morning and four in the evening. After 7 days, the recommended dose is twoAboxoma 2.5 mg tablets, given twice a day, for example, two in the morning and two in the evening.
For parents and caregivers: you should observe the child to ensure that the full dose is taken.
It is important to follow the scheduled visits to the doctor, as the dose may need to be adjusted with changes in the patient's body weight.

Your doctor may change your anticoagulant treatment as follows:

• Switching from Aboxoma to anticoagulant medicinesStop taking Aboxoma. Start treatment with anticoagulant medicines (e.g., heparin) at the time of the next scheduled dose.
• Switching from anticoagulant medicines to AboxomaStop taking anticoagulant medicines. Start treatment with Aboxoma at the time of the next scheduled dose of anticoagulant medicine, and then continue with the usual intake.
• Switching from treatment with a vitamin K antagonist (e.g., warfarin) to AboxomaStop taking the vitamin K antagonist. Your doctor will perform blood tests and inform you when to start taking Aboxoma.
• Switching from Aboxoma to treatment with a vitamin K antagonist (e.g., warfarin)If your doctor tells you to start taking a vitamin K antagonist, you should continue taking Aboxoma 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 Aboxoma.

Patients undergoing cardioversion

Patients who need to undergo cardioversion to restore a normal heart rhythm should take this medicine at the times specified by their doctor to prevent blood clots in the blood vessels of the brain and other blood vessels.

What to do if you take more Aboxoma than you should

If you take more Aboxoma than you should, contact your doctor immediately.
Take the package with you, even if it is empty.
If you take more Aboxoma than you should, you may be at increased risk of bleeding. If you experience bleeding, you may need surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition.

What to do if you miss a dose of Aboxoma

• If you miss a morning dose, take it as soon as you remember and take the evening dose as usual.
• If you miss an evening dose, you can take it only on the same evening. Do not take two doses the next morning, instead, continue taking the medicine the next day as recommended, twice a day.

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

one dose, ask your doctor, pharmacist, or nurse.

Stopping treatment with Aboxoma

Do not stop taking Aboxoma without consulting your doctor, as the risk of blood clots may be higher if you stop taking this medicine too early.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Aboxoma can cause side effects, although not everybody gets them.
Aboxoma 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 this medicine is bleeding, which can be life-threatening and may require immediate medical attention.
The following side effects may occur when taking Aboxoma 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 fatigue or pale skin;
• Bleeding, including:
• -bruising and swelling;
• Nausea (vomiting).

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

• Decreased platelet count (which can affect blood clotting);
• Bleeding:
• -after surgery, including bruising and swelling, bleeding or fluid leakage from the wound or surgical incision (wound discharge) or injection site;
• -from the stomach, intestines, or rectum;
• -blood in the urine;
• -from the nose;
• -from the genital tract;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Blood test results may indicate:
• -liver function disorders;
• -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, as well as difficulty breathing. In case of any of these symptoms, contact your doctor immediately;
• Bleeding:
• -into the muscle;
• -into 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:
• -into the brain or spinal cord;
• -into the lungs or throat;
• -into the abdominal cavity or retroperitoneal space;
• -from hemorrhoids;
• -blood test results indicating blood in the stool or urine;
• A skin rash, which can 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 surface, or bruising;
• Bleeding in the kidneys, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

The following side effects may occur when taking Aboxoma 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:
• -into the eye;
• -into the stomach or intestines;
• -from the rectum;
• -blood in the urine;
• -from the nose;
• -from the gums;
• -bruising and swelling;
• Anemia, which can cause fatigue or pale skin;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Nausea (vomiting);
• 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 throat;
• -into the abdominal cavity or genital tract;
• -bright red blood in the stool;
• -bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the wound or surgical incision (wound discharge) or injection site;
• -from hemorrhoids;
• Decreased 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 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, as well as difficulty breathing. In case of 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 retroperitoneal space;
• -into the muscle.

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 surface, or bruising;
• Bleeding in the kidneys, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

The following side effects may occur when taking Aboxoma to treat or prevent blood clots in the legs and blood vessels of the 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, intestines, or rectum;
• from the mouth;
• from the genital tract;
• Anemia, which can cause fatigue or pale skin;
• Decreased platelet count (which can affect blood clotting);
• Nausea (vomiting);
• 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:
• into the eyes;
• into the mouth or throat;
• bright red blood in the stool;
• blood test results indicating blood in the stool or urine;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the wound or surgical incision (wound discharge) 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, as well as difficulty breathing. In case of 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 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 retroperitoneal space.
• A skin rash, which can 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 surface, or bruising;
• Bleeding in the kidneys, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

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, as well as difficulty breathing. The frequency of these side effects is "common" (may affect up to 1 in 10 people).

Generally, the side effects observed in children and adolescents treated with Aboxoma were similar to those observed in adults and were mostly mild or moderate.
The side effects that occurred more frequently 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;
• from the intestines or rectum;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the wound or surgical incision (wound discharge) or injection site;
• Hair loss;
• Anemia, which can cause fatigue or pale skin;
• Decreased platelet count (which can affect blood clotting);
• Nausea (vomiting);
• 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 (cannot be estimated from the available data)

• Bleeding:
• into the abdominal cavity or retroperitoneal space;
• into the stomach;
• into the eyes;
• into the mouth;
• from hemorrhoids;
• into the mouth or throat;
• into the brain or spinal cord;
• into the lungs;
• into the muscle;
• A skin rash, which can 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 surface, or bruising;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• blood in the stool or urine;
• Bleeding in the kidneys, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Pharmacovigilance Department, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aboxoma

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 after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
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 Aboxoma contains

• The active substance is apixaban. Each film-coated tablet contains 2.5 mg of apixaban.
• The other ingredients are: microcrystalline cellulose (E 460), lactose monohydrate, sodium croscarmellose (E 468), sodium lauryl sulfate, hydroxyethyl cellulose, magnesium stearate (E 470b) in the tablet core, and hypromellose (E 464), propylene glycol (E 1520), titanium dioxide (E 171), and talc (E 553b) in the coating. See section 2 "Aboxoma contains lactose and sodium".

What Aboxoma looks like and contents of the pack

White, round, biconvex film-coated tablets (tablets) marked with the number 2.5 on one side of the tablet.
Tablet size: diameter approximately 6 mm.
Aboxoma is available in packs containing:

• 20, 56, or 60 film-coated tablets. Not all pack sizes may be marketed.

Patient Card: Information for use

Inside the Aboxoma package, along with the patient leaflet, you will find a Patient Card or your doctor may give you a similar card.
The Patient Card contains information that is helpful to you and warns other doctors that you are taking Aboxoma. Always carry this card with you.

• 1. Take the card.
• 2. If necessary, separate the relevant language (this is facilitated by perforated edges).

• 3. Fill in the following points or ask your doctor to fill them in:
• Name:
• Date of birth:
• Indication:
• Body weight (for children and adolescents):
• Dose: … mg twice a day
• Doctor's name:
• Doctor's phone number:
• 4. Fold the card and always carry it with you.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of last revision of the leaflet: 15.05.2025