ABOXOMA 5 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Aboxoma, 5 mg, coated tablets
   1. You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Aboxoma and what is it used for
4. Important information before taking Aboxoma
   1. When not to take Aboxoma
   2. Warnings and precautions
   3. Children and adolescents
   4. Aboxoma and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Aboxoma contains lactose and sodium
5. How to take Aboxoma
   1. Dose
   2. Instructions for crushing tablets:
   3. Aboxoma should be taken as recommended in the following indications:
   4. Your doctor may switch your anticoagulant treatment as follows:
   5. Patients undergoing cardioversion
   6. Taking more Aboxoma than recommended
   7. Missing a dose of Aboxoma
   8. If you have any doubts about taking the medicine or if you have missed more than
   9. Stopping treatment with Aboxoma
6. Possible side effects
   1. Common side effects (may affect up to 1 in 10 people)
   2. Uncommon side effects (may affect up to 1 in 100 people)
   3. Rare side effects (may affect up to 1 in 1000 people)
   4. Very rare side effects (may affect up to 1 in 10,000 people)
   5. Frequency not known (cannot be estimated from the available data)
   6. Common side effects (may affect up to 1 in 10 people)
   7. Uncommon side effects (may affect up to 1 in 100 people)
   8. Rare side effects (may affect up to 1 in 1000 people)
   9. Frequency not known (cannot be estimated from the available data)
   10. Very common side effects (may affect more than 1 in 10 people)
   11. Common side effects (may affect up to 1 in 10 people)
   12. Frequency not known (cannot be estimated from the available data)
   13. Reporting side effects
7. How to store Aboxoma
8. Contents of the pack and other information
   1. What Aboxoma contains
   2. What Aboxoma looks like and contents of the pack
   3. Patient Card: information for use
   4. Marketing authorization holder and manufacturer
   5. Date of last revision of the leaflet: 15.05.2025

Leaflet accompanying the packaging: information for the user

Aboxoma, 5 mg, coated tablets

Apixaban

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• 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, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Aboxoma and what is it 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 is Aboxoma and what is it used for

Aboxoma contains the active substance apixaban and belongs to a group of so-called anticoagulant medicines. This medicine helps prevent blood clots by blocking factor Xa, which is an important factor in blood clotting.
Aboxoma 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, leading to a stroke, or to other organs, disrupting blood flow to these 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 blood vessels of the legs and/or lungs.

Aboxoma 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 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 organ diseasethat increases the risk of serious bleeding (such as active or recently diagnosed stomach or intestinal ulcersor recent brain bleeding),
• if you have liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy),
• if you are taking medicines to prevent blood clotting(e.g. warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the treatment is being switched, when the patient has a venous or arterial access 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 his vein) due to irregular heartbeat (arrhythmia).

Warnings and precautions

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

• Increased risk of bleeding, such as:
• Bleeding disorders, including cases that result in decreased platelet activity,
• Very high blood pressure, uncontrolled 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.
• if you have a prosthetic heart valve,
• 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 to be particularly careful when taking Aboxoma

• 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 the treatment.

In case of 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 procedure may be associated with bleeding, you should ask your doctor.

Children and adolescents

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

Aboxoma and other medicines

You should tell your doctor, pharmacist, or nurse about all the medicines you are taking, have recently taken, or plan to take.
Some medicines may enhance the effect of Aboxoma, and some may weaken 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 enhance 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);
• anti-inflammatoryor analgesic 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 for high blood pressure or heart disease(e.g. diltiazem);
• antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin and noradrenaline reuptake inhibitors.

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

• medicines used to prevent seizures or fits(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, breastfeeding, and fertility

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 Aboxoma on pregnancy and the unborn child is not known. You should not take Aboxoma if you are pregnant. If you become pregnant while taking this medicine, 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

This medicine should always be taken 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 just before taking and mixed with water or 5% glucose solution, juice, or apple sauce.

Instructions for crushing tablets:

• -Crush the tablet with a pestle in a mortar.
• -Carefully transfer the powder to a suitable container and then mix it with a small amount, e.g. 30 mL (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 liquid.

Your doctor may give you a crushed Aboxoma tablet mixed with 60 mL of water or 5% glucose solution through a nasogastric tube if needed.

Aboxoma should be taken as recommended in the following indications:

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 daily.
The recommended dose is one Aboxoma 2.5 mg tablet twice daily 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 micromoles/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 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 blood vessels of the lungs
The recommended dose is twoAboxoma 5 mg 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 oneAboxoma 5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.
Prevention of recurrence of blood clots after completion of 6-month treatment
The recommended dose is one Aboxoma 2.5 mg 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 blood vessels of the lungs.
This medicine should always be taken or administered as recommended by your doctor or pharmacist.
If you are unsure, ask your doctor, pharmacist, or nurse.
To get the best effect, try to take or administer the dose 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 twoAboxoma 5 mg tablets, taken 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 oneAboxoma 5 mg tablet, taken twice daily, for example, one in the morning and one 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 switch your anticoagulant treatment as follows:

• Switching from Aboxoma to other anticoagulantsYou should stop taking Aboxoma. Treatment with other anticoagulants (e.g. heparin) should be started at the time of the next scheduled dose.
• Switching from other anticoagulants to AboxomaYou should stop taking other anticoagulants. Treatment with Aboxoma should be started at the time of the next scheduled dose of the other anticoagulant, and then continue as usual.
• Switching from treatment with a vitamin K antagonist (e.g. warfarin) to AboxomaYou should stop 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 a procedure to restore a normal heart rhythm (cardioversion) should take this medicine at the times specified by their doctor to prevent the formation of blood clots in the blood vessels of the brain and other blood vessels in the body.

Taking more Aboxoma than recommended

If you have taken more Aboxoma than recommended, you should contact your doctor immediately.
You should take the packaging with you, even if it is empty.
If you have taken more Aboxoma than recommended, you may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect on factor Xa may be necessary.

Missing 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 on the next day, instead, continue taking the medicine the next day as recommended, twice daily.

If you have any doubts about taking the medicine or if you have missed more than

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

Stopping treatment with Aboxoma

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common general 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 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 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:
• in the brain or spinal cord;
• in the mouth or coughing up blood;
• in the abdominal cavity or retroperitoneal space;
• in the muscles;
• 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;
• 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, you should contact your doctor immediately.

Rare side effects (may affect up to 1 in 1000 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 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 a skin rash or raised, flat, red, round patches under the skin, or bruising;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney dysfunction (nephropathy associated with anticoagulant therapy).

The following side effects may occur when taking Aboxoma to treat or prevent the recurrence of blood clots in the veins of the legs and blood clots in the 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;
• in the stomach, intestine, or rectum;
• in the mouth;
• from the genital tract;
• Anemia, which can cause fatigue or pale skin;
• Decreased platelet count in the blood (which can affect clotting);
• Nausea (vomiting);
• 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;
• 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 surgical wound or puncture 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, you should 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 1000 people)

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

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

• Bleeding:
• in the abdominal cavity or retroperitoneal space;
• 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 a skin rash or raised, flat, red, round patches under the skin, or bruising;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney dysfunction (nephropathy associated with anticoagulant therapy).

Additional side effects in children and adolescents
If you notice any of the following symptoms, you should 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 Aboxoma were similar to those observed in adults and were mostly mild or moderate in severity.
Side effects reported more frequently in children and adolescents include 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;
• red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or puncture site;
• Hair loss;
• Anemia, which can cause fatigue or pale skin;
• Decreased platelet count in the blood (which can affect clotting);
• Nausea (vomiting);
• 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:
• in the abdominal cavity 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 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 a 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;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney dysfunction (nephropathy associated with anticoagulant therapy).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
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 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 packaging 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. This will help protect the environment.

6. Contents of the pack and other information

What Aboxoma contains

• The active substance is apixaban. Each coated tablet contains 5 mg of apixaban.
• The other ingredients (excipients) 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), talc (E 553b), and yellow iron oxide (E 172) in the coating. See section 2 "Aboxoma contains lactose and sodium".

What Aboxoma looks like and contents of the pack

Brown-yellow, oval, biconvex, coated tablets (tablets) marked with the number 5 on one side of the tablet.
Tablet dimensions: length x width approximately 10.5 x 5.5 mm.
Aboxoma is available in packs containing:

• 20, 56, or 60 coated tablets.

Not all pack sizes may be marketed.

Patient Card: information for use

Inside the packaging of Aboxoma, together 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 useful for you and warns other doctors that you are taking Aboxoma. You should 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 daily
• 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
For more information about 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