Patient Information Leaflet

Aboxoma 5 mg film-coated tablets
Apixabanum
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

Keep this 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 personally. 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.

Leaflet Contents

What Aboxoma is and what it is used for
What you need to know before you take Aboxoma
How to take Aboxoma
Possible side effects
How to store Aboxoma
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 by blocking factor Xa, an important component in the blood clotting process.
Aboxoma is used in adults:

to prevent blood clots in the heart in patients with an irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and travel to the brain, causing stroke, or to other organs, blocking blood flow to these organs (also known as systemic embolism). Stroke can be life-threatening and requires immediate medical attention.
to treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

Aboxoma is used in children from 28 days up to but not including 18 years of age, for the treatment of blood clots and prevention of recurrent blood clots in veins or pulmonary blood vessels.
Information regarding body weight and recommended dosage can be found in section 3.

2. Important information before using Aboxoma

When not to use Aboxoma

if the patient is allergic to apixaban or any of the other ingredients of this medicine (listed in section 6),
if the patient has excessive bleeding,
if the patient has an organ disease that increases the risk of serious bleeding (such as active or recently diagnosed ulcer of the stomach or intestine, recently diagnosed intracranial bleeding),
if the patient has liver disease that leads to an increased risk of bleeding (hepatic coagulopathy),
if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, dabigatran or heparin), except when switching anticoagulant therapy, when a venous or arterial access line has been inserted and heparin is administered through the line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into the vein) due to irregular heartbeat (arrhythmia).

Warnings and precautions
Before starting treatment, discuss with your doctor, pharmacist or nurse if the patient has any of the following conditions:

increased risk of bleeding, for example:
conditions associated with bleeding, including those resulting in reduced platelet function,
very high blood pressure not controlled by medication,
if the patient is over 75 years of age,
if the patient weighs 60 kg or less,
severe kidney disease or if the patient is on dialysis,
liver disease or history of liver disease.
Aboxoma should be used with caution in patients showing signs of impaired liver function.
if the patient has a heart valve prosthesis,
if the doctor determines that the patient's blood pressure is unstable or other treatment is planned, or a surgical procedure to remove a blood clot from the lungs.

When to exercise particular caution when using Aboxoma

if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

If surgery or a procedure that may involve bleeding is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If in doubt whether a procedure may involve bleeding, ask the doctor.
Children and adolescents
Use of this medicine is not recommended in children and adolescents with body weight below 35 kg.
Aboxoma and other medicines
Tell your doctor, pharmacist or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may enhance the effect of Aboxoma, while others may reduce its effect. The doctor will decide whether the patient should receive Aboxoma while taking other medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Aboxoma and increase the risk of unwanted bleeding:

certain medicines used to treat fungal infections (e.g. ketoconazole and others);
certain antiviral medicines used to treat HIV/AIDS infection (e.g. ritonavir);
other medicines used to reduce blood clotting (e.g. enoxaparin and others);
anti-inflammatory or pain-relieving medicines (e.g. acetylsalicylic acid or naproxen),

especially if the patient is over 75 years of age and taking acetylsalicylic acid, the risk of unwanted bleeding may be increased;

medicines used for high blood pressure or heart conditions (e.g. diltiazem);
antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.

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

medicines used to prevent epilepsy or seizures (e.g. phenytoin and others);
St. John's wort (an herbal supplement used for depression);
medicines used to treat tuberculosis or other infections (e.g. rifampicin).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to have a baby, she should consult her doctor, pharmacist or nurse before using this medicine.
The effect of Aboxoma during pregnancy and on the unborn child is unknown. Aboxoma should not be taken during pregnancy. If the patient becomes pregnant while taking this medicine, she should contact her doctor immediately.
It is not known whether Aboxoma passes into breast milk. Consult your doctor, pharmacist or nurse before using this medicine during breastfeeding.
The patient may be advised to stop breastfeeding or to avoid taking this medicine.
Driving and operating machinery
Apixaban has no effect or a negligible effect on the ability to drive motor vehicles and operate machinery.
Aboxoma contains lactose and sodium
If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Aboxoma

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor, pharmacist, or nurse.
Dosage
The tablet should be swallowed with water. Aboxoma can be taken regardless of meals.
To achieve the best treatment results, it is recommended to take the tablets at the same times each day.
If a patient has difficulty swallowing the tablets whole, they should discuss alternative methods of taking
Aboxoma with their doctor. The tablet may be crushed immediately before administration and mixed with
water or a 5% aqueous glucose solution, juice, or applesauce.
Instructions for crushing tablets:

Crush the tablet using a mortar and pestle.
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 listed above to prepare a mixture.
Swallow the mixture.
Rinse the pestle, mortar, and container used for crushing the tablets with a small amount of water or another liquid (e.g., 30 mL), and swallow the rinsing liquid.

If necessary, your doctor may administer crushed Aboxoma tablets mixed with 60 mL of water or
5% aqueous glucose solution through a nasogastric tube.
Aboxoma should be taken as directed for 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:

the patient has severe renal impairment, or
two or more of the following conditions are met:
laboratory test results indicate reduced kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or higher)
the patient is 80 years of age or older
the patient’s 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 treatment should continue.
Treatment of blood clots in the deep veins of the legs and blood clots in blood vessels of the lungs
The recommended dose is two Aboxoma 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 one Aboxoma 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 treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrence of blood clots in veins or in blood vessels of the lungs.
This medicine should always be taken or administered exactly as directed by your doctor or pharmacist.
If you have any doubts, please consult your doctor, pharmacist, or nurse.
To achieve the best treatment effect, try to take or administer the dose at the same time each day.
The apixaban dose is based on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents weighing at least 35 kg is two Aboxoma 5 mg 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 Aboxoma 5 mg tablet, twice daily, for example, one in the morning and one in the evening.
For parents and caregivers: observe the child to ensure the full dose has been taken.
It is important to attend scheduled doctor visits, as dose adjustments may be necessary with changes in body weight.
Your doctor may switch anticoagulant therapy as follows:

Switching from Aboxoma to anticoagulant medicines Discontinue taking Aboxoma. Start treatment with anticoagulant medicines (e.g., heparin) at the time the next tablet was scheduled to be taken.
Switching from anticoagulant medicines to Aboxoma Discontinue taking anticoagulant medicines. Begin Aboxoma treatment at the time the next anticoagulant dose was scheduled, then continue taking it as usual.
Switching from anticoagulant therapy including a vitamin K antagonist (e.g., warfarin) to Aboxoma Discontinue the vitamin K antagonist medicine. Your doctor must perform blood tests and will inform you when to start taking Aboxoma.
Switching from Aboxoma to anticoagulant therapy including a vitamin K antagonist (e.g., warfarin) If your doctor tells you to start taking a vitamin K antagonist medicine, continue taking Aboxoma for at least 2 days after taking the first dose of the vitamin K antagonist medicine. Your doctor must perform blood tests and will inform you when to stop taking Aboxoma.

Patients undergoing cardioversion
Patients who require cardioversion to restore normal heart rhythm should take this medicine at the times
specified by their doctor to prevent the formation of blood clots in blood vessels of the brain and other parts of the body.
Taking more than the recommended dose of Aboxoma
If a patient takes more than the recommended dose of Aboxoma, they should immediately inform their doctor.
Bring the medicine packaging with you, even if it is empty.
If a patient takes more than the recommended dose of Aboxoma, the risk of bleeding may increase.
In case of bleeding, surgical treatment, blood transfusion, or other treatments to reverse the effect of factor Xa inhibition may be necessary.
Missed dose of Aboxoma

If a morning dose is missed, take it as soon as remembered, and the evening dose can be taken at the same time.
A missed evening dose may only be taken on the same evening. Do not take two doses the next morning; instead, continue taking the medicine the next day as directed, twice daily.

If you have any doubts about using the medicine or if more than one dose is missed, consult your doctor, pharmacist, or nurse.
Stopping Aboxoma
Do not stop taking this medicine without consulting your doctor, as stopping treatment prematurely may increase the risk of blood clots.
If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The most common general adverse effect of this medicine is bleeding, which may potentially
be life-threatening and may require immediate medical attention.

The following adverse effects may occur when taking Aboxoma to
prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common adverse effects (may occur in up to 1 in 10 people)

Bleeding, including:
into the eye;
into the stomach or intestine;
from the rectum;
blood in urine;
from the nose;
from the gums;
subcutaneous haemorrhage and swelling;
Anaemia, which may cause fatigue or paleness;
Low blood pressure, which may lead to fainting or rapid heartbeat;
Nausea (feeling sick);
Blood test results may indicate:
increased gamma-glutamyl transferase (GGT) activity.

Uncommon adverse effects (may occur in up to 1 in 100 people)

Bleeding:
into the brain or spinal canal;
in the mouth or coughing up blood;
in the abdominal cavity or from reproductive organs;
bright red blood in stool;
bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound or tissue incision site (wound discharge) or injection site;
from haemorrhoids;
presence of blood in stool or urine detected in laboratory tests;
Decreased number of platelets in blood (which may affect blood clotting);
Blood test results may indicate:
abnormal liver function;
increased activity of certain liver enzymes;
elevated bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes;
Skin rash;
Itching;
Hair loss;
Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms are observed, seek medical advice immediately.

Rare adverse effects (may occur in up to 1 in 1000 people)

Bleeding:
in the lungs or throat;
into the space located in the posterior abdominal cavity;
into muscles.

Very rare adverse effects (may occur in up to 1 in 10,000 people)

Skin rash, during which blisters may form, resembling small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

Frequency not known (cannot be estimated from available data)

Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-associated nephropathy).

The following adverse effects may occur when taking Aboxoma for the treatment or prevention of recurrent venous blood clots in the lower limbs and blood clots in the blood vessels of the lungs.

Common adverse effects (may occur in up to 1 in 10 people)

Bleeding, including:
from the nose;
from the gums;
blood in urine;
subcutaneous haemorrhage and swelling;
in the stomach, intestine, or from the rectum;
in the mouth;
from reproductive organs;
Anaemia, which may cause fatigue or paleness;
Decreased number of blood platelets (which may affect clotting);
Nausea (feeling sick);
Skin rash;
Blood test results may indicate:
increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT) activity.

Uncommon adverse effects (may occur in up to 1 in 100 people)

Low blood pressure, which may lead to fainting or rapid heartbeat;
Bleeding:
into the eyes;
in the mouth or coughing up blood;
bright red blood in stool;
test results indicating blood in stool or urine;
bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound or tissue incision site (wound discharge) or injection site;
from haemorrhoids;
into muscles;
Itching;
Hair loss;
Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms are observed, seek medical advice immediately;
Blood test results may indicate:
abnormal liver function;
increased activity of certain liver enzymes;
elevated bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

Rare adverse effects (may occur in up to 1 in 1000 people)

Bleeding:
into the brain or spinal canal;
in the lungs.

Frequency not known (cannot be estimated from available data)

Bleeding:
into the abdominal cavity or retroperitoneal space;
Skin rash, during which blisters may form, resembling small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-associated nephropathy).

Additional adverse effects in children and adolescents
If any of the following symptoms occur, seek immediate medical advice:

Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. The frequency of these adverse effects is classified as "common" (may occur in up to 1 in 10 people).

Generally, adverse effects observed in children and adolescents treated with Aboxoma
are similar to those seen in adults and are mostly mild or moderate in severity.
Adverse effects occurring more frequently in children and adolescents include nosebleeds
and abnormal vaginal bleeding.

Very common adverse effects (may occur in more than 1 in 10 people)

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

Common adverse effects (may occur in up to 1 in 10 people)

Bleeding, including:
from the gums;
blood in urine;
subcutaneous haemorrhages (bruising) and swelling;
from the intestine or rectum;
bright red blood in stool;
bleeding after surgery, including subcutaneous haemorrhages (bruising) and swelling, leakage of blood (discharge) from the surgical wound or injection site;
Hair loss;
Anaemia, which may cause fatigue or paleness;
Decreased platelet count (which may affect coagulation);
Nausea (feeling sick);
Skin rash;
Itching;
Low blood pressure, which may cause 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 available data)

Bleeding:
into the abdominal cavity or retroperitoneal space;
in the stomach;
in the eyes;
in the mouth;
from haemorrhoids;
in the mouth or blood in sputum when coughing;
in the brain or spine;
in the lungs;
in muscle;
Skin rash, during which blisters may form, resembling small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
Vasculitis, which may cause skin rash or raised, flat, red, circular spots beneath the skin surface or bruising;
Blood test results may indicate:
increased gamma-glutamyl transferase (GGT) activity;
presence of blood in stool or urine;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-associated nephropathy).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Aboxoma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply to this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging 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, hydroxyethylcellulose, magnesium stearate (E 470b) in the tablet core; hypromellose (E 464), propylene glycol (E 1520), titanium dioxide (E 171), talc (E 553b), and iron oxide, yellow (E 172) in the coating. See section 2, "Aboxoma contains lactose and sodium".

What Aboxoma looks like and contents of the pack
Brownish-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 Aboxoma packaging, together with the patient leaflet, there is a Patient Card, or the treating physician may provide the patient with a similar card.
The Patient Card contains helpful information for the patient and serves as a warning to other physicians that the patient is taking Aboxoma. You should always carry this card with you.

Take the card.
If necessary, separate the appropriate language section (facilitated by perforated edges).
Fill in the following details, or ask your doctor to complete them:
- Name and surname:
- Date of birth:
- Indication:
- Body weight (for children and adolescents):
- Dose: … mg twice daily
- Doctor’s name and surname:
- Doctor’s telephone number:
Fold the card and always carry it with you.

Marketing Authorisation Holder and Manufacturer/Importer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw, Poland
Tel. 22 57 37 500