Abatixent

Leaflet accompanying the packaging: patient information

Abatixent, 2.5 mg, coated tablets

Apixaban

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

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor, pharmacist, or nurse.
This medicine has been prescribed to a specific person. Do not pass it on to others.
The medicine may harm another person, even if their illness symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
See section 4.

Table of contents of the leaflet:

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

1. What is Abatixent and what is it used for

Abatixent contains the active substance apixaban and belongs to a group of so-called anticoagulant medicines.
This medicine helps prevent the formation of blood clots by blocking factor Xa, which is an important factor in blood clotting.
Abatixent is used in adults:

• to prevent the formation of blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, the patient may be at increased risk of blood clots in the veins of the lower limbs. This can lead to swelling of the legs, with or without pain. If a blood clot moves from the lower limb to the lungs, it can block blood flow through the lungs, causing shortness of breath with a feeling of chest pain or without. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
• to prevent the formation of 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 move to the brain, leading to a stroke, or to other organs, hindering 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 lower limbs (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 lower limbs and/or lungs.

2. Important information before taking Abatixent

When not to take Abatixent

• if the patient is allergicto apixaban or any of the other ingredients of this medicine (listed in section 6);
• if the patient has excessive bleeding;
• if the patient has organ diseasethat increases the risk of serious bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recently diagnosed bleeding in the brain);
• if the patient has liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy);
• if the patient is taking medicines that prevent blood clotting(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in situations where the anticoagulant treatment is changed, when the patient has a venous or arterial access line and heparin is administered through this line to maintain its patency or when the patient is undergoing catheter ablation (a catheter is inserted into their vein) due to irregular heart rhythm (arrhythmia).

Warnings and precautions

Before starting treatment with this medicine, the patient should discuss with their doctor, pharmacist, or nurse if they have any of the following conditions:

• increased risk of bleeding, for example:
• bleeding disorders, including cases resulting in decreased platelet activity;
• very high blood pressure, uncontrolled with medication;
• if the patient is over 75 years old;
• if the patient weighs 60 kg or less;
• severe kidney disease or if the patient is on dialysis;
• liver diseaseor history of liver disease; This medicine should be used with caution in patients with signs of liver function changes.
• tube (catheter) or injection into the spine(anesthetic or pain-relieving), in which case the doctor will recommend taking this medicine after 5 or more hours after catheter removal;
• if the patient has a prosthetic heart valve;
• if the doctor determines that the patient's blood pressure is unstable or plans other treatment or surgery to remove a blood clot from the lungs.

When to be particularly careful when taking Abatixent

• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide on possible treatment changes.

In case of need for surgery or a procedure that may be associated with bleeding, the doctor may ask the patient to temporarily stop taking this medicine for a short time. If there is any uncertainty whether a given procedure may be associated with bleeding, the doctor should be consulted.

Children and adolescents

Abatixent is not recommended for patients under 18 years of age.

Abatixent and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may enhance the effect of Abatixent, and some may weaken its effect. The doctor will decide whether the patient should receive Abatixent while taking other medicines and how closely they should be monitored.
The following medicines may enhance the effect of Abatixent and increase the risk of unwanted bleeding:

• certain antifungal medicines(e.g., ketoconazole and others);
• certain antiviral medicines used to treat HIV/AIDS(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 old and taking acetylsalicylic acid, may be at increased risk of unwanted bleeding;
• medicines used for high blood pressure or heart problems(e.g., diltiazem);
• antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin and noradrenaline reuptake inhibitors.

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

• medicines used to prevent seizures or convulsions(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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before taking this medicine.
The effect of Abatixent on pregnancy and the unborn child is unknown. This medicine should not be taken during pregnancy. If the patient becomes pregnant while taking this medicine, they should contact their doctor immediately.
It is not known whether Abatixent passes into breast milk. Before taking this medicine while breastfeeding, the patient should consult their doctor, pharmacist, or nurse. The patient may be advised to stop breastfeeding or stop/not start taking this medicine.

Driving and using machines

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

Abatixent contains lactose (a type of sugar) and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Abatixent

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist or nurse.

Dose

The tablet should be swallowed with water. Abatixent can be taken with or without food.
To achieve the best treatment results, it is recommended to take the tablets at the same time every day.
If the patient has problems swallowing the tablets whole, they should discuss other ways of taking Abatixent with their doctor. The tablet can be crushed immediately before administration and mixed with water or 5% aqueous 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, 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 liquid after rinsing.
If necessary, the doctor may administer a crushed Abatixent tablet mixed with 60 ml of water or 5% aqueous glucose solution through a nasogastric tube.

Abatixent should be taken as recommended in the following indications:

Prevention of blood clot formation after hip or knee replacement surgery
The recommended dose is one Abatixent 2.5 mg tablet twice a day. 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 the patient has undergone major hip replacement surgery, they will usually take the tablets for 32 to 38 days.
If the patient has undergone major knee replacement surgery, they will usually take the tablets for 10 to 14 days.
Prevention of blood clot formation in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor
The recommended dose is one Abatixent 5 mg tablet twice a day.
The recommended dose is one Abatixent 2.5 mg tablet twice a day if:

• the patient has severe kidney dysfunction;
• two or more of the following conditions are met:
• the patient's blood test results suggest decreased kidney function (serum creatinine level of 1.5 mg/dl (133 micromole/l) or higher);
• the patient is 80 years old or older;
• the patient's 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. The doctor will decide how long to continue treatment.
Treatment of blood clots in the veins of the lower limbs and blood clots in the blood vessels of the lungs
The recommended dose is twoAbatixent 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 oneAbatixent 5 mg tablet twice a day, for example, one tablet in the morning and one in the evening.
Prevention of recurrent blood clot formation after completing 6 months of treatment
The recommended dose is one Abatixent 2.5 mg tablet twice a day, for example, one tablet in the morning and one in the evening.
The doctor will decide how long to continue treatment.

The doctor may change the anticoagulant treatment as follows:

Switching from Abatixent to anticoagulant medicines
Abatixent should be discontinued. Treatment with anticoagulant medicines (e.g., heparin) should be started at the time of the scheduled intake of the next Abatixent tablet.
Switching from anticoagulant medicines to Abatixent
Anticoagulant medicines should be discontinued. Abatixent treatment should be started at the time of the scheduled intake of the next dose of anticoagulant medicine, and then continue with its usual intake.
Switching from treatment with a vitamin K antagonist (e.g., warfarin) to Abatixent
The vitamin K antagonist should be discontinued. The doctor must perform blood tests and inform the patient when to start taking Abatixent.
Switching from Abatixent to treatment with a vitamin K antagonist (e.g., warfarin)
If the doctor informs the patient that they should start taking a vitamin K antagonist, they should continue taking Abatixent for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor must perform blood tests and inform the patient when to stop taking Abatixent.

Patients undergoing cardioversion

Patients who require cardioversion to restore a normal heart rhythm 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.

Taking a higher dose of Abatixent than recommended

If the patient has taken a higher dose of this medicine than recommended, they should immediately inform their doctor.
The patient should take the packaging with them, even if it is empty.
If the patient has taken a higher dose of Abatixent than recommended, they may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment that can reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Abatixent

The patient should take the dose as soon as they remember and:

• take the next dose of Abatixent at the usual time
• then continue taking the medicine as before.

In case of doubts about taking the medicine or if more than one doseis missed

The patient should consult their doctor, pharmacist, or nurse.

Stopping Abatixent

The patient should not stop taking this medicine without consulting their doctor, as the risk of blood clot formation may be higher if Abatixent is stopped too early.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Abatixent can cause side effects, although not everybody gets them.
Abatixent 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 Abatixent to prevent blood clot formation after hip or knee replacement surgery.

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

• Anemia, which can cause fatigue or pallor;
• Bleeding, including:
• subcutaneous hemorrhages 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 surgical wound or incision (wound exudate) 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 dysfunction;
• 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 1000 people)

• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip, mouth, tongue, and (or) throat swelling, and difficulty breathing. If any of these symptoms occur, the patient should immediately contact their doctor.
• 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 into the space behind the abdominal cavity;
• 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 elevated, flat, red, round patches under the skin surface, or bruising.

The following side effects may occur when taking Abatixent to prevent blood clot formation 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;
• subcutaneous hemorrhage and swelling;
• Anemia, which can cause fatigue or pallor;
• 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 coughing up blood;
• into the abdominal cavity or from the genital tract;
• blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or incision (wound exudate) or injection site;
• from hemorrhoids;
• presence of blood in the stool or urine detected in laboratory tests;
• 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: facial swelling, lip, mouth, tongue, and (or) throat swelling, and difficulty breathing. If any of these symptoms occur, the patient should immediately contact their doctor.

Rare side effects (may affect up to 1 in 1000 people)

• Bleeding:
• into the lungs or throat;
• into 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, 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).

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

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

The following side effects may occur when taking Abatixent to treat or prevent the recurrence of blood clots in the veins of the lower limbs 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;
• subcutaneous hemorrhage and swelling;
• into the stomach, intestines, or rectum;
• into the mouth;
• from the genital tract;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (AlAT) 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 coughing up blood;
• 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 incision (wound exudate) or injection site;
• from hemorrhoids;
• into the muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip, mouth, tongue, and (or) throat swelling, and difficulty breathing. If any of these symptoms occur, the patient should immediately contact their doctor;
• 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 1000 people)

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

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

• Bleeding:
• into the abdominal cavity or into the space behind the abdominal cavity.
• 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 elevated, flat, red, round patches under the skin surface, or bruising.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Abatixent

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Abatixent contains

The active substance of Abatixent is apixaban. Each coated tablet contains 2.5 mg of apixaban.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate

• Coating: hypromellose (type 2910), hydroxypropylcellulose, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172)

See section 2 Abatixent contains lactose (a type of sugar) and sodium.

What Abatixent looks like and contents of the pack

The coated tablets are round, biconvex, yellow, with the inscription 'AX' on one side and '2.5' on the other side, with a diameter of 5.7-6.5 mm.
The coated tablets are available in:

• blister packs of 10, 12, 14, 20, 28, 30, 56, 60, 100, 168, 180, and 200 coated tablets.
• single-dose blister packs of 20 x 1, 60 x 1, 100 x 1, and 168 x 1 coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer/Importer
LEK Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
Lek S.A.
Podlipie 16
95-010 Stryków
Poland

This medicine is authorized in the European Economic Area member states under the following names:

Netherlands
Abatixent 2.5 mg film-coated tablets
Austria
Abatixent 2.5 mg film-coated tablets
Bulgaria
АБАТИКСЕНТ 2.5 mg филмирани таблетки
Abatixent 2.5 mg film-coated tablets
Estonia
Abatixent
Lithuania
Abatixent 2.5 mg plėvele dengtos tabletės
Croatia
Abatixent 2.5 mg filmom obložene tablete
Romania
Abatixent 2.5 mg comprimate filmate
Slovenia
Abatixent 2.5 mg filmsko obložene tablete

For more information on this medicine, please contact:

Sandoz Poland Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
tel. +48 22 209 70 00
Date of last revision of the leaflet:02/2024
Sandoz logo

Patient Alert Card: information for the user

A Patient Alert Card is included in the packaging with the Patient Leaflet.
A similar card can also be obtained from the patient's doctor.
This card contains information that may be useful for the patient and may serve as a warning to other doctors that the patient is taking Abatixent. The card should always be carried with the patient.

• 1. Remove the card.
• 2. Fill in the following points or ask the doctor for help:
• Name and surname
• Date of birth
• Indication
• Dosage: …. mg twice a day
• Doctor's name and surname
• Doctor's phone number
• 3. Fold the card and keep it with you at all times