Abatixent

Leaflet accompanying the packaging: patient information

Abatixent, 5 mg, film-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 you by a doctor and should not be given to others.
The medicine may harm another person, even if their symptoms are the same.
If you experience any side effects, including those not listed in this leaflet, tell your 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. Package contents 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 blood clots by blocking factor Xa, which is an important factor in blood clotting.
Abatixent 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 move to the brain, leading to a stroke, or to other organs, making it difficult for blood to reach 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.

2. Important information before taking Abatixent

When not to take Abatixent

• if you are allergic to apixaban or any of the other ingredients of this medicine (listed in section 6);
• if you have active bleeding;
• if you have a disease of an organ that increases the risk of serious bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recent brain bleeding);
• if you have liver disease that leads to an increased risk of bleeding (hepatic coagulopathy);
• if you are taking anticoagulant medicines (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where anticoagulant therapy is being changed, when

you have a venous or arterial access line and heparin is being administered through this line to maintain its patency or when you are undergoing catheter ablation (a catheter is inserted into your 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 pressure, uncontrolled by 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 diseaseor history of liver disease; This medicine 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 Abatixent

• 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.

In case of surgery or procedures 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, ask your doctor.

Children and adolescents

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

Abatixent 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 enhance the effect of Abatixent, and some may weaken its effect. Your doctor will decide whether you should take Abatixent while taking other medicines and how closely you 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 you are over 75 years old and taking acetylsalicylic acid, you may be at increased risk of unwanted bleeding;
• medicines used to treat high blood pressure or heart problems(e.g., diltiazem);
• antidepressant medicinesknown as 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 in 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, consult your doctor, pharmacist, or nurse before taking this medicine.
The effect of Abatixent on pregnancy and the unborn child is unknown. You should not take this medicine during pregnancy. If you become pregnant while taking this medicine, contact your doctor immediately.
It is not known whether Abatixent passes into breast milk. Before taking this medicine while breastfeeding, consult your doctor, pharmacist, or nurse. You may be advised to stop breastfeeding or stop/avoid 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 you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially 'sodium-free'.

3. How to take Abatixent

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

Dose

Swallow the tablet with water. Abatixent can be taken with or without food.
To get the best results from your treatment, 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 Abatixent. The tablet can be crushed and mixed with water or 5% glucose solution, juice, or apple sauce 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 or 2 tablespoons) of water or another liquid listed 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 liquid after rinsing.
If necessary, your doctor may give you a crushed Abatixent tablet mixed with 60 ml of water or 5% glucose solution through a nasogastric tube.

Abatixent should be taken as recommended in the following indications:

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 daily.
The recommended dose is one Abatixent 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 indicate decreased kidney function (serum creatinine level of 1.5 mg/dl or more);
• 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 two Abatixent 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 Abatixent 5 mg tablet twice daily, 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 Abatixent 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.

Your doctor may change your anticoagulant treatment as follows:

Switching from Abatixent to anticoagulant medicines
Stop taking Abatixent. Anticoagulant treatment (e.g., heparin) should be started at the time of the next scheduled Abatixent tablet.
Switching from anticoagulant medicines to Abatixent
Stop taking anticoagulant medicines. Abatixent treatment should be started at the time of the next scheduled dose of anticoagulant medicine, and then continue as usual.
Switching from treatment with a vitamin K antagonist (e.g., warfarin) to Abatixent
Stop taking the vitamin K antagonist. Your doctor will perform blood tests and inform you when to start taking Abatixent.
Switching from Abatixent 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 Abatixent 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 Abatixent.

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 clot formation in the blood vessels of the brain and other blood vessels.

Taking more than the recommended dose of Abatixent

If you have taken more than the recommended dose of this medicine, contact your doctor immediately.
Take the packaging with you, even if it is empty.
If you have taken more than the recommended dose of Abatixent, you may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Abatixent

Take the dose as soon as you 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 you have missed more than

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

Stopping Abatixent treatment

Do not stop taking this medicine without consulting your doctor, as the risk of blood clot formation may be higher if you stop taking Abatixent prematurely.
In case of any further doubts about taking this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Abatixent can cause side effects, although not everybody gets them.
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 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 abdomen or from the reproductive organs;
• red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the surgical wound or tissue incision (wound discharge) or injection 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, 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 lungs or throat;
• in the abdominal cavity or retroperitoneal space.

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.

The following side effects may occur when taking Abatixent to treat or prevent 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 reproductive organs;
• Anemia, which can cause fatigue or pale skin;
• Decreased platelet count in the blood (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:
• 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 from the surgical wound or tissue incision (wound discharge) or injection 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, 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.
• Skin rash, which can cause 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.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abatixent

Keep this medicine out of the 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 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. Package contents and other information

What Abatixent contains

The active substance is apixaban. Each film-coated tablet contains 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), iron oxide red (E 172), iron oxide yellow (E 172) See section 2 Abatixent contains lactose (a type of sugar) and sodium.

What Abatixent looks like and contents of the pack

The film-coated tablets are oval, biconvex, pink, with 'AX' engraved on one side and '5' on the other side, 5.0 - 5.7 mm in width and 9.6 - 10.3 mm in length.
The film-coated tablets are available in:

• blister packs of 10, 12, 14, 20, 28, 30, 56, 60, 100, 168, 180, and 200 film-coated tablets.
• unit dose blister packs of 20 x 1, 60 x 1, 100 x 1, and 168 x 1 film-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 Member States of the European Economic Area under the following names:

Netherlands
Abatixent 5 mg film-coated tablets
Austria
Abatixent 5 mg film tablets
Bulgaria
АБАТИКСЕНТ 5 mg филмирани таблетки
Abatixent 5 mg film-coated tablets
Estonia
Abatixent
Lithuania
Abatixent 5 mg plėvele dengtos tabletės
Croatia
Abatixent 5 mg filmom obložene tablete
Romania
Abatixent 5 mg comprimate filmate
Slovenia
Abatixent 5 mg filmsko obložene tablete

For more information about this medicine, contact:

Sandoz Polska 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

Inside the packaging, along with the Patient Leaflet, a Patient Alert Card is included.
A similar card can also be obtained from your doctor.
This card contains information that may be useful for you and may serve as a warning to other doctors that you are taking Abatixent. Keep this card with you at all times.

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