Abatixent: detailed information

Package leaflet: Information for the patient

Abatixent, 5 mg, film-coated tablets
Apixabanum
Please read the entire leaflet before using this medicine, as it contains important information for you.
Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual only. Do not pass it on to others.
It may harm someone else, even if their symptoms are the same as yours.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
See section 4.

Table of contents:

What Abatixent is and what it is used for
Important information before taking Abatixent
How to take Abatixent
Possible side effects
How to store Abatixent
Contents of the pack and other information

1. What Abatixent is and what it is used for

Abatixent contains the active substance apixaban and belongs to a group of medicines known as anticoagulants.
This medicine helps prevent blood clots by inhibiting factor Xa, an important component in the blood clotting process.
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 may break loose and travel to the brain, causing stroke, or to other organs, impairing blood flow to those 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), as well as to prevent recurrence of blood clots in the veins of the legs and/or lungs.

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

2. Important information before using Abatixent

When not to use Abatixent

if the patient has a hypersensitivity 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 a disease of an organ that increases the risk of serious bleeding (such as

active or recently diagnosed ulcer of the stomach or intestine, recently diagnosed bleeding
into the brain);

if the patient has liver disease leading to an increased risk of bleeding (hepatic coagulopathy);
if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, dabigatran or heparin), except in situations of switching anticoagulant therapy, when a venous or arterial access line has been inserted and heparin is administered through this 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 the 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 activity;
- 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 diseases or past history of liver disease; This medicine should be used with caution in patients showing signs of liver function abnormalities.
-if a tube (catheter) has been inserted or an injection into the spine has been given (for anaesthesia or pain relief), the doctor will advise taking this medicine at least 5 hours after removal of the catheter;
if the patient has a heart valve prosthesis;
if the doctor determines that the patient's blood pressure is unstable or other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Abatixent

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
Abatixent is not recommended for patients with body weight below 35 kg.
Abatixent and other medicines
Tell the 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 Abatixent, while others may reduce its effect. The doctor
will decide whether the patient should receive Abatixent while taking other
medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Abatixent 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, which may increase the risk of unwanted bleeding;
medicines used for high blood pressure or heart problems (e.g. diltiazem);
antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

The following medicines may reduce Abatixent's ability 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 and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult the doctor, pharmacist or nurse before using 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, she should immediately
contact the doctor.
It is not known whether Abatixent passes into human milk. Before using this medicine
during breastfeeding, consult the doctor, pharmacist or nurse. The patient may
be advised to stop breastfeeding or to stop or not start taking this
medicine.
Driving and using machines
Abatixent has no effect or a negligible effect on the ability to drive
motor vehicles and operate machinery.
Abatixent contains lactose (a type of sugar) and sodium
If a sugar intolerance has previously been diagnosed in the patient, the patient should
contact the doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".
3. How to use Abatixent
This medicine should always be used according to the doctor's or pharmacist's instructions. If in doubt,
consult the doctor, pharmacist or nurse.
Dosage
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 times each day.
If the patient has difficulty swallowing the tablets whole, discuss other
ways of taking Abatixent with the doctor. The tablet can be crushed immediately before administration and mixed with water or 5% aqueous glucose solution, juice or apple puree.
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 listed 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.
If necessary, the doctor may administer crushed Abatixent tablets mixed with 60 ml of water or 5% aqueous glucose solution through a nasogastric tube.
Abatixent should be taken according to recommendations for the following indications:
Prevention of blood clots 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:

the patient has severe kidney function impairment;
two or more of the following conditions are met:
- blood test results suggest reduced kidney function (serum creatinine concentration is 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. The doctor will decide how long treatment should continue.
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 tablets of Abatixent 5 mg 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 tablet of Abatixent 5 mg twice daily, for example one tablet in the morning and one in the evening.
Prevention of recurrent blood clots after completion of 6-month 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.
The doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrent blood clots in veins
or in the blood vessels of the lungs.
This medicine should always be taken or administered according to the doctor's or pharmacist's instructions.
If in doubt, consult the doctor, pharmacist or nurse.
To achieve the best treatment effect, try to take or administer the dose at the same time each day.
The dose of Abatixent depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing at least 35 kg is two tablets
of Abatixent 5 mg, administered 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 tablet of Abatixent 5 mg, administered 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 adjustment may be necessary as the patient's body weight changes.
The doctor may change anticoagulant treatment as follows:
Switching from Abatixent to anticoagulant medicines
Stop taking Abatixent. Start anticoagulant treatment (e.g. heparin) at the time the next tablet was scheduled to be taken.
Switching from anticoagulant medicines to Abatixent
Stop taking anticoagulant medicines. Start Abatixent at the time the next dose of anticoagulant medicine was scheduled to be taken, then continue regular administration.
Switching from anticoagulant treatment including a vitamin K antagonist (e.g. warfarin) to Abatixent
Discontinue the vitamin K antagonist-containing medicine. The doctor must perform blood tests and will inform the patient when to start taking Abatixent.
Switching from Abatixent to anticoagulant treatment including a vitamin K antagonist (e.g. warfarin)
If the doctor informs the patient that he should start taking a vitamin K antagonist-containing medicine, continue taking Abatixent for at least 2 days after taking the first dose of the vitamin K antagonist-containing medicine. The doctor must perform blood tests and inform the patient when to stop taking Abatixent.
Patients undergoing cardioversion
Patients in whom a cardioversion procedure is necessary to restore normal heart rhythm should take this medicine at the times specified by the doctor to prevent formation of blood clots in the blood vessels of the brain and other blood vessels in the body.
Taking more Abatixent than recommended
If the patient has taken more than the recommended dose of this medicine, contact the doctor immediately.
Bring the medicine packaging, even if empty.
If the patient has taken more than the recommended dose of Abatixent, there may be an increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion or other treatment to reverse the anti-factor Xa effect may be necessary.
Missing a dose of Abatixent

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

If in doubt about using the medicine or if more than one dose is missed, consult the doctor, pharmacist or nurse.
Stopping Abatixent
Do not stop taking this medicine without consulting the doctor, as stopping Abatixent prematurely may increase the risk of blood clot formation.
If there are any further doubts about using this medicine, consult the doctor, pharmacist or nurse.

4. Possible side effects

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

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

Common side 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;
nosebleeds;
bleeding from gums;
subcutaneous haemorrhage and swelling;
Anaemia, which may cause fatigue or paleness;
Low blood pressure, which may lead to fainting or rapid heartbeat;
Nausea;
Blood test results may show:
increased activity of gamma-glutamyl transferase (GGT).

Uncommon side 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 genital tract;
bright red blood in stool;
bleeding 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 platelet count in blood (which may affect blood clotting);
Blood test results may show:
abnormal liver function;
increased activity of certain liver enzymes;
increased bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes;
Skin rash;
Itching;
Hair loss;
Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms are observed, contact your doctor immediately.

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

Bleeding:
in the lungs or throat;
into the retroperitoneal space (located at the back of the abdominal cavity);
into muscles.

Very rare side 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 under the skin surface, or bruising.
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects may occur when taking Abatixent for the treatment or prevention of recurrent venous blood clots in the lower limbs and pulmonary embolism (blood clots in blood vessels of the lungs).

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

Bleeding, including:
nosebleeds;
bleeding from gums;
blood in urine;
subcutaneous haemorrhage and swelling;
in the stomach, intestine, or from the rectum;
in the mouth;
from genital tract;
Anaemia, which may cause fatigue or paleness;
Decreased platelet count in blood (which may affect clotting);
Nausea;
Skin rash;
Blood test results may show:
increased activity of gamma-glutamyl transferase (GGT) or alanine aminotransferase (AlAT).

Uncommon side 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 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 reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms are observed, contact your doctor immediately;
Blood test results may show:
abnormal liver function;
increased activity of certain liver enzymes;
increased bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

Rare side 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 under the skin surface, or bruising.
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional side effects in children and adolescents

If any of the following symptoms occur, contact your doctor immediately:

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

Generally, side effects observed in children and adolescents treated with Abatixent were similar to those seen in adults and were mostly mild or moderate in severity. Side effects occurring more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

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

Bleeding, including:
- from the vagina;
- nosebleeds.

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

Bleeding, including:
- from gums;
- blood in urine;
- subcutaneous haemorrhages (bruising) and swelling;
- from intestine or rectum;
- bright red blood in stool;
- postoperative bleeding, including subcutaneous haemorrhages (bruising) and swelling, leakage of blood or other fluid (discharge) from surgical wound or injection site;
Hair loss;
Anaemia, which may cause fatigue or paleness;
Decreased platelet count in blood (which may affect clotting);
Nausea;
Skin rash;
Itching;
Low blood pressure, which may cause fainting or rapid heartbeat;
Blood test results may show:
abnormal liver function;
increased activity of certain liver enzymes;
increased activity of alanine aminotransferase (AlAT).

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 under the skin surface or bruising;
Blood test results may show:
- increased activity of gamma-glutamyl transferase (GGT);
- presence of blood in stool or urine.
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

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

5. How to store Abatixent

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for 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 will help
protect the environment.

6. Contents of the pack and other information

What Abatixent contains
The active substance is apixaban. Each coated tablet contains 5 mg of apixaban.
Other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose,
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 coated tablets are oval, biconvex, pink in colour, marked with ‘AX’ on one side and ‘5’ on the other, with a width of 5.0–5.7 mm and length of 9.6–10.3 mm.
Coated tablets are available in:

PVC/PVDC/Aluminium foil blisters containing 10, 12, 14, 20, 28, 30, 56, 60, 100, 168, 180 and 200 coated tablets.
Unit-dose PVC/PVDC/Aluminium foil blisters containing 20 x 1, 60 x 1, 100 x 1, and 168 x 1 coated tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
Novartis Pharmaceutical Manufacturing LLC
Verovškova ulica 57
1000 Ljubljana
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands Abatixent 5 mg film-coated tablets
Austria Abatixent 5 mg – Filmtabletten
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
Latvia Abatixent 5 mg apvalkotās tabletes

For further information about this medicinal product, contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warszawa
tel. +48 22 209 70 00

Patient Alert Card: information for the user
Inside the pack, together with the Patient Leaflet, a Patient Alert Card is included.
An additional card may also be obtained from your physician.
This card contains information that may be helpful for the patient and may serve as a warning to other physicians that the patient is taking Abatixent. The card should always be kept on the person.

Remove the card.
Fill in the following details or ask your doctor for assistance:
- Name
- Date of birth
- Indication
- Body weight
- Dosage: …. mg twice daily
- Name of doctor
- Doctor’s telephone number
Fold the card and always keep it on you