Package leaflet: Information for the user

Banxiol 5 mg film-coated tablets
Apixabanum
Read the entire leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

What Banxiol is and what it is used for
What you need to know before taking Banxiol
How to take Banxiol
Possible side effects
How to store Banxiol
Contents of the pack and other information

1. What Banxiol is and what it is used for

Banxiol contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots by inhibiting factor Xa, an important component in the blood clotting process.
Banxiol 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 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), as well as to prevent recurrence of blood clots in the deep veins of the legs and (or) lungs.

Banxiol is used in children aged from 28 days to below 18 years for the treatment of blood clots and prevention of recurrence of blood clots in veins or in the blood vessels of the lungs.
Information regarding body weight and recommended dosage can be found in section 3.

2. Important information before using Banxiol

When not to use Banxiol

if the patient is allergic to apixaban or any of the other ingredients of this medicine (listed in section 6),
if the patient has active bleeding,
if the patient has a disease that increases the risk of serious bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently diagnosed intracranial bleeding),
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 when switching anticoagulant therapy, when an intravenous or arterial 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 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 with 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.
This medicine should be used with caution in patients showing signs of liver function abnormalities.
a spinal (epidural) catheter or injection (anaesthetic or pain relief), in which case the doctor will advise taking this medicine 5 or more 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 if other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Banxiol

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 treatment needs to be changed. 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, consult the doctor.

Children and adolescents
Use of this medicine is not recommended in children and adolescents weighing less than 35 kg.
Banxiol 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 use.
Some medicines may enhance the effect of Banxiol, while others may reduce its effectiveness.
The doctor will decide whether the patient should receive Banxiol while taking other medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Banxiol 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), particularly 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 (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs).

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

medicines used to prevent epilepsy or seizures (e.g. phenytoin and others)
St. John's wort (a 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 her doctor, pharmacist or nurse before using this medicine.
The effect of Banxiol 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 contact her doctor immediately.
It is not known whether Banxiol passes into human milk. The patient should consult her doctor, pharmacist or nurse before using this medicine during breastfeeding. She may be advised to stop breastfeeding, or to discontinue or not start taking this medicine.
Driving and operating machinery
Banxiol has no effect or a negligible effect on the ability to drive and operate machinery.
Banxiol contains lactose (a sugar) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Banxiol

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor, pharmacist, or nurse.
Dosage
The tablet should be swallowed whole with water. Banxiol may 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 a patient has difficulty swallowing tablets whole, they should discuss alternative ways of taking Banxiol with their doctor. The tablet may be crushed immediately before administration and mixed with water or a 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 and 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 for crushing the tablets, as well as the container, 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 Banxiol tablets mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Banxiol should be taken as directed for the following indications:
Prevention of blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor
The recommended dose is one 5 mg tablet of Banxiol twice daily.
The recommended dose is one 2.5 mg tablet of Banxiol twice daily if:

the patient has severe renal impairment
two or more of the following conditions are met :
blood test results suggest reduced kidney function (serum creatinine concentration 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 veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two 5 mg tablets of Banxiol 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 5 mg tablet of Banxiol 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 2.5 mg tablet of Banxiol 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 recurrent blood clots in veins or in the blood vessels of the lungs.
This medicine should always be taken or administered as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor, pharmacist, or nurse.
To achieve the best treatment effect, the dose should be taken or administered at the same time each day.
The dose of Banxiol depends on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents weighing at least 35 kg is two 5 mg tablets of Banxiol, 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 5 mg tablet of Banxiol, 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's appointments, as dose adjustments may be necessary with changes in body weight.
Your doctor may change anticoagulant treatment as follows:

Switching from Banxiol to anticoagulant medicines Discontinue Banxiol. Start anticoagulant treatment (e.g., heparin) at the time the next tablet was scheduled to be taken.
Switching from anticoagulant medicines to Banxiol Discontinue anticoagulant medicines. Start Banxiol at the time the next dose of anticoagulant medicine was scheduled to be taken, and continue regular dosing thereafter.
Switching from vitamin K antagonist anticoagulant treatment (e.g., warfarin) to Banxiol Discontinue the vitamin K antagonist medicine. Your doctor must perform blood tests and will inform you when to start taking Banxiol.
Switching from Banxiol to vitamin K antagonist anticoagulant treatment (e.g., warfarin) If your doctor informs you that you should start taking a vitamin K antagonist medicine, continue taking Banxiol for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor must perform blood tests and will inform you when to stop taking Banxiol.

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 the blood vessels of the brain and other parts of the body.
Taking more than the recommended dose of Banxiol
If a patient takes more than the recommended dose of Banxiol, you should contact your doctor immediately.
Bring the medicine packaging with you, even if it is empty.
If a patient takes more than the recommended dose of Banxiol, the risk of bleeding may increase. In case of bleeding, surgical treatment, blood transfusion, or other treatment directed against factor Xa may be required.
Missed dose of Banxiol

If a morning dose is missed, take it as soon as you remember, and you may take it at the same time as the evening dose.
A missed evening dose may only be taken that 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 you miss more than one dose, consult your doctor, pharmacist, or nurse.
Stopping treatment with Banxiol
Do not stop taking this medicine without consulting your doctor, as the risk of developing a blood clot may be higher if Banxiol is stopped prematurely.
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 can 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 Banxiol
to prevent blood clots in the heart in patients with irregular heart rhythm 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;
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 haemoptysis;
in the abdominal cavity or from genital tract;
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;
Decrease in platelet count (which may affect blood clotting);
Blood test results may indicate:
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, seek medical advice immediately.

Rare adverse 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 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 center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

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

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

The following adverse effects may occur when taking Banxiol
for the treatment or prevention of recurrence of blood clots in the veins of the lower limbs
and blood clots in 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 the genital tract;
Anaemia, which may cause fatigue or paleness;
Decrease in platelet count (which may affect blood clotting);
Nausea;
Skin rash;
Blood test results may indicate:
increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (AlAT) 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 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, seek medical advice 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, which may cause yellowing of the skin and eyes.

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

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

Frequency not known (frequency 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 center 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, round spots beneath the skin surface, or bruising;
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-associated nephropathy).

Additional adverse effects in children and adolescents
If any of the following symptoms occur, immediately inform the doctor:

Allergic reactions (hypersensitivity), 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 Banxiol
were similar to those observed in adults and were mostly mild or moderate in severity.
Adverse effects reported 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 or fluid (discharge) from the surgical wound or injection site;
Hair loss;
Anaemia, which may cause fatigue or paleness;
Decrease in platelet count (which may affect clotting);
Nausea;
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 spinal canal;
in the lungs;
in muscles;
Skin rash, during which blisters may form, resembling small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
Vasculitis, which may cause skin rash or raised, flat, red, round 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 the 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 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Banxiol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply 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. These measures will help protect the environment.

6. Contents of the packaging and other information

What Banxiol contains

The active substance is apixaban. Each tablet contains 5 mg of apixaban.
The other ingredients are:
Tablet core: lactose (see section 2 “Banxiol contains lactose”), microcrystalline cellulose (E460), sodium croscarmellose (see section 2 “Banxiol contains sodium”), sodium lauryl sulfate, magnesium stearate (E470b).
Coating: monohydrate lactose (see section 2 “Banxiol contains lactose”), hypromellose (E464), titanium dioxide (E171), triacetin, iron oxide red (E172).

What Banxiol looks like and contents of the pack
The coated tablets are pink, oval-shaped (approximately 5.2 mm x 9.8 mm), biconvex (convex on both sides), with the inscription “IU2” on one side and smooth on the other side.
Banxiol is available in:

blister packs in cardboard boxes containing 14, 20, 28, 56, 60, 100, 168 or 200 tablets;
unit-dose perforated blisters in cardboard boxes containing 14 x 1, 20 x 1, 28 x 1, 56 x 1, 60 x 1, 100 x 1, 168 x 1 or 200 x 1 tablets;
bottles containing 60, 180 or 1000 tablets. Bottles containing 60 coated tablets have child-resistant closure.

Not all pack sizes may be marketed.
Patient Warning Card: user information
The Patient Warning Card contains helpful information for the patient and warns other physicians that the patient is taking Banxiol. You should always carry this card with you.
You should cut the card from the patient leaflet or the cardboard box and complete the following sections or ask your doctor to complete them:

Name:
Date of birth:
Indication:
Body weight:
Dose: ........ mg twice daily
Doctor’s name:
Doctor’s phone number:

You should always carry this card with you.
Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland
Importer
McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin, Unit 35/36
Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, Mylan utca 1., Komárom, 2900, Hungary.
For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00