Patient Information Leaflet

Banxiol, 2.5 mg, coated tablets
Apixabanum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of 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 the formation of blood clots (deep vein thrombosis) after hip or knee replacement surgery. Following hip or knee surgery, patients have an increased risk of developing blood clots in the veins of the legs. This may lead to leg swelling, with or without pain. If a blood clot travels from the leg to the lungs, it may block blood flow through the lungs, causing breathlessness with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
To prevent blood clots in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing a stroke, or to other organs, impairing blood flow to these organs (also known as systemic embolism). Stroke may be life-threatening and requires immediate medical intervention.
To treat existing blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the 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 on 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 excessive 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 of switching anticoagulant therapy, when an intravenous or intra-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 a doctor, pharmacist or nurse if the patient has any of the following conditions:

increased risk of bleeding, for example:
conditions involving 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 history of liver disease.
This medicine should be used with caution in patients showing signs of impaired liver function.
a tube (catheter) or spinal injection (anaesthetic or pain-relieving), in which case the doctor will advise taking this medicine 5 or more hours after catheter removal,
if the patient has a heart valve prosthesis,
if the doctor determines that the patient's blood pressure is unstable or if another treatment or 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 clots), the patient should inform the doctor, who will decide whether a change in treatment is needed.

If surgery or a procedure associated with 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
This medicine is not recommended for use 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 take.
Some medicines may enhance the effect of Banxiol, while others may reduce its effect.
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:

some medicines used to treat fungal infections (e.g. ketoconazole and others)
some 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 old and taking acetylsalicylic acid, the risk of unwanted bleeding may be increased
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 Banxiol’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 a 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. Before using this medicine during breastfeeding, consult a doctor, pharmacist or nurse. The patient may be advised to stop breastfeeding, stop 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 consult a doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Banxiol

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor, pharmacist or nurse.
Dosage
The tablet should be swallowed 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 the tablets whole, they should speak with their doctor about
alternative ways of taking Banxiol. The tablet may 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 using a pestle and 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 any other liquid mentioned above

to prepare a mixture.

Swallow the mixture.
Rinse the pestle and mortar used for crushing the tablets and the container with a small amount of water or other liquid (e.g. 30 mL) and swallow the rinse liquid.

If necessary, a doctor may administer crushed Banxiol tablets mixed with 60 mL of water or
5% aqueous glucose solution through a nasogastric tube.
Banxiol should be taken as directed in the following indications:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one 2.5 mg Banxiol tablet twice daily. 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 surgery, they will usually take the tablets for 32 to 38 days.
If the patient has undergone major knee surgery, they will usually take the tablets for 10 to 14 days.
Prevention of blood clots in the heart in patients with irregular heart rhythm
and at least one additional risk factor
The recommended dose is one 5 mg Banxiol tablet twice daily.
The recommended dose is one 2.5 mg Banxiol tablet 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. The doctor will decide how long treatment should continue.
Treatment of blood clots in the deep veins of the legs and blood clots in the blood vessels of
the lungs
The recommended dose is two 5 mg Banxiol 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 5 mg Banxiol tablet twice daily, for example one
tablet in the morning and one in the evening.
Prevention of recurrence of blood clots after completion of 6-month treatment
The recommended dose is one 2.5 mg Banxiol 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 recurrence of blood clots in veins or in the blood
vessels of the lungs.
This medicine should always be taken or administered as directed by a doctor or pharmacist.
If in doubt, consult a doctor, pharmacist or nurse.
To achieve the best treatment effect, doses should be taken or administered at the same time
each day.
The dose of Banxiol depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing at least 35 kg is four 2.5 mg
Banxiol tablets, administered twice daily for the first 7 days, for example four in the morning and four
in the evening. After 7 days, the recommended dose is two 2.5 mg Banxiol tablets, administered twice
daily, for example two in the morning and two 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 appointments, as dose adjustments may be necessary
with changes in the patient's body weight.
The doctor may change anticoagulant treatment as follows:

Switching from Banxiol to anticoagulant medicines Discontinue taking Banxiol. Anticoagulant treatment (e.g. heparin) should be started at the time the next tablet was scheduled to be taken.
Switching from anticoagulant medicines to Banxiol Discontinue taking anticoagulant medicines. Banxiol treatment should be started at the time the next anticoagulant dose was scheduled, and then continued as usual.
Switching from anticoagulant treatment including a vitamin K antagonist (e.g. warfarin) to Banxiol Discontinue the vitamin K antagonist-containing medicine. The doctor must perform blood tests and will inform the patient when to start taking Banxiol.
Switching from Banxiol to anticoagulant treatment including a vitamin K antagonist (e.g. warfarin) If the doctor informs the patient that they should start taking a vitamin K antagonist-containing medicine, Banxiol should be continued for at least 2 days after the first dose of the vitamin K antagonist-containing medicine is taken. The doctor must perform blood tests and inform the patient when to discontinue Banxiol.

Patients undergoing cardioversion
Patients who require cardioversion 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 than the recommended dose of Banxiol
If a patient has taken more than the recommended dose of this medicine, they should contact a
doctor immediately . Bring the medicine packaging, even if it is empty.
If a patient has taken more than the recommended dose of Banxiol, there may be an increased risk
of bleeding. In case of bleeding, surgical treatment, blood transfusion or other treatment to reverse
the effect directed against factor Xa may be required.
Missed dose of Banxiol

If a morning dose is missed, it should be taken as soon as the patient remembers, and it may be taken at the same time as 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 directed, twice daily.

If in doubt about use of the medicine or if more than one dose is missed , consult a doctor,
pharmacist or nurse.
Stopping Banxiol
Do not stop taking this medicine without consulting a doctor, as the risk of developing a blood
clot may be higher if Banxiol is stopped prematurely.
If there are any further doubts about using this medicine, consult a doctor, pharmacist or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. Banxiol can be used for three different medical conditions. The known adverse reactions and their frequency of occurrence in each of these medical conditions may differ and are listed separately below. In these conditions, the most common general adverse reaction associated with this medicine is bleeding, which may potentially be life-threatening and may require immediate medical attention.

The following adverse reactions may occur when taking Banxiol to prevent blood clots after hip or knee surgery.

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

Anaemia, which may cause fatigue or paleness;
Bleeding including:
- Subcutaneous haemorrhages and swelling;
Nausea.

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

Reduced platelet count (which may affect blood clotting);
Bleeding:
- After surgery, including bruising and swelling, leakage of blood or other fluid from the surgical wound/incision (wound discharge) or injection site;
- From the stomach, intestines, or bright red blood in stool;
- Blood in urine;
- Nosebleeds;
- From genital tract;
Low blood pressure, which may lead to fainting or rapid heartbeat;
Blood test results may indicate:
- Liver function abnormalities;
- Increased activity of certain liver enzymes;
- Increased bilirubin levels, a product formed from destroyed red blood cells, which may cause yellowing of the skin and eyes;
Itching.

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

Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. If any of these symptoms occur, seek immediate medical advice;
Bleeding:
- Into muscle;
- Into the eyes;
- From gums and coughing up blood;
- From the rectum;
Hair loss.

Frequency unknown (frequency cannot be estimated from available data)

Bleeding:
- Into the brain or spinal cord;
- In the lungs or throat;
- In the mouth;
- Into the abdominal cavity or retroperitoneal space;
- From haemorrhoids;
- Test results indicating presence of blood in stool or urine;
Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

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

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

Bleeding, including:
- Into the eye;
- In the stomach or intestine;
- From the rectum;
- Blood in urine;
- Nosebleeds;
- 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 indicate:
- Increased gamma-glutamyl transferase (GGT) activity.

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

Bleeding:
- Into the brain or spinal cord;
- In the mouth or coughing up blood;
- In the abdominal cavity or from genital tract;
- Bright red blood in stool;
- Postoperative bleeding, 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 (which may affect 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 (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. If any of these symptoms are observed, seek immediate medical advice.

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

Bleeding:
- In the lungs or throat;
- Into the retroperitoneal space;
- Into muscle.

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

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

Frequency unknown (frequency cannot be estimated from available data)

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

The following adverse reactions may occur when taking Banxiol for the treatment or prevention of recurrent blood clots in the veins of the lower limbs and blood clots in blood vessels of the lungs.

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

Bleeding, including:
- Nosebleeds;
- 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;
Reduced platelet count (which may affect clotting);
Nausea;
Skin rash;
Blood test results may indicate:
- Increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT) activity.

Uncommon adverse reactions (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;
- Postoperative bleeding, 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 muscle;
Itching;
Hair loss;
Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. If any of these symptoms are observed, seek immediate medical advice;
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 reactions (may occur in up to 1 in 1000 people)

Bleeding:
- Into the brain or spinal cord;
- In the lungs.

Frequency unknown (frequency cannot be estimated from available data)

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

Additional adverse reactions in children and adolescents

If any of the following symptoms occur, immediate medical advice must be sought:

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

Overall, adverse reactions observed in children and adolescents treated with Banxiol were generally similar to those seen in adults and were mostly mild or moderate in severity. Adverse reactions occurring more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

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

Bleeding, including:
- From the vagina;
- Nosebleeds.

Common adverse reactions (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 fluid (discharge) from the surgical wound or injection site;
Hair loss;
Anaemia, which may cause fatigue or paleness;
Reduced platelet count (which may affect coagulability);
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 unknown (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;
- Into the brain or spinal cord;
- In the lungs;
- Into muscle;
Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
Vasculitis, which may cause skin rash or raised, flat, red, circular spots beneath the skin surface or bruising;
Blood test results may indicate:
- Increased gamma-glutamyl transferase (GGT) activity;
- Presence of blood in faeces or urine;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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
Adverse reactions may also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this 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 carton and blister pack after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions 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. This will help protect the environment.

6. Contents of the pack and other information

What Banxiol contains

The active substance is apixaban. Each tablet contains 2.5 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 sulphate, magnesium stearate (E470b).
Coating: monohydrate lactose (see section 2 “Banxiol contains lactose”), hypromellose (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172).

What Banxiol looks like and contents of the pack
Banxiol coated tablets are yellow, round (approximately 6 mm in diameter), biconvex (convex on both sides), with the imprint “IU1” on one side and smooth on the other.
Banxiol is available in:

blister packs in cardboard boxes containing 10, 20, 56, 60, 100, 168 or 200 tablets;
unit-dose perforated blisters in cardboard boxes containing 10 x 1, 20 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: information for use
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 details, or ask your doctor to complete them:

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

Keep this card with you at all times.
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