Banxiol

Package Leaflet: Information for the User

Banxiol, 5 mg, film-coated tablets

Apixaban

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the package leaflet

• 1. What Banxiol is and what it is used for
• 2. Important information before taking Banxiol
• 3. How to take Banxiol
• 4. Possible side effects
• 5. How to store Banxiol
• 6. 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 from forming by blocking factor Xa, which is an important factor in blood clotting.
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 can break loose and travel to the brain, leading to a stroke, or to other organs, reducing blood flow to those 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 Banxiol

When not to take Banxiol

• if you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6),
• -if you have active bleeding,
• -if you have a condition that increases the risk of major bleeding(such as active or recently diagnosed stomach or intestinal ulcer, recent bleeding in the brain),
• -if you have liver diseasethat increases the risk of bleeding (hepatic coagulopathy),
• -if you are taking other medicines that prevent blood clotting(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the treatment is being switched, when the patient has a venous or arterial access line and heparin is being 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).

if the patient has a venous or arterial access line and heparin is being 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 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 disease or a 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 you are scheduled for surgery to remove a blood clot from your lungs.

When to be particularly careful when taking Banxiol

• 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. If you need to undergo surgery or a procedure 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, you should ask your doctor.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age.

Banxiol and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or might take.
Some medicines may increase the effect of Banxiol, and some may reduce its effect.
Your doctor will decide whether you should take Banxiol while taking other medicines and how closely you should be monitored.
The following medicines may increase the effect of Banxiol and increase the risk of unwanted bleeding:

• some antifungal medicines(e.g., ketoconazole and others)
• some 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 medicinescalled selective serotonin reuptake inhibitorsor serotonin and norepinephrine reuptake inhibitors.

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

• medicines used to treat 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
The effect of Banxiol on pregnancy and the unborn child is not known. You should not take this medicine during pregnancy. If you become pregnant while taking this medicine, you should immediatelycontact your doctor.
It is not known whether Banxiol passes into breast milk. Before taking this medicine while breastfeeding, ask your doctor, pharmacist, or nurse for advice. You may be advised to stop breastfeeding, stop, or not start taking this medicine.

Driving and using machines

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

Banxiol contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially sodium-free.

3. How to take Banxiol

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

Dose

Swallow the tablet with water. Banxiol can be taken with or without food.
To get the best results, it is recommended to 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 Banxiol. The tablet can be crushed and mixed with water or 5% glucose solution, juice, or apple sauce 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 mentioned 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 rinse liquid.

If necessary, your doctor may give you a crushed Banxiol tablet mixed with 60 mL of water or 5% glucose solution through a nasogastric tube.

Banxiol should be taken as recommended in the following indications:

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 Banxiol 5 mg tablet twice daily.
The recommended dose is one Banxiol 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 (133 micromole/L) or higher)
• 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 twoBanxiol 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 oneBanxiol 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 Banxiol 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 switch your anticoagulant treatment as follows:

• Switching from Banxiol to other anticoagulantsStop taking Banxiol. Start treatment with other anticoagulants (e.g., heparin) at the time of the next scheduled dose.
• Switching from other anticoagulants to BanxiolStop taking other anticoagulants. Start taking Banxiol at the time of the next scheduled dose of the other anticoagulant, and then continue as usual.
• Switching from treatment with a vitamin K antagonist (e.g., warfarin) to BanxiolStop taking the vitamin K antagonist. Your doctor will perform blood tests and tell you when to start taking Banxiol.
• Switching from Banxiol 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 Banxiol for at least 2 days after taking the first dose of the vitamin K antagonist. Your doctor will perform blood tests and tell you when to stop taking Banxiol.

Patients undergoing cardioversion

Patients who need to undergo a cardioversion procedure to restore a normal heart rhythm should take this medicine at the times specified by their doctor to prevent blood clots in the blood vessels of the brain and other blood vessels.

If you take more Banxiol than you should

If you take more Banxiol than you should, contact your doctor immediately.
Take the medicine package with you, even if it is empty.
If you take more Banxiol than you should, 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.

If you forget to take Banxiol

Do not take a double dose to make up for a forgotten tablet.
Take the dose as soon as you remember, and:

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

If you have any further questions on the use of this medicine or if you have missed more than

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

If you stop taking Banxiol

Do not stop taking this medicine without consulting your doctor, as the risk of blood clots may be higher if you stop taking Banxiol too early.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Banxiol can cause side effects, although not everybody gets them.
The most common 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 Banxiol to prevent blood clots 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 tract;
• 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;
• into the muscles;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and 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 in the space behind the abdominal cavity;
• into the muscles.

Very rare side effects (may affect up to 1 in 10,000 people)

• -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).

Frequency not known (frequency 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 Banxiol to treat or prevent the 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 tract;
• 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 (ALT) 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;
• into the muscles;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and 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 (frequency cannot be estimated from the available data)

• Bleeding:
• in the abdominal cavity or in the space behind the abdominal cavity;
• 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 or pharmacist. 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 4921 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 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 after EXP. The expiry date refers to the last day of that month.
There are no special storage precautions 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. These measures will help protect the environment.

6. Contents of the pack 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), microcrystalline cellulose (E460), croscarmellose sodium, sodium lauryl sulfate, magnesium stearate (E470b).
• Coating: lactose monohydrate (see section 2), hypromellose (E464), titanium dioxide (E171), triacetin, iron oxide red (E172).

What Banxiol looks like and contents of the pack

The film-coated tablets are pink, oval (approximately 5.2 mm x 9.8 mm), biconvex (with a convex surface on both sides), with the inscription "IU2" on one side and smooth on the other.
Banxiol is available in:

• blister packs in cartons of 14, 20, 28, 56, 60, 100, 168, or 200 tablets;
• unit-dose perforated blisters in cartons of 14x1, 20x1, 28x1, 56x1, 60x1, 100x1, 168x1, or 200x1 tablets;
• bottles containing 60, 180, or 1000 tablets. Bottles containing 60 tablets have a child-resistant closure.

Not all pack sizes may be marketed.

Patient Alert Card: Information for use

This patient information leaflet includes a Patient Alert Card. The Patient Alert Card contains information to help you and to alert other doctors that you are taking Banxiol. Always carry this card with you.
Cut out the card from the patient information leaflet and fill in the following or ask your doctor to fill it in:

• Name:
• Date of birth:
• Indication:
• Dose: ........ mg twice daily
• Doctor's name:
• Doctor's phone number:

Always carry this card with you.

Marketing authorization 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 on this medicine, contact the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 546 64 00

Date of last revision of the leaflet: