Banxiol

Leaflet accompanying the packaging: information for the user

Banxiol, 2.5 mg, film-coated tablets

Apixaban

You should read the contents of this leaflet carefully before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• 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 pack

• 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 (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, the patient is at increased risk of blood clots in the veins of the legs. This can lead to swelling of the legs, which can be painful or painless. If a blood clot travels from the leg to the lungs, it can block blood flow to the lungs, causing shortness of breath with chest pain or without. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
• 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, causing a stroke, or to other organs, disrupting 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 veins 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 excessive bleeding,
• -if you have a disease of an organthat increases the risk of serious bleeding (such as active or recently diagnosed stomach or intestinal ulceror recent bleeding into the brain),
• -if you have liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy),
• -if you are taking anticoagulant medicines(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the treatment is changed, when the patient has a venous or arterial access line and heparin is administered through this line to maintain its patency or when the patient is undergoing catheter ablation (a catheter is inserted into his vein) due to irregular heart rhythm (arrhythmia).

Warnings and precautions

Before starting treatment, discuss with your doctor, pharmacist, or nurse if you have any of the following conditions:

• Increased risk of bleeding, such as:
• Bleeding disorders, including conditions that result in decreased platelet activity,
• Very high blood pressurethat is not controlled with medication,
• 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.
• Tube (catheter) or injection into the spine(anesthetic or pain-relieving), in which case the doctor will recommend taking this medicine after 5 or more hours after the catheter is removed,
• Artificial heart valve,
• If your doctor determines that your blood pressure is unstable or if other treatment or surgery is planned to remove a blood clot from the lungs.

When to be particularly careful when taking 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 particular 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 or have recently taken, as well as any medicines you plan to take.

Some medicines may enhance the effect of Banxiol, and some may weaken its effect.

Your doctor will decide whether you should receive Banxiol while taking other medicines and how closely you should be monitored.

The following medicines may enhance the effect of Banxiol and increase the risk of unwanted bleeding:

• Certain antifungal medicines(e.g., ketoconazole and others)
• Certain antiviral medicines used to treat HIV/AIDS(e.g., ritonavir)
• Other anticoagulant medicines(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 medicines called selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs).

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

• Medicines used to prevent seizures or fits(e.g., phenytoin and others)
• St. John's Wort (a herbal supplement used in 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 plan to have a child, 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 contact your doctor immediately.

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.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it 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 effect, try to take the tablets at the same time every day.

If you have difficulty 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 puree immediately before taking.

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 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 after hip or knee replacement surgery

The recommended dose is one 2.5 mg Banxiol tablet twice a day, 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 you have had major hip surgery, you will usually take the tablets for 32 to 38 days.

If you have had major knee surgery, you 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 a day.

The recommended dose is one 2.5 mg Banxiol tablet twice a day if:

• you have severe kidney problems,
• two or more of the following conditions apply:
• your blood test results suggest 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 a day, for example, one tablet in the morning and one in the evening. Your doctor will decide how long you should continue treatment.

Treatment of blood clots in the veins of the legs and blood clots in the blood vessels of the lungs

The recommended dose is two 5 mg Banxiol tabletstwice a day 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 tablettwice a day, 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 2.5 mg Banxiol tablet twice a day, for example, one tablet in the morning and one in the evening.

Your doctor will decide how long you should continue treatment.

Your doctor may change your anticoagulant treatment as follows:

• Switching from Banxiol to anticoagulant medicinesStop taking Banxiol. Anticoagulant treatment (e.g., heparin) should be started at the time of the next scheduled dose of Banxiol.
• Switching from anticoagulant medicines to BanxiolStop taking anticoagulant medicines. Banxiol treatment should be started at the time of the next scheduled dose of anticoagulant medicine and then continue as usual.
• Switching from treatment with a vitamin K antagonist (e.g., warfarin) to 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 from forming in the blood vessels of the brain and other blood vessels in the body.

Taking more Banxiol than recommended

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

If you take more Banxiol than recommended, you may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of 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 at the usual time

then continue taking the medicine as before.

If you have any doubts about taking the medicine or if you have missed more than

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

Stopping Banxiol treatment

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 about taking 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.

Banxiol can be used in three different medical conditions. The known side effects and their frequency may vary in each of these conditions and are listed separately below. In these conditions, the most common overall side effect of this medicine is bleeding, which can be life-threatening and may require immediate medical attention.

The following side effects may occur when taking Banxiol to prevent blood clots after hip or knee replacement surgery.

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

• Anemia, which can cause tiredness or pale skin;
• Bleeding, including:
• bruises and swelling;
• Nausea (feeling sick).

Uncommon side effects (may affect up to 1 in 100 people)

• Decreased platelet count (which can affect blood clotting);
• Bleeding:
• after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or incision site (wound discharge) or injection site;
• from the stomach, intestines, or black stools;
• blood in urine;
• from the nose;
• from the genital tract;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Blood test results may indicate:
• liver function disorders;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes;
• Itching.

Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately;
• Bleeding:
• into the muscle;
• into the eyes;
• from the gums and coughing up blood;
• from the anus;
• Hair loss.

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

• Bleeding:
• into the brain or spinal cord;
• into the lungs or throat;
• into the abdominal cavity or retroperitoneal space;
• from hemorrhoids;
• blood test results indicating blood in stools or urine;
• A 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 elevated, flat, red, round patches under the skin surface, or bruises.

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:
• into the eye;
• from the stomach or intestines;
• from the anus;
• blood in urine;
• from the nose;
• from the gums;
• bruises and swelling;
• Anemia, which can cause tiredness or pale skin;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Nausea (feeling sick);
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity.

Uncommon side effects (may affect up to 1 in 100 people)

• Bleeding:
• into the brain or spinal cord;
• into the mouth or coughing up blood;
• into the abdominal cavity or from the genital tract;
• black stools;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or incision site (wound discharge) or injection site;
• from hemorrhoids;
• Decreased platelet count (which can affect blood clotting);
• Blood test results may indicate:
• liver function disorders;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately;

Rare side effects (may affect up to 1 in 1,000 people)

• Bleeding:
• into the lungs or throat;
• into the retroperitoneal space;
• into the muscle.

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

• -A 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 elevated, flat, red, round patches under the skin surface, or bruises.

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 urine;
• bruises and swelling;
• from the stomach, intestines, or anus;
• from the mouth;
• from the genital tract;
• Anemia, which can cause tiredness or pale skin;
• Decreased platelet count (which can affect blood clotting);
• Nausea (feeling sick);
• 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:
• into the eyes;
• into the mouth or coughing up blood;
• black stools;
• blood test results indicating blood in stools or urine;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or incision site (wound discharge) or injection site;
• from hemorrhoids;
• into the muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately;
• Blood test results may indicate:
• liver function disorders;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 1,000 people)

• Bleeding:
• into the brain or spinal cord;
• into the lungs.

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

• Bleeding:
• into the abdominal cavity or retroperitoneal space.
• A 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 elevated, flat, red, round patches under the skin surface, or bruises.

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, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 the month.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. 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), 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 yellow (E172).

What Banxiol looks like and contents of the pack

The film-coated tablets are yellow, round (about 6 mm in diameter), and biconvex (with a convex surface on both sides), with the inscription "IU1" on one side and smooth on the other.

Banxiol is available in:

• blister packs in cartons of 10, 20, 56, 60, 100, 168, or 200 tablets;
• single-dose perforated blisters in cartons of 10x1, 20x1, 56x1, 60x1, 100x1, 168x1, or 200x1 tablets;
• bottles containing 60, 180, or 1000 tablets. Bottles containing 60 film-coated 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 that is helpful to you and warns other doctors that you are taking Banxiol.

You should 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 a day
• 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 more 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: