Baxiren

Package Leaflet: Information for the Patient

Baxiren, 5 mg, Coated Tablets

Apixaban

Read the Package Leaflet Carefully Before Taking the Medication, 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 medication 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.

Table of Contents of the Leaflet

• 1. What is Baxiren and What is it Used For
• 2. Important Information Before Taking Baxiren
• 3. How to Take Baxiren
• 4. Possible Side Effects
• 5. How to Store Baxiren
• 6. Contents of the Package and Other Information

1. What is Baxiren and What is it Used For

Baxiren contains the active substance apixaban and belongs to a group of so-called anticoagulant medications. This medication helps prevent the formation of blood clots by blocking factor Xa, which is an important factor in blood clotting.
Baxiren is used in adults:

• to prevent the formation of 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 move to the brain, leading to a stroke, or to other organs, hindering blood flow to these 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 lower limbs (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 lower limbs and/or lungs.

2. Important Information Before Taking Baxiren

When Not to Take Baxiren

• If you are allergicto apixaban or any of the other ingredients of this medication (listed in section 6),
• -if you have excessive bleeding,
• -if you have an organ diseasethat increases the risk of serious bleeding (such as an active or recently diagnosed stomach or intestinal ulcer, or recent brain bleeding),
• -if you have liver diseasethat leads to an increased risk of bleeding (liver coagulopathy),
• if you are taking medications that prevent blood clotting(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the anticoagulant treatment is changed, when a venous or arterial access line is inserted in the patient and heparin is administered through this line to maintain its patency or when the patient undergoes catheter ablation (a catheter is inserted into his vein) due to irregular heart rhythm (arrhythmia).

if you are taking medications that prevent blood clotting (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the anticoagulant treatment is changed, when a venous or arterial access line is inserted in the patient and heparin is administered through this line to maintain its patency or when the patient undergoes catheter ablation (a catheter is inserted into his vein) due to irregular heart rhythm (arrhythmia).

Warnings and Precautions

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

• Increased risk of bleeding, such as:
• Bleeding disorders, including cases resulting in reduced platelet activity,
• Very high blood pressure, uncontrolled with 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 problems or a history of liver problems.
• This medication should be used with caution in patients with signs of liver function changes,
• if you have a heart valve prosthesis,
• 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 Extra Careful When Taking Baxiren

In case of surgery or a procedure that may be associated with bleeding, your doctor may ask you to temporarily stop taking this medication for a short time. If you are unsure whether a given procedure may be associated with bleeding, you should ask your doctor.

Children and Adolescents

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

Baxiren and Other Medications

Tell your doctor, pharmacist, or nurse about all medications you are taking, have recently taken, or plan to take.
Some medications may enhance the effect of Baxiren, and some may weaken its effect. Your doctor will decide whether you should receive Baxiren while taking other medications and how closely you should be monitored.
The following medications may enhance the effect of Baxiren and increase the risk of unwanted bleeding:

• some antifungal medications(e.g., ketoconazole and others)
• some antiviral medications used to treat HIV/AIDS(e.g., ritonavir)
• other medications used to reduce blood clotting(e.g., enoxaparin and others)
• anti-inflammatoryor analgesic medications(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
• medications used to treat high blood pressure or heart problems(e.g., diltiazem)
• antidepressant medicationscalled selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

The following medications may reduce the ability of Baxiren to prevent blood clot formation:

• medications used to treat epilepsy or seizures(e.g., phenytoin and others)
• St. John's Wort(a herbal supplement used in depression)
• medications used to treat tuberculosisor 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 medication.
The effect of Baxiren on pregnancy and the unborn child is unknown. You should not take this medication during pregnancy. If you become pregnant while taking this medication, you should immediatelycontact your doctor.
It is not known whether Baxiren passes into breast milk. Before taking this medication while breastfeeding, ask your doctor, pharmacist, or nurse for advice. You may be advised to stop breastfeeding or stop/avoid taking this medication.

Driving and Using Machines

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

Baxiren Contains Lactose (a Sugar) and Sodium

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

3. How to Take Baxiren

Always take this medication 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. Baxiren can be taken with or without food.
To get the best effect, 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 Baxiren. The tablet can be crushed just before taking and mixed with water or 5% aqueous glucose solution, juice, or apple puree.

Instructions for Crushing Tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the powder to a suitable container, then mix it with a small amount, e.g., 30 mL (2 tablespoons), of water or another liquid mentioned above to prepare a mixture.
• Swallow the mixture.
• Rinse the pestle and mortar used to crush the tablets and the container with a small amount of water or another liquid (e.g., 30 mL) and swallow the rinse liquid.

If necessary, your doctor may give you a crushed Baxiren tablet mixed with 60 mL of water or 5% aqueous glucose solution through a nasogastric tube. The tube should be flushed with 10 mL of water immediately after administering the dose of Baxiren.

Baxiren Should be Taken as Follows in the Following Indications:

Prevention of blood clot formation in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor
The recommended dose is one Baxiren 5 mg tablet twice daily.
The recommended dose is one Baxiren 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 reduced 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 to continue the treatment.
Treatment of blood clots in the veins of the lower limbs and blood clots in the blood vessels of the lungs
The recommended dose is twoBaxiren 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 oneBaxiren 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 Baxiren 2.5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.
Your doctor will decide how long to continue the treatment.

Your Doctor May Change the Anticoagulant Treatment as Follows:

• Changing from Baxiren to Anticoagulant MedicationsStop taking Baxiren. Anticoagulant treatment (e.g., heparin) should be started at the time of the planned intake of the next Baxiren tablet.
• Changing from Anticoagulant Medications to BaxirenStop taking anticoagulant medications. Baxiren treatment should be started at the time of the planned intake of the next dose of anticoagulant medication, and then continue with the usual intake.
• Changing from Vitamin K Antagonist Treatment (e.g., Warfarin) to BaxirenStop taking the vitamin K antagonist medication. Your doctor will perform blood tests and inform you when to start taking Baxiren.
• Changing from Baxiren to Vitamin K Antagonist Treatment (e.g., Warfarin)If your doctor informs you that you should start taking a vitamin K antagonist medication, you should continue taking Baxiren for at least 2 days after taking the first dose of the vitamin K antagonist medication. Your doctor will perform blood tests and inform you when to stop taking Baxiren.

Patients Undergoing Cardioversion

Patients who need to undergo cardioversion to restore a normal heart rhythm should take this medication at the times specified by their doctor to prevent the 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 Baxiren

If you have taken more than the recommended dose of Baxiren, contact your doctor immediately.
Take the package with you, even if it is empty.
If you have taken more than the recommended dose of Baxiren, 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 Baxiren

• -Take the dose as soon as you remember, and:
• take the next dose of Baxiren at the usual time,
• then continue taking the medication as before.

If You Have Any Further Questions on the Use of This Medication or If You Have Missed More Than

One Dose, ask your doctor, pharmacist, or nurse.
Do not take a double dose to make up for a forgotten dose.

Stopping Baxiren

Do not stop taking this medication without consulting your doctor, as stopping Baxiren too early may increase the risk of blood clot formation.
If you have any further questions on the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Baxiren can cause side effects, although not everybody gets them.
The most common overall side effect of this medication is bleeding, which can be life-threatening and may require immediate medical attention.
The following side effects may occur when taking Baxiren to prevent blood clot formation 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 abdominal cavity or in the space behind the abdominal cavity;
• in the muscles;
• 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;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. If you notice any of these symptoms, contact your doctor immediately.

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;
• in the muscles.

Very Rare Side Effects (May Affect Up to 1 in 10,000 People)

• -Skin rash, which can form 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 bruising.

The following side effects may occur when taking Baxiren to treat or prevent the recurrence of blood clots in the veins of the lower limbs 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 vagina;
• Anemia, which can cause fatigue or pale skin;
• Reduced 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 (AlAT) 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;
• black, tarry stools;
• blood test results indicating blood in the stool or urine;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or puncture site, or bleeding from the injection site;
• from hemorrhoids;
• in the muscles;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, as well as 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 form 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 bruising.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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
PL-02-222 Warsaw
Phone: +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 medication.

5. How to Store Baxiren

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
This medication does not require any special storage conditions.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Baxiren Contains

• The active substance is apixaban. Each tablet contains 5 mg of apixaban.
• The other ingredients are:
• Tablet core: lactose, microcrystalline cellulose (PH 102) (E 460), croscarmellose sodium, sodium lauryl sulfate, magnesium stearate (E 470b),
• Coating: hypromellose (E 464), lactose monohydrate, titanium dioxide (E 171), triacetin, iron oxide red (E 172), iron oxide yellow (E 172). See section 2 "Baxiren contains lactose (a sugar) and sodium".

What Baxiren Looks Like and Contents of the Package

Baxiren 5 mg coated tablets are pink, oval, coated tablets with dimensions of approximately 10.0 mm x 5.2 mm.

• They are packaged in PCTFE/PVC//Aluminum blisters containing 10, 14, 20, 28, 30, 56, 60, and 100 coated tablets.

Not all pack sizes may be marketed.

Patient Alert Card: Information for Use

Inside the Baxiren package, next to the patient leaflet, you will find a Patient Alert Card or your doctor may give you a similar card.
The Patient Alert Card contains information that is helpful to you and warns other doctors that you are taking Baxiren. Always carry this card with you.

• 1. Take the card.
• 2. Fill in the following or ask your doctor to fill them in:
• Name and surname:
• Date of birth:
• Indication:
• Dose: ............. mg twice daily
• Doctor's name and surname:
• Doctor's phone number:
• 3. Fold the card and always carry it with you.

Marketing Authorization Holder

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: (22) 811-18-14

Manufacturer

PharmaPath S.A.
28is Oktovriou 1
Agia Varvara, 123 51
Greece
tel. +302105401500

This Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:

Denmark
Baxiren
Poland
Baxiren
Hungary
Baxiren 5 mg film-coated tablet

Date of Last Revision of the Leaflet: