Baxiren

Leaflet accompanying the packaging: patient information

Baxiren, 2.5 mg, film-coated tablets

Apixaban

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 medicines. This medicine 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 (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, the patient may be at increased risk of blood clots in the legs. This can lead to swelling of the legs, with or without pain. If a blood clot moves from the leg to the lungs, it can block blood flow through 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 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 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 Baxiren

When not to take Baxiren

• If the patient is allergicto apixaban or any of the other ingredients of this medicine (listed in section 6),
• -if the patient has excessive bleeding,
• if the patient has an organ diseasethat increases the risk of serious bleeding (such as active or recently diagnosed stomach or intestinal ulcersor recent brain bleeding),
• -if the patient has liver diseasethat leads to an increased risk of bleeding (liver coagulopathy),
• if the patient is taking anticoagulant medicines(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the anticoagulant 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 their vein) due to irregular heart rhythm (arrhythmia).

Warnings and precautions

Before starting Baxiren, the patient should discuss with their doctor, pharmacist, or nurse if they have any of the following conditions:

• Increased risk of bleeding, such as:
• Bleeding disorders, including cases resulting in decreased platelet activity,
• Very high blood pressurethat is not controlled with medication,
• if the patient is over 75 years old,
• if the patient weighs 60 kg or less,
• Severe kidney disease or if the patient is on dialysis,
• Liver problems or a history of liver problems.
• This medicine should be used with caution in patients with signs of liver function changes.
• Tube (catheter) or spinal injection(anesthetic or pain-relieving), in which case the doctor will recommend taking this medicine after 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 plans other treatment or surgery to remove a blood clot from the lungs.

When to be particularly cautious when taking Baxiren

• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether to change the treatment.

In case of need for surgery or a procedure that may be associated with bleeding, the doctor may ask the patient to temporarily stop taking this medicine for a short time. If there is any doubt whether a given procedure may be associated with bleeding, the doctor should be consulted.

Children and adolescents

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

Baxiren and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may enhance the effect of Baxiren, and some may weaken its effect. The doctor will decide whether the patient should receive Baxiren while taking other medicines and how closely they should be monitored.
The following medicines may enhance the effect of Baxiren 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-inflammatoryor analgesic medicines(e.g., acetylsalicylic acid or naproxen),

especially if the patient is over 75 years old and taking acetylsalicylic acid, they may be at increased risk of unwanted bleeding

• medicines used for 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 Baxiren to prevent blood clot formation:

• medicines used to prevent seizures or convulsions(e.g., phenytoin and others)
• St. John's Wort(a herbal supplement used for depression)
• medicines used to treat tuberculosisor other infections(e.g., rifampicin).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before taking this medicine.
The effect of Baxiren 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, they should immediatelycontact their doctor.
It is not known whether Baxiren passes into breast milk. Before taking this medicine while breastfeeding, the patient should consult their doctor, pharmacist, or nurse. The patient may be advised to stop breastfeeding or stop/avoid taking this medicine.

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 the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Baxiren

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.

Dose

The tablet should be swallowed with water. Baxiren can be taken with or without food.
To achieve the best treatment results, it is recommended to take the tablets at the same time every day.
If the patient has problems swallowing the tablets whole, they should discuss other ways of taking Baxiren with their doctor. The tablet can be crushed immediately before taking and mixed with water or a 5% aqueous glucose solution, juice, or apple sauce.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the powder to a suitable container and 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.

In case of need, the doctor may administer a crushed Baxiren tablet mixed with 60 mL of water or a 5% aqueous glucose solution through a nasogastric tube. The tube should be rinsed with 10 mL of water immediately after administering the Baxiren dose.

Baxiren should be taken as recommended in the following indications:

Prevention of blood clot formation after hip or knee replacement surgery
The recommended dose is one Baxiren 2.5 mg 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 the patient has undergone major hip replacement surgery, they will usually take the tablets for 32 to 38 days.
If the patient has undergone major knee replacement surgery, they will usually take the tablets for 10 to 14 days.
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 mgtablet twice a day.
The recommended dose is one Baxiren 2.5 mgtablet twice a day if:

• the patient has severe kidney problems,
• two or more of the following conditions are met:
• the patient's blood test results suggest decreased kidney function (serum creatinine level of 1.5 mg/dL (133 micromole/L) or higher),
• the patient is 80 years old or older,
• the patient's 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. The doctor will decide how long to 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 twoBaxiren 5 mgtablets twice 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 oneBaxiren 5 mgtablet twice 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 Baxiren 2.5 mgtablet twice a day, for example, one tablet in the morning and one in the evening.
The doctor will decide how long to continue treatment.

The doctor may change the anticoagulant treatment as follows:

• Changing from Baxiren to anticoagulant medicinesThe patient should stop taking Baxiren. Anticoagulant treatment (e.g., heparin) should be started at the time of the scheduled next Baxiren tablet intake.
• Changing from anticoagulant medicines to BaxirenThe patient should stop taking anticoagulant medicines. Baxiren treatment should be started at the time of the scheduled next anticoagulant dose intake and then continued as usual.
• Changing from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin)

to Baxiren
The patient should stop taking the vitamin K antagonist. The doctor will perform blood tests and inform the patient when to start taking Baxiren.

• Changing from Baxiren 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, they should continue taking Baxiren for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor will perform blood tests and inform the patient when to stop taking Baxiren.

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 clot formation in the brain and other blood vessels.

Taking a higher dose of Baxiren than recommended

If the patient has taken a higher dose of Baxiren than recommended, they should immediatelyinform their doctor. They should take the packaging with them, even if it is empty.
If the patient has taken a higher dose of Baxiren than recommended, they 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

• The patient should take the dose as soon as they remember and then take the next dose at the usual time.

In case of doubts about taking the medicine or if more than one dose is missed

The patient should consult their doctor, pharmacist, or nurse.
The patient should not take a double dose to make up for the missed dose.

Stopping Baxiren treatment

The patient should not stop taking this medicine without consulting their doctor, as stopping Baxiren treatment prematurely may increase the risk of blood clot formation.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Baxiren can cause side effects, although not everybody gets them.
Baxiren 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 Baxiren to prevent blood clot formation after hip or knee replacement surgery.

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

• Anemia, which can cause fatigue or pallor;
• Bleeding, including:
• bruises and swelling;
• Nausea (vomiting).

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/incision or injection site (wound discharge) or injection site;
• from the stomach, intestines, or bright red blood in the stool;
• blood in the urine;
• from the nose;
• from the vagina;
• 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: facial swelling, lip swelling, mouth swelling, tongue swelling, and (or) throat swelling, as well as difficulty breathing. If any of these symptoms are observed, the patient should immediatelycontact their doctor;
• Bleeding:
• into the muscle;
• into the eyes;
• from the gums and coughing up blood;
• from the rectum;
• 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 into the space behind the abdominal cavity;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• A 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 spots under the skin surface, or bruises.

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:
• into the eye;
• into the stomach or intestines;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• bruises and swelling;
• Anemia, which can cause fatigue or pallor;
• 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:
• into the brain or spinal cord;
• into the mouth or coughing up blood;
• into the abdominal cavity or from the vagina;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision or injection site (wound discharge) or injection site;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• 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: facial swelling, lip swelling, mouth swelling, tongue swelling, and (or) throat swelling, as well as difficulty breathing. If any of these symptoms are observed, the patient should immediatelycontact their doctor;

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

• Bleeding:
• into the lungs or throat;
• into the space behind the abdominal cavity;
• into the muscle.

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 spots under the skin surface, or bruises.

The following side effects may occur when taking Baxiren 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;
• bruises and swelling;
• in the stomach, intestines, or rectum;
• in the mouth;
• from the vagina;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count (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:
• into the eyes;
• into the mouth or coughing up blood;
• bright 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 leakage from the surgical wound/incision or injection site (wound discharge) or injection site;
• from hemorrhoids;
• into the muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling, and (or) throat swelling, as well as difficulty breathing. If any of these symptoms are observed, the patient should immediatelycontact their doctor;
• 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 into the space behind the abdominal cavity.
• A 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 spots under the skin surface, or bruises.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Baxiren

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

6. Contents of the packaging and other information

What Baxiren contains

• The active substance of Baxiren is apixaban. Each tablet contains 2.5 mg of apixaban.
• 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, yellow iron oxide (E 172). See section 2 "Baxiren contains lactose (a sugar) and sodium".

What Baxiren looks like and contents of the pack

Baxiren, 2.5 mg, film-coated tablets are yellow, round, film-coated tablets with a diameter of about 6 mm.

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

Not all pack sizes may be marketed.

Patient Alert Card: information for use

Inside the Baxiren packaging, next to the patient information leaflet, there is a Patient Alert Card or the doctor may give the patient a similar card.
The Patient Alert Card contains information that helps the patient and warns other doctors that the patient is taking Baxiren. The patient should always carry this card with them.

• 1. Take the card.
• 2. Fill in the following points or ask the doctor to fill them in:
• Name and surname:
• Date of birth:
• Indication:
• Dose: ............. mg twice a day
• 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: (22) 811-18-14

Manufacturer

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark
Baxiren
Poland
Baxiren
Hungary
Baxiren 2.5 mg film-coated tablets

Date of last revision of the leaflet: