Baxiren

Package leaflet: Information for the patient

Baxiren, 5 mg, film-coated tablets
Apixabanum
Read the entire leaflet before taking the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Baxiren is and what it is used for
2. What you need to know before taking Baxiren
3. How to take Baxiren
4. Possible side effects
5. How to store Baxiren
6. Contents of the pack and other information

1. What Baxiren is and what it is used for

Baxiren 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.
Baxiren is used in adults:

• to prevent blood clots forming in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or to other organs, impairing blood flow to these organs (also known as systemic embolism). Stroke can be life-threatening and requires immediate medical attention.
• to treat 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 blood vessels of the legs and/or lungs.

2. Important information before using Baxiren

When not to use Baxiren

• 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 an organ 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 arterial line has been inserted and heparin is administered through this line to maintain its patency, or when the patient undergoes catheter ablation (a catheter is inserted into the vein) due to irregular heartbeat (arrhythmia).

Warnings and precautions

Before starting treatment with Baxiren, discuss with the doctor, pharmacist or nurse if the patient has any of the following conditions:

• increased risk of bleeding, for example:
• conditions associated with bleeding, including those resulting in reduced platelet activity,
• very high blood pressure not controlled with 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 problems or history of liver problems.
• This medicine should be used with caution in patients showing signs of liver function abnormalities,
• if the patient has a heart valve prosthesis,
• if the doctor determines that the patient's blood pressure is unstable, or if other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Baxiren

• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

If surgery or a procedure that may involve bleeding is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If in doubt whether a given procedure may involve bleeding, consult the doctor.

Children and adolescents

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

Baxiren and other medicines

Tell the doctor, pharmacist or nurse about all medicines the patient is currently taking, has recently taken, or plans to take.
Some medicines may enhance the effect of Baxiren, while others may weaken its effect. The doctor will decide whether the patient should receive Baxiren while taking other medicines and how closely monitoring should be performed.

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

• certain medicines used to treat fungal infections (e.g. ketoconazole and others),
• certain 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), especially if the patient is over 75 years old and taking acetylsalicylic acid, which may increase the risk of unwanted bleeding,
• medicines used for high blood pressure or heart problems (e.g. diltiazem),
• antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.

The following medicines may reduce the ability of Baxiren 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 baby, she should consult her doctor, pharmacist or nurse before using 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, she should contact her doctor immediately.
It is not known whether Baxiren passes into human milk. Before using this medicine during breastfeeding, consult the doctor, pharmacist or nurse. The patient may be advised to discontinue breastfeeding or to discontinue/avoid starting this medicine.

Driving and operating machinery

Baxiren has no or negligible effect on the ability to drive motor vehicles and operate machinery.

Baxiren contains lactose (a sugar) and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Baxiren

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. Baxiren can be taken independently of meals.
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 tablets whole, they should consult their doctor about alternative
ways of taking Baxiren. 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 with a mortar and pestle.
• Carefully transfer the powder to a suitable container and mix it with a small amount, e.g., 30 mL (2 tablespoons), of water or another liquid listed above to prepare a mixture.
• Swallow the mixture.
• Rinse the mortar, pestle, and container used for crushing the tablets with a small amount of water or another liquid (e.g., 30 mL) and swallow the rinsing liquid.

If necessary, a doctor may administer crushed Baxiren tablets 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 administration of the Baxiren dose.
Baxiren should be taken as directed for the following indications:
Prevention of blood clots in the heart in patients with irregular heart rhythm
(atrial fibrillation) and at least one additional risk factor
The recommended dose is one Baxiren tablet 5 mg twice daily.
The recommended dose is one Baxiren tablet 2.5 mg 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 veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two tablets of Baxiren 5 mg 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 tablet of Baxiren 5 mg 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 Baxiren tablet 2.5 mg twice daily, for example, one tablet
in the morning and one in the evening.
The doctor will decide how long treatment should continue.
The doctor may change anticoagulant therapy as follows:

• Switching from Baxiren to anticoagulant medicines Discontinue Baxiren. Start anticoagulant treatment (e.g., heparin) at the time the next tablet was scheduled to be taken.
• Switching from anticoagulant medicines to Baxiren Discontinue anticoagulant medicines. Start Baxiren at the time the next anticoagulant dose was scheduled, then continue regular dosing.
• Switching from vitamin K antagonist anticoagulant therapy (e.g., warfarin) to Baxiren Discontinue the vitamin K antagonist medicine. The doctor must perform blood tests and inform the patient when to start taking Baxiren.
• Switching from Baxiren to vitamin K antagonist anticoagulant therapy (e.g., warfarin) If the doctor informs the patient that they should start taking a vitamin K antagonist medicine, continue taking Baxiren for at least 2 days after the first dose of the vitamin K antagonist medicine. The doctor must perform blood tests and inform the patient when to stop taking Baxiren.

Patients undergoing cardioversion
Patients who require a cardioversion procedure to restore normal heart rhythm should take this
medicine at the times specified by the doctor to prevent formation of blood clots in the brain's
blood vessels and other blood vessels in the body.
Taking more than the recommended dose of Baxiren
If a patient takes more than the recommended dose of Baxiren, they should immediately inform their doctor. Bring the medicine packaging, even if empty.
If a patient takes more than the recommended dose of Baxiren, the risk of bleeding may increase. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the anti-factor Xa effect may be necessary.
Missing a dose of Baxiren

• Take the missed dose as soon as the patient remembers and:
• take the next dose at the usual time,
• then continue taking the medicine as before.

If in doubt about how to take the medicine or if more than one dose is missed, consult a doctor, pharmacist, or nurse.
Do not take a double dose to make up for a missed dose.
Stopping Baxiren
Do not stop taking this medicine without consulting a doctor, as stopping Baxiren prematurely may increase the risk of blood clots.
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 will experience them.
The most common general adverse reaction 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 Baxiren to
prevent blood clots in the heart in patients with irregular heart rhythm and at least
one additional risk factor.

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

• Bleeding, including:
• into the eye;
• into the stomach or intestine;
• from the rectum;
• blood in urine;
• from the nose;
• from the gums;
• subcutaneous haemorrhage and swelling;
• Anaemia, which may cause fatigue or pallor;
• Low blood pressure, which may lead to fainting or rapid heartbeat;
• Nausea;
• Blood test results may show:
• increased gamma-glutamyltransferase (GGT) activity.

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

• Bleeding:
• into the brain or spinal canal;
• in the mouth or coughing up blood;
• in the abdomen or from the vagina;
• bright red blood in stool;
• bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
• from haemorrhoids;
• presence of blood in stool or urine detected in laboratory tests;
• Decreased number of platelets in the blood (which may affect blood clotting);
• Blood test results may show:
• 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 occur, contact your doctor immediately.

Rare adverse reactions (may occur in up to 1 in 1,000 people)

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

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 center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

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

• Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular spots under the skin, or bruising.

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

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

• Bleeding, including:
• from the nose;
• from the gums;
• blood in urine;
• subcutaneous haemorrhage and swelling;
• in the stomach, intestine, or from the rectum;
• in the mouth;
• from the vagina;
• Anaemia, which may cause fatigue or pallor;
• Decreased number of platelets in the blood (which may affect blood clotting);
• Nausea;
• Skin rash;
• Blood test results may show:
• increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (AlAT) 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;
• bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
• from haemorrhoids;
• into muscles;
• 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 occur, contact your doctor immediately;
• Blood test results may show:
• 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 1,000 people)

• Bleeding:
• into the brain or spinal canal;
• in the lungs.

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

• Bleeding:
• into the abdominal cavity or into the space behind the abdominal cavity;
• Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular spots under the skin, or bruising.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Baxiren

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack following the abbreviation EXP. The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Baxiren contains

• The active substance is apixaban. Each tablet contains 5 mg of apixaban.
• The other ingredients are:
  • Core of the tablet: lactose, microcrystalline cellulose (PH 102) (E 460), sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (E 470b),
  • Coating: hypromellose (E 464), monohydrate lactose, titanium dioxide (E 171), triacetin, red iron oxide (E 172), 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 5 mg film-coated tablets are pink, oval film-coated tablets of approximately 10.0 mm × 5.2 mm.

• 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 Warning Card: information on use
Inside the Baxiren packaging, alongside the patient leaflet, there is a Patient Warning Card, or your doctor may provide you with a similar card.
The Patient Warning Card contains helpful information for the patient and warns other doctors that the patient is taking Baxiren. You should always carry this card with you.

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

Marketing Authorisation Holder
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Telephone number: (22) 811-18-14

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

This medicinal product is authorised for sale in the European Economic Area under the following names:
Denmark Baxiren
Poland Baxiren
Hungary Baxiren 5 mg filmtabletta