Baxiren

Patient Information Leaflet

Baxiren, 2.5 mg, coated tablets
Apixabanum
Read the entire leaflet before using this 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 share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including those 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. Important information 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 the formation of blood clots (deep vein thrombosis) after hip or knee replacement surgery. Following hip or knee surgery, patients may have an increased risk of developing blood clots in the veins of the legs. This may lead to leg swelling, with or without pain. If a blood clot travels from the leg to the lungs, it may block blood flow through the lungs, causing breathlessness with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
• To prevent blood clots in the heart in patients with an irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing a stroke, or to other organs, impairing blood supply to these organs (also known as systemic embolism). Stroke may be life-threatening and requires immediate medical intervention.
• To treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as 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 haemorrhage),
• 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 is undergoing catheter ablation (a catheter is inserted into the vein) due to irregular heartbeat (arrhythmia).

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

• increased risk of bleeding, for example:
• conditions involving bleeding, including cases resulting in reduced platelet activity,
• very high blood pressure not controlled by 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.
• spinal catheter or spinal injection (anaesthetic or pain relief), in which case the doctor will recommend taking this medicine 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 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 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 your doctor, pharmacist or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may enhance the effect of Baxiren, while others may reduce 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 of age and taking acetylsalicylic acid, the risk of unwanted bleeding may be increased

• medicines used for high blood pressure or heart problems (e.g. diltiazem),
• antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs).

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 (a 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 child, 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. The patient should consult her doctor, pharmacist or nurse before using this medicine during breastfeeding. The patient may be advised to stop breastfeeding or to discontinue/avoid starting this medicine.
Driving and operating machinery
Baxiren has no effect or a negligible effect on the ability to drive motor vehicles and operate machinery.
Baxiren contains lactose (a sugar) and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should contact 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 exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor, pharmacist, or nurse.
Dosage
The tablet should be swallowed with water. Baxiren can be taken regardless 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 the tablets whole, they should discuss alternative methods of taking Baxiren with their doctor. The tablet may be crushed and mixed with water or 5% aqueous glucose solution, juice, or apple puree immediately before administration.
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 form a mixture.
• Swallow the mixture.
• Rinse the mortar, pestle, and container used for crushing the tablet with a small amount of water or another liquid (e.g., 30 mL), and swallow the rinse liquid.

If necessary, your doctor may administer crushed Baxiren tablet mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube. The tube should be flushed with 10 mL of water immediately after administration of Baxiren.
Baxiren should be taken as directed in the following indications:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one 2.5 mg Baxiren tablet twice daily, 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 surgery, they will usually take the tablets for 32 to 38 days.
If the patient has undergone major knee surgery, they will usually take the tablets for 10 to 14 days.
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 5 mg Baxiren tablet twice daily.
The recommended dose is one 2.5 mg Baxiren tablet 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 ≥1.5 mg/dL (133 micromoles/L)),
• 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. Your doctor will decide how long treatment should continue.
Treatment of blood clots in the deep veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two 5 mg Baxiren 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 one 5 mg Baxiren tablet 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 2.5 mg Baxiren tablet twice daily, for example, one tablet in the morning and one in the evening.
Your doctor will decide how long treatment should continue.
Your doctor may switch anticoagulant therapy as follows:

• Switching from Baxiren to anticoagulant medicines Discontinue Baxiren. Start anticoagulant treatment (e.g., heparin) at the time the next Baxiren dose is due.
• Switching from anticoagulant medicines to Baxiren Discontinue anticoagulant treatment. Start Baxiren at the time the next anticoagulant dose is due, then continue regular dosing.
• Switching from anticoagulant therapy including a vitamin K antagonist (e.g., warfarin)

to Baxiren
Discontinue the vitamin K antagonist medicine. Your doctor must perform blood tests and will inform you when to start taking Baxiren.

• Switching from Baxiren to anticoagulant therapy including a vitamin K antagonist (e.g., warfarin) If your doctor tells you to start taking a vitamin K antagonist medicine, continue taking Baxiren for at least 2 days after taking the first dose of the vitamin K antagonist. Your doctor must perform blood tests and will inform you when to stop taking Baxiren.

Patients undergoing cardioversion
Patients who require cardioversion to restore normal heart rhythm should take this medicine at the times specified by their doctor to prevent formation of blood clots in the blood vessels of the brain and other parts of the body.
Taking more Baxiren than recommended
If a patient takes more Baxiren than recommended, contact a doctor immediately. Take the medicine packaging with you, even if it is empty.
If a patient takes more Baxiren than recommended, there may be an 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.
Missed dose of Baxiren

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

If in doubt about use of the medicine or if more than one dose is missed, consult your 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 your doctor, as stopping Baxiren prematurely may increase the risk of developing blood clots.
If you have any further questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Baxiren can be used for three different medical conditions. The known adverse reactions and their frequency of occurrence may differ for each of these medical conditions and are listed separately below. In these conditions, 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 after hip or knee surgery.

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

• Anaemia, which may cause fatigue or paleness;
• Bleeding including:
  • Bruising and swelling;
• Nausea (feeling sick).

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

• Reduced platelet count (which may affect blood clotting);
• Bleeding:
  • After surgery, including bruising and swelling, leakage of blood or other fluid from the surgical wound/incision site (wound discharge) or injection site;
  • From the stomach, intestines, or bright red blood in stool;
  • Blood in urine;
  • Nosebleeds;
  • Vaginal bleeding;
• Low blood pressure, which may lead to fainting or rapid heartbeat;
• Blood test results may indicate:
  • Liver function abnormalities;
  • Increased activity of certain liver enzymes;
  • Increased bilirubin levels, a product formed from the breakdown of red blood cells, which may cause yellowing of the skin and eyes;
• Itching.

Rare adverse reactions (may occur in up to 1 in 1000 people)

• 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;
• Bleeding:
  • Into muscle tissue;
  • Into the eyes;
  • From gums and coughing up blood;
  • From the rectum;
• Hair loss.

Frequency not known (cannot be estimated from available data)

• Bleeding:
  • Into the brain or spinal cord;
  • In the lungs or throat;
  • In the mouth;
  • Into the abdominal cavity or retroperitoneal space;
  • From haemorrhoids;
  • Test results indicating presence of blood in stool or urine;
• Skin rash, which may develop blisters and resemble small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising.

The following adverse reactions may occur when taking Baxiren to prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

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

• Bleeding, including:
  • Into the eye;
  • In the stomach or intestine;
  • From the rectum;
  • Blood in urine;
  • Nosebleeds;
  • Gum bleeding;
  • Bruising and swelling;
• Anaemia, which may cause fatigue or paleness;
• Low blood pressure, which may lead to fainting or rapid heartbeat;
• Nausea (feeling sick);
• Blood test results may indicate:
  • Increased gamma-glutamyl transferase (GGT) activity.

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

• Bleeding:
  • Into the brain or spinal cord;
  • In the mouth or haemoptysis (coughing up blood);
  • Into the abdominal cavity or from the vagina;
  • Bright red blood in stool;
  • Post-surgical bleeding, 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 platelet count (which may affect blood clotting);
• Blood test results may indicate:
  • 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 are observed, seek medical advice immediately.

Rare adverse reactions (may occur in up to 1 in 1000 people)

• Bleeding:
  • In the lungs or throat;
  • Into the retroperitoneal space;
  • Into muscle tissue.

Very rare adverse reactions (may occur in up to 1 in 10,000 people)

• Skin rash, which may develop blisters and resemble small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

Frequency not known (cannot be estimated from available data)

• Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising.

The following adverse reactions may occur when taking Baxiren for the treatment or prevention of recurrent blood clots in the deep 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:
  • Nosebleeds;
  • Gum bleeding;
  • Blood in urine;
  • Bruising and swelling;
  • In the stomach, intestine, or from the rectum;
  • In the mouth;
  • Vaginal bleeding;
• Anaemia, which may cause fatigue or paleness;
• Decreased platelet count (which may affect blood clotting);
• Nausea (feeling sick);
• Skin rash;
• Blood test results may indicate:
  • Increased gamma-glutamyl transferase (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;
  • Post-surgical bleeding, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
  • From haemorrhoids;
  • Into muscle tissue;
• 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 are observed, 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, which may cause yellowing of the skin and eyes.

Rare adverse reactions (may occur in up to 1 in 1000 people)

• Bleeding:
  • Into the brain or spinal cord;
  • In the lungs.

Frequency not known (cannot be estimated from available data)

• Bleeding:
  • Into the abdominal cavity or retroperitoneal space.
• Skin rash, which may develop blisters and resemble small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, 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
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Baxiren

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister after 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 no longer in use. This will help protect
the environment.

6. Contents of the packaging and other information

What Baxiren contains

• The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
• The other ingredients are:
  • Tablet core: lactose, microcrystalline cellulose (PH 102) (E 460), sodium croscarmellose, sodium lauryl sulphate, magnesium stearate (E 470b),
  • Coating: hypromellose (E 464), monohydrate lactose, 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 approximately 6 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 the treating physician may provide the patient with a similar card.
The Patient Warning Card contains helpful information for the patient and warns other physicians that the patient is taking Baxiren. You should always carry this card with you.

1. Take the card.
2. Fill in the following details yourself 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 keep 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 in the European Economic Area member states under the following names:
Denmark Baxiren
Poland Baxiren
Hungary Baxiren 2.5 mg filmtabletta