Package leaflet: Information for the patient

PRUBDAQ, 2.5 mg coated tablets
Apixabanum
Please read the entire leaflet before taking this medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Prubdaq is and what it is used for
Important information before taking Prubdaq
How to take Prubdaq
Possible side effects
How to store Prubdaq
Contents of the pack and other information

1. What Prubdaq is and what it is used for

Prubdaq contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots by blocking factor Xa, an important component in the blood clotting process.

Prubdaq is used in adults:

to prevent blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, patients have an increased risk of developing blood clots in the veins of the lower limbs. 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 formation of blood clots 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 those organs (also known as systemic embolism). Stroke may 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), as well as to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

Prubdaq is used in children aged from 28 days up to below 18 years, for the treatment of blood clots and prevention of recurrence of blood clots in veins or in the blood vessels of the lungs.
Information regarding body weight and recommended dosage can be found in section 3.

2. Important information before taking Prubdaq

When not to take Prubdaq:
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 anticoagulant therapy switch, when
an intravenous or intra-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 Prubdaq, 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 those leading to 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 impairment.
a spinal catheter or spinal injection (anaesthetic or pain-relieving), in which
case the doctor will advise taking this medicine at least 5 hours after removal of the catheter,
if the patient has a heart valve prosthesis,
if the doctor determines that the patient's blood pressure is unstable or other treatment
or surgery is planned to remove a blood clot from the lungs.

When to exercise particular caution when using Prubdaq:

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 treatment adjustment 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
Prubdaq is not recommended for use in children and adolescents weighing less than 35 kg.

Prubdaq 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 Prubdaq, while others may reduce its effectiveness. The doctor will decide whether the patient should receive Prubdaq while taking other medicines and how closely monitoring should be performed.

The following medicines may enhance the effect of Prubdaq and increase the risk of unwanted bleeding:
some medicines used to treat fungal infections (e.g. ketoconazole and others),
some 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);
particularly when 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
or serotonin-norepinephrine reuptake inhibitors.

The following medicines may reduce the ability of Prubdaq 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 Prubdaq on pregnancy and the unborn child is unknown. This medicine should not be used during pregnancy. If the patient becomes pregnant while taking this medicine, she should contact her doctor immediately.
It is not known whether Prubdaq passes into human milk. Consult your doctor, pharmacist or nurse before using this medicine during breastfeeding. The patient may be advised to discontinue breastfeeding or to stop or not start taking this medicine.

Driving and using machines
Prubdaq has no or negligible influence on the ability to drive or operate machinery.

Prubdaq contains lactose (a sugar) and sodium
If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Prubdaq

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. Prubdaq may be taken independently of meals.
To achieve the best treatment results, it is recommended to take the tablets at the same times
every day.
If a patient has difficulty swallowing tablets whole, they should discuss alternative methods of taking
Prubdaq with their doctor. The tablet may be crushed immediately before administration and mixed
with water or 5% 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 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 pestle and mortar used for crushing the tablets, as well as the container, with a small amount of water or another liquid (e.g. 30 ml), and swallow the rinse liquid.

If necessary, a doctor may administer crushed Prubdaq tablets mixed with 60 ml of water or 5% glucose solution via a nasogastric tube.
Prubdaq should be taken as directed for the following indications:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one Prubdaq 2.5 mg 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 joint surgery, they will usually take tablets for 32 to 38 days.
If the patient has undergone major knee joint surgery, they will usually take tablets for 10 to 14 days.
Prevention of blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor
The recommended dose is one Prubdaq 5 mg tablet twice daily.
The recommended dose is one Prubdaq 2.5 mg tablet twice daily if:

the patient has severe renal impairment, or
two or more of the following conditions are met: laboratory blood tests 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, or 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 venous blood clots in the legs and pulmonary embolism
The recommended dose is two tablets of Prubdaq 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 Prubdaq 5 mg twice daily, for example, one tablet in the morning and one in the evening.
Prevention of recurrent blood clots after completion of 6-month treatment
The recommended dose is one Prubdaq 2.5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.
The doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrent blood clots in veins or pulmonary blood vessels
This medicine should always be taken or administered as directed by a doctor or pharmacist.
If in doubt, consult a doctor, pharmacist or nurse.
To achieve the best treatment effect, the dose should be taken or administered at the same time each day.
The dose of Prubdaq depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing at least 35 kg is four tablets of Prubdaq 2.5 mg, given twice daily for the first 7 days, for example, four in the morning and four in the evening. After 7 days, the recommended dose is two tablets of Prubdaq 2.5 mg, given twice daily, for example, two in the morning and two in the evening.
For parents and caregivers: observe the child to ensure the full dose has been taken.
It is important to attend scheduled doctor visits, as dose adjustments may be necessary as the patient's body weight changes.
The doctor may change anticoagulant therapy as follows:
Switching from Prubdaq to other anticoagulant medicines
Stop taking Prubdaq. Start treatment with another anticoagulant (e.g. heparin) at the time the next tablet was due.
Switching from other anticoagulant medicines to Prubdaq
Stop taking other anticoagulants. Start Prubdaq treatment at the time the next dose of the other anticoagulant was due, and continue taking it as usual.
Switching from vitamin K antagonist anticoagulant therapy (e.g. warfarin) to Prubdaq
Discontinue the vitamin K antagonist medicine. The doctor must perform blood tests and will inform the patient when to start taking Prubdaq.
Switching from Prubdaq to vitamin K antagonist anticoagulant therapy (e.g. warfarin)
If the doctor informs the patient to start taking a vitamin K antagonist medicine, continue taking Prubdaq 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 Prubdaq.
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 blood clots in the brain's blood vessels and other blood vessels in the body.
Taking more Prubdaq than recommended
If a patient takes more than the recommended dose of this medicine, they should contact their doctor immediately. Bring the medicine packaging, even if it is empty.
If a patient takes more than the recommended dose of Prubdaq, the risk of bleeding may increase. In case of bleeding, surgical treatment, blood transfusion, or other treatment reversing the anti-factor Xa effect may be required.
Missing a dose of Prubdaq
If a morning dose is missed, take it as soon as remembered, and it may be taken together with the evening dose.
A missed evening dose may only be taken on the same evening. Do not take two doses the next morning. Instead, continue taking the medicine the next day as directed, twice daily.
If in doubt about how to take the medicine or if more than one dose is missed, consult a doctor, pharmacist or nurse.
Stopping Prubdaq
Do not stop taking this medicine without consulting a doctor, as stopping Prubdaq 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 they do not occur in everyone.
Prubdaq can be used in three different medical conditions. The known adverse reactions
and their frequency of occurrence in each of these medical conditions may differ 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 Prubdaq to prevent blood clots after hip or knee replacement surgery.

Common adverse reactions (may occur in up to 1 in 10 people)
Anaemia, which may cause fatigue or paleness,
Bleeding including:

subcutaneous haemorrhages and swelling;
Nausea (feeling sick).

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

Decreased 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 (wound discharge) or injection site;
from the stomach, intestines, or bright red blood in stool;
blood in urine;
nosebleeds;
from the vagina;
Low blood pressure, which may lead to fainting or rapid heartbeat;
Blood test results may show:
liver function abnormalities;
increased activity of certain liver enzymes;
increased bilirubin levels, a product 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 a 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 (space behind the abdominal cavity);
from haemorrhoids;
test results indicating blood in stool or urine;
Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the centre 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, round spots under the skin surface, or bruising;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse reactions may occur when taking Prubdaq 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;
from gums;
subcutaneous haemorrhage 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 show:
increased activity of gamma-glutamyl transferase (GGT).

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

Bleeding:
into the brain or spinal cord;
in the mouth or in the lungs (haemoptysis);
into the abdominal cavity 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 (wound discharge) or injection site;
from haemorrhoids;
presence of blood in stool or urine detected in laboratory tests;
Decreased platelet count (which may affect 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 are observed, contact a doctor 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 resembles 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)

Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, round spots under the skin surface, or bruising;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse reactions may occur when taking Prubdaq to treat or prevent recurrence of blood clots in the veins of the lower limbs and blood clots in blood vessels in the lungs.

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

Bleeding, including:
nosebleeds;
from gums;
blood in urine;
subcutaneous haemorrhage and swelling;
in the stomach, intestines, or from the rectum;
in the mouth;
from the vagina;
Anaemia, which may cause fatigue or paleness;
Decreased platelet count (which may affect clotting);
Nausea (feeling sick);
Skin rash;
Blood test results may show: increased activity of gamma-glutamyl transferase (GGT) or alanine aminotransferase (AlAT).

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 (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 a 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 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 resembles small target-like lesions (dark spots in the centre 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, round spots under the skin surface, or bruising;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional adverse reactions in children and adolescents
If any of the following symptoms occur, contact a doctor immediately:

Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. The frequency of these adverse reactions is classified as “common” (may occur in up to 1 in 10 people).

In general, adverse reactions observed in children and adolescents treated with Prubdaq were similar to those seen in adults and were mostly mild or moderate in severity. Adverse reactions occurring more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

Very common adverse reactions (may occur in more than 1 in 10 people)

Bleeding, including:
from the vagina;
nosebleeds.

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

Bleeding, including:
from gums;
blood in urine;
subcutaneous haemorrhages (bruising) and swelling;
from the intestine or rectum;
bright red blood in stool;
postoperative bleeding, including subcutaneous haemorrhages (bruising) and swelling, leakage of blood from the surgical wound/incision (wound discharge) or injection site;
Hair loss;
Anaemia, which may cause fatigue or paleness;
Decreased platelet count (which may affect clotting);
Nausea (feeling sick);
Skin rash;
Itching;
Low blood pressure, which may cause fainting or rapid heartbeat;
Blood test results may show:
abnormal liver function;
increased activity of certain liver enzymes;
increased alanine aminotransferase (ALT) activity.

Frequency not known (cannot be estimated from available data)

Bleeding:
into the abdominal cavity or retroperitoneal space;
in the stomach;
in the eyes;
in the mouth;
from haemorrhoids;
in the mouth or blood in sputum when coughing;
into the brain or spinal cord;
in the lungs;
into muscle tissue;
Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
Vasculitis, which may cause skin rash or raised, flat, red, round spots under the skin surface or bruising;
Blood test results may show:
increased gamma-glutamyl transferase (GGT) activity;
presence of blood in stool or urine.
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

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 the medicine Prubdaq

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 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 no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Prubdaq contains

The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
The other ingredients are:
- Tablet core: mannitol, microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate;
- Tablet coating: hypromellose (type 2910, 6 mPa*s), titanium dioxide (E 171), lactose monohydrate, macrogol 3350, triacetin, yellow iron oxide (E 172).

What Prubdaq looks like and contents of the pack
Round, biconvex, light yellow film-coated tablets with a diameter of 5.9–6.3 mm.
Prubdaq is available in PVC/PVDC/Aluminium blister packs in cardboard cartons.
The pack contains 10, 20, 60, 168 or 200 film-coated tablets.
Not all pack sizes may be marketed.

Patient Card: information for use
Inside the Prubdaq 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 Prubdaq. You should always carry this card with you.

Take the card.
If necessary, detach the appropriate language section (facilitated by perforated edges).
Complete the following sections, or ask your doctor to complete them:
- Name:
- Date of birth:
- Indication:
- Dose: ........ mg twice daily
- Doctor’s name:
- Doctor’s telephone number:
Fold the card and always keep it with you.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19,
83-200 Starogard Gdański
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names
Poland Prubdaq
Czech Republic PRUBDAQ
Estonia PRUBDAQ
Hungary PRUBDAQ 2.5 mg filmtabletta
Lithuania PRUBDAQ 2.5 mg plėvele dengtos tabletės
Slovakia PRUBDAQ 2.5 mg

December 2025