Prubdaq

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

PRUBDAQ, 5 mg coated tablets

Apixaban

Before taking the medicine, you should read the contents of this leaflet carefully, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Prubdaq and what is it used for

Prubdaq contains the active substance apixaban and belongs to a group of so-called anticoagulant medicines. This medicine helps prevent blood clots by blocking factor Xa, which is an important factor in blood clotting.
Prubdaq is used in adults:
to prevent 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 travel to the brain, leading to a stroke, or to other organs, disrupting blood flow to these organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention,
to treat blood clots in the veins of the lower limbs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the blood vessels of the lower limbs and/or lungs.
Prubdaq is used in children aged from 28 days to less than 18 years to treat and prevent the recurrence of blood clots in the veins or in the blood vessels of the lungs.
Information on body weight and recommended dose can be found in section 3.

2. Important information before taking Prubdaq

When not to take Prubdaq:

If you are allergic toapixaban or any of the other ingredients of this medicine (listed in section 6),
,
that increases the risk of serious bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recent brain bleeding),
that leads to an increased risk of bleeding (hepatic coagulopathy),
(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the anticoagulant treatment is changed, when a venous or arterial access line is inserted in the patient and heparin is administered through this line to maintain its patency or when the patient undergoes catheter ablation (a catheter is inserted into his vein) due to irregular heart rhythm (arrhythmia).

Warnings and precautions

Before starting to take Prubdaq, you should discuss with your doctor, pharmacist, or nurse if you have any of the following conditions:
increased risk of bleeding, for example:
bleeding disorders, including cases resulting in decreased platelet activity,
very high blood pressurethat is not controlled with medication,
,
,
severe kidney disease or if you are 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, spinal or epidural catheter(anesthetic or analgesic). In such cases, the doctor will recommend taking this medicine after 5 or more hours after catheter removal, if the patient has a prosthetic heart valve, if the doctor determines that the patient's blood pressure is unstable or if other treatment or surgery is planned to remove a blood clot from the lungs.

When to be particularly careful when taking Prubdaq

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

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

Children and adolescents

This medicine is not recommended for children and adolescents weighing less than 35 kg.

Prubdaq and other medicines

You should tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may enhance the effect of Prubdaq, and some may weaken its effect. Your doctor will decide whether you should receive Prubdaq while taking other medicines and how closely you should be monitored.
The following medicines may enhance the effect of Prubdaq 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-inflammatory or 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 Prubdaq to prevent blood clot formation:
medicines used to prevent seizures or fits(e.g., phenytoin and others),
St. John's Wort(a herbal supplement used in depression),
medicines used to treat tuberculosis or other infections(e.g., rifampicin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor, pharmacist, or nurse before taking this medicine.
The effect of Prubdaq on pregnancy and the unborn child is unknown. You should not take this medicine during pregnancy. If you become pregnant while taking this medicine, you should immediately contact your doctor.
It is not known whether Prubdaq passes into breast milk. Before taking this medicine while breastfeeding, you should consult your doctor, pharmacist, or nurse. You may be advised to stop breastfeeding or stop/avoid taking this medicine.

Driving and using machines

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

Prubdaq contains lactose (a sugar) and sodium

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Prubdaq

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor, pharmacist, or nurse.

Dose

Note that a dose of 2.5 mg cannot be obtained using the Prubdaq 5 mg product because it cannot be divided into two equal halves for dosing purposes. You should take other medicinal products containing apixaban 2.5 mg.
The tablet should be swallowed with water. Prubdaq can be taken with or without food.
To achieve the best treatment results, you should try to take the tablets at the same time every day.
If you have problems swallowing the tablets whole, you should talk to your doctor about other ways of taking Prubdaq. The tablet can be crushed immediately before administration and mixed with water or a 5% aqueous glucose solution, juice, or apple puree.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the powder to a suitable container 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, your doctor may administer a crushed Prubdaq tablet mixed with 60 ml of water or a 5% aqueous glucose solution through a nasogastric tube.

Prubdaq should be taken as follows in the following indications:

Prevention of blood clot formation in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor.
The recommended dose is one Prubdaq 5 mg tablet twice a day.
The recommended dose is one Prubdaq 2.5 mg tablet twice a day if:

• you have severe kidney problems,
• one or more of the following conditions are met: the results of your blood tests indicate decreased kidney function (serum creatinine level of 1.5 mg/dl (133 micromoles/l) or higher), you are over 80 years old, your body 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. Your doctor will decide how long you should continue the treatment.
Treatment of blood clots in the veins of the lower limbs and blood clots in the blood vessels of the lungs
The recommended dose is two Prubdaq 5 mg tablets 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 one Prubdaq 5 mg tablet twice a day, 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 Prubdaq 2.5 mg tablet twice a day, for example, one tablet in the morning and one in the evening.
Your doctor will decide how long you should continue the treatment.
Use in children and adolescents
Treatment and prevention of recurrence of blood clots in the veins or in the blood vessels of the lungs.
This medicine should always be taken or administered as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor, pharmacist, or nurse.
To achieve the best treatment results, you should try to take or administer the dose at the same time every day.
The dose of Prubdaq is based on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents weighing at least 35 kg is two Prubdaq 5 mg tablets, administered 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 one Prubdaq 5 mg tablet, administered twice a day, for example, one tablet in the morning and one in the evening.
For parents and caregivers: you should observe the child to ensure that they have taken the full dose.
It is essential to follow the scheduled doctor's appointments, as the dose may need to be adjusted with changes in the patient's body weight.

The doctor may change the anticoagulant treatment as follows:

Changing from Prubdaq to other anticoagulant medicines
You should stop taking Prubdaq. Treatment with other anticoagulant medicines (e.g., heparin) should be started at the time of the scheduled intake of the next Prubdaq tablet.
Changing from other anticoagulant medicines to Prubdaq
You should stop taking other anticoagulant medicines. Treatment with Prubdaq should be started at the time of the scheduled intake of the next dose of the other anticoagulant medicine, and then continue with the usual intake of Prubdaq.
Changing from treatment with a vitamin K antagonist (e.g., warfarin) to Prubdaq
You should stop taking the vitamin K antagonist. Your doctor will perform blood tests and inform you when to start taking Prubdaq.
Changing from Prubdaq to treatment with a vitamin K antagonist (e.g., warfarin)
If your doctor informs you that you should start taking a vitamin K antagonist, you should continue to take Prubdaq for at least 2 days after taking the first dose of the vitamin K antagonist. Your doctor will perform blood tests and inform you when to stop taking Prubdaq.

Patients undergoing cardioversion

Patients who require cardioversion to restore a normal heart rhythm should take this medicine at the times specified by their doctor to prevent blood clot formation in the blood vessels of the brain and other blood vessels.

Overdose of Prubdaq

If you have taken more than the recommended dose of Prubdaq, you should immediately contact your doctor. You should take the medicine packaging with you, even if it is empty.
If you have taken more than the recommended dose of Prubdaq, you may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition may be necessary.

Missed dose of Prubdaq

If you miss a morning dose, you should take it as soon as you remember, and you can take it together with the evening dose.
A missed evening dose can only be taken on the same evening. You should not take two doses the next morning instead; you should continue taking the medicine the next day as advised, twice a day.

• .

In case of doubts about taking the medicine or if you have missed more than

one dose, you should consult your doctor, pharmacist, or nurse.

Stopping Prubdaq treatment

You should not stop taking this medicine without consulting your doctor, as the risk of blood clot formation may be higher if you stop taking Prubdaq prematurely.
In case of any further doubts about taking this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Prubdaq can cause side effects, although not everybody gets them.
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 Prubdaq to prevent blood clot formation in the heart in patients with irregular heart rhythm and at least one additional risk factor.

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

• Bleeding, including:
• in the eye;
• in the stomach or intestine;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• bruising and swelling;
• Anemia, which can cause fatigue or 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:
• in the brain or spinal cord;
• in the mouth or coughing up blood;
• in the abdominal cavity or from the vagina;
• red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• from hemorrhoids;
• presence of blood in the stool or urine detected in laboratory tests;
• Decreased platelet count in the blood (which can affect blood clotting);
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown that can cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, as well as difficulty breathing. In case of any of these symptoms, you should immediately contact your doctor.

Rare side effects (may affect up to 1 in 1000 people)

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

Very rare side effects (may affect up to 1 in 10,000 people)

• A skin rash that may form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme).

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

• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin, or bruising.
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function impairment (nephropathy associated with anticoagulant administration).

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

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

• Bleeding, including:
• from the nose;
• from the gums;
• blood in the urine;
• bruising and swelling;
• in the stomach, intestine, or rectum;
• in the mouth;
• from the vagina;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count in the blood (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT) activity.

Uncommon side effects (may affect up to 1 in 100 people)

• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Bleeding:
• in the eyes;
• in the mouth or coughing up blood;
• red blood in the stool;
• presence of blood in the stool or urine detected in laboratory tests;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• from hemorrhoids;
• in the muscles;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, as well as difficulty breathing. In case of any of these symptoms, you should immediately contact your doctor;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown that can cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 1000 people)

• Bleeding:
• in the brain or spinal cord;
• in the lungs.

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

• Bleeding:
• in the abdominal cavity or retroperitoneal space;
• A skin rash that may 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 raised, flat, red, round patches under the skin, or bruising;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function impairment (nephropathy associated with anticoagulant administration).

Additional side effects in children and adolescents
If you experience any of the following symptoms, you should immediately contact your doctor:

• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, as well as difficulty breathing. The frequency of these side effects is "common" (may affect up to 1 in 10 people).

Generally, the side effects reported in children and adolescents taking Prubdaq were similar to those observed in adults and were mostly mild or moderate. Side effects reported more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

Very common side effects (may affect more than 1 in 10 people)

• Bleeding, including:
• from the vagina;
• from the nose.

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

• Bleeding, including:
• from the gums;
• blood in the urine;
• bruising and swelling;
• in the intestine or rectum;
• red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• Hair loss;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count in the blood (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Itching;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased alanine aminotransferase (ALT) activity.

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

• Bleeding:
• in the abdominal cavity or retroperitoneal space;
• in the stomach;
• in the eyes;
• in the mouth or coughing up blood;
• in the brain or spinal cord;
• in the lungs;
• in the muscles;
• A skin rash that may 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 raised, flat, red, round patches under the skin, or bruising;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• presence of blood in the stool or urine;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function impairment (nephropathy associated with anticoagulant administration).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prubdaq

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 EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Prubdaq contains

• The active substance is apixaban. Each tablet contains 5 mg of apixaban.
• Other ingredients are:
• tablet core: mannitol, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate;

film coating: hypromellose (type 2910, 6 mPa*s), titanium dioxide (E 171), lactose monohydrate, macrogol 3350, triacetin, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172).

• film coating: hypromellose (type 2910, 6 mPa*s), titanium dioxide (E 171), lactose monohydrate, macrogol 3350, triacetin, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172).

What Prubdaq looks like and contents of the pack

Prubdaq is a prolonged-release, biconvex, pink film-coated tablet, 9.9-10.3 mm in length and 4.9-5.3 mm in width
Prubdaq is available in PVC/PVDC/Aluminum blisters in a cardboard box.
The pack contains 14, 20, 28, 56, 60, 168, or 200 film-coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: information for use

Inside the Prubdaq packaging, next to the patient information leaflet, you will find a Patient Alert Card or your doctor may give you a similar card.
The Patient Alert Card contains information that will help you and alert other doctors that you are taking Prubdaq. You should always carry this card with you.

• 1. Take the card.
• 2. If necessary, separate the relevant language (this is facilitated by perforated edges).
• 3. Fill in the following points or ask your doctor to fill them in:
• Name:
• Date of birth:
• Indication:
• Dose: ........ mg twice a day
• Doctor's name:
• Doctor's phone number:
• 4. Fold the card and always carry it with you.

Marketing authorization holder

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

Manufacturer

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

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

Poland
Prubdaq
Czech Republic
PRUBDAQ
Estonia
PRUBDAQ
Hungary
PRUBDAQ 5 mg film-coated tablet
Lithuania
PRUBDAQ 5 mg film-coated tablets
Slovakia
PRUBDAQ 5 mg

Date of last revision of the leaflet:

July 2025