Prubdaq

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

PRUBDAQ, 2.5 mg coated tablets

Apixaban

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, 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 (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, the patient may be at increased risk of blood clots in the veins of the legs.
This can lead to swelling of the legs, with or without pain.
If a blood clot moves from the leg to the lungs, it can block blood flow through the lungs, causing shortness of breath with chest pain or without. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention,
to prevent blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and move to the brain, causing a stroke, or to other organs, impairing blood flow to these organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention,
to treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.
Prubdaq is used in children from 28 days to less than 18 years of age to treat and prevent blood clots in the veins or pulmonary blood vessels.
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 the patient is allergic toapixaban or any of the other ingredients of this medicine (listed in section 6),
if the patient has excessive bleeding,
if the patient has an organ diseasethat increases the risk of serious bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recently diagnosed bleeding into the brain),
if the patient has liver diseasethat leads to an increased risk of bleeding (liver coagulopathy),
if the patient is taking anticoagulant medicines(e.g. warfarin, rivaroxaban, dabigatran or heparin), except in cases where the anticoagulant treatment is changed, when the patient has a venous or arterial access line and heparin is administered through this line to maintain its patency or when the patient is undergoing catheter ablation (a catheter is inserted into his vein) due to irregular heartbeat (arrhythmia).

Warnings and precautions

Before starting to take Prubdaq, 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 reduced platelet activity,
very high blood pressure, uncontrolled with medication,
if you are over 75 years old,
if you weigh 60 kg or less,
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.
Tube (catheter) or injection into the spine(anesthetic or pain-relieving), in which case the doctor will recommend taking this medicine after 5 or more hours after catheter removal,
if you have a heart valve replacement,
if your doctor determines that your 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 the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide on possible treatment changes.

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

Children and adolescents

It is not recommended to use this medicine in children and adolescents with a body weight below 35 kg.

Prubdaq and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or plan to take.
Some medicines may enhance the effect of Prubdaq, and some may weaken its effect. The 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 pain-relieving medicines(e.g. acetylsalicylic acid or naproxen),
especially if the patient is over 75 years old and taking acetylsalicylic acid, 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 tuberculosisor other infections(e.g. rifampicin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
The effect of Prubdaq on pregnancy and the unborn child is not known. You should not take this medicine during pregnancy. If you become pregnant while taking this medicine, you should immediatelycontact your doctor.
It is not known whether Prubdaq passes into breast milk. Before taking this medicine while breastfeeding, ask your doctor, pharmacist, or nurse for advice. 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, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially 'sodium-free'.

3. How to take Prubdaq

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

Dose

Swallow the tablet with water. Prubdaq can be taken with or without food.
To get the best effect, try to take the tablets at the same time every day.
If you have problems swallowing the tablets whole, talk to your doctor about other ways to take Prubdaq. The tablet can be crushed just before taking 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, 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 liquid after rinsing.

If necessary, your doctor may give you a crushed Prubdaq tablet mixed with 60 ml of water or 5% glucose solution through a nasogastric tube.

Prubdaq should be taken as recommended in the following indications:

Prevention of blood clots after hip or knee replacement surgery
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.
The first tablet should be taken 12 to 24 hours after surgery.
If the patient has undergone major hip replacement surgery, they will usually take the tablets for 32 to 38 days.
If the patient has undergone major knee replacement surgery, they will usually take the tablets for 10 to 14 days.
Prevention of blood clots 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 mgtablet twice a day.
The recommended dose is one Prubdaq 2.5 mgtablet twice a day, if:

• the patient has severe kidney problems,
• one or more of the following conditions are met: the patient's blood test results suggest impaired kidney function (serum creatinine level of 1.5 mg/dl (133 micromole/l) or higher), the patient is over 80 years old, the patient weighs 60 kg or less.

The recommended dose is one tablet twice a day, for example, one tablet in the morning and one in the evening. The doctor will decide how long to continue treatment.
Treatment of blood clots in the veins of the legs and blood vessels of the lungs
The recommended dose is twoPrubdaq 5 mgtablets twice a day for the first 7 days, for example, two tablets in the morning and two in the evening.
After 7 days, the recommended dose is onePrubdaq 5 mgtablet 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 mgtablet twice a day, for example, one tablet in the morning and one in the evening.
The doctor will decide how long to continue treatment.
Use in children and adolescents
Treatment and prevention of blood clots in the veins or pulmonary blood vessels.
This medicine should always be taken or administered as recommended by your doctor or pharmacist.
If you are not sure, ask your doctor, pharmacist, or nurse.
To get the best effect, 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 fourPrubdaq 2.5 mgtablets, given twice a day for the first 7 days, for example, four in the morning and four in the evening. After 7 days, the recommended dose is twoPrubdaq 2.5 mgtablets, given twice a day, for example, two in the morning and two in the evening.
For parents and caregivers: observe the child to ensure that the full dose is taken.
It is important to follow the scheduled doctor's visits, 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:

Switching from Prubdaq to other anticoagulant medicines
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.
Switching from other anticoagulant medicines to Prubdaq
Stop taking other anticoagulant medicines. Prubdaq treatment should be started at the time of the scheduled intake of the next dose of the other anticoagulant medicine, and then continue with its usual intake.
Switching from anticoagulant treatment with a vitamin K antagonist (e.g. warfarin) to Prubdaq
Stop taking the vitamin K antagonist medicine. The doctor must perform blood tests and inform the patient when to start taking Prubdaq.
Switching from Prubdaq to anticoagulant treatment with a vitamin K antagonist (e.g. warfarin)
If the doctor informs the patient that they should start taking a vitamin K antagonist medicine, they should continue to take Prubdaq for at least 2 days after taking 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 a normal heart rhythm should take this medicine at the times specified by the doctor to prevent blood clot formation in the brain and other blood vessels.

Taking a higher dose of Prubdaq than recommended

If you have taken more than the recommended dose of this medicine, contact your doctor immediately.
You should take the 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.

Missing a dose of Prubdaq

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

If you have any doubts about taking the medicine or if you have missed more than

one dose, ask your doctor, pharmacist, or nurse.

Stopping Prubdaq treatment

Do not stop taking this medicine without consulting your doctor, as the risk of blood clots may be higher if you stop taking Prubdaq too early.
If you have any further doubts about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Prubdaq can cause side effects, although not everybody gets them.
Prubdaq can be used in three different medical conditions. Known side effects and their frequency may vary in each of these conditions and are listed separately below. In these conditions, the most common overall side effect of this medicine is bleeding, which can be life-threatening and may require immediate medical attention.
The following side effects may occur when taking Prubdaq to prevent blood clots after hip or knee replacement surgery.

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

Anemia, which can cause fatigue or pale skin ,
Bleeding, including:

• bruises and swelling; Nausea (vomiting).

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

• Decreased platelet count (which can affect blood clotting),
• Bleeding:
• after surgery, including bruising and swelling, bleeding or fluid leakage from the wound/incision (wound discharge) or injection site;
• from the stomach, intestines, or bright red blood in the stool;
• blood in the urine;
• from the nose;
• from the vagina;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Blood test results may indicate:
• liver function disorders;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes;
• Itching.

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

• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling, and (or) throat swelling, as well as difficulty breathing. In case of any of these symptoms, contact your doctor immediately;
• Bleeding:
• into the muscle;
• into the eyes;
• from the gums and coughing up blood;
• from the rectum;
• Hair loss.

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

• Bleeding:
• into the brain or spinal cord;
• into the lungs or throat;
• into the abdominal cavity or retroperitoneal space;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• A skin rash, which can cause 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 surface, or bruising;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

The following side effects may occur when taking Prubdaq to prevent blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.

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

• Bleeding, including:
• into the eye;
• into the stomach or intestine;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• bruises and swelling;
• Anemia, which can cause fatigue or pale skin;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Nausea (vomiting);
• Blood test results may indicate: increased gamma-glutamyltransferase (GGT) activity.

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

• Bleeding:
• into the brain or spinal cord;
• into the mouth or coughing up blood;
• into the abdominal cavity or vagina;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the wound/incision (wound discharge) or injection site;
• from hemorrhoids;
• into the muscle,
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling, and (or) throat swelling, as well as difficulty breathing. In case of any of these symptoms, contact your doctor immediately;
• Blood test results may indicate:
• liver function disorders;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes.

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

• Bleeding:
• into the lungs or throat;
• into the retroperitoneal space;
• into the muscle.

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 surface, or bruising;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

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

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

• Bleeding, including:
• from the nose;
• from the gums;
• blood in the urine;
• bruises and swelling;
• into the stomach, intestine, or rectum;
• into the mouth;
• from the vagina;
• Anemia, which can cause fatigue or pale skin;
• Decreased platelet count (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:
• into the eyes;
• into the mouth or coughing up blood;
• bright red blood in the stool;
• blood test results indicating blood in the stool or urine;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the wound/incision (wound discharge) or injection site;
• from hemorrhoids;
• into the muscle,
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling, and (or) throat swelling, as well as difficulty breathing. In case of any of these symptoms, contact your doctor immediately;
• Blood test results may indicate:
• liver function disorders;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes.

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

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

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

• Bleeding:
• into the abdominal cavity or retroperitoneal space,
• A skin rash, which can cause 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 surface, or bruising;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

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

• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling, 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 of Prubdaq in children and adolescents are similar to those in adults and are mostly mild or moderate. Side effects that are more common 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;
• bruises and swelling;
• into the intestine or rectum;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the wound/incision (wound discharge) or injection site;
• Hair loss;
• Anemia, which can cause fatigue or pale skin;
• Decreased platelet count (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Itching;
• Low blood pressure, which can cause fainting or rapid heartbeat;
• Blood test results may indicate:
• liver function disorders;
• increased activity of certain liver enzymes;
• increased alanine aminotransferase (ALT) activity.

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

• Bleeding
• into the abdominal cavity or retroperitoneal space;
• into the stomach;
• into the eyes;
• into the mouth;
• from hemorrhoids;
• into the mouth or coughing up blood;
• into the brain or spinal cord;
• into the lungs;
• into the muscle;
• A skin rash, which can cause 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 surface, or bruising;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• blood in the stool or urine.
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

Reporting side effects

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

5. How to store Prubdaq

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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, croscarmellose sodium, 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, yellow tablets, 5.9-6.3 mm in diameter.
Prubdaq is available in PVC/PVDC/Aluminum blisters in a cardboard box.
The pack contains 10, 20, 60, 168, or 200 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 to help you and to warn other doctors that you are taking Prubdaq. 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 and surname:
• 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 2.5 mg film-coated tablet
Lithuania
PRUBDAQ 2.5 mg coated tablets
Slovakia
PRUBDAQ 2.5 mg

Date of last revision of the leaflet:

July, 2025