Prubdaq: detailed information

Patient Information Leaflet

PRUBDAQ, 5 mg coated tablets
Apixabanum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

What PRUBDAQ is and what it is used for
What you need to know 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 blood clotting.
PRUBDAQ is used in adults:
to prevent blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or to other organs, impairing blood flow to these organs (also known as systemic embolism). Stroke 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), and to prevent recurrence of such clots in the veins of the legs and/or lungs.
PRUBDAQ is used in children aged 28 days to below 18 years for the treatment of blood clots and to prevent recurrence of blood clots in the veins or in the blood vessels of the lungs.
Information on 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 stomach or intestinal ulcer, recently diagnosed
intracranial bleeding),
if the patient has liver disease leading to an increased risk of
bleeding (hepatic coagulopathy),
if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban,
dabigatran or heparin), except in situations of switching anticoagulant therapy, when
a venous or arterial access 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 a vein) due to irregular heartbeat (arrhythmia).

Warnings and precautions
Before starting Prubdaq, discuss with your doctor, pharmacist or nurse if the patient has any of the following conditions:
increased risk of bleeding, for example:
conditions associated with bleeding, including those resulting in reduced
platelet activity,
very high blood pressure uncontrolled 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 (tube) or spinal injection (anaesthetic or pain-relieving). In such cases, the doctor will recommend taking this medicine 5 or more 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 if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

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 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 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 and noradrenaline 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 taking this medicine.
The effect of Prubdaq 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 Prubdaq passes into human milk. Before taking this medicine during breastfeeding, consult a doctor, pharmacist or nurse. The patient may be advised to discontinue breastfeeding or to stop/avoid starting this medicine.

Driving and using machines
Prubdaq has no effect or a negligible effect on the ability to drive motor vehicles
and operate machinery.

Prubdaq contains lactose (a sugar) and sodium
If the patient has been diagnosed with an intolerance to certain sugars, consult a 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 Prubdaq

This medicine should always be taken as instructed by your doctor or pharmacist. If you are unsure,
you should consult your doctor, pharmacist, or nurse.
Dosage
Please note that a 2.5 mg dose cannot be obtained using the Prubdaq 5 mg product, as it cannot be divided into two equal halves for dosing purposes. Other medicinal products containing apixaban 2.5 mg should be used instead.
The tablet should be swallowed with water. Prubdaq can be taken with or without food.
To achieve the best treatment results, it is recommended to take the tablets at the same times each day.
If a patient has difficulty swallowing tablets whole, they should discuss alternative methods of taking Prubdaq with their doctor. The tablet may be crushed immediately before administration and mixed with water or 5% aqueous glucose solution, juice, or apple puree.
Instructions for crushing tablets:

Crush the tablet with a 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 form a mixture.
Swallow the mixture.
Rinse the pestle and mortar used for crushing the tablet, 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% aqueous glucose solution via a nasogastric tube.
Prubdaq should be taken as directed for the following indications:
Prevention of blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.
The recommended dose is one tablet of Prubdaq 5 mg twice daily.
The recommended dose is one tablet of Prubdaq 2.5 mg twice daily if:

the patient has severe renal impairment,
two or more of the following conditions are met: blood test results suggest reduced kidney function (serum creatinine concentration of 1.5 mg/dl (133 micromoles/l) or higher), the patient is 80 years of age or older, 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. 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 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 recurrence of blood clots after completion of 6-month treatment
The recommended dose is one tablet of Prubdaq 2.5 mg twice daily, for example, one tablet in the morning and one in the evening.
Your doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrence of blood clots in veins or in the blood vessels of the lungs.
This medicine should always be taken or administered as directed by a doctor or pharmacist.
If you are unsure, you should consult your 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 two tablets of Prubdaq 5 mg, administered twice daily for the first 7 days, for example, two in the morning and two in the evening. After 7 days, the recommended dose is one tablet of Prubdaq 5 mg, administered twice daily, for example, one in the morning and one 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’s appointments, as dose adjustments may be necessary as the patient’s body weight changes.
Your doctor may change anticoagulant treatment as follows:
Switching from Prubdaq to other anticoagulant medicines
Stop taking Prubdaq. Treatment with other anticoagulant medicines (e.g., heparin) should begin at the time the next tablet was due.
Switching from other anticoagulant medicines to Prubdaq
Stop taking other anticoagulant medicines. Treatment with Prubdaq should begin at the time the next dose of the other anticoagulant medicine was due, and then continue as usual.
Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Prubdaq
Discontinue the vitamin K antagonist-containing medicine. Your doctor must perform blood tests and will inform you when to start taking Prubdaq.
Switching from Prubdaq to anticoagulant treatment including a vitamin K antagonist (e.g., warfarin)
If your doctor informs you that you should start taking a vitamin K antagonist-containing medicine, continue taking Prubdaq for at least 2 days after taking the first dose of the vitamin K antagonist-containing medicine. Your doctor must perform blood tests and will inform you 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 the formation of blood clots in the blood vessels of the brain and other parts of the body.
Taking more than the recommended dose of Prubdaq
If you have taken more than the recommended dose of this medicine, you should contact your doctor immediately. Bring the medicine packaging with you, even if it is empty.
If you have taken more than the recommended dose of Prubdaq, your risk of bleeding may be increased. In the event of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the anti-factor Xa effect may be necessary.
Missing a dose of Prubdaq
If you miss a morning dose, take it as soon as you remember, and you may take it at the same time as your evening dose.
A missed evening dose may only be taken on the same evening. Do not take two doses the next morning instead; instead, continue taking the medicine the next day as directed, twice daily.
If you have any doubts about taking the medicine or if you miss more than one dose, consult your doctor, pharmacist, or nurse.
Stopping Prubdaq
Do not stop taking this medicine without consulting your doctor, as stopping Prubdaq prematurely may increase the risk of blood clots.
If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most common general side effect of this medicine is bleeding, which may potentially
be life-threatening and may require immediate medical attention.
The following side effects 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 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 urine;
from the nose;
from the gums;
subcutaneous haemorrhage and swelling;
Anaemia, which may cause fatigue or paleness;
Low blood pressure, which may lead to fainting or rapid heartbeat;
Nausea;
Blood test results may show:
increased gamma-glutamyl transferase (GGT) activity.

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

Bleeding:
into the brain or spinal canal;
in the oral cavity or haemoptysis;
in the abdominal cavity or from the vagina;
bright red blood in stool;
bleeding after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
from haemorrhoids;
presence of blood in stool or urine detected in laboratory tests;
Decreased number of platelets in blood (which may affect clotting);
Blood test results may show:
abnormal liver function;
increased activity of certain liver enzymes;
elevated bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes;
Skin rash;
Itching;
Hair loss;
Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. If any of these symptoms occur, contact your doctor immediately.

Rare side effects (may affect up to 1 in 1,000 people)

Bleeding:
in the lungs or throat;
into the retroperitoneal space (area behind the abdominal cavity);
into muscles.

Very rare side effects (may affect 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, circular spots beneath the skin surface, or bruising.
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects may occur when taking Prubdaq
for the treatment or prevention of recurrent venous blood clots in the lower limbs
and pulmonary embolism (blood clots in the lung vessels).
Common side effects (may affect up to 1 in 10 people)

Bleeding, including:
from the nose;
from the gums;
blood in urine;
subcutaneous haemorrhage and swelling;
in the stomach, intestine, or from the rectum;
in the oral cavity;
from the vagina;
Anaemia, which may cause fatigue or paleness;
Decreased number of platelets in blood (which may affect clotting);
Nausea;
Skin rash;
Blood test results may show:
increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT) activity.

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

Low blood pressure, which may lead to fainting or rapid heartbeat;
Bleeding:
into the eyes;
in the oral cavity or coughing up blood;
bright red blood in stool;
test results indicating blood in stool or urine;
bleeding after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
from haemorrhoids;
into muscles;
Itching;
Hair loss;
Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. If any of these symptoms occur, contact your doctor immediately;
Blood test results may show:
abnormal liver function;
increased activity of certain liver enzymes;
elevated bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 1,000 people)

Bleeding:
into the brain or spinal canal;
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, circular spots beneath the skin surface, or bruising.
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional side effects in children and adolescents
If any of the following symptoms occur, contact your 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 side effects is classified as "common" (may affect up to 1 in 10 people).

Generally, side effects observed in children and adolescents taking Prubdaq were similar to
those seen in adults and were mostly mild or moderate in severity. 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 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;
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 oral cavity;
from haemorrhoids;
in the oral cavity or blood in sputum when coughing;
in the brain or spine;
in the lungs;
into muscle;
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, circular spots beneath 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 side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects 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 "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. Such measures 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.
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, red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E 172).

What Prubdaq looks like and contents of the pack
Oval, biconvex, film-coated pink tablets, 9.9–10.3 mm in length and 4.9–5.3 mm in width.
Prubdaq is available in blister packs made of PVC/PVDC/aluminium, packed in cardboard boxes.
Pack sizes contain 14, 20, 28, 56, 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 Card, or your physician may provide you with a similar card.
The Patient Card contains helpful information for the patient and serves as a warning to other physicians that the patient is taking Prubdaq. You should always carry this card with you.

Take the card.
If necessary, separate the appropriate language section (facilitated by perforated edges).
Complete the following sections, or ask your doctor to complete them:
- Name and surname:
- 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 European Economic Area countries under the following names:
Poland Prubdaq
Czech Republic PRUBDAQ
Estonia PRUBDAQ
Hungary PRUBDAQ 5 mg filmtabletta
Lithuania PRUBDAQ 5 mg plėvele dengtos tabletės
Slovakia PRUBDAQ 5 mg

December 2025