Voziberin

Leaflet accompanying the packaging: information for the user

Voziberin, 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.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Voziberin and what is it used for

Voziberin contains the active substance apixaban and belongs to a group of so-called anticoagulant medicines. This medicine helps prevent the formation of blood clots by blocking factor Xa, which is an important element in the blood clotting process.
Voziberin is used in adults:

• to prevent the formation of 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 leg veins. 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 the formation of 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, leading to 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 leg veins (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 leg and/or lung blood vessels.

Voziberin is used in children from 28 days to less than 18 years of age to treat and prevent the recurrence of blood clots in the veins or pulmonary blood vessels.
The recommended dose, adjusted for body weight, is found in section 3.

2. Important information before taking Voziberin

When not to take Voziberin:

• -if the patient is allergicto apixaban or any of the other ingredients of this medicine (listed in section 6);
• if the patient has excessive bleeding;
• if the patient has organ diseasethat increases the risk of significant bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recent brain bleeding);
• if the patient has liver diseasethat leads to an increased risk of bleeding (coagulopathy of the liver);
• if the patient is taking medicines that prevent blood clotting(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in situations 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 their vein) due to irregular heart rhythm (arrhythmia).

Warnings and precautions

Before starting treatment, the patient should discuss with their doctor, pharmacist, or nurse if they have any of the following conditions:

• increased risk of bleeding, such as bleeding disorders, including cases resulting in decreased platelet activity; very high blood pressure, uncontrolled with medication; if the patient is over 75 years old; if the patient's body weight is 60 kg or less;
• severe kidney disease or if the patient is 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;
• if the patient has had a tube (catheter) or injection into the spine(anesthetic or pain-relieving), in such a case, the doctor will advise the patient to take this medicine after 5 or more hours from the 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 other treatment or surgery is planned to remove a blood clot from the lungs.

When to be particularly careful when taking Voziberin

• if the patient has a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether to change the treatment.

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 uncertainty whether a given procedure may be associated with bleeding, the patient should ask their doctor.

Children and adolescents

This medicine is not recommended for use in children and adolescents with a body weight below 35 kg.

Voziberin and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may enhance the effect of Voziberin, and some may weaken its effect. The doctor will decide whether the patient should receive Voziberin while taking other medicines and how closely they should be monitored.
The following medicines may enhance the effect of Voziberin 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-inflammatoryor 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 Voziberin to prevent blood clot formation:

• medicines used to prevent seizures or convulsions(e.g., phenytoin and others);
• St. John's Wort(a herbal supplement used for depression);
• medicines used to treat tuberculosisor other infections(e.g., rifampicin).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before taking this medicine.
The effect of apixaban 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, they should immediatelycontact their doctor.
It is not known whether apixaban passes into breast milk. Before taking this medicine during breastfeeding, the patient should consult their doctor, pharmacist, or nurse. The patient may be advised to stop breastfeeding, stop, or not start taking this medicine.

Driving and using machines

No effects of apixaban on the ability to drive and use machines have been observed.

Voziberin contains lactose (a type of sugar) and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Voziberin

This medicine should always be taken exactly as advised by the doctor or pharmacist. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.

Dose

The tablet should be swallowed with water. Apixaban can be taken with or without food.
To achieve the best treatment results, it is recommended to take the tablets at the same time every day.
If the patient has problems swallowing the tablets whole, they should discuss this with their doctor about other ways of taking apixaban. The tablet can be crushed just 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 entire 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 then swallow the rinse liquid.

If necessary, the doctor may administer a crushed Voziberin tablet mixed with 60 mL of water or 5% glucose solution through a nasogastric tube.

Voziberin should be taken as advised in the following indications:

Prevention of blood clot formation after hip or knee replacement surgery.
The recommended dose is one Voziberin 2.5 mg tablet twice a day. For example, one 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 clot formation in the heart in patients with irregular heart rhythm and at least one additional risk factor.
The recommended dose is one Voziberin 5 mgtablet twice a day.
The recommended dose is one Voziberin 2.5 mgtablet twice a day if:

• the patient has severe kidney problems;
• two or more of the following conditions are met:the patient's blood test results suggest decreased kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or higher); the patient is 80 years old or older; the patient's 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. The doctor will decide how long to continue treatment.
Treatment of blood clots in the leg veins and blood clots in the pulmonary blood vessels
The recommended dose is twoVoziberin 5 mgtablets twice a day for the first 7 days, for example, two in the morning and two in the evening.
After 7 days, the recommended dose is oneVoziberin 5 mgtablet twice a day, for example, one tablet in the morning and one in the evening.
Prevention of recurrent blood clot formation after completing 6 months of treatment
The recommended dose is one Voziberin 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 recurrent blood clots in the veins or pulmonary blood vessels.
This medicine should always be taken or administered as advised by the doctor or pharmacist. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
To achieve the best treatment results, the dose should be taken or administered at the same time every day.
The dose of Voziberin is dependent on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents with a body weight of at least 35 kg is fourVoziberin 2.5 mgtablets, administered 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 twoVoziberin 2.5 mgtablets, administered twice a day, for example, two in the morning and two in the evening.
For parents and caregivers: the child should be observed to ensure they take the full dose.
It is essential 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:

• Changing from Voziberin to anticoagulant medicinesThe patient should stop taking Voziberin. Anticoagulant treatment (e.g., heparin) should be started at the time of the scheduled next dose of Voziberin.
• Changing from anticoagulant medicines to VoziberinThe patient should stop taking anticoagulant medicines. Voziberin treatment should be started at the time of the scheduled next dose of anticoagulant medicine, and then continue with the usual dosing schedule.
• Changing from treatment with a vitamin K antagonist (e.g., warfarin) to VoziberinThe patient should stop taking the vitamin K antagonist. The doctor will order blood tests and inform the patient when to start taking Voziberin.
• Changing from Voziberin to treatment with a vitamin K antagonist (e.g., warfarin)If the doctor advises the patient to start taking a vitamin K antagonist, they should continue taking Voziberin for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor will order blood tests and inform the patient when to stop taking Voziberin.

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 the formation of blood clots in the brain and other blood vessels.

Taking a higher dose of Voziberin than recommended

If the patient has taken a higher dose of this medicine than recommended, they should immediatelyinform their doctor. They should take the packaging with them, even if there are no tablets left.
If the patient has taken a higher dose of Voziberin than recommended, they 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 Voziberin

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

In case of doubts about taking the medicine or missing more than

one dose, the patient should consult their doctor, pharmacist, or nurse.

Stopping Voziberin treatment

The patient should not stop taking this medicine without consulting their doctor, as stopping treatment too early may increase the risk of blood clot formation.
In case of further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Voziberin can cause side effects, although not everybody gets them.
Voziberin can be used in three different medical conditions. The known side effects and their frequency may vary in each of these medical conditions and are listed separately below. In these conditions, the most common overall side effect of this medicine is bleeding, which can potentially be life-threatening and may require immediate medical attention.
The following side effects may occur when taking Voziberin to prevent blood clot formation 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:
• subcutaneous hemorrhages 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 subcutaneous hemorrhages and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or injection site;
• from the stomach, intestines, or rectum;
• 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 1,000 people)

• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip, mouth, tongue, and (or) throat swelling, as well as difficulty breathing. If any of these symptoms occur, the patient should immediatelycontact their doctor.
• Bleeding:
• into the muscle;
• into the eyes;
• from the gums and presence of blood in sputum when coughing;
• 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 the space behind the abdominal cavity; from hemorrhoids; blood test results indicating blood in the stool or urine;
• A skin rash, which can 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 surface or subcutaneous hemorrhages;
• Bleeding in the kidneys, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

The following side effects may occur when taking Voziberin 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:
• into the eyes;
• from the stomach or intestines;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• subcutaneous hemorrhages and swelling;

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

• Bleeding:
• into the brain or spinal cord;
• into the mouth or presence of blood in sputum when coughing;
• into the abdominal cavity or from the vagina;
• bright red blood in the stool;
• blood test results indicating blood in the stool or urine;
• bleeding after surgery, including subcutaneous hemorrhages and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or injection site;
• from hemorrhoids;

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

• Bleeding:
• into the lungs or throat;
• into the abdominal cavity;
• into the muscles.

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 subcutaneous hemorrhages;
• Bleeding in the kidneys, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

The following side effects may occur when taking Voziberin to treat or prevent the recurrence of blood clots in the leg veins and pulmonary blood vessels.

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

• Bleeding, including:
• from the nose;
• from the gums;
• blood in the urine;
• subcutaneous hemorrhages and swelling;
• from the stomach, intestines, or rectum;

in 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 presence of blood in sputum when coughing;
• bright red blood in the stool;
• blood test results indicating blood in the stool or urine;
• bleeding after surgery, including subcutaneous hemorrhages and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or injection site;
• from hemorrhoids;
• into the muscles;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip, mouth, tongue, and (or) throat swelling, as well as difficulty breathing. In case of any of these symptoms, the patient should immediatelycontact their doctor.
• 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 1,000 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 the space behind the abdominal cavity.
• A skin rash, which can 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 surface or subcutaneous hemorrhages;
• Bleeding in the kidneys, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

Additional side effects in children and adolescents
If any of the following symptoms occur, the patient should immediatelyinform their doctor:

• Allergic reactions (hypersensitivity), which can cause: facial swelling, 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 observed in children and adolescents treated with apixaban were similar to those in adults and were mostly mild or moderate. Side effects more frequently observed in children and adolescents include nosebleeds and unusual 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;
subcutaneous hemorrhages and swelling;
from the intestines or rectum;
bright red blood in the stool;
bleeding after surgery, including subcutaneous hemorrhages and swelling, bleeding or fluid leakage from the surgical 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 in the child;
• 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 the space behind the abdominal cavity;
into the stomach;
into the eyes;
into the mouth;
from hemorrhoids;
into the mouth or presence of blood in sputum when coughing;
into the brain or spinal cord;
into the lungs;
into the muscles;

• A skin rash, which can 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 surface or subcutaneous hemorrhages;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• blood in the stool or urine;
• Bleeding in the kidneys, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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 authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Voziberin

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 the month stated.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Voziberin contains

• The active substance of Voziberin is apixaban. Each tablet contains 2.5 mg of apixaban.
• The other ingredients are:
• Tablet core: lactose monohydrate (see section 2), microcrystalline cellulose (E 460), sodium croscarmellose (E 468), sodium lauryl sulfate (E 487), magnesium stearate (E 470b);
• Tablet coating: lactose monohydrate (see section 2), hypromellose (E 464), titanium dioxide (E 171), triacetin, yellow iron oxide (E 172).

What Voziberin looks like and contents of the pack

The tablets are yellow, round (about 6 mm in diameter), biconvex, with the inscription "M" on one side and "2.5" on the other.
Voziberin is available in blisters in a cardboard box containing 10, 20, 60, 168, and 200 film-coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: information for use

Inside the Voziberin packaging, next to the patient information leaflet, there is a Patient Alert Card or the doctor may give the patient a similar card.
The Patient Alert Card contains information that helps the patient and warns other doctors that the patient is taking Voziberin. The patient should always carry this card with them.

• 1. Take the card.
• 2. Fill in the following points or ask the doctor to complete them:
• Name and surname:
• Date of birth:
• Indication:
• Dose: ........mg twice a day
• Doctor's name:
• Doctor's phone number:
• 3. Fold the card and always carry it with you.

Marketing authorization holder:

MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147
{logo of the marketing authorization holder}

Manufacturer/Importer:

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta

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

Bulgaria:

EN: Voziberin 2.5 mg film-coated tablets
BG: Voziberin 2,5 mg филмирани таблетки

Croatia:

Voziberin 2,5 mg filmom obložene tablete

Czech Republic:

Voziberin

Estonia:

Voziberin

Lithuania:

Voziberin 2,5 mg plėvele dengtos tabletės

Latvia:

Voziberin 2,5 mg apvalkotās tabletes

Poland:

Voziberin

Romania:

Voziberin 2,5 mg comprimate filmate

Slovakia:

Voziberin 2,5 mg

Slovenia:

Voziberin 2,5 mg filmsko obložene tablete

Sweden:

Voziberin 2,5 mg filmdragerade tabletter

Hungary:

Voziberin 2,5 mg filmtabletta

Date of last revision of the leaflet: 05/2025

The latest approved information on the product, educational materials on this medicine are available by scanning the following QR code with a smartphone. The same information is also available on the following website (URL): https://rejestry.ezdrowie.gov.pl/rpl/search/public
After moving to the website, the patient should enter the name of the medicine and then open "Materials to download".