Embavi

Leaflet attached to the packaging: information for the user

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

1. What is Embavi and what is it used for

Embavi contains apixaban as the active substance and belongs to a group of medicines called anticoagulants. It helps prevent blood clots by blocking factor Xa, which is an important element in the blood clotting process.
Embavi 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 higher risk of developing blood clots in 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, causing shortness of breath, which may or may not be accompanied by chest pain. 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 travel to the brain - leading to a stroke - or to other organs - preventing blood flow to those organs (known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• to treat blood clots in the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and to prevent the recurrence of blood clots in the legs and/or lungs.

Embavi 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 in the blood vessels of the lungs.
The recommended dose, adjusted for body weight, is found in section 3.

2. Important information before taking Embavi

When not to take Embavi:

• 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 severe bleeding (e.g., active or recent stomach or intestinal ulcers, recent brain bleeding);
• if the patient has liver diseasethat leads to an increased risk of bleeding (coagulopathy);
• if the patient is taking anticoagulant medicines(such as warfarin, rivaroxaban, dabigatran, or heparin) except in situations where one anticoagulant is being switched for another, when the patient has a permanent venous or arterial catheter and is receiving heparin through the catheter to maintain its patency, or when a catheter is being inserted into a blood vessel (during catheter ablation) to treat irregular heart rhythm (arrhythmia).

Warnings and precautions

Before starting treatment, the patient should discuss the following with their doctor, pharmacist, or nurse:

• if the patient has an increased risk of bleeding, for example:
• bleeding disorders, including conditions with decreased platelet activity;
• very high, uncontrolled blood pressure;
• if the patient is over 75 years old;
• if the patient's body weight is 60 kg or less;
• if the patient has severe kidney disease or is on dialysis;
• if the patient has current or past liver disease. The use of this medicine requires caution in patients with signs of liver function disorders.
• if the patient has had a tube (catheter) inserted or an injection into the spine(for anesthesia or pain treatment), the doctor will advise the patient to take this medicine at least 5 hours after the catheter is removed;
• if the patient has a heart valve prosthesis;
• if the doctor considers 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 Embavi

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

If the patient needs to undergo surgery or a procedure that may involve bleeding, the doctor may ask them to temporarily stop taking this medicine. If in doubt whether a procedure may cause 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.

Embavi and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are taking, have recently taken, or plan to take.
Some medicines may enhance the effect of Embavi, while others may reduce its effect.
The doctor will decide whether the patient should take Embavi while being treated with other medicines and how closely the patient should be monitored.
The following medicines may enhance the effect of Embavi and increase the risk of unwanted bleeding:

• certain antifungal medicines(e.g., ketoconazole and others);
• certain 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, they may be at higher risk of bleeding;
• medicines used to treat high blood pressure or heart disease(e.g., diltiazem);
• antidepressant medicinesknown as selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors.

The following medicines may reduce Embavi's ability to prevent blood clots:

• medicines used to prevent seizures or fits(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, 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 Embavi on pregnancy and the unborn child is unknown. This medicine should not be used during pregnancy. If the patient becomes pregnant while taking this medicine, they should immediatelycontact their doctor.
It is not known whether Embavi passes into breast milk. Before taking this medicine while breastfeeding, the patient should consult their doctor, pharmacist, or nurse. They will advise whether to stop breastfeeding, stop, or not start taking this medicine.

Driving and using machines

It has not been found that Embavi affects the ability to drive or use machines.

Embavi 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 this 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 Embavi

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. Embavi can be taken with or without food.
It is recommended to take the tablets every day at the same time to achieve the best treatment results.
If the patient has difficulty swallowing the whole tablet, they should talk to their doctor about other ways to take Embavi. The tablet can be crushed just before taking and mixed with water, 5% aqueous glucose solution, apple juice, or apple sauce.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer all the powder to a suitable container and then mix it with a small amount of water or one of the above-mentioned liquids to obtain a mixture.
• Swallow (drink) the resulting mixture.
• Rinse the pestle and mortar used to crush the tablet and the container in which the mixture was prepared with a small amount of water or one of the above-mentioned liquids, and then swallow (drink) the rinse liquid.

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

Embavi should be taken as follows in the following indications:

Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one 2.5 mg Embavi tablet twice a day. For example, one tablet in the morning and one tablet in the evening.
The first tablet should be taken 12 to 24 hours after surgery.

• After major hip replacement surgery, the patient will usually take the tablets for 32 to 38 days.
• After major knee replacement surgery, the patient will usually take the tablets for 10 to 14 days.

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 5 mg Embavi tablet twice a day.
The recommended dose is one 2.5 mg Embavi tablet twice a day if:

• the patient has severe kidney function disorders;
• at least two of the following criteria are met:
• the patient's blood test results indicate 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 tablet in the evening. The doctor will decide how long to continue treatment.
Treatment of blood clots in the legs and blood clots in the blood vessels of the lungs
The recommended dose is two5 mg Embavi tablets twice a day for the first 7 days, for example, two tablets in the morning and two tablets in the evening.
After 7 days, the recommended dose is one5 mg Embavi tablet twice a day, for example, one tablet in the morning and one tablet in the evening.
Prevention of recurrent blood clots after completing 6 months of treatment
The recommended dose is one 2.5 mg Embavi tablet twice a day, for example, one tablet in the morning and one tablet in the evening.
The doctor will decide how long to continue treatment.
Use in children and adolescents
For the treatment and prevention of recurrent blood clots in the veins or in the blood vessels of the lungs.
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, it is recommended to take or administer the tablets every day at the same time.
The dose of Embavi depends 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 four2.5 mg Embavi tablets twice a day for the first 7 days, for example, four tablets in the morning and four tablets in the evening.
After 7 days, the recommended dose is two2.5 mg Embavi tablets twice a day, for example, two tablets in the morning and two tablets in the evening.
For parents and caregivers: the child should be observed to ensure they take the full dose.
The patient should follow the scheduled doctor's visits, as it may be necessary to adjust the dose based on changes in the child's body weight.

The doctor may change the anticoagulant treatment as follows:

• Switching from Embavi to other anticoagulantsThe patient should stop taking Embavi. At the time when the next scheduled dose of Embavi would have been taken, the patient should start treatment with another anticoagulant (e.g., heparin).
• Switching from other anticoagulants to EmbaviThe patient should stop taking the other anticoagulant. At the time when the next scheduled dose of the other anticoagulant would have been taken, the patient should start treatment with Embavi and continue taking it as usual.
• Switching from anticoagulant treatment with a vitamin K antagonist (e.g., warfarin) to EmbaviThe patient should stop taking the vitamin K antagonist. The doctor will order blood tests and tell the patient when to start taking Embavi.
• Switching from Embavi to anticoagulant treatment with a vitamin K antagonist (e.g., warfarin)If the doctor advises the patient to start taking a vitamin K antagonist, the patient should continue taking Embavi for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor will order blood tests and tell the patient when to stop taking Embavi.

Use in patients undergoing cardioversion

If the patient needs a procedure called cardioversion to restore a normal heart rhythm due to irregular heart rhythm, the medicine should be taken at the times strictly specified by the doctor to prevent the formation of blood clots in the blood vessels of the brain and other blood vessels in the body.

Taking a higher dose of Embavi than recommended

If the patient has taken a higher dose of Embavi than recommended, they should immediatelyinform their doctor.
The patient should take the packaging with them, even if there are no tablets left.
Taking a higher dose of Embavi than recommended may increase the risk of bleeding. If bleeding occurs, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Embavi

• If the patient misses a morning dose, they should take it as soon as possible and can take it with the evening dose.
• If the patient misses an evening dose, they can take it only on the same evening. They should not take two doses the next morning, but instead continue with the twice-daily dosing schedule as usual the next 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 Embavi treatment

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

4. Possible side effects

Like all medicines, Embavi can cause side effects, although not everybody gets them.
Embavi can be used in three different medical conditions. The known side effects and their frequency may vary in each of these conditions and are listed separately.
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 are known to occur when taking Embavi to prevent blood clots after hip or knee replacement surgery:

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

• anemia, which can cause fatigue or pallor;
• bleeding, including bruising (hematomas) and swelling;
• nausea (vomiting).

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

• decreased platelet count in the blood (which can affect blood clotting);
• bleeding:
• after surgery, including bruising (hematomas) and swelling, as well as bleeding or fluid leakage from the wound/surgical incision site or injection site;
• from the stomach or intestines, or the presence of bright red blood in the stool;
• presence of 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:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of destroyed red blood cells, which can cause yellowing of the skin and eyes;
• itching

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

• allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, 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, 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 retroperitoneal space;
• from hemorrhoids;
• blood tests showing blood in the stool or urine;
• skin rash, which can cause blisters and looks like small targets (dark spots surrounded by a lighter area, with a dark border on the edge) (erythema multiforme).
• vasculitis (inflammation of blood vessels), which can cause skin rash or flat, red, round spots under the skin surface or bruising (hematomas).
• kidney bleeding, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

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

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

• bleeding, including:
• into the eyes;
• from the stomach or intestines;
• from the rectum;
• presence of blood in the urine;
• from the nose;
• from the gums;
• bruising (hematomas) 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 (GGTP) activity.

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

• bleeding:
• into the brain or spinal cord;
• in the mouth or presence of blood in sputum when coughing;
• in the abdominal cavity or from the vagina;
• presence of bright red blood in the stool;
• bleeding after surgery, including bruising (hematomas) and swelling, as well as bleeding or fluid leakage from the wound/surgical incision site or injection site;
• skin rash;
• itching;
• hair loss;
• allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. If any of these symptoms occur, the patient should immediatelycontact their doctor.
• blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of destroyed red blood cells, which can cause yellowing of the skin and eyes.

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

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

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

• skin rash, which can cause blisters and looks like small targets (dark spots surrounded by a lighter area, with a dark border on 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 flat, red, round spots under the skin surface or bruising (hematomas).
• kidney bleeding, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

The following side effects are known to occur when taking Embavi to prevent recurrent blood clots in the legs and in the blood vessels of the lungs.

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

• bleeding, including:
• from the nose;
• from the gums;
• presence of blood in the urine;
• bruising (hematomas) and swelling;
• from the stomach, intestines, 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 (GGTP) or alanine aminotransferase (ALT) activity.

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

• low blood pressure, which can lead to fainting or rapid heartbeat;
• bleeding:
• into the eyes;
• in the mouth or presence of blood in sputum when coughing;
• presence of bright red blood in the stool;
• blood test results showing blood in the stool or urine;
• bleeding after surgery, including bruising (hematomas) and swelling, as well as bleeding or fluid leakage from the wound/surgical incision site or injection site;
• from hemorrhoids;
• into the muscle;
• itching;
• hair loss;
• allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. If any of these symptoms occur, the patient should immediatelycontact their doctor;
• blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of destroyed red blood cells, which can cause yellowing of the skin and eyes.

Rare side effects (may occur in 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;
• skin rash, which can cause blisters and looks like small targets (dark spots surrounded by a lighter area, with a dark border on the edge) (erythema multiforme).
• vasculitis (inflammation of blood vessels), which can cause skin rash or flat, red, round spots under the skin surface or bruising (hematomas).
• kidney bleeding, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

Additional side effects in children and adolescents
The patient should immediately inform their doctorif they observe any of the following symptoms:

• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. These are common side effects (may occur in up to 1 in 10 people).

Generally, the side effects observed in children and adolescents treated with Embavi were similar to those observed in adults and were mostly mild to moderate. The side effects that occurred more frequently in children and adolescents were nosebleeds and unusual vaginal bleeding.

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

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

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

• Bleeding, including:
• from the gums;
• presence of blood in the urine;
• bruising (hematomas) and swelling;
• from the intestines or rectum;
• bright red blood in the stool;
• bleeding after surgery, including bruising (hematomas) and swelling, as well as bleeding or fluid leakage from the wound/surgical incision site 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 in the child;
• 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:
• into the abdominal cavity or retroperitoneal space;
• into the stomach;
• into the eyes;
• in the mouth;
• from hemorrhoids;
• in the mouth or presence of blood in sputum when coughing;
• into the brain or spinal cord;
• into the lungs;
• into the muscle;
• skin rash, which can cause blisters and looks like small targets (dark spots surrounded by a lighter area, with a dark border on the edge) (erythema multiforme).
• vasculitis (inflammation of blood vessels), which can cause skin rash or flat, red, round spots under the skin surface or bruising (hematomas).
• blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity.
• presence of blood in the stool or urine.
• kidney bleeding, sometimes with blood in the urine, leading to kidney function disorders (nephropathy associated with anticoagulant administration).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient 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:
Jerozolimskie Avenue 181C, 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 gather more information on the safety of this medicine.

5. How to store Embavi

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, and on the 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Embavi contains

• The active substance is apixaban. Each coated tablet contains 2.5 mg of apixaban.
• The other ingredients are:
• Tablet core: lactose anhydrous (see section 2. Embavi contains lactose (a type of sugar) and sodium), microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate (E470b).
• Coating: lactose monohydrate (see section 2. Embavi contains lactose (a type of sugar) and sodium), hypromellose type 2910 (E464), titanium dioxide (E171), triacetin, and yellow iron oxide (E172).

What Embavi looks like and contents of the pack

Yellow, round, biconvex coated tablets with "C" embossed on one side and "73" on the other, approximately 6.1 mm in diameter and 3.0 mm in thickness.
This medicine is available in aluminum/PVC/PVdC blisters in cardboard boxes.
Package sizes: 10, 14, 15, 20, 28, 56, 60, 100, 168, or 200 coated tablets.
Not all package sizes may be marketed.

Patient Alert Card: information for use

Inside the Embavi packaging, along with the Patient Leaflet, there is a Patient Alert Card. The doctor may also provide the patient with a similar card.
The Patient Alert Card contains information that may be useful for the patient and may serve as a warning to other doctors that the patient is taking Embavi. The card should always be carried with the patient.

• 1. Take the card.

• 2. If necessary, separate the card in the patient's language (facilitated by perforated edges).
• 3. Fill in the following points or ask the 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 carry it with the patient at all times.

Marketing authorization holder:

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Importer:

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

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

Germany
Embavi 2.5 mg, 5 mg film-coated tablets
Bulgaria
Ембави 2.5 mg, 5 mg филмирани таблетки
Embavi 2.5 mg, 5 mg film-coated tablets
Czech Republic
Embavi
Hungary
Embavi 2.5 mg, 5 mg filmtabletta
Lithuania
Embavi 2.5 mg, 5 mg plėvele dengtos tabletės
Latvia
Embavi 2.5 mg, 5 mg apvalkotās tabletes
Poland
Embavi
Romania
Embavi 2.5 mg, 5 mg comprimate filmate
Slovakia
Embavi 2.5 mg, 5 mg
To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00
Date of last revision of the leaflet:05/2025