Embavi

Package Leaflet: Information for the User

Embavi, 5 mg, Film-Coated Tablets

Apixaban

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

• Keep this package leaflet, as 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 those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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 pack 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 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 veins of 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 blood vessels of 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 blood vessels of the lungs.
The recommended dose is adjusted according to body weight and 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 bleeding into the brain);
• if the patient has liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy);
• if the patient is taking medicines to prevent blood clotting(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, discuss the following with your doctor, pharmacist, or nurse:

• if the patient has an increased risk of bleeding, such as:
• bleeding disorders, including conditions with reduced 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 dysfunction.
• if the patient has a prosthetic heart valve;
• if the doctor considers that the patient's blood pressure is unstable or if treatment to remove a blood clot from the lungs is planned or another surgical procedure is planned.

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 whether 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 about 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 or have recently taken, as well as any medicines they 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 a 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 noradrenaline reuptake inhibitors.

The following medicines may reduce the ability of Embavi 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 baby, 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 contact their doctor immediately.
It is not known whether Embavi passes into human 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 found to have an 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 it is essentially 'sodium-free'.

3. How to take Embavi

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If in doubt, 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 discuss this with their doctor. The tablet can be crushed just before taking and mixed with water, 5% aqueous glucose solution, apple juice, or apple puree.

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 (e.g., 30 mL or 2 tablespoons) of water or one of the above-mentioned liquids to make a mixture.
• Swallow (drink) the resulting mixture.
• Rinse the pestle and mortar used to crush the tablet and the container used to prepare the mixture with a small amount of water or one of the above-mentioned liquids (e.g., 30 mL) 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 recommended in 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 Embavi 5 mg tablet twice a day.
The recommended dose is one Embavi 2.5 mg tablet twice a day if:

• the patient has severe kidney problems;
• at least 2 of the following criteria are met:
• the patient's blood test results indicate reduced 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 veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is twoEmbavi 5 mg 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 oneEmbavi 5 mg tablet twice a day, for example, one tablet in the morning and one tablet in the evening.
Prevention of the recurrence of blood clots after completing 6 months of treatment
The recommended dose is one Embavi 2.5 mg 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 the recurrence of blood clots in the veins or blood vessels of the lungs.
This medicine should always be taken or administered as recommended by the doctor or pharmacist.
If in doubt, the patient should consult their doctor, pharmacist, or nurse.
To achieve the best treatment results, it is recommended to take 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 twoEmbavi 5 mg 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 oneEmbavi 5 mg tablet twice a day, for example, one tablet in the morning and one tablet in the evening.
For parents and caregivers: observe the child to ensure they take the full dose.
Follow the scheduled doctor's visits, as it may be necessary to adjust the dose depending on the child's weight change.

The doctor may change the anticoagulant treatment as follows:

• Switching from Embavi to other anticoagulantsStop taking Embavi. At the time when the next scheduled dose of Embavi is due, start treatment with another anticoagulant (e.g., heparin).
• Switching from other anticoagulants to EmbaviStop taking the other anticoagulant. At the time when the next scheduled dose of the other anticoagulant is due, start taking Embavi and continue with its usual administration.
• Switching from treatment with a vitamin K antagonist (e.g., warfarin) to EmbaviStop taking the vitamin K antagonist. The doctor will order blood tests and tell you when to start taking Embavi.
• Switching from Embavi to treatment with a vitamin K antagonist (e.g., warfarin)If the doctor recommends starting treatment with a vitamin K antagonist, 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 you when to stop taking Embavi.

Use in patients undergoing cardioversion

If, due to irregular heart rhythm, a procedure called cardioversion is needed to restore a normal heart rhythm, the medicine should be taken at the times strictly specified by the doctor to prevent 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. They should take the package 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 on factor Xa 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 together with the evening dose.
• A missed evening dose can only be taken on the same evening. Do not take two doses the next morning instead; continue with the twice-daily dosing schedule as recommended the next day.

If in doubt about taking the medicine or if more than one doseis missed

The patient should consult their doctor, pharmacist, or nurse.

Stopping Embavi

The patient should not stop taking this medicine without consulting their doctor, as stopping treatment too early may increase the risk of blood clots.
If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Embavi can cause side effects, although not everybody gets them.
The most common general side effect of this medicine is bleeding, which can potentially be life-threatening and may require immediate medical attention.
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 affect up to 1 in 10 people)

• Bleeding, including:
• into the eyes;
• into the stomach or intestines;
• from the rectum;
• presence of 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 heart rate;
• Nausea (feeling sick);
• Blood test results may indicate:
• increased activity of gamma-glutamyltransferase (GGTP).

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 retroperitoneal space;
• presence of bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, and bleeding or fluid leakage from the wound or surgical incision site;
• from hemorrhoids;
• into the muscles.
• Reduced platelet count (which can affect blood clotting);
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of broken-down red blood cells, which can cause yellowing of the skin and eyes;
• 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 contact their doctor immediately.

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

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

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

• A skin rash that can cause blisters and looks like small targets (dark spots surrounded by a lighter area with a dark border) (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;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney dysfunction (nephropathy associated with anticoagulant therapy).

The following side effects are known to occur when taking Embavi to prevent the recurrence of 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;
• presence of blood in the urine;
• bruises and swelling;
• from the stomach, intestines, or rectum;
• in the mouth;
• from the vagina;
• Anemia, which can cause fatigue or pale skin;
• Reduced platelet count (which can affect blood clotting);
• Nausea (feeling sick);
• Skin rash;
• Blood test results may indicate:
• increased activity of gamma-glutamyltransferase (GGTP) or alanine aminotransferase (AlAT).

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

• Low blood pressure, which can lead to fainting or rapid heart rate;
• Bleeding:
• into the eyes;
• into the mouth or presence of blood in sputum when coughing;
• presence of bright red blood in the stool;
• blood test results indicating presence of blood in the stool or urine;
• bleeding after surgery, including bruising and swelling, and bleeding or fluid leakage from the wound or surgical incision site;
• from hemorrhoids;
• into the muscles.
• 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 contact their doctor immediately;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of broken-down red blood cells, 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 that can cause blisters and looks like small targets (dark spots surrounded by a lighter area with a dark border) (erythema multiforme).
• Vasculitis (inflammation of blood vessels), which can cause skin rash or flat, red, round spots under the skin surface or bruising;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney dysfunction (nephropathy associated with anticoagulant therapy).

Additional side effects in children and adolescents
The doctor should be informed immediatelyif any of the following symptoms are observed:

• 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 affect 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 in severity. Side effects observed more frequently 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;
• presence of blood in the urine;
• bruises and swelling;
• from the intestines or rectum;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, and bleeding or fluid leakage from the wound or surgical incision site;
• Hair loss;
• Anemia, which can cause fatigue or pale skin;
• Reduced platelet count in the child (which can affect blood clotting);
• Nausea (feeling sick);
• Skin rash;
• Itching;
• Low blood pressure, which can lead to fainting or rapid heart rate in the child;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes; increased activity of alanine aminotransferase (AlAT)

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 presence of blood in sputum when coughing;
• into the brain or spinal cord;
• into the lungs;
• into the muscles.
• A skin rash that can cause blisters and looks like small targets (dark spots surrounded by a lighter area with a dark border) (erythema multiforme).
• Vasculitis (inflammation of blood vessels), which can cause skin rash or flat, red, round spots under the skin surface or bruising;
• Blood test results may indicate:
• increased activity of gamma-glutamyltransferase (GGT)
• presence of blood in the stool or urine.
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney dysfunction (nephropathy associated with anticoagulant therapy).

Reporting side effects

If side effects occur, including those not listed in this package leaflet, the patient should inform 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 to gather more information on the safety of this medicine.

5. How to store Embavi

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, and blister after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Embavi contains

• The active substance is apixaban. Each film-coated tablet contains 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, sodium carboxymethylcellulose, sodium lauryl sulfate, and magnesium stearate.
• Coating: lactose monohydrate (see section 2. Embavi contains lactose (a type of sugar) and sodium), hypromellose type 2910 (E464), titanium dioxide (E171), triacetin, iron oxide red (E172).

What Embavi looks like and contents of the pack

Oval, pink, biconvex film-coated tablets with "C" embossed on one side and "74" on the other side, approximately 9.95 mm in length and 5.35 mm in width.
This medicine is available in blisters of aluminum/PVC/PVdC in cardboard boxes.
Package sizes: 10, 14, 15, 20, 28, 56, 60, 100, 168, or 200 film-coated tablets.
Not all package sizes may be marketed.

Patient Alert Card: Information for use

Inside the Embavi package, in addition to the package leaflet, there is a Patient Alert Card. A similar card may be provided by the doctor.
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.

Always carry the card with you.

• 1. Take the card.
• 2. If necessary, separate the card in your language (the perforated edges make it easier).
• 3. Fill in the following 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:

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 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 film tabletta
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.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00
Date of last revision of the package leaflet:05/2025