Apixaban Gedeon Rihter

Package Leaflet: Information for the User

APIXABAN GEDEON RICHTER, 2.5 mg, film-coated tablets

Apixaban

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

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

Table of Contents of the Package Leaflet

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

1. What is Apixaban Gedeon Richter and what is it used for

Apixaban Gedeon Richter contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots by blocking factor Xa, which is an important part of the blood clotting process.

Apixaban Gedeon Richter is used in adults:

• to prevent blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After hip or knee surgery, the patient is at increased risk of 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 to the lungs, causing shortness of breath with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
• to prevent blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and travel to the brain, causing a stroke, or travel to other organs, reducing blood flow to those organs (also 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 blood clots in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the legs and/or lungs.

Apixaban Gedeon Richter 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.

• Information on body weight and recommended dose can be found in section 3.

2. Important information before taking Apixaban Gedeon Richter

When not to take Apixaban Gedeon Richter:

• If you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6),
• If you have excessive bleeding,
• If you have an organ diseasethat increases the risk of severe bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recent brain bleeding),
• If you have liver diseasethat increases the risk of bleeding (liver coagulopathy),
• If you are taking anticoagulant medicines(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the treatment is changed and 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 the vein) due to irregular heart rhythm (arrhythmia).

Warnings and precautions

Before starting treatment, you should discuss with your doctor, pharmacist, or nurse if you have any of the following conditions:

• Increased risk of bleeding, such as:
• Bleeding disorders, including conditions that result in reduced platelet activity,
• Uncontrolled high blood pressure,
• If you are over 75 years old,
• If your body weight is 60 kg or less,
• Severe kidney disease or if you are on dialysis,
• Liver disease or a history of liver disease.
• This medicine should be used with caution in patients with signs of liver function changes.
• Tube (catheter) or spinal injection, in which case the doctor will recommend taking this medicine at least 5 hours after catheter removal,
• If you have a heart valve replacement,
• If your doctor determines that your blood pressure is unstable or if other treatment or surgery is planned to remove a blood clot from the lungs. When to be particularly careful when taking Apixaban Gedeon Richter
• If you have antiphospholipid syndrome(an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change the treatment.

In case of surgery or a procedure that may cause bleeding, the doctor may ask you to temporarily stop taking this medicine for a short time. If you are unsure whether a procedure may be associated with bleeding, you should ask your doctor.

Children and adolescents

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

Apixaban Gedeon Richter and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or might take.

Some medicines may increase the effect of Apixaban Gedeon Richter, and some may reduce its effect. Your doctor will decide whether you should receive Apixaban Gedeon Richter while taking other medicines and how closely you should be monitored.

The following medicines may increase the effect of Apixaban Gedeon Richter and increase the risk of unwanted bleeding:

• Some antifungal medicines(e.g., ketoconazole and others);
• Some antiviral medicines used to treat HIV/AIDS(e.g., ritonavir);
• Other medicines used to reduce blood clotting(e.g., enoxaparin and others);
• Anti-inflammatory or pain-relieving medicines(e.g., acetylsalicylic acid or naproxen), especially if you are over 75 years old and taking acetylsalicylic acid, you may be at increased risk of unwanted bleeding;
• Medicines used to treat high blood pressure or heart problems(e.g., diltiazem);
• Antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs).

The following medicines may reduce the ability of Apixaban Gedeon Richter to prevent blood clots:

• Medicines used to prevent seizures or fits(e.g., phenytoin and others)
• St. John's Wort(a herbal supplement used in depression)
• Medicines used to treat tuberculosis or other infections(e.g., rifampicin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.

The effect of Apixaban Gedeon Richter on pregnancy and the unborn child is not known. This medicine should not be taken during pregnancy. If you become pregnant while taking this medicine, you should contact your doctor immediately.

It is not known whether Apixaban Gedeon Richter passes into breast milk. Before taking this medicine while breastfeeding, ask your doctor, pharmacist, or nurse for advice.

You may be advised to stop breastfeeding or stop/avoid taking this medicine.

Driving and using machines

Apixaban Gedeon Richter has not been shown to affect the ability to drive or use machines.

Apixaban Gedeon Richter contains lactose (a type of sugar) and sodium

If you have been told that you have an intolerance to some sugars, contact your 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 Apixaban Gedeon Richter

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

Dose

Swallow the tablet with water. Apixaban Gedeon Richter can be taken with or without food.

To get the best effect, it is recommended to take the tablets at the same time every day.

If you have problems swallowing the tablets whole, you should talk to your doctor about other ways to take Apixaban Gedeon Richter. The tablet can be crushed just before taking and mixed with water or 5% glucose solution, juice, or apple puree.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer all the powder to a suitable container and then mix it with a small amount of liquid (e.g., 30 mL or 2 tablespoons of water or one of the above-mentioned liquids) to prepare a mixture.
• Swallow (drink) the mixture.
• Rinse the pestle and mortar used to crush the tablets and the container with a small amount of water or another liquid (e.g., 30 mL) and swallow (drink) the liquid after rinsing.

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

Apixaban Gedeon Richter should be taken as recommended in the following indications:

Prevention of blood clots after hip or knee replacement surgery.

The recommended dose is one Apixaban Gedeon Richter 2.5 mg tablet twice a day. For example, one tablet in the morning and one in the evening.

The first tablet should be taken 12 to 24 hours after surgery.

If you have had major hip replacement surgery, you will usually take the tablets for 32 to 38 days.

If you have had major knee replacement surgery, you will usually take the tablets for 10 to 14 days.

Prevention of blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor.

The recommended dose is one Apixaban Gedeon Richter 5 mgtablet twice a day.

The recommended dose is one Apixaban Gedeon Richter 2.5 mgtablet twice a day if:

• you have severe kidney problems,
• two or more of the following conditions are met:
• your blood test results suggest reduced kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or higher),
• you are 80 years old or older,
• your 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. Your 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 two tabletsof Apixaban Gedeon Richter 5 mgtwice a day for the first 7 days, for example, two tablets in the morning and two in the evening.

After 7 days, the recommended dose is one tabletof Apixaban Gedeon Richter 5 mgtwice a day, for example, one tablet in the morning and one in the evening.

Prevention of recurrence of blood clots after completion of 6 months of treatment

The recommended dose is one Apixaban Gedeon Richter 2.5 mgtablet twice a day, for example, one tablet in the morning and one in the evening.

Your doctor will decide how long to continue treatment.

Use in children and adolescents

Treatment and prevention of recurrence of blood clots in the veins or blood vessels of the lungs.

This medicine should always be taken or administered as recommended by your doctor or pharmacist. If you are not sure, ask your doctor, pharmacist, or nurse.

To get the best effect, the dose should be taken or administered at the same time every day.

The dose of Apixaban Gedeon Richter is based on body weight and will be calculated by your doctor.

The recommended dose for children and adolescents weighing 35 kg or more is four tabletsof Apixaban Gedeon Richter 2.5 mg, given twice a day for the first 7 days, for example, four in the morning and four in the evening. After 7 days, the recommended dose is two tabletsof Apixaban Gedeon Richter 2.5 mg, given twice a day, for example, two in the morning and two in the evening.

For parents and caregivers: you should observe the child to ensure that the full dose is taken.

It is important to follow the scheduled visits to the doctor, as the dose may need to be adjusted with changes in the patient's body weight.

The doctor may change the anticoagulant treatment as follows:

• Switching from Apixaban Gedeon Richter to other anticoagulantsStop taking Apixaban Gedeon Richter. Anticoagulant treatment (e.g., heparin) should be started at the time of the scheduled next dose of Apixaban Gedeon Richter.
• Switching from other anticoagulants to Apixaban Gedeon RichterStop taking other anticoagulants. Apixaban Gedeon Richter treatment should be started at the time of the scheduled next dose of the other anticoagulant, and then continue with the usual dosing schedule.
• Switching from treatment with a vitamin K antagonist (e.g., warfarin) to Apixaban Gedeon RichterStop taking the vitamin K antagonist. The doctor will perform blood tests and inform you when to start taking Apixaban Gedeon Richter.
• Switching from Apixaban Gedeon Richter to treatment with a vitamin K antagonist (e.g., warfarin)If the doctor informs you that you should start taking a vitamin K antagonist, you should continue taking Apixaban Gedeon Richter for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor will perform blood tests and inform you when to stop taking Apixaban Gedeon Richter.

Patients undergoing cardioversion

Patients with irregular heart rhythm who require a procedure to restore a normal heart rhythm (cardioversion) should take this medicine at the times specified by the doctor to prevent the formation of blood clots in the blood vessels of the brain and other blood vessels.

Taking a higher dose of Apixaban Gedeon Richter than recommended

If you take more of this medicine than you should, contact your doctor immediately. You should take the package with you, even if it is empty.

If you take more Apixaban Gedeon Richter than recommended, you may be at increased 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 Apixaban Gedeon Richter

• If you miss a morning dose, take it as soon as you remember and take the evening dose as scheduled.
• If you miss an evening dose, you can take it only on the same evening. Do not take two doses the next morning, instead, continue taking the medicine the next day as scheduled, twice a day.

If you have any doubts about taking the medicine or if you miss more than one dose

contact your doctor, pharmacist, or nurse.

Stopping Apixaban Gedeon Richter

Do not stop taking this medicine without consulting your doctor, as the risk of blood clots may be higher if you stop taking Apixaban Gedeon Richter prematurely.

If you have any further doubts about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Apixaban Gedeon Richter 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 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 Apixaban Gedeon Richter to prevent blood clots after hip or knee replacement surgery.

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

• Anemia, which can cause fatigue or pale skin;
• Bleeding, including:
• bruises and swelling;
• Nausea (vomiting).

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

• Reduced platelet count (which can affect blood clotting);
• Bleeding:
• after surgery, including bruises and swelling, bleeding or fluid leakage from the wound/incision 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: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately;
• 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 retroperitoneal space;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• 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 bruising.

The following side effects may occur when taking Apixaban Gedeon Richter 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;
• from the stomach or intestines;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• bruises and swelling;
• Anemia, which can cause fatigue or pale skin;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Nausea (vomiting);
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity.

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

• Bleeding:
• into the brain or spinal cord;
• into the mouth or presence of blood in sputum when coughing;
• into the abdominal cavity or vagina;
• bright red blood in the stool;
• bleeding after surgery, including bruises and swelling, bleeding or fluid leakage from the wound/incision or injection site;
• from hemorrhoids;
• Reduced platelet count (which can affect blood clotting);
• 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;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately;

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

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

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

• 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).

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

• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin surface, or bruising.

The following side effects may occur when taking Apixaban Gedeon Richter to treat or prevent the recurrence of blood clots in the legs and blood clots in the blood vessels of the lungs.

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

• Bleeding, including:
• from the nose;
• from the gums;
• blood in the urine;
• bruises and swelling;
• from the stomach, intestines, or rectum;
• from the mouth;
• from the vagina;
• Anemia, which can cause fatigue or pale skin;
• Reduced 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 bruises and swelling, bleeding or fluid leakage from the wound/incision 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, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately;
• Blood test results may indicate:
• liver function disorders;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 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 retroperitoneal space.
• 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 bruising.

Additional side effects in children and adolescents

If you experience any of the following symptoms, contact your doctor immediately:

• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and 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 observed in adults and were mostly mild or moderate in severity.

The side effects that occurred more frequently in children and adolescents were nosebleeds and abnormal vaginal bleeding.

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

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

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

• Bleeding, including:
• from the gums;
• blood in the urine;
• bruises and swelling;
• from the intestines or rectum;
• bright red blood in the stool;
• bleeding after surgery, including bruises and swelling, bleeding or fluid leakage from the wound/incision or injection site;
• Hair loss;
• Anemia, which can cause fatigue or pale skin;
• Reduced platelet count (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Itching;
• 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 alanine aminotransferase (ALT) activity.

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

• Bleeding:
• into the abdominal cavity or retroperitoneal space;
• into the stomach;
• into the eyes;
• into the mouth;
• from hemorrhoids;
• into the mouth or presence of blood in sputum when coughing;
• into the brain or spinal cord;
• into the lungs;
• into the muscle;
• 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 bruising;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• presence of blood in the stool or urine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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

By reporting side effects, you can help provide more information on the safety of this medicine.

Side effects can also be reported to the marketing authorization holder.

5. How to store Apixaban Gedeon Richter

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP".

The expiry date refers to the last day of that month.

No special storage precautions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Apixaban Gedeon Richter contains

• The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
• The other ingredients are:
• Tablet core: microcrystalline cellulose, anhydrous lactose(see section 2 "Apixaban Gedeon Richter contains lactose (a type of sugar) and sodium"), sodium croscarmellose, sodium lauryl sulfate, magnesium stearate;
• Coating: hypromellose 15 mPas, lactose monohydrate(see section 2 "Apixaban Gedeon Richter contains lactose (a type of sugar) and sodium"), titanium dioxide (E 171), triacetin, yellow iron oxide (E 172).

What Apixaban Gedeon Richter looks like and contents of the pack

The film-coated tablets are yellow, round, biconvex (diameter) and approximately 6 mm in size, with the inscription "L0" on one side.

They are packaged in blisters in cardboard boxes containing 20, 60, or 168 film-coated tablets.

Not all pack sizes may be marketed.

Patient Alert Card: Information for use

Inside the Apixaban Gedeon Richter package, next to the patient leaflet, you will find a Patient Alert Card or your doctor may give you a similar card.

The Patient Alert Card contains information that is helpful to you and warns other doctors that you are taking Apixaban Gedeon Richter. You should always carry this card with you.

• 1. Take the card.
• 2. If necessary, separate the relevant language (this is facilitated by perforated edges).
• 3. Fill in the following points or ask your doctor to fill them in:
• Name and surname:
• Date of birth:
• Indication:
• Dose: ................. mg twice a day
• Name and surname of the doctor:
• Doctor's phone number:
• 4. Fold the card and always carry it with you.

Marketing authorization holder and manufacturer

Gedeon Richter Polska Sp. z o.o.

ul. Ks. J. Poniatowskiego 5

05-825 Grodzisk Mazowiecki

Poland

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

Bulgaria:

АПИКСАБАН ГЕДЕОН РИХТЕР 2,5 mg филмирани таблетки

Czech Republic:

APIXABAN GEDEON RICHTER

Estonia:

APIXABAN GEDEON RICHTER

Hungary:

APIXABAN GEDEON RICHTER 2,5 mg filmtabletta

Lithuania:

APIXABAN GEDEON RICHTER 2,5 mg plėvele dengtos tabletės

Poland:

APIXABAN GEDEON RICHTER

Romania:

APIXABAN GEDEON RICHTER 2,5 mg comprimate filmate

Slovakia:

APIXABAN GEDEON RICHTER 2,5 mg filmom obalené tablety

For more information on this medicine, contact:

Gedeon Richter Polska Sp. z o.o.

Medical Department

ul. Ks. J. Poniatowskiego 5

05-825 Grodzisk Mazowiecki

tel.: +48 (22) 755 96 48

lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet: April 2025