Apixaban Gedeon Rihter

Leaflet accompanying the packaging: information for the user

APIXABAN GEDEON RICHTER, 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 them, 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 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 so-called anticoagulant medicines. This medicine helps prevent blood clots by blocking factor Xa, which is an important element in the blood clotting process.
Apixaban Gedeon Richter 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 travel to other organs, hindering 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 veins of the legs (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 blood vessels of 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 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 an organ diseasethat increases the risk of severe bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recently diagnosed bleeding in the brain),
• If the patient has liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy),
• If the patient is taking anticoagulant medicines(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases 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 to take this medicine, the patient should discuss it with their doctor, pharmacist, or nurse if they have any of the following conditions:

• Increased risk of bleeding, for example:
• Bleeding disorders, including cases that result in decreased platelet activity,
• Very high blood pressurethat is not controlled 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 disease or a history of liver disease.
• This medicine should be used with caution in patients with signs of liver function changes.
• 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 Apixaban Gedeon Richter
• 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 to change the treatment.

In case of a need for surgery or a procedure that may cause bleeding, the doctor may ask the patient to temporarily stop taking this medicine for a short time. If there is any uncertainty about whether a procedure may be associated with bleeding, the doctor should be consulted.

Children and adolescents

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

Apixaban Gedeon Richter 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 Apixaban Gedeon Richter, and some may weaken its effect. The doctor will decide whether the patient should receive Apixaban Gedeon Richter while taking other medicines and how closely they should be monitored.
The following medicines may enhance the effect of Apixaban Gedeon Richter 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 anticoagulant medicines(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, 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 or serotonin and norepinephrine reuptake inhibitors.

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 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 Apixaban Gedeon Richter 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 contact their doctor immediately.
It is not known whether Apixaban Gedeon Richter passes into breast milk. Before taking this medicine while breastfeeding, the patient should consult their doctor, pharmacist, or nurse. The patient may be advised to stop breastfeeding or stop/restart taking this medicine.

Driving and using machines

It has not been found that Apixaban Gedeon Richter affects the ability to drive and use machines.

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

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

3. How to take Apixaban Gedeon Richter

This medicine should always be taken exactly as prescribed 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 Gedeon Richter can be taken with or without food.
To achieve the best treatment results, the patient should try to take the dose at the same time every day.
The recommended dose is one tablet of Apixaban Gedeon Richter 5 mgtwice a day.
The recommended dose is one tablet of Apixaban Gedeon Richter 2.5 mgtwice 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 (creatinine level in the blood is 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 the treatment should be continued.
Treatment of blood clots in the veins of 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 completing 6 months of treatment
The recommended dose is one tablet of Apixaban Gedeon Richter 2.5 mgtwice a day, for example, one tablet in the morning and one in the evening.
The doctor will decide how long the treatment should be continued.
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 exactly as prescribed 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 Apixaban Gedeon Richter depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing 35 kg or more is two tabletsof Apixaban Gedeon Richter 5 mg, administered twice 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 mg, administered twice a day, for example, one tablet in the morning and one in the evening.
For parents and caregivers: the child should be observed to ensure that the full dose is taken.
It is essential to follow the scheduled doctor's appointments, 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 anticoagulant medicinesThe patient should stop taking Apixaban Gedeon Richter. Anticoagulant treatment (e.g., heparin) should be started at the time of the scheduled intake of the next tablet.
• Switching from anticoagulant medicines to Apixaban Gedeon RichterThe patient should stop taking anticoagulant medicines. Apixaban Gedeon Richter treatment should be started at the time of the scheduled intake of the next dose of anticoagulant medicine and then continued as usual.
• Switching from treatment with a vitamin K antagonist (e.g., warfarin) to Apixaban Gedeon RichterThe patient should stop taking the vitamin K antagonist. The doctor will perform blood tests and inform the patient 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 the patient that they should start taking a vitamin K antagonist, the patient should continue to take 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 the patient when to stop taking Apixaban Gedeon Richter.

Patients undergoing cardioversion

Patients with irregular heart rhythm 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 blood vessels of the brain and other blood vessels in the body.

Taking a higher dose of Apixaban Gedeon Richter than recommended

If the patient has taken a higher dose of Apixaban Gedeon Richter than recommended, they should immediately inform their doctor.
The patient should take the packaging of the medicine with them, even if there are no more tablets left.
If the patient has taken a higher dose of Apixaban Gedeon Richter 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 Apixaban Gedeon Richter

• 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 prescribed, 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 the intake of Apixaban Gedeon Richter

The patient should not stop taking this medicine without consulting their doctor, as the risk of blood clots may be higher if the treatment is stopped prematurely.
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, Apixaban Gedeon Richter can cause side effects, although not everybody gets them.
The most common general side effect of this medicine is bleeding, which can be life-threatening and may require immediate medical attention.
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:
• in the eyes;
• in 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 paleness;
• 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:
• in the brain or spinal cord;
• in the mouth or throat, or blood in sputum when coughing;
• in the abdominal cavity or retroperitoneal space;
• from hemorrhoids;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the surgical wound or injection site;
• from the uterus;
• Decreased platelet count in the blood (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 red blood cell breakdown, which can cause yellowing of the skin and eyes;
• 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 are observed, the patient should immediately contact their doctor.

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

• Bleeding:
• in the lungs or throat;
• in the muscles.

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

• A rash that may 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 a rash or raised, flat, red, round patches under the skin, or bruising.

The following side effects may occur when taking Apixaban Gedeon Richter to treat or prevent the recurrence of blood clots in the veins of 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;
• in the stomach, intestines, or rectum;
• in the mouth;
• from the uterus;
• Anemia, which can cause fatigue or paleness;
• Decreased platelet count in the blood (which can affect blood clotting);
• Nausea (vomiting);
• 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:
• in the eyes;
• in the mouth or throat, or blood in sputum when coughing;
• blood in the stool;
• blood test results indicating blood in the stool or urine;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the surgical wound or injection site;
• from hemorrhoids;
• in 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 are observed, the patient should immediately contact their doctor;
• Blood test results may indicate:
• abnormal liver function;
• 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:
• in the brain or spinal cord;
• in the lungs.

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

• Bleeding:
• in the abdominal cavity or retroperitoneal space;
• A rash that may 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 a rash or raised, flat, red, round patches under the skin, or bruising.

Additional side effects in children and adolescents
If any of the following symptoms are observed, the patient should immediately inform their doctor:

• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, 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 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 uterus;
• 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;
• in the intestines or rectum;
• blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the surgical wound or injection site;
• Hair loss;
• Anemia, which can cause fatigue or paleness;
• Decreased platelet count in the blood (which can affect blood clotting);
• Nausea (vomiting);
• Rash;
• Itching;
• 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 alanine aminotransferase (ALT) activity.

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

• Bleeding:
• in the abdominal cavity or retroperitoneal space;
• in the stomach;
• in the eyes;
• in the mouth or throat, or blood in sputum when coughing;
• in the brain or spinal cord;
• in the lungs;
• in the muscles;
• A rash that may 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 a rash or raised, flat, red, round patches under the skin, or bruising;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• blood in the stool or urine.

Reporting side effects

If the patient experiences any side effects, including any side effects 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
By reporting side effects, more information can be gathered on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Apixaban Gedeon Richter

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 that are no longer needed. This 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 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 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, iron oxide red (E 172).

What Apixaban Gedeon Richter looks like and contents of the pack

The tablets are pink, oval (approximately 10 mm long and 5 mm wide) with the inscription "L1" on one side.
They are packaged in blisters in cardboard boxes containing 28, 56, 60, or 168 coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: information for use

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

• 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 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 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 5 mg филмирани таблетки
Czech Republic:
APIXABAN GEDEON RICHTER
Estonia:
APIXABAN GEDEON RICHTER
Hungary:
APIXABAN GEDEON RICHTER 5 mg filmtabletta
Lithuania:
APIXABAN GEDEON RICHTER 5 mg plėvele dengtos tabletės
Poland: APIXABAN GEDEON RICHTER
Romania:
APIXABAN GEDEON RICHTER 5 mg comprimate filmate
Slovakia:
APIXABAN GEDEON RICHTER 5 mg filmom obalené tablety
To obtain more detailed information on this medicine, the patient should 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
[email protected]

Date of last revision of the leaflet: April 2025