Apixaban gedeon richter: detailed information

Package leaflet: Information for the user

APIXABAN GEDEON RICHTER, 5 mg, film-coated tablets
Apixabanum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Apixaban Gedeon Richter is and what it is used for
What you need to know before taking Apixaban Gedeon Richter
How to take Apixaban Gedeon Richter
Possible side effects
How to store Apixaban Gedeon Richter
Contents of the pack and other information

1. What Apixaban Gedeon Richter is and what it is 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, an important component in the blood clotting process.

Apixaban Gedeon Richter is used in adults:

To prevent blood clots forming in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break off and travel to the brain, causing a stroke, or may travel to other organs, impairing blood flow to those organs (also known as systemic embolism). A stroke may be life-threatening and requires immediate medical attention.
To treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the veins or lungs.

Apixaban Gedeon Richter is used in children aged from 28 days to below 18 years for the treatment of blood clots and prevention of recurrence of blood clots in veins or in the blood vessels of the lungs.
Information on body weight and recommended dosage can be found in section 3.

2. What you need to know before taking Apixaban Gedeon Richter

Do not take Apixaban Gedeon Richter:

if you are allergic to apixaban or any of the other ingredients of this medicine (listed in section 6),
if you have active bleeding,
if you have a disease of an organ that increases the risk of severe bleeding (such as active or recently diagnosed stomach or intestinal ulcer, recently diagnosed bleeding into the brain),
if you have liver disease that leads to an increased risk of bleeding (hepatic coagulopathy),
if you are taking anticoagulant medicines (e.g. warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, when a venous or arterial catheter has been inserted and heparin is administered through the catheter to maintain patency, or when undergoing catheter ablation (a catheter is inserted into the vein) due to an irregular heartbeat (arrhythmia).

Warnings and precautions
Before starting this medicine, talk to your doctor, pharmacist, or nurse if you have any of the following conditions:

Increased risk of bleeding, for example:
- Conditions associated with bleeding, including those resulting in reduced platelet activity,
- Very high blood pressure that is not controlled with medication,
- if you are over 75 years of age,
- if your body weight is 60 kg or less,
- severe kidney disease or if you are on dialysis,
- liver disease or history of liver disease.
This medicine should be used with caution in patients showing signs of liver function impairment.
Spinal catheter or spinal injection (anaesthetic or pain relief). In such cases, your doctor will advise you to take this medicine at least 5 or more hours after removal of the catheter.
if you have a heart valve prosthesis,
if your doctor determines that your blood pressure is unstable, or if you are scheduled for other treatments or surgery to remove a blood clot from the lungs.

When to exercise particular caution when taking Apixaban Gedeon Richter

If you have a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), you should inform your doctor, who will decide whether a change in treatment is necessary.

If you need to undergo surgery or a procedure that may cause bleeding, your doctor may ask you to temporarily stop taking this medicine for a short period. If you are unsure whether a procedure may involve bleeding, ask your doctor.

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

Apixaban Gedeon Richter and other medicines
Tell your doctor, pharmacist, or nurse about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines may enhance the effect of Apixaban Gedeon Richter, while others may reduce its effect. Your doctor will decide whether you should take Apixaban Gedeon Richter while taking other medicines and how closely you should be monitored.

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

certain medicines used to treat fungal infections (e.g. ketoconazole and others);
certain antiviral medicines used to treat HIV/AIDS infection (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 of age and taking acetylsalicylic acid, you may be at increased risk of unwanted bleeding;
medicines used for high blood pressure or heart problems (e.g. diltiazem);
antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs).

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

medicines used to prevent epilepsy or seizures (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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your 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 you become pregnant while taking this medicine, you should contact your doctor immediately.
It is not known whether Apixaban Gedeon Richter passes into human milk. Consult your doctor, pharmacist, or nurse before taking this medicine during breastfeeding.
You may be advised to discontinue breastfeeding or to discontinue/avoid starting treatment with this medicine.

Driving and using machines
Apixaban Gedeon Richter has not been shown to affect the ability to drive or operate machinery.

Apixaban Gedeon Richter contains lactose (a type of sugar) and sodium
If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered to be “sodium-free”.

3. How to take Apixaban Gedeon Richter

This medicine should always be taken as instructed by a doctor or pharmacist. If in doubt,
consult a doctor, pharmacist or nurse.
Dosage
The tablet should be swallowed with water. Apixaban Gedeon Richter may be taken
regardless of meals.
To achieve the best treatment outcomes, it is recommended to take the tablets at the same
times each day.
If a patient has difficulty swallowing the tablets whole, they should discuss alternative
administration methods with their doctor. The tablet may be crushed immediately before
administration and mixed with water, 5% aqueous glucose solution, juice, or apple puree.
Instructions for crushing tablets:

Crush the tablet with a mortar and pestle.
Carefully transfer the entire powder to a suitable container, then mix it with a small amount (e.g., 30 mL [2 tablespoons]) of water or one of the liquids listed above to form a mixture.
Swallow (drink) the mixture.
Rinse the pestle and mortar used for crushing the tablets, as well as the container, with a small amount of water or another liquid (e.g., 30 mL), and swallow (drink) the rinse liquid.

If necessary, a doctor may administer crushed Apixaban Gedeon Richter tablets mixed with
60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Apixaban Gedeon Richter should be taken as recommended for the following
indications:
Prevention of blood clots in the heart in patients with irregular heartbeat (arrhythmia) and at
least one additional risk factor.
The recommended dose is one Apixaban Gedeon Richter 5 mg tablet twice daily.
The recommended dose is one Apixaban Gedeon Richter 2.5 mg tablet twice daily if:

the patient has severe renal impairment,
two or more of the following conditions are met:
blood test results suggest reduced kidney function (serum creatinine concentration of 1.5 mg/dL [133 micromoles/L] or higher),
the patient is 80 years of age or older,
the patient's body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one tablet in the morning and one
in the evening. The doctor will decide how long treatment should continue.
Treatment of blood clots in the deep veins of the legs and blood clots in the blood vessels of the
lungs
The recommended dose is two Apixaban Gedeon Richter 5 mg tablets twice daily 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 Apixaban Gedeon Richter 5 mg tablet twice daily,
for example, one tablet in the morning and one in the evening.
Prevention of recurrent blood clots after completion of 6-month treatment
The recommended dose is one Apixaban Gedeon Richter 2.5 mg tablet twice daily, for
example, one tablet in the morning and one in the evening.
The doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrent blood clots in veins or in the blood vessels
of the lungs.
This medicine should always be taken or administered as directed by a doctor or pharmacist. If
in doubt, consult a doctor, pharmacist or nurse.
To achieve the best treatment effect, the dose should be taken or administered at the same
time each 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 at least 35 kg is two Apixaban
Gedeon Richter 5 mg tablets, administered twice daily for the first 7 days, for example, two in
the morning and two in the evening. After 7 days, the recommended dose is one Apixaban Gedeon
Richter 5 mg tablet, administered twice daily, for example, one in the morning and one in the
evening.
For parents and caregivers: observe the child to ensure the full dose has been taken.
It is important to attend scheduled doctor's appointments, as changes in body weight may
require dose adjustment.
The doctor may change anticoagulant treatment as follows:

Switching from Apixaban Gedeon Richter to anticoagulant medicines Discontinue Apixaban Gedeon Richter. Start anticoagulant treatment (e.g., heparin) at the time the next tablet was scheduled to be taken.
Switching from anticoagulant medicines to Apixaban Gedeon Richter Discontinue anticoagulant medicines. Begin Apixaban Gedeon Richter treatment at the time the next anticoagulant dose was scheduled, then continue regular dosing.
Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Apixaban Gedeon Richter Discontinue the vitamin K antagonist medicine. The doctor must perform blood tests and will inform when to start taking Apixaban Gedeon Richter.
Switching from Apixaban Gedeon Richter to anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) If the doctor informs the patient to start taking a vitamin K antagonist medicine, continue taking Apixaban Gedeon Richter for at least 2 days after the first dose of the vitamin K antagonist medicine. The doctor must perform blood tests and inform when to stop taking Apixaban Gedeon Richter.

Patients undergoing cardioversion
Patients with irregular heartbeat who require a cardioversion procedure to restore normal heart
rhythm should take this medicine at the times specified by the doctor to prevent blood clots in
the brain's blood vessels and other blood vessels in the body.
Taking more Apixaban Gedeon Richter than recommended
If a patient takes more Apixaban Gedeon Richter than recommended, they should
immediately inform their doctor. Bring the medicine packaging, even if no tablets remain.
If a patient takes more Apixaban Gedeon Richter than recommended, the risk of bleeding may
increase. If bleeding occurs, surgical treatment, blood transfusion, or other treatments to reverse
the effect directed against factor Xa may be necessary.
Missed dose of Apixaban Gedeon Richter

If a morning dose is missed, take it as soon as remembered, and it may be taken together with the evening dose.
A missed evening dose may be taken only on the same evening. Do not take two doses the next morning instead; continue taking the medicine the next day as directed, twice daily.

If in doubt about use of the medicine or if more than one dose is missed, consult a doctor,
pharmacist or nurse.
Stopping Apixaban Gedeon Richter
Do not stop taking this medicine without consulting a doctor, as stopping Apixaban Gedeon
Richter prematurely may increase the risk of blood clots.
If further doubts arise regarding use of this medicine, consult a doctor, pharmacist or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The most common general adverse reaction with this medicine is bleeding, which may potentially
be life-threatening and may require immediate medical attention.
The following adverse reactions may occur when taking Apixaban Gedeon Richter to prevent
blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common adverse reactions (may occur in not more than 1 in 10 people)

Bleeding, including:
into the eyes;
into the stomach or intestine;
from the rectum;
blood in urine;
from the nose;
from the gums;
subcutaneous haemorrhages (bruising) and swelling;
Anaemia, which may cause fatigue or pallor;
Low blood pressure, which may lead to fainting or rapid heartbeat;
Nausea;
Blood test results may indicate:
increased gamma-glutamyl transferase (GGT) activity.

Uncommon adverse reactions (may occur in not more than 1 in 100 people)

Bleeding:
into the brain or spinal canal;
in the mouth or presence of blood in sputum when coughing;
in the abdominal cavity or from the vagina;
bright red blood in stool;
bleeding following surgery, including subcutaneous haemorrhages (bruising) and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
from haemorrhoids;
presence of blood in stool or urine detected in laboratory tests;
Decreased platelet count in blood (which may affect blood clotting);
Blood test results may indicate:
abnormal liver function;
increased activity of certain liver enzymes;
increased bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes;
Skin rash;
Itching;
Hair loss;
Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, seek medical advice immediately.

Rare adverse reactions (may occur in not more than 1 in 1000 people)

Bleeding:
in the lungs or throat;
into the retroperitoneal space (area behind the abdominal cavity);
into muscles.

Very rare adverse reactions (may occur in not more than 1 in 10,000 people)

Skin rash, with blister formation, resembling small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

Frequency not known (cannot be estimated from available data)

Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or subcutaneous haemorrhages (bruising);
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse reactions may occur when taking Apixaban Gedeon Richter for the treatment or prevention of recurrent venous blood clots in the legs and pulmonary embolism (blood clots in the blood vessels of the lungs).

Common adverse reactions (may occur in not more than 1 in 10 people)

Bleeding, including:
from the nose;
from the gums;
blood in urine;
subcutaneous haemorrhages (bruising) and swelling;
in the stomach, intestine, or from the rectum;
in the mouth;
from the vagina;
Anaemia, which may cause fatigue or pallor;
Decreased platelet count in blood (which may affect blood clotting);
Nausea;
Skin rash;
Blood test results may indicate:
increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT) activity.

Uncommon adverse reactions (may occur in not more than 1 in 100 people)

Low blood pressure, which may lead to fainting or rapid heartbeat;
Bleeding:
into the eyes;
in the mouth or presence of blood in sputum when coughing;
bright red blood in stool;
test results indicating blood in stool or urine;
bleeding following any surgery, including subcutaneous haemorrhages (bruising) and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
from haemorrhoids;
into muscles;
Itching;
Hair loss;
Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, seek medical advice immediately;
Blood test results may indicate:
abnormal liver function;
increased activity of certain liver enzymes;
increased bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

Rare adverse reactions (may occur in not more than 1 in 1000 people)

Bleeding:
into the brain or spinal canal;
in the lungs.

Frequency not known (cannot be estimated from available data)

Bleeding:
into the abdominal cavity or retroperitoneal space;
Skin rash, with blister formation, resembling small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or subcutaneous haemorrhages (bruising);
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional adverse reactions in children and adolescents
If any of the following symptoms occur, immediately inform the doctor:

Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. The frequency of these adverse reactions is classified as “common” (may occur in not more than 1 in 10 people). In general, adverse reactions observed in children and adolescents treated with apixaban were similar to those seen in adults and were mostly mild or moderate in severity. Adverse reactions occurring more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

Very common adverse reactions (may occur in more than 1 in 10 people)

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

Common adverse reactions (may occur in not more than 1 in 10 people)

Bleeding, including:
from the gums;
blood in urine;
subcutaneous haemorrhages (bruising) and swelling;
from the intestine or rectum;
bright red blood in stool;
postoperative bleeding, including subcutaneous haemorrhages (bruising) and swelling, leakage of blood or fluid (discharge) from the surgical wound or injection site;
Hair loss;
Anaemia, which may cause fatigue or pallor;
Decreased platelet count in blood (which may affect clotting);
Nausea;
Skin rash;
Itching;
Low blood pressure, which may cause 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 available data)

Bleeding:
into the abdominal cavity or retroperitoneal space;
in the stomach;
in the eyes;
in the mouth;
from haemorrhoids;
in the mouth or blood in sputum when coughing;
into the brain or spinal canal;
in the lungs;
into muscle;
Skin rash, with blister formation, resembling small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
Vasculitis, which may cause skin rash or raised, flat, red, circular spots beneath the skin surface or bruising;
Blood test results may indicate:
increased gamma-glutamyl transferase (GGT) activity;
presence of blood in stool or urine.
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.
Adverse reactions can also be reported to the responsible entity.

5. How to store Apixaban Gedeon Richter

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP."
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must 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 5 mg of apixaban.
Other ingredients are:
- Tablet core: microcrystalline cellulose type, anhydrous lactose (see section 2 “Apixaban Gedeon Richter contains lactose (a type of sugar) and sodium*”), sodium croscarmellose (see section 2 “Apixaban Gedeon Richter contains lactose (a type of sugar) and sodium*”), sodium lauryl sulfate, magnesium stearate;
- Coating: hypromellose 15 mPas, monohydrate lactose (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 coated tablets are pink, oval-shaped (approximately 10 mm long and 5 mm wide), with the engraved
marking “L1” on one side.
The tablets are packed in blisters within 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, alongside the patient leaflet, a Patient Alert Card is included, or your physician may provide you with a similar card.
The Patient Alert Card contains helpful information for the patient and serves to alert other healthcare professionals that the patient is taking Apixaban Gedeon Richter. You should always carry this card with you.

Take the card.
If necessary, separate the appropriate language section (perforated edges make this easier).
Fill in the following details, or ask your doctor to complete them:
- Name and surname:
- Date of birth:
- Indication:
- Dose: ................. mg twice daily
- Doctor’s name:
- Doctor’s telephone number:
Fold the card and always keep it with you.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Polska Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
This medicinal product is authorised 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
For further information about this medicinal product, please contact:
Gedeon Richter Polska Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: +48 (22) 755 96 48
[email protected]