RIVAROXABAN ZENTIVA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Rivaroxaban Zentiva2.5 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Rivaroxaban Zentiva and what is it used for
2. What you need to know before taking Rivaroxaban Zentiva
3. How to take Rivaroxaban Zentiva
4. Possible side effects
5. Storage of Rivaroxaban Zentiva
6. Package contents and additional information

1. What is Rivaroxaban Zentiva and what is it used for

You have been prescribed Rivaroxaban Zentiva because:

• you have been diagnosed with acute coronary syndrome (a group of disorders that include myocardial infarction and unstable angina, a type of severe chest pain) and your blood test results show elevated levels of certain heart tests.

Rivaroxaban reduces the risk of having another myocardial infarction in adults or reduces the risk of death due to heart or blood vessel disease.

You will be prescribed rivaroxaban along with another medication. Your doctor will also instruct you to take:

• aspirin, or
• aspirin plus clopidogrel or ticlopidine.

or

• you have been diagnosed with a high risk of blood clot formation due to coronary artery disease or peripheral artery disease that causes symptoms.

Rivaroxaban reduces the risk of blood clot formation (atherothrombotic events) in adults.

You will be prescribed rivaroxaban along with another medication. Your doctor will also instruct you to take aspirin.

In some cases, if you are administered rivaroxaban after an intervention to open a narrowed or blocked artery in the leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take in addition to aspirin for a short period of time.

Rivaroxaban Zentiva contains the active ingredient rivaroxaban, which belongs to a group of medications called antithrombotic agents. It works by blocking a clotting factor (factor Xa) and thereby reducing the tendency of blood to form clots.

2. What you need to know before taking Rivaroxaban Zentiva

Do not take Rivaroxaban Zentiva

• if you are allergic to rivaroxaban or any of the other ingredients of this medication (listed in section 6)
• if you bleed excessively
• if you have a disease or problem in an organ of the body that increases the risk of severe bleeding (e.g., stomach ulcer, brain injury or bleeding, or recent brain or eye surgery)
• if you are taking medications to prevent blood clot formation (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter, so that it does not become obstructed
• if you have acute coronary syndrome and have previously had a bleeding or blood clot in the brain (stroke)
• if you have coronary artery disease or peripheral artery disease and have previously had a bleeding in the brain (stroke) or an obstruction of the small arteries that supply blood to the deep tissues of the brain (lacunar stroke) or if you have had a blood clot in the brain (non-lacunar ischemic stroke) in the past month
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding

Do not take Rivaroxaban Zentiva and inform your doctorif any of these circumstances apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rivaroxaban Zentiva.

Rivaroxaban Zentiva should not be used in combination with other medications that reduce blood clotting, such as prasugrel or ticagrelor, other than aspirin or clopidogrel/ticlopidine.

Be careful with Rivaroxaban Zentiva

• if you have an increased risk of bleeding, as may occur in the following situations:

• moderate or severe kidney impairment, as kidney function may affect the amount of medication that works in your body
• if you are taking other medications to prevent blood clot formation (e.g., warfarin, dabigatran, apixaban, or heparin), when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter, so that it does not become obstructed (see section "Other medications and Rivaroxaban Zentiva")
• bleeding disorder
• very high blood pressure, not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, such as stomach or intestinal inflammation, esophageal inflammation (e.g., due to gastroesophageal reflux disease), or tumors located in the stomach, intestines, genital tract, or urinary tract
• a problem in the blood vessels of the back of the eyes (retinopathy)
• a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or a previous lung bleeding
• you are over 75 years old
• you weigh less than 60 kg
• you have coronary artery disease with severe symptomatic heart failure

• if you have a heart valve prosthesis
• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), inform your doctor to decide if it may be necessary to modify the treatment

Inform your doctor if you have any of these situationsbefore taking Rivaroxaban Zentiva. Your doctor will decide if you should be treated with this medication and if you should be kept under closer observation.

If you need surgery

• it is very important to take Rivaroxaban Zentiva before and after surgery, exactly at the times indicated by your doctor.
• if your operation requires the placement of a catheter or injection in the spinal column (e.g., for epidural or spinal anesthesia, or pain relief):

• it is very important to take Rivaroxaban Zentiva exactly at the times indicated by your doctor
• inform your doctor immediately if you experience numbness or weakness in the legs or problems in the intestine or bladder at the end of anesthesia, as urgent attention is necessary.

Children and adolescents

Rivaroxaban Zentiva 2.5 mg tablets are not recommended for children under 18 years of age. There is not enough information available on its use in children and adolescents.

Other medications and Rivaroxaban Zentiva

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

• If you are taking:
• • any medication for a fungal infection (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless it is only applied to the skin
  • ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)
  • any medication for bacterial infections (e.g., clarithromycin, erythromycin)
  • any antiviral medication for HIV/AIDS (e.g., ritonavir)
  • other medications to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol)
  • anti-inflammatory medications and pain relievers (e.g., naproxen or aspirin)
  • dronedarone, a medication for the treatment of irregular heartbeat
  • certain medications for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of the above circumstances apply to you, inform your doctorbefore taking Rivaroxaban Zentiva, as the effect of this medication may be increased. Your doctor will decide if you should be treated with this medication and if you should be kept under closer observation.

If your doctor considers that you have a higher risk of developing stomach or intestinal ulcers, they will recommend that you also use an ulcer prevention treatment.

• If you are taking:
• • any medication for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St. John's Wort (Hypericum perforatum), a herbal remedy for the treatment of depression
  • rifampicin, an antibiotic

If any of the above circumstances apply to you, inform your doctorbefore taking Rivaroxaban Zentiva, as the effect of this medication may be decreased. Your doctor will decide if you should be treated with Rivaroxaban Zentiva and if you should be kept under closer observation.

Pregnancy and breastfeeding

Do not take Rivaroxaban Zentiva if you are pregnant or breastfeeding. If there is any possibility that you may become pregnant, use a reliable contraceptive while taking Rivaroxaban Zentiva. If you become pregnant while taking this medication, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban Zentiva may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, "Possible side effects"). You should not drive, ride a bicycle, or use tools or machines if you are affected by these symptoms.

Rivaroxaban Zentiva contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Rivaroxaban Zentiva

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

What dose to take

The recommended dose is one 2.5 mg tablet twice a day. Take Rivaroxaban Zentiva at the same time every day (e.g., one tablet in the morning and one in the evening).

This medication can be taken with or without food.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways to take Rivaroxaban Zentiva. The tablet can be crushed and mixed with water or apple sauce, immediately before taking it.

If necessary, your doctor may also administer the crushed Rivaroxaban Zentiva tablet through a gastric tube.

You will be prescribed Rivaroxaban Zentiva along with another medication. Your doctor will also instruct you to take aspirin. If you receive Rivaroxaban Zentiva after an acute coronary syndrome, your doctor may also instruct you to take clopidogrel or ticlopidine.

If you are administered Rivaroxaban Zentiva after an intervention to open a narrowed or blocked artery in the leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take in addition to aspirin for a short period of time.

Your doctor will indicate the dose to take (usually between 75 and 100 mg of aspirin per day, or a dose of 75 to 100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to take Rivaroxaban Zentiva

Treatment with Rivaroxaban Zentiva after an acute coronary syndrome should be started as soon as possible, once the acute coronary syndrome has been stabilized, usually within 24 hours after hospital admission and when parenteral anticoagulant treatment (by injection) is finished.

Your doctor will indicate when to start treatment with Rivaroxaban Zentiva if you have been diagnosed with coronary artery disease or peripheral artery disease.

The doctor will decide how long you should continue taking the treatment.

If you take more Rivaroxaban Zentiva than you should

Call your doctor immediately if you have taken too many Rivaroxaban Zentiva tablets. Taking too much Rivaroxaban Zentiva increases the risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Rivaroxaban Zentiva

Do not take a double dose to make up for forgotten doses.

If you forget to take a dose, take the next dose at the usual time.

If you stop taking Rivaroxaban Zentiva

Take Rivaroxaban Zentiva regularly for the time indicated by your doctor.

Do not stop taking Rivaroxaban Zentiva without talking to your doctor first. If you stop taking this medication, you may increase your risk of having another myocardial infarction, a stroke, or dying from a heart or blood vessel disease.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Rivaroxaban Zentiva can cause adverse effects, although not all people suffer from them.

Like other similar medicines to reduce blood clot formation, Rivaroxaban Zentiva can cause bleeding, which can put the patient's life at risk. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be evident.

Tell your doctor immediately if you suffer from any of the following adverse effects:

• Signs of bleeding
• • bleeding in the brain or inside the skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, decreased level of consciousness, and stiffness in the neck. This is a serious medical emergency. Go to the doctor immediately!)

• prolonged and excessive bleeding.
• exceptional weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina.

Your doctor will decide to keep you under closer observation or modify your treatment.

• Signs of severe skin reactions

• intense skin rashes that spread, blisters, or lesions on the mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities, and systemic disease (DRESS syndrome).

The frequency of these adverse effects is very rare (up to 1 in 10,000 people).

• Signs of severe allergic reactions

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure.

The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

General list of possible adverse effects

Frequent(may affect up to 1 in 10 people)

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• bleeding in the stomach or intestine, urogenital hemorrhage (including blood in the urine and heavy menstrual bleeding), nasal bleeding, gum bleeding
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into a tissue or cavity of the body (hematoma, bruising)
• bloody cough
• bleeding from the skin or under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling of the limbs
• pain in the limbs
• alteration of kidney function (may be seen in tests performed by the doctor)
• fever
• stomach pain, indigestion, dizziness or feeling of dizziness, constipation, diarrhea
• low blood pressure (symptoms may be dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• blood tests may show an increase in some liver enzymes

Uncommon(may affect up to 1 in 100 people)

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• bleeding in a joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells that help blood clotting)
• allergic reaction, including skin allergic reaction
• alteration of liver function (may be seen in tests performed by the doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or platelet count
• fainting
• feeling of discomfort
• increased heart rate
• dry mouth
• hives

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

• bleeding in a muscle
• cholestasis (decrease in bile flow), hepatitis, including hepatocellular injury (inflammation of the liver, including liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• blood accumulation (hematoma) in the groin as a complication after cardiac surgery in which a catheter is inserted into the leg artery (pseudoaneurysm)

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

• accumulation of eosinophils, a type of granulocytic white blood cells that cause inflammation in the lung (eosinophilic pneumonia)

Frequency not known(cannot be estimated from available data)

• renal failure after severe bleeding
• increase in pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome due to bleeding)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rivaroxaban Zentiva

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

Do not use this medicine after the expiration date that appears on the packaging and on the blister, after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Rivaroxaban Zentiva

• The active ingredient is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• The other components are:

• Core of the tablet: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, and magnesium stearate.
• Coating of the tablet (OPADRY YELLOW 03F520307): hypromellose, titanium dioxide (E-171), macrogol 3350, yellow iron oxide (E-172).

Appearance of the product and package contents

Rivaroxaban Zentiva 2.5 mg film-coated tablets are yellow, round, biconvex, film-coated (approximately 5 mm in diameter), with "2.5" embossed on one side and smooth on the other side.

Rivaroxaban Zentiva 2.5 mg is available in packages of 20, 28, 56, 100, 168, and 196 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder

Zentiva k.s.

U Kabelovny 130,

Dolní Mecholupy

102 37 Prague 10

Czech Republic

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola

PLA3000 Malta

or

S.C Zentiva S.A.

B-dul Theodor Pallady nr. 50,

sector 3,

Bucharest, cod 032266

Romania

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

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

Czech Republic, Austria, Denmark, Spain, Norway, Netherlands, Sweden, and Germany: Rivaroxaban Zentiva

Croatia: Rivaroksaban Zentiva

France: RIVAROXABAN ZENTIVA

Italy: Rivaroxaban Zentiva Italia

Portugal: Rivaroxabano Zentiva

Date of the last revision of this prospectus:December 2023.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es