RIVAROXABAN PENSA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Pensa 2.5 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 Pensa and what is it used for
2. What you need to know before taking Rivaroxaban Pensa
3. How to take Rivaroxaban Pensa
4. Possible side effects
5. Storage of Rivaroxaban Pensa

1. Contents of the pack and further information

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

You have been prescribed rivaroxaban 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 tests have shown elevated results in 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:

• acetylsalicylic acid (also known as aspirin), or
• acetylsalicylic acid plus clopidogrel or ticlopidine

• you have been diagnosed with a high risk of blood clot formation due to coronary artery disease or peripheral arterial disease that causes symptoms. Rivaroxaban reduces the risk of blood clot formation (atherothrombotic events) in adults. Your doctor will also instruct you to take acetylsalicylic acid.

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

Rivaroxaban Pensa 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 thus reducing the tendency of blood to form clots.

2. What you need to know before taking Rivaroxaban Pensa

Do not take Rivaroxaban Pensa

• if you are allergic to rivaroxaban or any of the other ingredients of this medication (listed in section 6)
• if you have excessive bleeding
• 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, to prevent it from becoming blocked
• if you have been diagnosed with acute coronary syndrome and have previously had a bleeding or blood clot in the brain (stroke)
• if you have coronary artery disease or peripheral arterial 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 have had a blood clot in the brain (non-lacunar ischemic stroke) in the past month
• if you have a liver disease that may increase the risk of bleeding
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

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

Be careful with Rivaroxaban Pensa

• If you have an increased risk of bleeding, such as in the following situations:
  • severe kidney failure, 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, to prevent it from becoming blocked (see section "Using Rivaroxaban Pensa with other medications")
  • bleeding disorder
  • uncontrolled high blood pressure
  • 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 in the stomach, intestines, genital tract, or urinary tract
  • a problem in the blood vessels of the back of your eyes (retinopathy)
  • a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or a previous bleeding in the lungs
  • you are over 75 years old
  • you weigh less than 60 kg
  • You have coronary artery disease with severe symptomatic heart failure.

Tell your doctor if you have any of these situationsbefore taking this medication. 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 before and after the operation, 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 before and after the injection or catheter removal, exactly at the times indicated by your doctor.

Tell your doctor immediately if you experience numbness or weakness in your legs or problems in your intestines or bladder after anesthesia, as urgent attention is necessary.

Children and adolescents

Rivaroxaban is not recommended in children and adolescents under 18 years of age.There is not enough information about its use in children and adolescents.

Other medications and Rivaroxaban Pensa

Tell 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), except if 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, prasugrel, and ticagrelor (see section "Warnings and precautions"))
  • anti-inflammatory medications and pain relievers (e.g., naproxen or acetylsalicylic acid)
  • 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, tell your doctorbefore taking rivaroxaban, as the effect of rivaroxaban 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 a stomach or intestinal ulcer, they may recommend that you also use a preventive treatment.

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

If any of the above circumstances apply to you, tell your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may be reduced. Your doctor will decide if you should be treated with rivaroxaban and if you should be kept under closer observation.

Pregnancy and breastfeeding

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

Driving and using machines

Rivaroxaban Pensa may cause dizziness (common side effect) or fainting (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 Pensa contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking Rivaroxaban Pensa.

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

3. How to take Rivaroxaban Pensa

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

What dose to take

The recommended dose is one 2.5 mg tablet twice a day. Take rivaroxaban 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 Pensa. 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 Pensa tablet through a gastric tube.

You will be prescribed rivaroxaban along with another medication. Your doctor will instruct you to take acetylsalicylic acid (also known as aspirin) as well.

If you receive rivaroxaban after an acute coronary syndrome, your doctor may also instruct you to take clopidogrel or ticlopidine.

If you are given rivaroxaban after an intervention to open a narrowed or closed artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take in addition to acetylsalicylic acid for a short period of time.

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

When to start treatment with Rivaroxaban Pensa

Treatment with rivaroxaban after an acute coronary syndrome should be started as soon as possible, i.e., from 24 hours after hospital admission and when parenteral anticoagulant treatment (by injection) is finished.

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

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

If you take more Rivaroxaban Pensa than you should

Call your doctor immediately if you have taken too many rivaroxaban tablets. Taking too much rivaroxaban 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 taken.

If you forget to take Rivaroxaban Pensa

Do not take a double dose to make up for the forgotten dose. If you forget to take a dose, take the next tablet at the usual time.

If you interrupt treatment with Rivaroxaban Pensa

Take rivaroxaban regularly for the time indicated by your doctor.

Do not interrupt treatment with rivaroxaban 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, this medicine can cause adverse effects, although not all people suffer from them.

Like other similar medicines to reduce blood clot formation, rivaroxaban can cause bleeding that 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 immediatelyifyou experience any of the following symptoms:

• 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 of the neck. This is a serious medical emergency. Go to the doctor immediately!)
• prolonged or excessive bleeding
• exceptional weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina, as they can be signs of bleeding.

Your doctor will decide whether to keep you under closer observation or change 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 patients):

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• stomach or intestinal bleeding, 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)
• coughing up blood
• 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)

Uncommon(may affect up to 1 in 100 patients):

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• bleeding into 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 patients):

• bleeding into a muscle
• cholestasis (decrease in bile flow), hepatitis, including traumatic hepatocellular injury (inflammation or 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 the available data):

• renal failure after severe bleeding

- bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to malfunction (anticoagulant-related nephropathy)

increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after bleeding)

Reporting of adverse effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this leaflet. 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 pensa

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 each blister after "CAD" or "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Rivaroxaban pensa

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

Core of the tablet: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, sodium lauryl sulfate, magnesium stearate, and hypromellose.

Coating of the tablet: macrogol, hypromellose, titanium dioxide (E-171), yellow iron oxide (E-172).

Appearance of the product and package contents

The film-coated tablets of Rivaroxaban pensa 2.5 mg are round, biconvex, yellow, engraved with "E21" on one side and smooth on the other side.

They are packaged in PVC-PVdC/Aluminum blisters, in boxes of 30, 56, 100, or 168 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Towa Pharmaceutical, S.A.

c/Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

TOWA Pharmaceutical Europe S.L.

C/Sant Martí s/n, Polígono Industrial, 08107, Martorelles, Barcelona, Spain.

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, PLA3000, Paola, Malta

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

Sweden: Rivadia

Denmark: Rivadia

Norway: Rivadia

Germany: Rivadia

Spain: Rivaroxabán pensa

Date of the last revision of this leaflet: January 2024

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