RIVAXA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaxa 2.5 mg film-coated tablets EFG

rivaroxaban

Read the entire package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. Contents of the pack and other information

1. What is Rivaxa 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 test results have shown 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 medicine. Your doctor will also tell 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 arterial disease that causes symptoms. Rivaroxaban reduces the risk of blood clot formation (atherothrombotic events) in adults.

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

• In some cases, if you are given rivaroxaban after a procedure to open a narrowed or blocked artery in your 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.

Rivaxa contains the active substance rivaroxaban, which belongs to a group of medicines called antithrombotic medicines. 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 you take Rivaxa

Do not take Rivaxa

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (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, injury or bleeding in the brain, or recent brain or eye surgery)
• if you are taking medicines to prevent blood clot formation (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to another anticoagulant treatment or while being administered heparin through a venous or arterial catheter, so that it does not become blocked
• if you have acute coronary syndrome and have previously had a bleed or had a blood clot in the brain (stroke)
• if you have coronary artery disease or peripheral arterial disease and have previously had a bleed 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 last month
• if you have a liver disease that may increase the risk of bleeding
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take rivaroxaban.

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

Be careful with Rivaxa

• if you have an increased risk of bleeding, as may occur in the following situations:
• • severe kidney failure, as kidney function may affect the amount of medicine that works in your body
  • if you are taking other medicines 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 blocked (see section "Other medicines and Rivaxa")
  • bleeding disorder
  • very high blood pressure, not controlled by medical treatment
  • stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach or intestine, inflammation of the esophagus (throat), e.g. due to gastroesophageal reflux disease (a disease in which stomach acid rises up into the esophagus), or tumors located 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 you have had a previous bleed in the lungs
  • you are over 75 years old
  • if 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 (a disorder of the immune system that increases the risk of blood clot formation), inform your doctor to decide if it may be necessary to modify the treatment.

Tell your doctor if you have any of these situationsbefore taking rivaroxaban. Your doctor will decide if you should be treated with this medicine 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 into 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 removal of the catheter, exactly at the times indicated by your doctor.
  • Tell your doctor immediately if you experience numbness or weakness in your legs or problems with your intestines or bladder at the end of anesthesia, as urgent attention is needed.

Children and adolescents

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

Other medicines and Rivaxa

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

• If you are taking
• • any medicine 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 too much cortisol)
  • any medicine for bacterial infections (e.g. clarithromycin, erythromycin)
  • any antiviral medicine for HIV/AIDS (e.g. ritonavir)
  • other medicines 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 and pain-relieving medicines (e.g. naproxen or aspirin)
  • dronedarone, a medicine for the treatment of irregular heartbeat
  • certain medicines 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 medicine 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 medicine for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St. John's Wort (Hypericum perforatum) a herbal medicine 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 a 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 may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, "Possible side effects"). Do not drive, ride a bicycle, or use tools or machines if you are affected by these symptoms.

Rivaxa contains lactose and sodium

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

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

3. How to take Rivaxa

Follow the instructions for administration of this medicine 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 at the same time every day (e.g. one tablet in the morning and one in the evening). This medicine can be taken with or without food.

If you have difficulty swallowing the whole tablet, consult your doctor about other ways to take rivaroxaban. 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 tablet through a gastric tube.

You will be prescribed rivaroxaban along with another medicine.

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

If you are given rivaroxaban after a procedure to open a narrowed or blocked artery in your 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 tell you the dose to take (usually between 75 and 100 mg of aspirin per day, or a daily 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 start treatment with Rivaxa

Treatment with rivaroxaban after an acute coronary syndrome should be started as soon as possible, once the acute coronary syndrome has been stabilized, i.e. from 24 hours after hospital admission and at the time when parenteral anticoagulant treatment (by injection) would be finished.

Your doctor will tell you 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 Rivaxa 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, contact your doctor or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Rivaxa

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

If you stop taking Rivaxa

Take rivaroxaban regularly for the time indicated by your doctor.

Do not stop taking rivaroxaban without talking to your doctor first. If you stop taking this medicine, 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Tell your doctor immediately if you 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
  • extreme weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina

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

?

• severe skin rash that spreads, 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 side effects is very rare (up to 1 in 10,000 people).

?

• 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 from 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)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after an operation
• 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 include dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, skin itching
• blood tests may show an increase in some liver enzymes

Infrequent(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 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 heart 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(frequency cannot be estimated from available data)

• kidney failure after severe bleeding
• bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to malfunction (nephropathy related to anticoagulants)
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensitivity, numbness, or paralysis (compartment syndrome after bleeding)

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report it 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 Rivaxa

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 blister after "CAD". 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. 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

Rivaxa Composition

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

Core of the tablet: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose, sodium croscarmellose, magnesium stearate. See section 2 "Rivaxa contains lactose and sodium".

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

Appearance of the Product and Package Contents

Rivaxa 2.5 mg film-coated tablets are yellow, round, biconvex (6 mm in diameter), marked with "2.5" on one side and smooth on the other side.

They are packaged in blisters, in boxes of 20, 28, 45, 56, or 196 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b, Praha 4

140 78 Czech Republic

Manufacturer:

S.C. Labormed-Pharma S.A.

Bd. Theodor Pallady nr. 44B, sector 3

Bucharest cod 032266

Romania

Adalvo Ltd

Malta Life Sciences Park

Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann

SGN 3000, Malta

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

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

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

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

Germany Rivaxa 2.5 mg Filmtabletten

Denmark Rivaxa

Spain Rivaxa 2.5 mg film-coated tablets EFG

Finland Rivaxa

Norway Rivaxa

Czech Republic Rivaxa 2.5 mg potahované tablety

Sweden Rivaxa

Date of the Last Revision of this Prospectus:March 2024

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/).