RIVAROXABAN SANDOZ 2.5 mg FILM-COATED TABLETS

2. What you need to know before taking Rivaroxaban Sandoz

Do not take Rivaroxaban Sandoz

• 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 problems 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 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 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 if you have had a blood clot in the brain (non-lacunar ischemic stroke) in the previous month,
• if you have a liver disease that may increase the risk of bleeding,
• if you are pregnant or breastfeeding.

Do not take rivaroxaban and inform your doctorif any of these circumstances apply to your case.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rivaroxaban.

Rivaroxaban should not be taken with other medications that reduce blood clotting, other than aspirin, such as prasugrel or ticagrelor and clopidogrel/ticlopidine.

Be careful with Rivaroxaban Sandoz

• 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 medication that acts 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 Sandoz"),
• 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 or intestine or genital 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 bleeding in the lungs,
• you are over 75 years old,
• your weight is 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. 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 removal of the catheter, 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 Sandoz is not recommended for persons under 18 years of age.There is not enough information about its use in children and adolescents.

Other medications and Rivaroxaban Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, even 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,
• tablets with ketoconazole (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 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 these circumstances apply to you,inform your doctorbefore taking rivaroxaban, 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 a stomach or intestinal ulcer, they may recommend using a preventive treatment in addition.

• 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 these circumstances apply to you,inform 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, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban may cause dizziness (a frequent 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 Sandoz contains lactose

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

Rivaroxaban Sandoz contains azoic dyes.This medication may cause allergic reactions because it contains orange yellow S (E 110) and tartrazine.

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

3. How to take Rivaroxaban Sandoz

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you have any doubts, 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. 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 medication.

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

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.

Your doctor will instruct you on 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 Rivaroxaban Sandoz

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

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

If you take more Rivaroxaban Sandoz than you should

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.

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

If you forget to take Rivaroxaban Sandoz

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

If you interrupt treatment with Rivaroxaban Sandoz

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 medicines to reduce 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.

Inform 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,
• exceptional 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.

• 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 this adverse effect 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 these severe adverse 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)
• 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)
• 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 traumatic hepatocellular injury (inflammation or liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• accumulation of blood (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(frequency cannot be estimated from 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),
• increase in 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 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 it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Rivaroxaban Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging, blister, or bottle after CAD/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 the sewers or in the trash. 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 Sandoz

• The active ingredient is rivaroxaban. Each film-coated tablet contains 2.5 mg of rivaroxaban.
• The other components are:
• Core of the tablet: lactose monohydrate, sodium lauryl sulfate (E-487), hypromellose (substitution type 2910) (E-464), sodium croscarmellose (E-468), magnesium stearate (E 470b), microcrystalline cellulose (E-460), anhydrous colloidal silica (E-551).

Coating of the tablet: hypromellose (substitution type 2910) (E-464), macrogol 3350 (E-1521), titanium dioxide (E-171), tartrazine (E-102), carmine indigo (E-132), orange yellow S (E-110).

Appearance of the Product and Package Contents

Yellow, round, biconvex film-coated tablets, marked with "2.5" on one side, with a diameter of 6 mm.

PVC/PVDC-Aluminum transparent or opaque blister

Package sizes: 5, 10, 14, 20, 28, 30, 42, 56, 60, 98, 100, 168, and 196 film-coated tablets.

PVC/PVDC-Aluminum transparent or opaque unit-dose blisters

Package sizes: 5x1, 10x1, 14x1, 20x1, 28x1, 30x1, 42x1, 56x1, 98x1, 100x1 film-coated tablets.

HDPE bottles with child-resistant screw cap containing desiccant (silica gel).

Packages of 100, 112, and 200 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto von Guericke Allee 1

39179 Barleben

Germany

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/