RIVAROXABAN SANDOZ 2.5 mg FILM-COATED TABLETS

2. What you need to know before taking Rivaroxaban Sandoz Pharmaceutical

Do not take Rivaroxaban Sandoz Pharmaceutical

• 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 blocked,
• 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 brain bleed (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 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 or clopidogrel/ticlopidine, such as prasugrel or ticagrelor.

Be careful with Rivaroxaban Sandoz Pharmaceutical

• 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 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 blocked (see section "Other medications and Rivaroxaban Sandoz Pharmaceutical"),
• 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),
• 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 have had a previous lung bleed,
• 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 (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 into your 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.
• Inform your doctor immediately if you experience numbness or weakness in your legs or problems in your intestine or bladder at the end of anesthesia, as urgent attention is necessary.

Children and Adolescents

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

Other medications and Rivaroxaban Sandoz Pharmaceutical

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take 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,
• 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 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 for ulcers.

• 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 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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant or breastfeeding, do not take rivaroxaban. 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 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 Sandoz Pharmaceutical contains lactose and sodium

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

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 Pharmaceutical

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 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 not be prescribed rivaroxaban alone.

Your doctor will instruct you to take 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 receive rivaroxaban after a procedure to open a narrowed or blocked artery in your leg to restore blood flow, your doctor may also instruct you to take aspirin for a short period.

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 Pharmaceutical

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 discontinued.

Your doctor will instruct you on when to start treatment with rivaroxaban 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 Sandoz Pharmaceutical 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 ingested.

If you forget to take Rivaroxaban Sandoz Pharmaceutical

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 Sandoz Pharmaceutical

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, 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 immediatelyif 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, vomiting, seizures, low level of consciousness, and stiff neck. It is a serious medical emergency. Seek medical help 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

• severe 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, bleeding from the gums,
• 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 include feeling of 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 into a joint, which causes 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 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 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)

• 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, which causes 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 leaflet. You can also report them 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. Storage of Rivaroxaban Sandoz Pharmaceutical

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 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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in 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 Pharmaceutical

• The active ingredient is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• The other components are:
• Core of the tablet: sodium lauryl sulfate, lactose, poloxamer, microcrystalline cellulose (E 460), sodium croscarmellose, magnesium stearate (E 470b), anhydrous colloidal silica (E 551). See section 2 "Rivaroxaban Sandoz Pharmaceutical contains lactose and sodium".

Coating of the tablet: hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), yellow iron oxide (E 172).

Appearance of the product and package contents

Rivaroxaban Sandoz Pharmaceutical 2.5 mg are slightly yellow, round, biconvex tablets, with a diameter of 8.6 mm, marked with "2.5" on one side and smooth on the other side.

Packaged in:

• Blister pack in cardboard box of 5, 10, 14, 20, 28, 30, 42, 50, 56, 60, 98, 100, 168, or 196 film-coated tablets or,
• Unit-dose blister pack in cardboard box of 5x1, 10x1, 14x1, 28x1, 30x1, 42x1, 56x1, 98x1, 100x1 film-coated tablets or,
• Bottles of 56, 100, or 112 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Rontis Hellas Medical and

Pharmaceutical S.A

Products Area of Larissa,

P.O. Box 3012

GR-41004 Larissa

Greece

Or

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

Or

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000,

Malta

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

Netherlands Rivaroxaban Sandoz 2.5 mg, film-coated tablets

Germany Rivaroxaban HEXAL 2.5 mg film-coated tablets

Austria Rivaroxaban Sandoz GmbH 2.5 mg film-coated tablets

Belgium Rivaroxaban Sandoz GmbH 2.5 mg film-coated tablets

Denmark Rivaroxaban Hexal

Spain Rivaroxaban Sandoz Pharmaceutical 2.5 mg film-coated tablets EFG

Finland Rivaroxaban Hexal 2.5 mg film-coated tablets

Hungary Rivaroxaban 1 A Pharma 2.5 mg film-coated tablets

Iceland Rivaroxaban Hexal 2.5 mg film-coated tablets

Norway Rivaroxaban Hexal

Sweden Rivaroxaban Hexal 2.5 mg film-coated tablets

Date of last revision of this leaflet:January 2024

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