RIVAROXABAN SANDOZ 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Sandoz Pharmaceutical 10 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Rivaroxaban Sandoz Pharmaceutical and what is it used for

Rivaroxaban Sandoz Pharmaceutical contains the active substance rivaroxaban and is used in adults for:

• preventing the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medication because after surgery you have a higher risk of developing blood clots.
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent these blood clots from occurring again in the blood vessels of the legs and/or lungs.

Rivaroxaban 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 Sandoz Pharmaceutical

Do not takeRivaroxaban 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, injury or bleeding in the brain, or recent brain or eye surgery),
• if you are taking medications to prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching to anticoagulant treatment or while being administered heparin through a venous or arterial catheter, so that it does not become obstructed,
• 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 you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rivaroxaban.

Be particularly careful with Rivaroxaban SandozPharmaceutical

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

• moderate or 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 clotting (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 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 bleeding in the lungs,

• 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 clots), inform your doctor so that they can decide whether it is necessary to modify the treatment,
• if your doctor determines that your blood pressure is unstable or you are scheduled to receive another treatment or undergo surgery to remove a blood clot from your lungs.

Inform your doctor if you have any of these situationsbefore taking rivaroxaban. Your doctor will decide whether you should be treated with this medication and whether 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, 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 intestines or bladder at the end of anesthesia, as urgent attention is necessary.

Children and adolescents

Rivaroxaban 10 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 obtained 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,
• 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 decrease 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 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, inform your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may be increased. Your doctor will decide whether you should be treated with this medication and whether 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 the ulcer.

• Ifyou 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, inform your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may be reduced. Your doctor will decide whether you should be treated with rivaroxaban and whether you should be kept under closer observation.

Pregnancy andbreastfeeding

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 this medication. 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 (a rare side effect) (see section 4, "Possible side effects"). Do not drive, ride a bicycle, or use 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 administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

What dose to take

• To prevent the formation of blood clots in the veins after hip or knee replacement surgery. The recommended dose is one 10 mg rivaroxaban tablet once a day.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent these blood clots from occurring again.

After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed rivaroxaban 10 mg once a day.

Swallow the tablet, preferably with water.

Rivaroxaban 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 tablet through a gastric tube.

When to take Rivaroxaban SandozPharmaceutical

Take the tablet every day, until your doctor indicates otherwise.

Try to take the tablet at the same time every day, to help you remember.

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

To prevent the formation of blood clots in the veins after hip or knee replacement surgery:

Take the first tablet 6 to 10 hours after surgery.

If you have undergone major hip surgery, you will usually take tablets for 5 weeks.

If you have undergone major knee surgery, you will usually take tablets for 2 weeks.

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 SandozPharmaceutical

If you forget to take a dose, take it as soon as you remember. Take the next tablet the following day and, thereafter, take one tablet every day, as usual.

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

If you interrupt treatment with Rivaroxaban Sandoz Pharmaceutical

Do not interrupt treatment with rivaroxaban without first talking to your doctor, as rivaroxaban prevents the development of a serious condition.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Like other similar medications, rivaroxaban may cause bleeding that can be life-threatening. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be apparent.

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, 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, pallor, 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 these side effects is very rare (up to 1 in 10,000 people).

Signsof severe allergic reactions

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

The frequency of severe allergic reactions is 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 side effects

Frequent(may affect up to 1 in 10 people)

• decrease in red blood cells that can cause pallor and weakness or difficulty breathing
• stomach or intestinal bleeding, urogenital bleeding (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 your 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.

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 your 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 white blood cell granulocyte that causes 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 fail to function properly (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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 via wastewater or household waste. Deposit the packaging and medicines you no longer need at 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 Pharmaceutical

• The active ingredient is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other components are:

Tablet core: 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".

Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), red iron oxide (E172).

Appearance of the Product and Package Contents

Rivaroxaban Sandoz Pharmaceutical 10 mg are slightly red, round, biconvex tablets, 8.6 mm in diameter, marked with "10" on one side and smooth on the other side.

The tablets are available in:

• Blister pack in a cardboard box of 5, 10, 14, 20, 28, 30, 42, 50, 60, 98 or 100 film-coated tablets or,

• Unit-dose blister pack in a cardboard box of 5x1, 10x1, 14x1, 28x1, 30x1, 42x1, 56x1, 98x1 or 100x1 film-coated tablets or,
• Bottles of 56, 100 or 112 film-coated tablets

Only some 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 10 mg, film-coated tablets

Germany Rivaroxaban HEXAL 10 mg film-coated tablets

Austria Rivaroxaban Sandoz GmbH 10 mg - film-coated tablets

Belgium Rivaroxaban Sandoz GmbH 10 mg film-coated tablets

Denmark Rivaroxaban Hexal

France RIVAROXABAN GNR 10 mg film-coated tablets

Spain Rivaroxaban Sandoz Pharmaceutical 10 mg film-coated tablets EFG

Finland Rivaroxaban Hexal 10 mg tablets, film-coated

Hungary Rivaroxaban 1 A Pharma 10 mg film-coated tablets

Iceland Rivaroxaban Hexal 10 mg film-coated tablets

Norway Rivaroxaban Hexal

Sweden Rivaroxaban Hexal 10 mg film-coated tablets

Date of the last revision of this prospectus: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