RIVAROXABAN VIR 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban 15mg film-coated tablets EFG

Rivaroxaban 20mg 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 Vir and what is it used for
2. What you need to know before taking Rivaroxaban Vir
3. How to take Rivaroxaban Vir
4. Possible side effects
5. Storage of Rivaroxaban Vir
6. Package contents and additional information

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

Rivaroxaban Vir contains the active substance rivaroxaban.

Rivaroxaban is used in adults to:

• prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation.
• treat 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 is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:

• treat blood clots and prevent the recurrence of these blood clots in the veins or in the blood vessels of the lungs, after initial treatment of at least 5 days with injectable medications used to treat blood clots.

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 Vir

Do not take Rivaroxaban Vir

• if you are allergic to rivaroxaban or to 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, injury or bleeding in the brain or recent surgery in the brain or eyes)
• 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 to prevent it from becoming clogged
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Rivaroxaban Vir 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 careful with Rivaroxaban Vir

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

• severe kidney failure in adults and moderate or severe kidney failure in children and adolescents, as kidney function may affect the amount of medication that acts in the 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 to prevent it from becoming clogged (see section "Other medications and Rivaroxaban Vir")
• bleeding disorder
• very high blood pressure, not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, such as intestinal or stomach inflammation, esophageal inflammation (e.g., due to gastroesophageal reflux disease), 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 previous lung bleeding

• 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 to decide if it may be necessary to modify the treatment.
• if your doctor determines that your blood pressure is unstable or if you are scheduled to receive another treatment or undergo surgery to remove a blood clot from your lungs.

Inform your doctorif you have any of these conditionsbefore 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 surgery, 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 your legs or problems in your intestines or bladder after anesthesia, as urgent attention is necessary.

Children and adolescents

Rivaroxaban tablets are not recommended in children with a body weight of less than 30kg.

There is not enough information about the use of rivaroxaban in children and adolescents for the indications in adults.

Other medications and Rivaroxaban Vir

Inform your doctor or pharmacist if you are using, have recently used, or may need to use 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 too much 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)
• 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 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, inform your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may be reduced. Your doctor will decide if you should be treated with this medication 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 this medication, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban may cause dizziness (frequent 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.

This medication 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 tablet; this is, essentially "sodium-free".

3. How to take Rivaroxaban Vir

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

You must take Rivaroxaban Vir with food.

Swallow the tablets, preferably with water.

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 puree, immediately before taking it. Then, take food.

If necessary, your doctor may also administer the crushed rivaroxaban tablet through a gastric tube.

What dose to take

• Adults

• to prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body

The recommended dose is one 20 mg rivaroxaban tablet once a day.

If you have kidney problems, the dose may be reduced to one 15 mg rivaroxaban tablet once a day.

If you need to undergo a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent insertion), there is limited evidence to reduce the dose to one 15 mg rivaroxaban tablet once a day (or one 10 mg rivaroxaban tablet once a day if your kidneys do not function properly) in addition to an antiplatelet medication such as clopidogrel.

• 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.

The recommended dose is one 15 mg rivaroxaban tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg rivaroxaban tablet once a day.

After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg tablet once a day or one 20 mg tablet once a day.

If you have kidney problems and are taking one 20 mg rivaroxaban tablet once a day, your doctor may decide to reduce the treatment dose to one 15 mg rivaroxaban tablet once a day after 3 weeks if the risk of bleeding is higher than the risk of having another blood clot.

• Children and adolescents

The dose of rivaroxaban depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight of between 30kg and less than 50kgis one rivaroxaban 15mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50kgor more is one rivaroxaban 20mgtablet once a day.

Take each dose of rivaroxaban with a drink (e.g., water or juice) during a meal. Take the tablets every day at approximately the same time. Consider setting an alarm to remind you.

For parents or caregivers: observe the child to ensure they take the entire dose.

Since the dose of rivaroxaban is based on body weight, it is important to attend scheduled visits with the doctor, as it may be necessary to adjust the dose as the weight changes.

Never adjust the dose of rivaroxaban on your own. Your doctor will adjust the dose if necessary.

Do not divide the tablet to try to obtain a fraction of the tablet dose. If a smaller dose is required, please use the alternative rivaroxaban oral suspension presentation.

In children and adolescents who cannot swallow whole tablets, please use rivaroxaban oral suspension.

If the oral suspension is not available, you can crush the rivaroxaban tablet and mix it with water or apple puree immediately before taking it. Take some food after taking this mixture. If necessary, your doctor may also administer the crushed rivaroxaban tablet through a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking rivaroxaban, take a new dose.
• more than 30 minutes after taking rivaroxaban, do nottake a new dose. In this case, take the next dose of rivaroxaban at the usual time.

Call your doctor if you spit out the dose or vomit repeatedly after taking rivaroxaban.

When to take Rivaroxaban Vir

Take the tablets every day, until your doctor tells you to stop.

Try to take the tablets at the same time every day to remember when you should take them.

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

To prevent the formation of blood clots in the brain (stroke) or in other blood vessels:

If it is necessary to normalize your heartbeat through a procedure called cardioversion, take rivaroxaban at the times indicated by your doctor.

If you forget to take rivaroxaban

• Adults, children, and adolescents:

If you are taking one 20 mg or one 15 mg tablet oncea day, and you forget to take a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a forgotten dose. Take the next tablet the next day and, after that, continue taking one tablet every day.

• Adults:

If you are taking one 15 mg tablet twicea day, and you forget to take a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you forget to take a dose, you can take two 15 mg tablets at the same time, for a total of two tablets (30 mg) in a day. The next day, you should continue taking one 15 mg tablet twice a day.

If you take more Rivaroxaban Vir 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 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 interrupt treatment with Rivaroxaban Vir

Do not interrupt treatment with rivaroxaban without consulting your doctor first, as rivaroxaban treats and prevents serious conditions.

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 endanger the patient's life. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be evident.

Tell your doctor immediately if you or your child experience any of the following symptoms:

• Signs of bleeding

• bleeding in the brain or inside the skull (symptoms may include headache, unilateral weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. 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 may decide 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 found in adults, children, and adolescents

Common adverse effects(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), nosebleeds, bleeding 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 liquid 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 adverse effects(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, 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 a subcategory of bilirubin (direct bilirubin, bile pigment) or some pancreatic or liver enzymes, or platelet count
• fainting
• feeling of discomfort
• increased heart rate
• dry mouth
• hives

Rare adverse effects(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 after a complication in cardiac surgery where a catheter is inserted into the leg artery (pseudoaneurysm)

Frequency not known(frequency cannot be estimated from available data)

• renal failure after severe bleeding.
• 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)

Adverse effects in children and adolescents

In general, the adverse effects observed in children and adolescents treated with Xarelto were similar to those observed in adults and their severity was mainly mild to moderate.

Adverse effects that were more frequently observed in children and adolescents:

Very common(may affect more than 1 in 10 people)

• headache
• fever
• nosebleeds
• vomiting

Common(may affect up to 1 in 10 people)

• accelerated heartbeats
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (low platelet count, cells that help blood clotting)
• heavy menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

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 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 Vir

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and on each blister or vial after "CAD" or "EXP".

The expiration date is the last day of the month indicated.

No special storage conditions are required.

Crushed tablets

Crushed tablets are stable in water or apple sauce for up to 4 hours.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE 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 Vir

• The active ingredient is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other components are:

Core of the tablet: microcrystalline cellulose, lactose monohydrate, hypromellose (2910), croscarmellose sodium, magnesium stearate, sodium lauryl sulfate.

Coating of the tablet:

Rivaroxaban Vir 15 mg: hypromellose (2910), macrogol (3350), titanium dioxide (E 171), red iron oxide (E 172).

Rivaroxaban Vir 20 mg: hypromellose (2910), macrogol (3350), red iron oxide (E 172), titanium dioxide (E 171).

Appearance of the product and package contents

Rivaroxaban Vir 15 mg

The film-coated tablets of Rivaroxaban Vir 15 mg are red, round, biconvex tablets (5.6 mm in diameter) marked with "15" on one face and smooth on the other face.

Packages containing 14, 28, 42, or 100 film-coated tablets in transparent PVC/PVDC-Aluminum blisters.

Rivaroxaban Vir 20 mg

The film-coated tablets of Rivaroxaban Vir 20 mg are dark red, round, biconvex tablets (6.5 mm in diameter) marked with "20" on one face and smooth on the other face.

Packages containing 7, 28, 30, or 100 film-coated tablets in transparent PVC/PVDC-Aluminum blisters.

Not all package sizes may be marketed.

Marketing authorization holder

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-68-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Manufacturer:

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

or

Adalvo Limited

Malta Life Sciences Park, Building 1,

Level 4, Sir Temi Zammit Buildings,

San Gwann

SGN 3000, Malta

Date of the last revision of this prospectus:

July 2022

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