RIVAROXABAN VIATRIS 20 mg FILM-COATED TABLETS

2. What you need to know before you take Rivaroxaban Viatris

Do not take Rivaroxaban Viatris

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you have bleeding problems
• if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, recent injury or bleeding in the brain or recent brain or eye surgery)
• if you are taking medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching from one anticoagulant treatment to another or when being treated with heparin through a venous or arterial catheter to prevent it from becoming blocked
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting Rivaroxaban Viatris.

Be careful with Rivaroxaban Viatris

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

• severe kidney problems in adults and moderate or severe kidney problems in children and adolescents, as kidney function may affect the amount of medicine that works in the body
• if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), when switching from one anticoagulant treatment to another or when receiving heparin through a venous or arterial catheter to prevent it from becoming blocked (see section "Other medicines and Rivaroxaban Viatris")
• bleeding disorders
• very high blood pressure, not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestine or stomach, 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 previous lung bleeding

• if you have a heart valve replacement
• 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 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.

Tell your doctorif you have any of these conditionsbefore taking Rivaroxaban Viatris. Your doctor will decide whether you should be treated with this medicine and whether you should be kept under closer observation.

If you need to have surgery

• It is very important to take Rivaroxaban Viatris before and after surgery, exactly at the times indicated by your doctor.
• If your operation requires the insertion of a catheter or injection into the spine (e.g. for epidural or spinal anesthesia, or pain relief):

• It is very important to take Rivaroxaban Viatris 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 after anesthesia, as urgent attention is needed.

Children and adolescents

Rivaroxaban Viatris tablets are not recommended in children with a body weight below 30 kg.

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

Other medicines and Rivaroxaban Viatris

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. ketoconazole, 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 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)
• anti-inflammatory medicines and pain relievers (e.g. naproxen or acetylsalicylic acid)
• 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 applies to you, tell your doctorbefore taking Rivaroxaban Viatris, as the effect of Rivaroxaban Viatris may be increased. Your doctor will decide whether you should be treated with this medicine 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.

• 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 applies to you,tell your doctorbefore taking Rivaroxaban Viatris, as the effect of Rivaroxaban Viatris may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Viatris and whether you should be kept under closer observation.

Pregnancy and breastfeeding

Do not take Rivaroxaban Viatris if you are pregnant or breastfeeding. If there is a possibility that you may become pregnant, use a reliable contraceptive while taking Rivaroxaban Viatris. If you become pregnant while taking this medicine, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban Viatris 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 Viatris contains lactose and sodium

If your doctor has told you that you have an intolerance to some 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 Rivaroxaban Viatris

Follow exactly the instructions of administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

You must take Rivaroxaban Viatris 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 Viatris. 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 Viatris 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 Rivaroxaban Viatris 20 mg tablet once a day.

If you have kidney problems, the dose may be reduced to one Rivaroxaban Viatris 15 mg 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 Rivaroxaban Viatris 15 mg tablet once a day (or to one Rivaroxaban Viatris 10 mg tablet once a day if your kidneys do not work properly) in addition to an antiplatelet medicine such as clopidogrel.

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

The recommended dose is one Rivaroxaban Viatris 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Rivaroxaban Viatris 20 mg 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 Rivaroxaban Viatris 20 mg tablet once a day, your doctor may decide to reduce the treatment dose to one Rivaroxaban Viatris 15 mg 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 Viatris depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one Rivaroxaban Viatris 15 mg tablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Rivaroxaban Viatris 20 mg tablet once a day.

Take each dose of Rivaroxaban Viatris 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 Viatris 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 Viatris on your own. Your doctor will adjust the dose if necessary.

Do not split the tablet to try to get a fraction of the tablet dose. If a smaller dose is required, please use alternative formulations such as oral suspension granules. In children and adolescents who cannot swallow whole tablets, please use suitable pharmaceutical forms such as oral suspension granules.

If the oral suspension is not available, you can crush the Rivaroxaban Viatris 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 Viatris tablet through a gastric tube.

If you spit out the dose or vomit

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

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

When to take Rivaroxaban Viatris

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 to take the treatment.

To prevent 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 Viatris at the times indicated by your doctor.

If you forget to take Rivaroxaban Viatris

• 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 one day to make up for a forgotten dose. Take the next tablet the next day and then continue to take 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 one 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 one day. The next day, you should continue to take one 15 mg tablet twice a day.

If you take more Rivaroxaban Viatris than you should

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

If you stop taking Rivaroxaban Viatris

Do not stop taking Rivaroxaban Viatris without first consulting your doctor, as Rivaroxaban Viatris treats and prevents serious conditions.

If you have any further questions on the use of this medicine, 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 Viatris may 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 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, which can be signs of bleeding.

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

• Signs of severe skin reactions

• intensive 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.

These 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

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 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 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
• blood accumulation (hematoma) in the groin after a complication in heart surgery where 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(cannot be estimated from available data)

• kidney 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 rivaroxaban 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 frequent(may affect more than 1 in 10 people)

• headache
• fever
• nasal bleeding
• vomiting

Frequent(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. Conservation of Rivaroxaban Viatris

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 vial after "CAD" or "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple puree for up to 2 hours.

Medicines should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package contents and additional information

Composition of Rivaroxaban Viatris

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

Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 "Rivaroxaban Viatris contains lactose and sodium"

Tablet film coating: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide (E171), red iron oxide (E172).

Appearance ofRivaroxaban Viatrisand package contents

The film-coated tablets of Rivaroxaban Viatris 15 mg are pink to orange-red, round, biconvex, and beveled (diameter of 6.4 mm) and bear the mark "RX" on one face of the tablet and "3" on the other face.

They are packaged in

• blister packs in boxes of 14, 28, 30, 42, 98, or 100 film-coated tablets, or
• unit-dose blisters in packs of 14 × 1, 28 × 1, 30 × 1, 42 × 1, 50 × 1, 98 × 1, or 100 × 1 film-coated tablets, or
• bottles of 98 or 100 film-coated tablets

The film-coated tablets of Rivaroxaban Viatris 20 mg are brown-red, round, biconvex, and beveled (diameter of 7.0 mm) and bear the mark "RX" on one face of the tablet and "4" on the other face.

They are packaged in

• blister packs in boxes of 14, 28, 30, 98, or 100 film-coated tablets, or
• unit-dose blisters in packs of 14 × 1, 28 × 1, 30 × 1, 50 × 1, 90 × 1, 98 × 1, or 100 × 1 film-coated tablets, or
• bottles of 98 or 100 film-coated tablets, or
• calendar blisters of 14, 28, or 98 film-coated tablets

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Ireland Limited

Unit 35/36 Grange Parade

Baldoyle Industrial Estate

Dublin 13

Ireland

Manufacturer

Mylan Germany GmbH

Benzstrasse 1

Bad Homburg,

Hesse,

61352,

Germany

Mylan Hungary Kft,

Mylan utca 1,

Komárom,

H-2900,

Hungary

McDermott Laboratories Limited t/a Gerard Laboratories,

35/36 Baldoyle Industrial Estate,

Grange Road,

Dublin 13,

Ireland

Medis International (Bolatice),

Prumyslova 961/16,

Bolatice,

74723,

Czech Republic

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

Date of the last revision of this prospectus: October 2023

Detailed information about this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.