RIVAROXABAN BAYER 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Bayer 15mg film-coated tablets EFG

Rivaroxaban Bayer 20mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Rivaroxaban Bayer and what is it used for
2. What you need to know before you take Rivaroxaban Bayer
3. How to take Rivaroxaban Bayer
4. Possible side effects
5. Storage of Rivaroxaban Bayer
6. Contents of the pack and other information

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

This medicine contains the active substance rivaroxaban.

This medicine 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 heart rhythm 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 happening again in the blood vessels of the legs and/or lungs.

This medicine is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:

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

This medicine belongs to a group of medicines called antithrombotic agents. It works by blocking a factor in the blood clotting process (factor Xa) and thus reduces the tendency of the blood to form clots.

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

Do not takeRivaroxaban Bayer

• 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 to another or while 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 breast-feeding.

Do not takethis medicineand inform your doctorif any of these conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Be particularly careful withRivaroxaban Bayer

• if you have an increased risk of bleeding, as may occur 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 to another or while receiving heparin through a venous or arterial catheter to prevent it from becoming blocked (see section "Other medicines and Rivaroxaban Bayer")
• bleeding disorders
• very high blood pressure, not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, such as inflammatory bowel disease or stomach inflammation, inflammation of the oesophagus (gullet), e.g. due to gastroesophageal reflux disease (a disease in which stomach acid rises up into the oesophagus), or tumours located in the stomach, intestines, genital or urinary tract
• a problem with the blood vessels in 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 (a disorder of the immune system 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 this medicine. 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 this medicine before and after surgery, exactly at the times your doctor has indicated.
• If your operation requires the insertion of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia, or pain relief):

• It is very important to take this medicine before and after the injection or removal of the catheter, exactly at the times your doctor has indicated.
• Tell your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia, as urgent attention is needed.

Children and adolescents

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

There is not enough information on the use of this medicine in children and adolescents for the indications in adults.

Other medicines andRivaroxaban Bayer

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. fluconazole, itraconazole, voriconazole, posaconazole), except if only applied to the skin
• ketoconazole tablets (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 this medicine, as the effect of this medicine 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 take a preventative 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 this medicine, as the effect of this medicine may be reduced. Your doctor will decide whether you should be treated with this medicine and whether you should be kept under closer observation.

Pregnancy and breast-feeding

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

Driving and using machines

This medicine 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 Bayercontains 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 Bayer

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

You must take this medicine with food.

Swallow the tablets, preferably with water.

If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take this medicine. 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 rivaroxaban 20 mg tablet once daily.

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

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 15 mg tablet once daily (or to one rivaroxaban 10 mg tablet once daily 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 these blood clots from happening again.

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

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

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

• Children and adolescents

The dose of this medicine depends on body weight and will be calculated by your doctor.

• The recommended dose for children and adolescents with a body weight of 30kg to less than 50kgis one rivaroxaban15mgtablet once daily.
• The recommended dose for children and adolescents with a body weight of 50kgor more is one rivaroxaban20mgtablet once daily.

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 your doctor, as it may be necessary to adjust the dose as the weight changes.

Never adjust the dose of this medicine yourself. Your doctor will adjust the dose if necessary.

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

In children and adolescents who cannot swallow whole tablets, please use rivaroxaban granules for 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 up the dose or vomit

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

Call your doctor if you spit up the dose or vomit repeatedly after taking this medicine.

When to take Rivaroxaban Bayer

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 to take them.

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

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

If you need to have your heart rhythm normalized through a procedure called cardioversion, take this medicine at the times your doctor has indicated.

If you forget to take Rivaroxaban Bayer

• Adults, children and adolescents:

If you are taking one 20 mg or one 15 mg tablet oncea day, and you miss 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 missed dose. Take the next tablet the next day and then continue taking one tablet a day.

• Adults:

If you are taking one 15 mg tablet twicea day, and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you miss 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 Bayer 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you stop taking Rivaroxaban Bayer

Do not stop taking this medicine without first talking to your doctor, as this medicine 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, this medicine 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. Seek medical attention 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

• 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

Frequent(may affect up to 1 in 10 people)

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• stomach or intestinal bleeding, 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
• limb pain
• kidney function alteration (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 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
• liver function alteration (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 cardiac 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(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)
• increased 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 this medicine 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 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: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rivaroxaban Bayer

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the packaging and on each blister 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 disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Rivaroxaban Bayer Composition

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

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

Tablet film coating: macrogol, hypromellose, titanium dioxide (E 171), red iron oxide (E 172).

Product Appearance and Package Contents

Rivaroxaban Bayer 15 mg film-coated tablets are round, red, biconvex, and bear the Bayer cross on one side and "15" and a triangle on the other.

They are packaged

• in blisters, in packs of 14, 28, 42, or 98 film-coated tablets, or
• in single-dose blisters, in a clinical pack of 100 film-coated tablets.

Rivaroxaban Bayer 20 mg film-coated tablets are round, reddish-brown, biconvex, and bear the Bayer cross on one side and "20" and a triangle on the other.

They are packaged

• in blisters, in packs of 14, 28, or 98 film-coated tablets, or
• in single-dose blisters, in a clinical pack of 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

The manufacturer can be identified by the batch number printed on the side flap of the pack and on each blister:

• If the first and second characters are BX, the manufacturer is

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

• If the first and second characters are IT, the manufacturer is

Bayer HealthCare Manufacturing Srl.

Via delle Groane, 126

20024 Garbagnate Milanese

Italy

• If the first and second characters are BT, the manufacturer is

Bayer Bitterfeld GmbH

Ortsteil Greppin, Salegaster Chaussee 1

06803 Bitterfeld-Wolfen

Germany

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

Germany, Austria, Denmark, Spain, France, Italy, Poland, Sweden: Rivaroxaban Bayer

Date of Last Revision of this Leaflet:08/2023.

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/).