Rivaroxaban Baier

Package Leaflet: Information for the User

Rivaroxaban Bayer, 15 mg, film-coated tablets

Rivaroxaban Bayer, 20 mg, film-coated tablets

Rivaroxaban

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Rivaroxaban Bayer and what is it used for
• 2. Important information before taking Rivaroxaban Bayer
• 3. How to take Rivaroxaban Bayer
• 4. Possible side effects
• 5. How to store 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) and other blood vessels in the body if you have a type of irregular heartbeat called atrial fibrillation not caused by heart valve problems.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent the formation of new blood clots in the blood vessels of the legs and/or lungs. This medicine is used in children and adolescents under 18 years of age and weighing 30 kg or more to:
• treat and prevent the formation of 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 anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thus reduce the tendency to form blood clots.

2. Important information before taking Rivaroxaban Bayer

When not to take Rivaroxaban Bayer

• -if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have a disease or condition of an organ that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent surgical procedure on the brain or eyes),
• if you are taking other medicines that prevent the formation of blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a venous or arterial catheter,
• if you have liver disease that increases the risk of bleeding,
• if you are pregnant or breastfeeding. Do not take this medicine and inform your doctorif you suspect that these circumstances apply to you.

Warnings and precautions

Before starting treatment with this medicine, consult your doctor or pharmacist.

When to be careful when taking Rivaroxaban Bayer

• if you have an increased risk of bleeding, such as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine that works in the body,
• bleeding disorders,
• taking other medicines that prevent the formation of blood clots (e.g., warfarin, dabigatran etexilate, apixaban, or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a venous or arterial catheter (see "Rivaroxaban Bayer and other medicines"),
• very high blood pressure that does not decrease despite treatment,
• stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g., due to reflux disease of the esophagus (backflow of stomach acid into the esophagus) or tumors located in the stomach, intestines, genital, or urinary system,
• disease of the blood vessels in the back of the eyeballs (retinopathy),
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), you should inform your doctor, who will decide whether to change the treatment,
• if you have been diagnosed with abnormal blood pressure or if a surgical procedure is planned to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, inform

your doctorbefore taking this medicine. Your doctor will decide whether to use this medicine or to monitor you closely.

If you need to undergo surgery:

• you must follow your doctor's instructions regarding the intake of this medicine at a specific time before or after surgery,
• if a procedure to open blood vessels in the heart (called percutaneous coronary intervention with stent placement) is planned:
• it is very important to take this medicine before and after the procedure, according to your doctor's instructions,
• due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder disorders after anesthesia.

Children and adolescents

Rivaroxaban Bayer tablets are not recommended for children with a body weight below 30 kg.
There is not enough data on the use of this medicine in children and adolescents for adult indications.

Rivaroxaban Bayer and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• -If you are taking:
• certain medicines used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketokonazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain medicines used to treat bacterial infections (e.g., clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV or AIDS (e.g., ritonavir),
• other medicines used to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol),
• anti-inflammatory and pain-relieving medicines (e.g., naproxen or acetylsalicylic acid),
• dronedarone, a medicine used to treat heart rhythm disorders,
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If you suspect that you have any of the above conditions, inform

your doctorbefore taking this medicine ,as the effect of this medicine may be increased. Your doctor will decide whether to use this medicine or to monitor you closely.

• -If you are taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort ( Hypericum perforatum), a herbal medicine used to treat depression,
• rifampicin, which belongs to a group of antibiotics.

If you suspect that you have any of the above conditions, inform

your doctorbefore taking this medicine ,as the effect of this medicine may be reduced. Your doctor will decide whether to use this medicine or to monitor you closely.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception during treatment with this medicine. If you become pregnant while taking Rivaroxaban Bayer, inform your doctor immediately, who will decide on further treatment.

Driving and using machines

This medicine may cause dizziness (common side effect) and fainting (uncommon side effect) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

Rivaroxaban Bayer contains lactose and sodium.

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is "sodium-free".

3. How to take Rivaroxaban Bayer

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
This medicine should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing whole tablets, talk to your doctor about other ways to take this medicine. The tablet can be crushed and mixed with water or soft food, such as apple puree, immediately before taking. After such a mixture, eat the meal immediately. If necessary, your doctor may also administer the crushed tablet through a gastric tube.

How many tablets to take

• Adultsin preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body The recommended dose is one Rivaroxaban Bayer 20 mg tablet once a day. If you have kidney problems,the dose may be reduced to one Rivaroxaban Bayer 15 mg tablet once a day.

If you need a procedure to open blood vessels in the heart (called percutaneous coronary intervention with stent placement), there is limited evidence to support a dose reduction to one Rivaroxaban Bayer 15 mg tablet once a day (or one Rivaroxaban Bayer 10 mg tablet once a day in case of kidney problems) in combination with an antiplatelet medicine such as clopidogrel.
o
In the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the formation of new blood clots The recommended dose is one Rivaroxaban Bayer 15 mg tablet twice a day for the first 3 weeks.
After 3 weeks, the recommended dose is one Rivaroxaban Bayer 20 mg tablet once a day.
After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either 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 Bayer 20 mg tablet once a day, your doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban Bayer 15 mg tablet once a day if the risk of bleeding is higher than the risk of new blood clots.

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 30 kg to less than 50 kgis one Rivaroxaban Bayer 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one Rivaroxaban Bayer 20 mgtablet once a day. Each dose of Rivaroxaban Bayer should be taken with food, with a drink (e.g., water or juice). Tablets should be taken daily at approximately the same time. It's a good idea to set an alarm to remind you. For parents or caregivers: you should observe the child to ensure they take the entire dose.

The dose of Rivaroxaban Bayer is based on body weight, so it's essential to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose.
Do not split the tablet to get a partial dose. If a smaller dose is needed, use another rivaroxaban medicine in the form of granules for oral suspension.
For children and adolescents who are unable to swallow whole tablets, use Rivaroxaban Bayer in the form of granules for oral suspension.
If the oral suspension is not available, you can crush the Rivaroxaban Bayer tablet and mix it with water or apple puree immediately before taking. After this mixture, eat the meal. If necessary, your doctor may also administer the crushed tablet through a gastric tube.

If you spit out 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 Bayer at the usual time.

Contact your doctor if you spit out the dose or vomit repeatedly after taking this medicine.

When to take Rivaroxaban Bayer

Take the tablet(s) every day until your doctor decides to stop the treatment.
It's best to take the tablet(s) at the same time every day, as it's easier to remember.
Your doctor will decide how long you should continue the treatment.
Preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored to normal using a procedure called cardioversion, take this medicine as directed by your doctor.

Missing a dose of Rivaroxaban Bayer

• Adults, children, and adolescents: If you take one 20 mg or one 15 mg tablet once a day and miss a dose, take it as soon as possible. Do not take more than one tablet in a day to make up for the missed dose. Take the next tablet the next day, and then take one tablet once a day.

Adults:
If you take one 15 mg tablet twice a day and miss a dose, take it as soon as possible. Do not take more than two 15 mg tablets in a day. If you miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in a day. The next day, continue taking one 15 mg tablet twice a day.

Taking more than the recommended dose of Rivaroxaban Bayer

If you take too many Rivaroxaban Bayer tablets, contact your doctor immediately. Taking too much Rivaroxaban Bayer increases the risk of bleeding.

Stopping treatment with Rivaroxaban Bayer

Do not stop taking this medicine without consulting your doctor first, as this medicine treats and prevents serious diseases.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other medicines that reduce blood clotting, this medicine can cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). Not all of these will be obvious or visible signs of bleeding.
Tell your doctor immediatelyif you experience any of the following side effects:

• Signs of bleeding:
• bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness in the neck. This is a serious medical emergency. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina .Your doctor may decide to monitor you closely or change the treatment.

Signs of severe skin reactions

• widespread, severe skin rash, blistering, or changes in the mucous membranes, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic symptoms (DRESS syndrome). The frequency of these side effects is very rare (less than 1 in 10,000 people).

Signs of severe allergic reactions

• swelling of the face, lips, mouth, tongue, or throat; hives and difficulty breathing; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible side effects in adults, children, and adolescents:

Common(may affect up to 1 in 10 people)

• reduced red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum when coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney problems (which can be seen in tests performed by your doctor),
• fever,
• stomach pain, nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching,
• increased activity of certain liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see above signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver problems (which can be seen in tests performed by your doctor),
• blood test results may show increased bilirubin levels, certain liver or pancreatic enzyme activity, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

Rare(may affect up to 1 in 1,000 people)

• bleeding into the muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• accumulation of blood (hematoma) in the groin as a complication of cardiac catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white blood cell, which can cause inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure after severe bleeding,
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant therapy),
• increased pressure in the muscles of the legs and arms, occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Generally, the side effects seen in children and adolescents treated with this medicine were similar in type to those seen in adults and were mostly mild to moderate.
Side effects seen more frequently 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)
• rapid heartbeat
• blood test results may show increased bilirubin levels
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• excessive menstrual bleeding Uncommon(may affect up to 1 in 100 people)
• blood test results may show increased direct bilirubin levels.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Bayer

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Bayer contains

• The active substance is rivaroxaban. One film-coated 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". Coating: macrogol, hypromellose, titanium dioxide (E 171), iron oxide red (E 172).

What Rivaroxaban Bayer looks like and contents of the pack

Rivaroxaban Bayer 15 mg film-coated tablets are red, round, biconvex, and have the Bayer logo printed on one side and the number "15" and a triangle on the other side.
Tablets are available:

• in blisters packaged in cartons containing 14, 28, 42, or 98 film-coated tablets or
• in single-dose blisters packaged in cartons containing 100 x 1.

Rivaroxaban Bayer 20 mg film-coated tablets are brown-red, round, biconvex, and have the Bayer logo printed on one side and the number "20" and a triangle on the other side.
Tablets are available:

• in blisters packaged in cartons containing 14, 28, or 98 film-coated tablets or
• in single-dose blisters packaged in cartons containing 100 x 1.

Not all pack sizes may be marketed.

Marketing authorization holder

Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany
Tel: +48 22 572 35 00

Manufacturer

Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany
Bayer HealthCare Manufacturing Srl.
Via delle Groane, 126
20024 Garbagnate Milanese
Italy
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:

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

Date of last revision of the package leaflet: 08/2023