Rivaroxaban Baier

Package Leaflet: Information for the User

Rivaroxaban Bayer, 15 mg, film-coated tablets

Rivaroxaban Bayer, 20 mg, film-coated tablets

Rivaroxabanum

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, 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 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 patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of 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 recurrence of blood clots in the veins or blood vessels in 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 based on blocking the blood clotting factor (factor Xa) and thereby reducing the tendency to form blood clots.

2. Important information before taking Rivaroxaban Bayer

When not to take Rivaroxaban Bayer

• -if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has a disease or condition of the body that leads to an increased risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if the patient is 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 vein or artery catheter,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not take this medicine, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take this medicine, consult your doctor or pharmacist.

When to be particularly careful when taking Rivaroxaban Bayer

• if the patient has an increased risk of bleeding, in conditions 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 patient's 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 vein or artery 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 or intestines, or the genital or urinary system,
• vascular disease in the back of the eye (retinopathy),
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with artificial heart valves,
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide whether to change the treatment,
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking this medicine. The doctor will decide whether to use this medicine or to subject the patient to particularly close monitoring.

If the patient needs to undergo surgery:

• it is essential to follow the doctor's instructions regarding the intake of this medicine at a precisely specified time before or after surgery,
• if catheterization or spinal puncture is planned during surgery (e.g., for epidural or spinal anesthesia or pain relief):
• it is crucial to take this medicine before and after the puncture or catheter removal, as instructed by the doctor,
• due to the need for particular caution, the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder disorders occur after the anesthesia is completed.

Children and adolescents

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

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 norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking this medicine ,as the effect of this medicine may be enhanced. The doctor will decide whether to use this medicine or to subject the patient to particularly close monitoring.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use a treatment to prevent ulcers.
Ulcers are sores in the lining of the stomach or duodenum (the first part of the intestine) that can cause pain and bleeding.

• -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 the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking this medicine ,as the effect of this medicine may be reduced. The doctor will decide whether to use this medicine or to subject the patient to particularly close monitoring.

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 while taking 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 (frequent side effects) and fainting (uncommon side effects) (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 that the medicine is considered "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 sauce, immediately before taking. After such a mixture, eat the meal immediately.
If necessary, your doctor may also give you a crushed tablet of Rivaroxaban Bayer through a gastric tube.

How many tablets to take

• Adultsto prevent 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 the patient needs a procedure to open up blood vessels in the heart (called percutaneous coronary intervention - PCI 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 agent such as clopidogrel.
o
To treat blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of 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, the 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 Bayer 20 mg tablet once a day, the 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 further blood clots.

Children and adolescents

The dose of this medicine 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 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 a meal, with a drink (e.g., water or juice). Tablets should be taken daily at approximately the same time. It is a good idea to set an alarm to remind you. For parents or caregivers: observe the child to ensure they have taken the entire dose.

The dose of Rivaroxaban Bayer is based on body weight, so it is essential to attend scheduled doctor's appointments, as it may be necessary to adjust the dose based on weight changes.
Never adjust the dose yourself.If necessary, the doctor will adjust the dose.
Do not divide the tablet to get a partial dose. If a smaller dose is needed, use another rivaroxaban-containing 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 sauce immediately before taking. After such a mixture, eat the meal. If necessary, the doctor may also give you a 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.

Consult 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 the doctor decides to stop the treatment.
It is best to take the tablet(s) at the same time every day, as it will be easier to remember.
The doctor will decide how long you should continue the treatment.
To prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored with a procedure called cardioversion, take this medicine as instructed 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 one 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 one day. If you forget to take a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day. The next day, continue taking one 15 mg tablet twice a day.

Taking more than the recommended dose of Rivaroxaban Bayer

If you have taken 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). These may not always 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 skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of 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 .The doctor may decide to monitor you closely or change the treatment.

Signs of severe skin reactions

• widespread, acute skin rash, blistering, or changes to the mucous membranes, such as the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is rare (maximum 1 in 10,000 people).

Signs of severe allergic reactions

• swelling of the face, lips, mouth, tongue, or throat; hives, and difficulty breathing; a sudden drop in blood pressure. The frequency of severe allergic reactions is rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 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 intestine, bleeding from the urinary or reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the conjunctiva of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• blood in the 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 the doctor),
• fever,
• stomach pain, nausea, vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• 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 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 the doctor),
• blood test results may show increased bilirubin levels, increased activity of certain pancreatic or liver enzymes, 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,
• blood accumulation (hematoma) in the groin as a complication of heart catheterization, when the 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 granular blood cells that 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 after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Overall, the side effects seen in children and adolescents treated with this medicine were similar in type to those seen in adults and were mainly 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 (bile pigment)
• 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 levels of a bilirubin subtype (direct bilirubin, bile pigment).

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 Safety 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 the medicine.
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. Ask your pharmacist how to dispose of medicines that are no longer needed. 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 company logo embossed 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 company logo embossed 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 leaflet: 08/2023