Rivaroxaban Baier

Leaflet attached to the packaging: information for the user

Rivaroxaban Bayer, 2.5 mg, film-coated tablets

Rivaroxabanum

You should read the contents of this leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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, you should 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 packaging and other information

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

You have been given this medicine because

• you have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, acute chest pain) and have elevated levels of cardiac biomarkers. This medicine reduces the risk of having another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. This medicine will not be given to you as the only medicine. Your doctor will also prescribe you to take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.

or

• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. This medicine reduces the risk of blood clots (atherothrombotic events) in adults. This medicine will not be given to you as the only medicine. Your doctor will also prescribe you to take aspirin. In some cases, if you are taking this medicine after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin.

This medicine contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thereby 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 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 you are taking other medicines that prevent 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 (see section "Rivaroxaban Bayer and other medicines"),
• if you have had an acute coronary syndrome and have had bleeding or blood clots in the brain (stroke),
• if you have coronary artery disease or peripheral arterial disease and have had bleeding in the brain (stroke) or blockage of small arteries that supply blood to the tissues in the deep structures of the brain (cerebral sinus thrombosis) or if you have had a blood clot in the brain (ischemic stroke) in the last month),
• if you have liver disease that leads to an increased risk of bleeding,
• if you are 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

You should tell your doctor or pharmacist before starting to take this medicine.
This medicine should not be taken with other medicines that prevent blood clotting, such as prasugrel or ticagrelor, except for aspirin, clopidogrel, or ticlopidine.

When to be particularly careful when taking Rivaroxaban Bayer

• if you have increased risk of bleeding, in such conditions as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• taking other medicines that prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see section "Rivaroxaban Bayer and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• 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 genital or urinary system,
• disease of the blood vessels 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,
• if you are over 75 years old,
• if you weigh less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• in patients with prosthetic heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change the treatment.

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

your doctorbefore taking this medicine. Your doctor will decide whether to take this medicine or whether you should be under close observation.

If you need to have surgery:

• you should carefully follow your doctor's instructions regarding the intake of this medicine at a strictly defined 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 very important to take this medicine before and after the puncture or removal of the catheter, 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 of the legs, bowel or bladder disorders after anesthesia.

Children and adolescents

Rivaroxaban Bayer 2.5 mg tablets are not recommended for people under 18 years old. There is not enough data on the use of the medicine in children and adolescents.

Rivaroxaban Bayer and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those that are available 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 in 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, prasugrel, and ticagrelor (see section "Warnings and precautions")),
• anti-inflammatory and pain-relieving medicines (e.g., naproxen or aspirin),
• 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 you suspect that you have any of the above conditions, you should inform

your doctorbefore taking this medicine, as the effect of this medicine may be enhanced.
Your doctor will decide whether to take this medicine or whether you should be under close observation.
If your doctor believes that you are at increased risk of developing stomach or intestinal ulcers, they may use a treatment to prevent ulcers.

• -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, you should inform

your doctorbefore taking this medicine, as the effect of this medicine may be reduced.
Your doctor will decide whether to take this medicine or whether you should be under close observation.

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 this medicine, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

This medicine may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4, "Possible side effects").
Patient 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 previously been diagnosed with intolerance to some sugars, you should contact 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

You should always take this medicine exactly as your doctor has told you. If you are unsure, you should ask your doctor or pharmacist.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. You should take this medicine at approximately the same time every day (e.g., one tablet in the morning and one in the evening). You can take this medicine with or without food.
If you have difficulty swallowing the whole tablet, you should 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, just before taking it.
If necessary, your doctor may give you the crushed tablet of Rivaroxaban Bayer through a gastric tube.
This medicine will not be given to you as the only medicine.
Your doctor will also prescribe you to take aspirin. If you are taking this medicine after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine for you to take.
If you are taking Rivaroxaban Bayer after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin.
Your doctor will tell you how much of these medicines to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to take Rivaroxaban Bayer

Treatment with this medicine after an acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the latest 24 hours after hospital admission and when parenteral (by injection) anticoagulant treatment would normally be discontinued.
Your doctor will tell you when to start treatment with this medicine if you have been diagnosed with coronary artery disease or peripheral arterial disease.
Your doctor will decide how long to continue treatment.

Taking a higher dose of Rivaroxaban Bayer than recommended

If you have taken a higher dose of Rivaroxaban Bayer than recommended, you should immediately contact your doctor. Taking too much of Rivaroxaban Bayer increases the risk of bleeding.

Missing a dose of Rivaroxaban Bayer

Do not take a double dose to make up for a missed dose. If you miss a dose, you should take the next dose at the scheduled time.

Stopping treatment with Rivaroxaban Bayer

You should take this medicine regularly and for the time prescribed by your doctor.
You should not stop taking this medicine without first consulting your doctor. If you stop taking this medicine, you may increase the risk of having another heart attack, stroke, or death due to heart or blood vessel disease.
If you have any further questions about the use of this medicine, you should 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 with similar blood clotting-reducing effects, this medicine can cause bleeding, which can potentially 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.
You should immediately inform your doctorif 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. A serious, sudden medical condition. You should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide to closely monitor you or change the treatment.

Signs of severe skin reactions:

• widespread, acute skin rash, blistering, or changes to 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, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side 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; hives, and difficulty breathing; a sudden drop in blood pressure. The frequency of severe allergic reactions is very 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:

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 genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum (hemoptysis) while 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 disorders (can be observed 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 up),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• skin rash, itching,
• increased activity of some 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 the joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver disorders (can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, activity of some 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,
• accumulation of blood (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, 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 drugs),
• 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).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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

You should 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 sauce for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rivaroxaban Bayer contains

• The active substance of the medicine is rivaroxaban. One film-coated tablet contains 2.5 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 coating: macrogol, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172).

What Rivaroxaban Bayer looks like and contents of the pack

Rivaroxaban Bayer 2.5 mg film-coated tablets are light yellow, round, biconvex, and have the Bayer company logo embossed on one side and the number "2.5" and a triangle on the other side.
The tablets are available in:

• blister packs packaged in cardboard boxes, containing 28, 30, 56, 60, 98, or 196 film-coated tablets, or
• blister packs divided into single doses, packaged in cardboard boxes containing 100 x 1 tablets.

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