Rivaroxaban Baier

Leaflet attached to the packaging: information for the user

Rivaroxaban Bayer, 10 mg, film-coated tablets

Rivaroxaban
You should read the contents of this leaflet carefully before taking the medicine because it contains important information for you.
Important information for patients

• You should keep this leaflet so that 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 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, 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 pack and other information

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

This medicine contains the active substance rivaroxaban and is used in adults to

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of blood clot formation is increased after surgery.
• 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 recurrence of blood clots in the veins of the legs and/or lungs.

This medicine belongs to a group 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 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 that increases the 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 clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when heparin is given to maintain catheter patency in a vein or artery,
• 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 you have any of the above conditions.

Warnings and precautions

You should consult your doctor or pharmacist before taking this medicine.

When to be particularly careful when taking Rivaroxaban Bayer

• if you have an increased risk of bleeding, such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine in your body,
• if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when heparin is given to maintain catheter patency in a vein or artery (see "Rivaroxaban Bayer and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach and intestines or esophageal inflammation (e.g. due to gastroesophageal reflux disease) or tumors in the stomach, intestines, genital or urinary tract,
• vascular disease in the back of the eye (retinopathy),
• pulmonary disease with dilated bronchi and pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with artificial heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clotting), you should inform your doctor, who will decide whether to change your treatment,
• if you have abnormal blood pressure or are scheduled for surgery to remove a blood clot from the lungs.

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 prescribe this medicine or whether you need to be closely monitored.

If you need to have surgery:

• you should carefully follow your doctor's instructions regarding the timing of taking this medicine before or after surgery,
• if you are scheduled to have a lumbar puncture or spinal catheter insertion (e.g. for epidural or spinal anesthesia or to relieve pain):
• you should carefully follow your doctor's instructions regarding the timing of taking this medicine,
• you should immediately inform your doctor if you experience symptoms such as numbness, weakness of the lower limbs, disturbances in bowel or bladder function after anesthesia, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Bayer 10 mg tablets are not recommended for people under 18 years of age. There is not enough data on the use of this medicine in children and adolescents.

Rivaroxaban Bayer and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

• - If you are taking:
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
• ketokonazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain antibacterial medicines (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV or AIDS (e.g. ritonavir),
• other medicines that prevent 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 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 prescribe this medicine or whether you need to be closely monitored.

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 (a common side effect) and fainting (an 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 previously been diagnosed with intolerance to certain 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

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

• To prevent blood clots in the veins after hip or knee replacement surgery, the recommended dose is one Rivaroxaban Bayer 10 mg tablet taken once a day.

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 recurrence of blood clots.
After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Rivaroxaban Bayer 10 mg once a day for you.
The tablet should be swallowed whole, preferably with water.
This medicine can be taken 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 a soft food, such as apple puree, immediately before taking it.
If necessary, your doctor may administer the crushed tablet of Rivaroxaban Bayer through a gastric tube.

When to take Rivaroxaban Bayer

You should take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time every day, as this will help you remember to take it.
Your doctor will decide how long you should continue treatment.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:

The first tablet should be taken 6 to 10 hours after surgery.
In patients after major hip surgery, treatment usually lasts 5 weeks.
In patients after major knee surgery, treatment usually lasts 2 weeks.

Taking a higher dose of Rivaroxaban Bayer than recommended

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

Missing a dose of Rivaroxaban Bayer

If you forget to take a dose, you should take the tablet as soon as you remember. The next tablet should be taken the next day, and then you should take the tablets as usual, once a day.
You should not take a double dose to make up for a missed tablet.

Stopping treatment with Rivaroxaban Bayer

You should not stop taking this medicine without first talking to your doctor, as this medicine prevents a serious disease.
If you have any further questions about taking 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 a similar anticoagulant effect, 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.
You should immediately inform your doctorif 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 of the neck. This is a serious medical emergency. 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 your treatment.

Signs of severe skin reactions:

• widespread, acute skin rash, blistering or changes in the mucous membranes, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing 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

You should immediately inform your doctorif you experience any of the following side effects:

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; 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 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)

• decrease in 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 tract (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),
• appearance of blood in sputum (hemoptysis) 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 function disorders (can be observed in tests performed by your doctor)
• fever,
• stomach pain, nausea, feeling of 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,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may be visible 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 the joint causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• blood test results may show increased bilirubin levels, activity of certain pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives,
• liver function disorders (can be observed in tests performed by your doctor).

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 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 granulocytic 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,
• bleeding in the kidneys, 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 syndromeafter 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 Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry date and on each blister 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
The 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. 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 pack and other information

What Rivaroxaban Bayer contains

• The active substance of the medicine is rivaroxaban. One film-coated tablet contains 10 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 10 mg film-coated tablets are light red, round, biconvex, and have the Bayer company logo embossed on one side and the number "10" and a triangle on the other side.
The tablets are

• in blisters packed in cardboard boxes, containing 5, 10, 30, or 98 film-coated tablets, or
• in perforated unit dose blisters packed in cardboard boxes, containing 100 x 1 film-coated 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