Rivaroxaban bayer

Package leaflet: Information for the user

Rivaroxaban Bayer, 2.5 mg, coated tablets
Rivaroxabanum
Read the entire leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Rivaroxaban Bayer is and what it is used for
2. What you need to know 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 Rivaroxaban Bayer is and what it is used for

You have been prescribed this medicine because:

• You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been detected. This medicine reduces the risk of a subsequent heart attack in adults and reduces the risk of death due to heart or blood vessel disease. This medicine will not be given to you as a single treatment. Your doctor will also prescribe:
  • acetylsalicylic acid, or
  • acetylsalicylic acid 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 causing symptoms. This medicine reduces the risk of blood clots (atherosclerotic thrombotic events) in adults. This medicine will not be given to you as monotherapy. Your doctor will also prescribe acetylsalicylic acid. In certain cases, if you are receiving this medicine after a procedure to unblock a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel to be taken in addition to acetylsalicylic acid for a short period.

This medicine contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

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 is experiencing excessive bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent surgery on the brain or eyes),
• if the patient is taking other medicines that prevent blood clots (e.g., warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery,
• if the patient has been diagnosed with acute coronary syndrome and previously experienced bleeding or blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and previously had a brain hemorrhage (hemorrhagic stroke), or occlusion of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient had a blood clot in the brain (ischemic, non-lacunar stroke) within the past month,
• if the patient has a liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not use this medicine, and you must inform your doctor if you suspect any of the above conditions apply.

Warnings and precautions
Before starting this medicine, consult your doctor or pharmacist.
This medicine should not be used in combination with other anticoagulant medicines besides acetylsalicylic acid, clopidogrel, or ticlopidine, such as prasugrel or ticagrelor.
When to exercise special caution when taking Rivaroxaban Bayer

• if the patient has an increased risk of bleeding , such as in the following conditions:
• severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
• taking other medicines that prevent blood clots (e.g., warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "Rivaroxaban Bayer and other medicines"),
• coagulation disorders,
• very high blood pressure that does not decrease despite medication,
• stomach or intestinal diseases that may cause bleeding, e.g., intestinal and stomach inflammation or esophagitis (throat and esophagus), e.g., due to gastroesophageal reflux disease (acid reflux into the esophagus), or tumors located in the stomach or intestines, or in the genital or urinary system,
• blood vessel disease in the back of the eye (retinopathy),
• lung disease in which bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding,
• if the patient is over 75 years old,
• if the patient's body weight is below 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• in patients with heart valve prostheses,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment adjustment is necessary.

If the patient suspects any of the above conditions apply, they must inform their doctor
before taking this medicine. The doctor will decide whether to use this medicine or whether the patient requires particularly close monitoring.
If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding taking this medicine at a specific time before or after surgery,
• if catheterization or spinal puncture (e.g., for epidural or spinal anesthesia or pain relief) is planned during surgery:
• it is very important to take this medicine before and after the puncture or catheter removal, as directed by the doctor,
• due to the need for special caution, immediately inform the doctor if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after anesthesia ends.

Children and adolescents
Rivaroxaban Bayer 2.5 mg tablets are not recommended for patients under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.
Rivaroxaban Bayer and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take, including those available without a prescription.

• If the patient is taking
• certain antifungal medicines (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
• ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol),
• certain antibiotics (e.g., clarithromycin, erythromycin),
• certain antiviral medicines used in HIV infection or AIDS treatment (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 acetylsalicylic acid),
• dronedarone, a medicine used to treat heart rhythm disorders,
• certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects any of the above conditions apply, they must inform their doctor
before taking this medicine, as the effect of this medicine may be enhanced.
The doctor will decide whether to use this medicine or whether the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, they may initiate preventive treatment for ulcer prevention.

• If the patient is taking
• certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital),
• St. John's wort ( Hypericum perforatum ), a herbal medicine used for depression,
• rifampicin, which belongs to the group of antibiotics.

If the patient suspects any of the above conditions apply, they must inform their doctor
before taking this medicine, as the effect of this medicine may be reduced.
The doctor will decide whether to use this medicine or whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use this medicine if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with this medicine. If the patient becomes pregnant while taking this medicine, they must immediately inform their doctor, who will decide on further management.
Driving and operating machinery
This medicine may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4, "Possible side effects").
Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban Bayer contains lactose and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take RIVAROXABAN BAYER

This medicine should always be taken as directed by the doctor. If in doubt, contact your doctor or pharmacist.

How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. This medicine should be taken at approximately the same time each day (for example, one tablet in the morning and one in the evening). This medicine may be taken with or without food.

If a patient has difficulty swallowing the whole tablet, talk to the doctor about other ways of taking this medicine. The tablet may be crushed and mixed with water or soft food such as apple puree immediately before administration.

If necessary, the doctor may administer crushed Rivaroxaban Bayer tablets through a gastric tube.

This medicine will not be given to the patient as the only treatment.

The doctor will prescribe acetylsalicylic acid for the patient to take. If the patient is receiving this medicine after an acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine.

If the patient is receiving Rivaroxaban Bayer after a procedure to open a narrowed or blocked artery in the lower limb to restore blood flow, the doctor may also prescribe clopidogrel to be taken for a short time in addition to acetylsalicylic acid.

The doctor will inform the patient how much of these medicines to take (usually 75–100 mg acetylsalicylic acid per day or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of 75 mg clopidogrel or the standard daily dose of ticlopidine).

When to take Rivaroxaban Bayer
Treatment with this medicine after acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, no earlier than 24 hours after hospital admission and at the time when parenteral (by injection) anticoagulant treatment would normally be discontinued.

The doctor will inform the patient when to start treatment with this medicine if coronary artery disease or peripheral artery disease has been diagnosed.

The doctor will decide how long treatment should continue.

Taking more than the recommended dose of Rivaroxaban Bayer
If the patient has taken more than the recommended dose of Rivaroxaban Bayer, contact the doctor immediately. Taking too high a dose 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 the patient misses a dose, the next dose should be taken at the scheduled time.

Stopping Rivaroxaban Bayer
This medicine should be taken regularly and for the duration recommended by the doctor.

Do not stop taking this medicine without first consulting the doctor. Stopping treatment with this medicine may increase the risk of another heart attack, stroke, or death due to heart or blood vessel disease.

If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Like other medicines with a similar mechanism of action that reduces blood clot formation, this medicine may cause bleeding, which could potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You should contact your doctor immediately if any of the following side effects occur:

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

Signs of severe skin reactions:

• widespread, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological abnormalities and systemic involvement. The frequency of these side effects is very rare (occurring in up to 1 in 10,000 people).

Signs of severe allergic reactions:

• swelling of the face, lips, mouth, tongue or throat; hives and breathing difficulties; 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 number of red blood cells, which may cause pale skin and lead to weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in urine and severe menstrual bleeding), nosebleeds, bleeding from gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from or under the skin,
• postoperative bleeding,
• oozing of blood or fluid from surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, feeling of nausea or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general loss of strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may 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, blood cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (may be observed in tests performed by a doctor),
• blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

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

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• localized swelling,
• blood collection (hematoma) in the groin as a complication of cardiac 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 granulocytic blood cells, causing lung inflammation (eosinophilic pneumonia).

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

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with presence of blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy),
• increased pressure in the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of side effects
If any side effects occur, including any possible side effects not listed in this leaflet, speak to your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting side effects helps 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 outer cardboard box after:
Expiry date and on each blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines must 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 coated tablet contains 2.5 mg of rivaroxaban.
• 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), iron oxide yellow (E 172).

What Rivaroxaban Bayer looks like and contents of the pack
Rivaroxaban Bayer 2.5 mg coated tablets are light yellow, round, biconvex, and marked with the BAYER logo on one side and the number "2.5" and a triangle on the other side.
The tablets are contained:

• in blisters packed in cardboard boxes containing 28, 30, 56, 60, 98 or 196 coated tablets, or
• in unit-dose blister packs packed in cardboard boxes containing 100 x 1 tablet.

Not all pack sizes may be marketed.
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Denmark, Germany, France, Italy, Poland, Sweden: Rivaroxaban Bayer