Rivaxar

Package Leaflet: Information for the User

Rivaxar, 2.5 mg, Film-Coated Tablets

Rivaroxaban

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This leaflet should be kept in case it needs to be read again.
• In case of further doubts, the doctor or pharmacist should be consulted.
• This medication has been prescribed to a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Rivaxar and What is it Used For
• 2. Important Information Before Taking Rivaxar
• 3. How to Take Rivaxar
• 4. Possible Side Effects
• 5. How to Store Rivaxar
• 6. Contents of the Pack and Other Information

1. What is Rivaxar and What is it Used For

The patient has been given Rivaxar because

• they 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. Rivaxar reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Rivaxar will not be given to the patient as the only medication. The doctor will also prescribe:
• aspirin or
• aspirin and clopidogrel or ticlopidine.
• they have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Rivaxar reduces the risk of blood clots (atherothrombotic events) in adults. Rivaxar will not be given to the patient as the only medication. The doctor will also prescribe aspirin.

Rivaxar 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 Rivaxar

When Not to Take Rivaxar

• -if the patient is allergic to rivaroxaban or any of the other ingredients of this medication (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has 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 the patient is taking other medications that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter,
• if the patient has had acute coronary syndrome and has had bleeding or a blood clot in the brain (stroke),
• if the patient has coronary artery disease or peripheral arterial disease and has had bleeding in the brain (stroke) or blockage of small arteries supplying blood to the brain tissues (cerebral sinus thrombosis) or has had a blood clot in the brain (ischemic stroke) within the last month,
• if the patient has liver disease that increases the risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not take Rivaxar, and inform your doctorif you think you have any of the above conditions.

Warnings and Precautions

Before starting Rivaxar, discuss it with your doctor or pharmacist. Rivaxar should not be taken with other anticoagulant medications, except for aspirin, clopidogrel, or ticlopidine.

When to be Cautious When Taking Rivaxar

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medication in the patient's body,
• taking other medications that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter (see "Rivaxar and Other Medications"),
• bleeding disorders,
• very high blood pressure that does not decrease despite medication,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach and intestines or esophagitis (e.g., due to gastroesophageal reflux disease),
• vascular disease in the back of the eye (retinopathy),
• lung disease with dilated bronchi and pus (bronchiectasis) or previous bleeding from the lungs,
• if the patient is over 75 years old,
• if the patient weighs 60 kg or less,
• coronary artery disease with severe symptomatic heart failure,
• in patients with prosthetic 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 their doctor, who will decide whether to change the treatment.

If the Patient Thinks They Have Any of the Above Conditions, They Should Inform

their doctorbefore taking Rivaxar. The doctor will decide whether to prescribe Rivaxar and whether the patient should be closely monitored.

If the Patient Needs to Undergo Surgery:

• the patient should carefully follow the doctor's instructions regarding the intake of Rivaxar at a specific time before or after surgery,
• if catheterization or spinal puncture is planned (e.g., for epidural or spinal anesthesia or pain relief):
• it is very important to take Rivaxar before and after the puncture or catheter removal, as instructed by the doctor,
• due to the need for caution, the doctor should be informed immediately if the patient experiences numbness or weakness in the legs, bowel or bladder dysfunction after anesthesia.

Children and Adolescents

Rivaxar is not recommended for people under 18 years old. There is a lack of sufficient data on the use of Rivaxar in children and adolescents.

Rivaxar and Other Medications

The patient should tell their doctor or pharmacist about all medications they are taking, have recently taken, or plan to take, including those available without a prescription.

• - If the patient is taking
• certain medications for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain medications for bacterial infections (e.g., clarithromycin, erythromycin),
• certain antiviral medications used to treat HIV or AIDS (e.g., ritonavir),
• other medications that prevent blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol, prasugrel, and ticagrelor (see "Warnings and Precautions")),
• anti-inflammatory and pain medications (e.g., naproxen or aspirin),
• dronedarone, a medication used to treat heart rhythm disorders,
• certain medications used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If the Patient Thinks They Have Any of the Above Conditions, They Should Inform

their doctorbefore taking Rivaxar, as the effect of Rivaxar may be increased. The doctor will decide whether to prescribe Rivaxar and whether the patient should be closely monitored.

• - If the patient is taking
• certain medications for epilepsy (e.g., phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum), a herbal remedy used for depression,
• rifampicin, an antibiotic.

If the Patient Thinks They Have Any of the Above Conditions, They Should Inform

their doctorbefore taking Rivaxar, as the effect of Rivaxar may be decreased when taken with these medications. The doctor will decide whether to prescribe Rivaxar and whether the patient should be closely monitored.

Pregnancy and Breastfeeding

Rivaxar should not be taken if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use effective contraception while taking Rivaxar. If the patient becomes pregnant while taking Rivaxar, they should inform their doctor immediately, who will decide on further treatment.

Driving and Using Machines

Rivaxar may cause dizziness (frequent side effects) or fainting (uncommon side effects) (see section 4, "Possible Side Effects"). Patients who experience these side effects should not drive or operate machinery.

Rivaxar Contains Lactose and Sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medication. The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Rivaxar

This medication should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.

How Many Tablets to Take

The recommended dose is one 2.5 mg tablet twice a day. Rivaxar should be taken at approximately the same time every day (e.g., one tablet in the morning and one in the evening). The medication can be taken with or without food. If the patient has difficulty swallowing the whole tablet, they should talk to their doctor about other ways to take Rivaxar. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before taking. If necessary, the doctor may administer the crushed Rivaxar tablet through a gastric tube. Rivaxar will not be given to the patient as the only medication. The doctor will also prescribe aspirin. If the patient is taking Rivaxar after acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine. The doctor will tell the patient what dose of these medications 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 Start Taking Rivaxar

Treatment with Rivaxar after 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 (injectable) anticoagulant therapy would normally be discontinued. The doctor will tell the patient when to start treatment with Rivaxar if they have been diagnosed with coronary artery disease or peripheral arterial disease. The doctor will decide how long to continue treatment.

Taking More Than the Recommended Dose of Rivaxar

If the patient has taken more than the recommended dose of Rivaxar, they should contact their doctor immediately. Taking too much Rivaxar increases the risk of bleeding.

Missing a Dose of Rivaxar

The patient should not take a double dose to make up for a missed dose. If the patient misses a dose, they should take the next dose at the scheduled time.

Stopping Rivaxar

Rivaxar should be taken regularly and for the duration prescribed by the doctor. The patient should not stop taking Rivaxar without first consulting their doctor. If the patient stops taking Rivaxar, the risk of another heart attack, stroke, or death due to heart or blood vessel disease may increase. In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Rivaxar can cause side effects, although not everyone will experience them. Like other medications with similar effects (anticoagulants), Rivaxar may 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.

Possible Side Effects That May be a Sign of Bleeding:

The patient should inform their doctor immediatelyif they experience any of the following side effects:

• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina, which may be signs of bleeding. The doctor may decide to closely monitor the patient or change the treatment.

Possible Side Effects That May be a Sign of a Skin Reaction:

The patient should inform their doctor immediatelyif they experience any of the following skin reactions, such as:

• widespread, severe skin rash, blistering, or changes in the mucous membranes, such as in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of these side effects is very rare (may occur in less than 1 in 10,000 patients),
• drug reaction with eosinophilia and systemic symptoms (DRESS). The frequency of these side effects is very rare (may occur in less than 1 in 10,000 patients).

Possible Side Effects That May be a Sign of a Severe Allergic Reaction

The patient should inform their doctor immediatelyif they 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 these side effects is very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in less than 1 in 100 patients).

General List of Possible Side Effects:

Frequent(may occur in 1 in 10 patients)

• 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 reproductive 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),
• 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 function disorders (which can be observed in tests performed by the 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 can be seen in blood test results.

Uncommon(may occur in 1 in 100 patients)

• bleeding into the brain or within the skull,
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (which can be observed in tests performed by the doctor),
• 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.

Rare(may occur in 1 in 1,000 patients)

• 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 a catheter is inserted into an artery in the leg (pseudoaneurysm).

Frequency Not Known(frequency cannot be estimated from available data)

• kidney failure after severe bleeding,
• 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, more information can be collected on the safety of the medication.

5. How to Store Rivaxar

The medication should be stored out of sight and reach of children. Do not use this medication after the expiration date stated on the carton and on each blister after EXP. The expiration date refers to the last day of the month stated. There are no special precautions for storing the medication. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Rivaxar Contains

• The active substance of Rivaxar is rivaroxaban. One film-coated tablet contains 2.5 mg of rivaroxaban.
• Other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose 2910, croscarmellose sodium, magnesium stearate. See section 2 "Rivaxar contains lactose and sodium". Tablet coating: hypromellose 2910, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172).

What Rivaxar Looks Like and What the Pack Contains

Rivaxar 2.5 mg film-coated tablets are yellow, round, biconvex (6 mm in diameter), with the number "2.5" embossed on one side and smooth on the other side. Transparent blisters of PVC/PVDC/Aluminum in cardboard boxes. The pack contains 5, 10, 14, 15, 20, 28, 30, 42, 45, 50, 56, 90, 98, or 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

S-LAB Sp. z o.o. ul. Kiełczowska 2 55-095 Mirków e-mail: [email protected]

Manufacturer:

S.C. Labormed-Pharma S.A. 44B Theodor Pallady Blvd, 3 District 032266 Bucharest Romania Adalvo Ltd Malta Life Sciences Park Building 1, Level 4 Sir Temi Zammit Buildings San Gwann SGN 3000 Malta

This Medicinal Product is Authorized in the Member States of the EEA Under the Following Names:

Iceland: Rivaroxaban AdAlvo 2.5 mg film-coated tablets Estonia: Rivaroxaban Auxilia Finland: Rivaroxaban Avansor 2.5 mg tablets, film-coated Latvia: Rivaroxaban Auxilia 2.5 mg coated tablets Lithuania: Rivaroxaban Auxilia 2.5 mg film-coated tablets Poland: Rivaxar Sweden: Rivaroxaban Avansor 2.5 mg film-coated tablets

Date of Last Revision of the Leaflet: