Rivanoptim

Leaflet accompanying the packaging: information for the user

Rivanoptim, 2.5 mg, film-coated tablets

Rivaroxaban

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

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult your doctor or pharmacist if you have any further questions.
• 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 any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rivanoptim and what is it used for
• 2. Important information before taking Rivanoptim
• 3. How to take Rivanoptim
• 4. Possible side effects
• 5. How to store Rivanoptim
• 6. Contents of the packaging and other information

1. What is Rivanoptim and what is it used for

You have been given Rivanoptim 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.
• Rivanoptim reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults.
• Rivanoptim 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.
• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Rivanoptim reduces the risk of blood clots (atherothrombotic events) in adults. Rivanoptim 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 Rivanoptim 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.

Rivanoptim contains the active substance rivaroxaban and 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 Rivanoptim

When not to take Rivanoptim

• 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 clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a catheter in a vein or artery
• if you have been diagnosed with acute coronary syndrome and have had bleeding or blood clots in the brain (stroke)
• if you have been diagnosed with 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 (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 Rivanoptim, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Rivanoptim, you should consult your doctor or pharmacist. Rivanoptim should not be taken with other blood clotting inhibitors, such as prasugrel or ticagrelor, except for aspirin, clopidogrel or ticlopidine.

When to be particularly careful when taking Rivanoptim

• if you have an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in your body
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a catheter in a vein or artery (see "Rivanoptim and other medicines")
• bleeding disorders
• very high blood pressure that does not decrease despite taking medicines
• stomach or intestinal diseases that can 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 bronchi 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 artificial 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 Rivanoptim. Your doctor will decide whether to use this medicine and whether you should be under close observation.

If you need to have surgery:

• you should follow your doctor's instructions regarding taking Rivanoptim at a specific 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 Rivanoptim before and after the puncture or catheter removal, 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 in your legs, bowel or bladder problems after anesthesia.

Children and adolescents

Rivanoptim 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.

Rivanoptim and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those that are 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
• -ketoconazole 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, prasugrel and ticagrelor (see "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 noradrenaline reuptake inhibitors (SNRIs))

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

your doctorbefore taking Rivanoptim, as the effect of Rivanoptim may be increased. Your doctor will decide whether to use this medicine and whether you should be under close observation. If your doctor believes that you are at increased risk of 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 Rivanoptim, as the effect of Rivanoptim may be reduced if taken with the above medicines. Your doctor will decide whether to use Rivanoptim and whether you should be under close observation.

Pregnancy and breastfeeding

Rivanoptim should not be taken if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking Rivanoptim. If you become pregnant while taking this medicine, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Rivanoptim may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4, "Possible side effects"). Patients who experience these side effects should not drive, ride a bike or operate tools or machines.

Rivanoptim contains lactose and sodium

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine. This 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 Rivanoptim

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should consult your doctor or pharmacist.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Rivanoptim should be taken at approximately the same time every day (e.g. one tablet in the morning and one in the evening). 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 Rivanoptim. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before taking. If necessary, your doctor may give you the crushed Rivanoptim tablet through a nasogastric tube. Rivanoptim will not be given to you as the only medicine. Your doctor will also prescribe you to take aspirin. If you are taking Rivanoptim after acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine. If you are taking Rivanoptim 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 what dose of these medicines to take (usually 75-100 mg of aspirin per day or 75-100 mg of aspirin per day plus 75 mg of clopidogrel per day or standard daily dose of ticlopidine).

When to take Rivanoptim

Treatment with Rivanoptim after acute coronary syndrome should be started as soon as possible after stabilization of 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 Rivanoptim if you have been diagnosed with coronary artery disease or peripheral arterial disease. Your doctor will decide how long to continue treatment.

Taking more Rivanoptim than prescribed

If you have taken more Rivanoptim tablets than prescribed, you should immediately contact your doctor. Taking too much Rivanoptim increases the risk of bleeding.

Missing a dose of Rivanoptim

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 Rivanoptim treatment

Rivanoptim should be taken regularly and for the time prescribed by your doctor. You should not stop taking Rivanoptim without first talking to your doctor. If you stop taking this medicine, you may increase the risk of another heart attack, stroke or death due to heart or blood vessel disease. If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivanoptim can cause side effects, although not everybody gets them. As with other medicines that have a similar effect of reducing blood clot formation, Rivanoptim can cause bleeding, which can potentially be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These are not always obvious or visible signs of bleeding.

You should immediately inform your doctor if 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. A serious medical emergency. You should immediately seek 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 to monitor you closely or change the 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 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; 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 paleness of the skin and be the cause of weakness or shortness of breath
• bleeding from the stomach or intestines, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds

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 a wound after surgery
• swelling of the limbs
• limb pain
• kidney problems (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 decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• 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 inside the 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 (can be observed in tests performed by your doctor)
• blood test results may show increased levels of bilirubin, 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 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 cardiac catheterization, when a catheter is inserted into an artery in the leg.

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
• bleeding in the kidneys, 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 any 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.: 22 49 21 301, fax: 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 Rivanoptim

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 and on each blister or bottle after: Expiry date. The expiry date refers to the last day of the month. This medicine does not require any special storage conditions. 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 Rivanoptim contains

• -The active substance of Rivanoptim is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• -The other ingredients are: Tablet core: lactose monohydrate, cellulose powder, crospovidone type A, crospovidone type B, copovidone, sodium lauryl sulfate, colloidal silica anhydrous, magnesium stearate. See section 2 "Rivanoptim contains lactose and sodium". Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172).

What Rivanoptim looks like and what the pack contains

Rivanoptim 2.5 mg film-coated tablets are yellow, round, biconvex (diameter 8 mm), with the marking 'C01' on one side. The tablets are:

• in blisters packed in cardboard boxes, containing 28, 56 or 100 film-coated tablets or
• in containers containing 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o. ul. Krakowiaków 65 02-255 Warsaw Tel. 607 696 231 e-mail: [email protected]

Manufacturer

Coripharma ehf. Reykjavikurvegur 78-80 220 Hafnarfjörður Iceland Email: [email protected] Tel: +354 4206700

This medicine is authorized in the Member States of the European Economic Area under the following names:

Iceland Rivaroxaban Coripharma Poland Rivanoptim Date of last revision of the leaflet:February 2024