Rivanoptim

Package Leaflet: Information for the User

Rivanoptim, 10 mg, film-coated tablets

Rivaroxaban
Read the contents of this leaflet carefully before taking the medicine, as it contains important information for you.
This information is important for your safety.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, 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, please inform 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 pack and other information

1. What is Rivanoptim and what is it used for

Rivanoptim 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 to prevent the recurrence of blood clots in the veins of the legs and/or lungs. Rivanoptim belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thus 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 switching anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter
• if you have liver disease that leads to an increased risk of bleeding
• if you are pregnant or breastfeeding. Do not take Rivanoptim and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Rivanoptim, consult your doctor or pharmacist.

When to be particularly careful when taking Rivanoptim

• if you have an increased risk of bleeding, in conditions such as:
• mild or moderate kidney disease, as kidney function may affect the amount of medicine that works in your body
• if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Rivanoptim and other medicines")
• bleeding disorders
• very high blood pressure that does not decrease despite treatment
• 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
• vascular disease of 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
• in patients with artificial heart valves
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), you should inform your doctor, who will decide whether to change the 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, 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 undergo surgery:

• you must strictly follow your doctor's instructions regarding the intake of Rivanoptim at a precisely specified time before or after surgery.
• if spinal puncture or catheter insertion into the spine is planned during surgery (e.g. for spinal anesthesia or epidural anesthesia or pain relief):
• you must strictly follow your doctor's instructions regarding the intake of Rivanoptim at a precisely specified time
• you should immediately inform your doctor if, after anesthesia, you experience symptoms such as numbness, weakness of the lower limbs, disorders of bowel or bladder function, as immediate treatment may be necessary.

Children and adolescents

Rivanoptim 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.

Rivanoptim and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.

• - If you are taking:
• some antifungal medicines (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)

• some antibacterial medicines (e.g. clarithromycin, erythromycin)
• some 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)
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine used to treat heart rhythm disorders
• some 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, inform

your doctorbefore taking Rivanoptim, as the effect of Rivanoptim may be enhanced when taken with the above medicines. 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 developing stomach or intestinal ulcers, he or she may use treatment to prevent stomach ulcers.

• - If you are taking
• -some 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, inform

your doctorbefore taking Rivanoptim, as the effect of Rivanoptim may be reduced when taken with the above medicines. Your doctor will decide whether to use Rivanoptim and whether you should be under close observation.

Pregnancy and breastfeeding

Do not take Rivanoptim if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception during treatment with 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 bicycle, 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 instructed. If you are in doubt, consult your doctor or pharmacist.

How many tablets to take

• In order to prevent blood clots in the veins after hip or knee replacement surgery, the recommended dose is one Rivanoptim 10 mg tablet taken once a day.

Your doctor has prescribed Rivanoptim 10 mg 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 in the veins of the legs and/or lungs, 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.

Swallow the tablet 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 of taking Rivanoptim. The tablet can be crushed and mixed with water or soft food, such as apple puree, immediately before taking it. If necessary, your doctor may give you the crushed Rivanoptim tablet through a gastric tube.

When to take Rivanoptim

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.
In order to prevent blood clots in the veins of the legs after hip or knee replacement surgery:

Take the first tablet 6 to 10 hours after surgery.
Treatment usually lasts 5 weeks in patients after major hip surgery.
Treatment usually lasts 2 weeks in patients after major knee surgery.

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

If you forget to take a dose, take the tablet as soon as you remember. Take the next tablet the next day, and then take the tablets as usual, once a day.
Do not take a double dose to make up for a missed tablet.

Stopping treatment with Rivanoptim

Do not stop taking Rivanoptim without first talking to your doctor, as Rivanoptim prevents a serious disease.
If you have any further questions about the use of this medicine, ask 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 of similar action that reduce 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 signs of bleeding may not always be obvious or visible.

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. 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 pectoris. Your doctor may decide to monitor you closely or change the treatment.

Signs of severe skin reactions:

• widespread, severe 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, blood 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; 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 intestines, bleeding from the urinary or reproductive 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)
• presence 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 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 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 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
• blood accumulation (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 granular blood cells, which can cause inflammation in the lungs (eosinophilic pneumonia). Frequency not known(frequency cannot be estimated from 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, 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, please inform your 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.: 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Rivanoptim

Keep this medicine out of the 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 stated.
This medicine does not require any special storage conditions.
Crushed tablets
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. 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 Rivanoptim contains

• -The active substance of Rivanoptim is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• -The other ingredients are:

Core: lactose monohydrate, cellulose powder, crospovidone type A, crospovidone type B, copovidone, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate. See section 2 "Rivanoptim contains lactose and sodium".
Coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, iron oxide red (E 172).

What Rivanoptim looks like and contents of the pack

Rivanoptim 10 mg film-coated tablets are pink, round, biconvex (diameter 8 mm), with the marking 'C02' on one side.
The tablets are:

• in blisters packaged in cardboard boxes, containing 5, 10, or 30 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