Rivanoptim

Leaflet accompanying the packaging: information for the user

Rivanoptim, 15 mg, coated tablets

Rivanoptim, 20 mg, coated tablets

Rivaroxaban

You should read the contents of the 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 a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in the 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

Rivanoptim contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a form of irregular heart rhythm called atrial fibrillation not associated with valve disease.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivanoptim is used in children and adolescents under 18 years of age and weighing 30 kg or more to:

• treat and prevent the recurrence of blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots. 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 the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if the patient has excessive bleeding
• if the patient has 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 the patient is taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter

if the patient has liver disease that leads to an increased risk of bleeding

• if the patient is pregnant or breastfeeding Do not take Rivanoptim, and also inform your doctorif the patient suspects that the above circumstances have occurred.

Warnings and precautions

Before starting to take Rivanoptim, you should consult a doctor or pharmacist.

When to be particularly careful when taking Rivanoptim

• if the patient has an increased risk of bleeding, in such conditions as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body
• taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when changing 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 taking medicines
• 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
• 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
• in patients with prosthetic valves
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform the doctor, who will decide on possible changes to the treatment
• if the patient has been found to have abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If the patient suspects that they have the above conditions, they should inform

their doctorbefore taking Rivanoptim. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery:

• it is very important to follow the doctor's instructions regarding the intake of Rivanoptim at a strictly defined time before or after surgery.
• if a procedure to clear the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement) is planned: it is very important to take Rivanoptim before and after the procedure, in accordance with the doctor's instructions
• due to the need for particular caution, the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder disorders occur after the anesthesia has ended.

Children and adolescents

Rivanoptim tablets are not recommended for children with a body weight below 30 kg.
There is insufficient data on the use of Rivanoptim in children and adolescents for indications in adults.

Rivanoptim and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription.

• If the patient is taking
• some medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
• some medicines used to treat bacterial infections (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 noradrenaline reuptake inhibitors (SNRIs))

If the patient suspects that they have the above conditions, they should inform

their doctorbefore taking Rivanoptim ,as the action of Rivanoptim may be enhanced if taken with the above medicines. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use a treatment to prevent ulcer disease.

• If the patient is taking
• -some medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital)
• -St. John's Wort (Hypericum perforatum) herbal medicine used to treat depression
• -rifampicin, which belongs to the group of antibiotics

If the patient suspects that they have the above conditions, they should inform

their doctorbefore taking Rivanoptim ,as the action of Rivanoptim may be reduced if taken with the above medicines. The doctor will decide whether to use Rivanoptim and whether the patient should be subject to particularly close monitoring.

Pregnancy and breastfeeding

Rivanoptim 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 Rivanoptim. If the patient becomes pregnant while taking Rivanoptim, they should inform their doctor immediately, who will decide on further treatment.

Driving and operating machinery

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

Rivanoptim contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their 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 according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
Rivanoptim should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If the patient has difficulty swallowing the whole tablet, they should discuss other ways of taking Rivanoptim with their doctor. The tablet can be crushed and mixed with water or soft food, such as apple puree, immediately before intake. The mixture should be taken immediately after meals.
If necessary, the doctor may also administer the crushed Rivanoptim tablet through a gastric tube.

How many tablets to take

Adults

• In preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body. The recommended dose is one Rivanoptim 20 mg tablet once a day. If the patient has kidney problems, the dose may be reduced to one Rivanoptim 15 mg tablet once a day.

If the patient needs a procedure to clear the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one Rivanoptim 15 mg tablet once a day (or one Rivanoptim 10 mg tablet once a day in case of kidney problems) in combination with an antiplatelet medicine such as clopidogrel.

• In treating blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and preventing the recurrence of blood clots. The recommended dose is one Rivanoptim 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Rivanoptim 20 mg tablet once a day. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with one 10 mg tablet once a day or one 20 mg tablet once a day. If the patient has kidney problems and is taking one Rivanoptim 20 mg tablet once a day, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivanoptim 15 mg tablet once a day, if the risk of bleeding is greater than the risk of recurrent blood clots.

Children and adolescents

The dose of Rivanoptim depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one Rivanoptim 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Rivanoptim 20 mgtablet once a day. Each dose of Rivanoptim should be taken with a meal, with a drink (e.g. water or juice). The tablets should be taken daily at approximately the same time. It is a good idea to set an alarm to remind you. For parents or caregivers: you should observe the child to make sure they have taken the entire dose.

The dose of Rivanoptim is dependent on body weight, so it is important to attend scheduled doctor's appointments, as it may be necessary to adjust the dose due to changes in weight. Never adjust the dose yourself.If necessary, the doctor will adjust the dose.
Do not divide the tablet to get a partial dose. If a smaller dose is needed, other pharmaceutical forms, such as an oral suspension, may be more suitable. For children and adolescents who are unable to swallow whole tablets, rivaroxaban should be used in the form of an oral suspension.
If the oral suspension is not available, the Rivanoptim tablet can be crushed and mixed with water or apple puree immediately before intake. The mixture should be taken immediately after meals. If necessary, the doctor may also administer the crushed Rivanoptim tablet through a gastric tube.

In case of spitting up a dose or vomiting

• less than 30 minutes after taking Rivanoptim, a new dose should be taken.
• more than 30 minutes after taking Rivanoptim, a new dose should not be taken. In this case, the next dose of Rivanoptim should be taken at the usual time.

The patient should consult their doctor if they spit up a dose or vomit repeatedly after taking Rivanoptim.

When to take Rivanoptim

The tablet(s) should be taken every day until the doctor decides to stop the treatment.
It is best to take the tablet(s) at the same time every day, as this makes it easier to remember.
The doctor will decide how long the patient should continue the treatment.
Preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body:
If the patient's heart rhythm needs to be restored to normal using a procedure called cardioversion, Rivanoptim should be taken at the time specified by the doctor.

Missing a dose of Rivanoptim

• Adults, children, and adolescents: If the patient takes one 20 mg or one 15 mg tablet once a day and misses a dose, they should take it as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. The next tablet should be taken the next day, and then one tablet should be taken once a day.
• Adults: If the patient takes one 15 mg tablet twice a day and misses a dose, they should take it as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient misses a dose, they can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day. The next day, they should continue taking one 15 mg tablet twice a day.

Taking more than the recommended dose of Rivanoptim

If the patient has taken too many Rivanoptim tablets, they should contact their doctor immediately. Taking too much Rivanoptim increases the risk of bleeding.

Stopping Rivanoptim treatment

The patient should not stop taking Rivanoptim without first talking to their doctor, as Rivanoptim treats and prevents serious diseases.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivanoptim can cause side effects, although not everybody gets them.
Like other medicines with a similar action to 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 may not always be obvious or visible signs of bleeding.

The patient should inform their doctor immediately if they or their child 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. Medical help should be sought immediately!)
• -prolonged or excessive bleeding
• -unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. The doctor may decide to monitor the patient 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, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (maximum 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 in adults, children, and adolescents:

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 intestine, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding into the eye (including bleeding from the sclera)
• bleeding into tissues or body cavities (hematoma, bruising)
• presence of blood in sputum when 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 function disorders (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 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 function disorders (can be observed in tests performed by the doctor)
• blood test results may show increased bilirubin levels, increased activity of some 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 the muscles
• cholestasis (bile stasis), hepatitis, including liver cell damage
• jaundice (yellowing of the skin and eyes)
• localized 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 the available data)

• renal 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).

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with Rivanoptim were similar in type to those observed in adults and were mainly mild to moderate.
Side effects observed more frequently in children and adolescents:

Very common(may affect more than 1 in 10 people)

• headache
• fever
• nasal bleeding, vomiting.

Common(may affect up to 1 in 10 people)

• rapid heartbeat
• blood test results may show increased bilirubin levels
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• excessive menstrual bleeding.

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased direct bilirubin levels.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
By reporting side effects, more information can be gathered on the safety of the 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 (EXP). The expiry date refers to the last day of the month stated.
Rivanoptim 15 mg tablets in blisters: Do not store above 30°C.
Rivanoptim 15 mg tablets in containers and Rivanoptim 20 mg tablets in blisters and containers: 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. The patient should ask their 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 15 mg or 20 mg of rivaroxaban.
• -The other ingredients are: Tablet 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". Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, iron oxide red (E 172).

What Rivanoptim looks like and contents of the pack

Rivanoptim 15 mg coated tablets are red, round, biconvex (diameter 7 mm), with the marking 'C03' on one side.
The tablets are available in:

• blisters packed in cartons, containing 14, 28, 42, or 100 coated tablets, or
• containers containing 100 coated tablets.

Rivanoptim 20 mg coated tablets are dark red, round, biconvex (diameter 8 mm), with the marking 'C04' on one side.
The tablets are available in:

• blisters packed in cartons, containing 14, 28, or 100 coated tablets, or
• containers containing 100 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