Rivertaxo

Package Leaflet: Information for the Patient

Rivertaxo, 15 mg, Coated Tablets

Rivertaxo, 20 mg, Coated Tablets

Rivaroxaban

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

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Rivertaxo and What is it Used For

Rivertaxo contains the active substance rivaroxaban. The medication is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels in the body in patients with a certain type of irregular heart rhythm, called non-valvular atrial fibrillation;
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivertaxo is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:

• treat and prevent the recurrence of blood clots in the veins or blood vessels of the lungs, after at least 5 days of initial treatment with injectable medications used to treat blood clots.

Rivertaxo belongs to a group of medications called anticoagulants. Its action involves blocking a blood clotting factor (factor Xa) and thereby reducing the tendency to form blood clots.

2. Important Information Before Taking Rivertaxo

When Not to Take Rivertaxo

• 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 disorder affecting any organ, which increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent surgical procedure in the brain or eyes);
• if the patient is taking other medications that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin); except during the transition period of anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery catheter;
• if the patient has liver disease, which leads to an increased risk of bleeding;
• if the patient is pregnant or breastfeeding.

If any of these situations apply to the patient, they should not take Rivertaxo and should
consult a doctor.

Warnings and Precautions

Before starting treatment with Rivertaxo, the patient should discuss it with their doctor or pharmacist.

During Treatment with Rivertaxo, the Patient Should be Particularly Careful

• if the patient has an increased risk of bleeding, in situations such as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medication acting in the patient's body;
• taking other medications that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) with the exception of the transition period of anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery catheter (see "Rivertaxo and Other Medications");
• bleeding disorders;
• very high blood pressure that does not decrease despite medication;
• stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) due to reflux disease of the esophagus (backflow of stomach acid into the esophagus) or tumors located in the stomach, intestines, genital, or urinary system;
• disease of the blood vessels in the back of the eyeballs (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 the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide on possible changes to the treatment;
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If Any of These Situations Apply to the Patient, Before Taking Rivertaxo, They Should

consult a doctor. The doctor will decide whether the patient should take this medication and whether close monitoring of their condition is necessary at that time.

If the Patient Needs to Undergo Surgery:

• they must strictly follow the doctor's instructions regarding the intake of Rivertaxo at a precisely specified time before or after surgery;
• if a lumbar puncture or spinal catheter insertion is planned during surgery (e.g., for epidural or spinal anesthesia or to reduce pain):
• it is very important to take Rivertaxo exactly as instructed by the doctor;
• the patient should immediately inform their doctor if they experience numbness or weakness in their legs or bowel or bladder disturbances after anesthesia, as immediate treatment may be necessary.

Children and Adolescents

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

Rivertaxo and Other Medications

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

If the Patient is Taking:

• certain medications 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);
• certain medications used to treat bacterial infections (e.g., clarithromycin, erythromycin);
• certain antiviral medications used to treat HIV or AIDS (e.g., ritonavir);
• other medications used to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol);
• anti-inflammatory and pain-relieving medications (e.g., naproxen or acetylsalicylic acid);
• 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 Any of the Above Applies to the Patient, They Should

tell their doctorbefore taking Rivertaxo, as the effect of the medication may be enhanced. The doctor will decide whether the patient should take Rivertaxo and whether close monitoring of their condition is necessary at that time.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use treatment to prevent the development of ulcer disease.

If the Patient is Taking:

• certain medications used to treat epilepsy (phenytoin, carbamazepine, phenobarbital);
• St. John's Wort ( Hypericum perforatum) - a herbal remedy used in depression;
• rifampicin, which belongs to a group of antibiotics.

If Any of the Above Applies to the Patient, They Should

tell their doctorbefore taking Rivertaxo, as the effect of the medication may be reduced. The doctor will decide whether the patient should take Rivertaxo and whether close monitoring of their condition is necessary at that time.

Pregnancy and Breastfeeding

Rivertaxo should not be usedif the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child. Women of childbearing age should use effective contraception while taking Rivertaxo. If the patient becomes pregnant during treatment, they should immediately inform their doctor, who will decide on further treatment.

Driving and Operating Machines

Rivertaxo 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.

Rivertaxo Contains Lactose Monohydrate and Sodium

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

3. How to Take Rivertaxo

This medication should always be taken exactly as instructed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The tablet should be swallowed, preferably with water.
The medication should be taken with food.
If the patient has difficulty swallowing the whole tablet, they should discuss other ways of taking Rivertaxo with their doctor. The tablet can be crushed and mixed with water or soft food, such as apple sauce, and taken immediately. The patient should then eat a meal.
If necessary, the doctor may administer the crushed Rivertaxo tablet through a gastric tube.

How Many Tablets to Take

Adults

To prevent the formation of blood clots in the brain (stroke) and in other blood vessels
The recommended dose is one 20 mg tablet once a day.
In patients with kidney function disorders, the doctor may reduce the dose to one 15 mg tablet once a day.
If a procedure to widen blocked coronary arteries (percutaneous coronary intervention - PCI with stent implantation) is necessary, limited data suggest reducing the dose to one 15 mg Rivertaxo tablet once a day (or to one 10 mg Rivertaxo tablet once a day in patients with impaired kidney function), in addition to an antiplatelet medication, such as clopidogrel.
To treat 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
The recommended dose is one 15 mg tablet twice a day for the first 3 weeks.
After 3 weeks, the recommended dose is one 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 function disorders and is taking one 20 mg tablet once a day, the doctor may decide to reduce the dose to one 15 mg tablet once a day after 3 weeks of treatment, if the risk of bleeding is greater than the risk of recurrent blood clots.

Children and Adolescents

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

• The recommended dose for children and adolescents with a body weight from 30 kg to less than 50 kgis one Rivertaxo 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one Rivertaxo 20 mgtablet once a day.

Each dose of Rivertaxo should be taken with food, washed down 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 as a reminder.
For parents or caregivers: observe the child to ensure they have taken the entire dose.
The dose of Rivertaxo is dependent on body weight, so it is essential to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes.
Never adjust the dose yourself.If necessary, the doctor will adjust the dose.

In Case of Spitting Up the Dose or Vomiting

• if it occurs less than 30 minutes after taking the medication, a new dose should be taken.
• if it occurs more than 30 minutes after taking the medication, do nottake a new dose. In this case, the next dose should be taken at the usual time.

The patient should contact their doctor in case of repeated spitting up of the dose or vomiting after taking the medication.

When to Take Rivertaxo

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

Taking a Higher Than Recommended Dose of Rivertaxo

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

Missing a Dose of Rivertaxo

• Adults, children, and adolescents: If the patient takes one 20 mg or one 15 mg tablet once a dayand misses a dose, they should take it as soon as they remember. They should not take more than one tablet in a 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 dayand misses a dose, they should take it as soon as they remember. They should not take more than two 15 mg tablets in a 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 a day. The next day, they should continue taking one 15 mg tablet twice a day.

Stopping Treatment with Rivertaxo

The patient should not stop taking Rivertaxo without consulting their doctor, as this medication prevents a serious disease.
In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Rivertaxo can cause side effects, although not everybody gets them.
Like other medications with a similar mechanism of action that reduce blood clot formation, Rivertaxo can cause bleeding, which can potentially be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). Not all of these will be obvious or visible signs of bleeding.
The patient should immediately inform their doctorif they experience any of the following side effects:

Side Effects That May be Symptoms 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. Immediate medical help is required!);
• prolonged or excessive bleeding;
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris. The doctor may decide to closely monitor the patient or change the treatment.

Side Effects That May be Symptoms of a Severe Skin Reaction

• 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 reaction to the medication causing a rash, fever, inflammation of internal organs, hematologic disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (no more than 1 in 10,000 people).

Side Effects That May be Symptoms of a Severe Allergic Reaction

• swelling of the face, lips, mouth, tongue, or throat, hives, and difficulty breathing, a sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in no more than 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 can cause pallor and be the cause of weakness or shortness of breath
• bleeding from the stomach or intestine, bleeding from the urinary or reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• bleeding into the eye (including bleeding from the sclera)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood (hemoptysis)
• bleeding from the skin or subcutaneous bleeding
• postoperative bleeding
• oozing of blood or fluid from the surgical wound
• swelling of the limbs
• limb pain
• kidney function disorders (which may be indicated by laboratory test results)
• fever
• stomach pain, nausea, 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
• increased activity of certain liver enzymes, which may be visible 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 (which may be indicated by laboratory test results)
• 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 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
• accumulation of blood (hematoma) in the groin as a complication of a cardiac catheterization procedure involving the insertion of a catheter 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):

• kidney failure after severe bleeding
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant medications)
• 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 syndromeafter bleeding).

Side Effects in Children and Adolescents

Generally, the side effects observed in children and adolescents treated with rivaroxaban were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed more frequently in children and adolescents:
Very Common(may affect more than 1 in 10 people):

• headache
• fever
• nosebleeds, 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 levels of a bilirubin subtype (direct bilirubin, a bile pigment).

Reporting Side Effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform 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
Phone: +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 will help to gather more information on the safety of the medication.

5. How to Store Rivertaxo

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the carton, blister, or packaging after "EXP". The expiry date refers to the last day of the month stated.
No special storage precautions are required.
The batch number on the packaging is labeled as "Lot".
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Rivertaxo Contains

• The active substance of Rivertaxo is rivaroxaban. The coated tablet contains 15 mg or 20 mg of rivaroxaban.
• Other ingredients are:
• Tablet core: hypromellose, microcrystalline cellulose, sodium lauryl sulfate, lactose monohydrate, croscarmellose sodium, magnesium stearate.
• Coating: hypromellose 2910, titanium dioxide (E 171), macrogol 3350, iron oxide yellow (E 172).

What Rivertaxo Looks Like and Contents of the Package

Rivertaxo, 15 mg, is a red, round, biconvex, coated tablet with the inscription "15" on one side, smooth on the other, with a diameter of approximately 6.1 mm.
Rivertaxo, 15 mg, is packaged in blisters. One package contains: 14, 28, or 42 coated tablets in a carton.
Rivertaxo, 20 mg, is a brown-red, round, biconvex, coated tablet with the inscription "20" on one side, smooth on the other, with a diameter of approximately 6.1 mm.
Rivertaxo, 20 mg, is packaged in blisters. One package contains 14 or 28 coated tablets in a carton.

Marketing Authorization Holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: (42) 22-53-100

Manufacturer

Genepharm SA
18 km Marathonos Avenue
15351 Pallini Attiki
Greece

Date of Last Revision of the Leaflet: