RIVERTAXO 15 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Rivertaxo, 15 mg, coated tablets
3. Rivertaxo, 20 mg, coated tablets
   1. You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Rivertaxo and what is it used for
5. Important information before taking Rivertaxo
   1. When not to take Rivertaxo
   2. Warnings and precautions
   3. While taking Rivertaxo, the patient should be particularly careful
   4. If any of these situations apply to the patient, before taking Rivertaxo, they should
   5. If the patient is to undergo surgery:
   6. Children and adolescents
   7. Rivertaxo and other medicines
   8. If the patient is taking:
   9. If any of the above cases apply to the patient, they should tell their
   10. If the patient is taking:
   11. If any of the above cases apply to the patient, they should tell their
   12. Pregnancy and breastfeeding
   13. Driving and using machines
   14. Rivertaxo contains lactose monohydrate and sodium
6. How to take Rivertaxo
   1. How many tablets to take
   2. Adults
   3. Children and adolescents
   4. In case of spitting up a dose or vomiting
   5. When to take Rivertaxo
   6. Taking a higher dose of Rivertaxo than recommended
   7. Missing a dose of Rivertaxo
   8. Stopping the intake of Rivertaxo
7. Possible side effects
   1. Side effects that may be symptoms of bleeding
   2. Side effects that may be symptoms of a severe skin reaction
   3. Side effects that may be symptoms of a severe allergic reaction
   4. General list of possible side effects in adults, children and adolescents:
   5. Side effects in children and adolescents
   6. Reporting side effects
8. How to store Rivertaxo
9. Package contents and other information
   1. What Rivertaxo contains
   2. What Rivertaxo looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Rivertaxo, 15 mg, coated tablets

Rivertaxo, 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.
• If you have any doubts, you should consult a doctor or pharmacist.
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 medicine 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 heartbeat, 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 medicines used to treat blood clots.

Rivertaxo 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 Rivertaxo

When not to take Rivertaxo

• 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 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 medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin); an exception is the period of change of anticoagulant treatment or if 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 to take Rivertaxo, the patient should discuss it with their doctor or pharmacist.

While taking Rivertaxo, the patient should be particularly careful

• if the patient has an increased risk of bleeding, in such situations 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 blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) with the exception of a change of anticoagulant treatment or if heparin is administered to maintain the patency of a vein or artery catheter (see "Rivertaxo and other medicines");
• bleeding disorders;
• very high blood pressure, which does not decrease despite the use of 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) for example due to reflux disease of the esophagus (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines, or the 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 prosthetic 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 a surgical procedure is planned 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 medicine and whether close monitoring of their condition is necessary at that time.

If the patient is 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 at the time specified by the doctor;
• the patient should immediately inform their doctor if, after the anesthesia is finished, they experience numbness or weakness of the legs or disturbances of bowel or bladder function, 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 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 available without a prescription.

If the patient is taking:

• certain medicines used to treat 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 medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin);
• certain antiviral medicines used to treat HIV infection 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);
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If any of the above cases apply to the patient, they should tell their

doctorbefore taking Rivertaxo, as it is possible to enhance the effect of the medicine. 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 medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital);
• St. John's wort ( Hypericum perforatum) - a herbal medicine used in depression;
• rifampicin, which belongs to the group of antibiotics.

If any of the above cases apply to the patient, they should tell their

doctorbefore taking Rivertaxo, as it is possible to weaken its effect. 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 using 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 medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Rivertaxo

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The tablet should be swallowed, preferably with water.
The medicine 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. Then the patient should eat a meal.
If necessary, the doctor may administer a 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 (so-called percutaneous coronary intervention - PCI with stent implantation) is necessary, limited data indicate a dose reduction to one 15 mg Rivertaxo tablet once a day (or in patients with impaired kidney function to one 10 mg Rivertaxo tablet once a day), added to an antiplatelet agent, such as clopidogrel.
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
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 after 3 weeks of treatment to one 15 mg tablet once a day, if the risk of bleeding is greater than the risk of further blood clots.

Children and adolescents

The dose of the medicine 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 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 to remind you.
For parents or caregivers: you should observe the child to make sure they have taken the entire dose.
The dose of Rivertaxo is dependent on body weight, so it is important to come to 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.

In case of spitting up a dose or vomiting

• less than 30 minutes after taking the medicine, a new dose should be taken.
• more than 30 minutes after taking the medicine, 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 a dose or vomiting after taking the medicine.

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 a fixed time every day, as it is easier to remember.
The doctor will decide how long to continue the treatment.
Preventing the formation of blood clots in the brain (stroke) and in other blood vessels
If the heart rhythm needs to be restored with a cardioversion procedure, Rivertaxo should be taken at the time specified by the doctor.

Taking a higher dose of Rivertaxo than recommended

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

Missing a dose of Rivertaxo

• Adults, children and adolescents: If the patient is taking 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 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 is taking 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 one day. If the patient has forgotten to take 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.

Stopping the intake of Rivertaxo

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

4. Possible side effects

Like all medicines, Rivertaxo can cause side effects, although not everybody gets them.
Like other medicines with a similar action of reducing 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, paleness, dizziness, headache, swelling of unknown cause, 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, acute skin rash, blistering or changes to the mucous membranes, e.g. tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• a drug reaction causing rash, fever, inflammation of internal organs, hematological disorders and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (up to 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, 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):

• decrease in red blood cell count, which can cause paleness of the skin 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)
• coughing up blood (hemoptysis)
• bleeding from the skin or subcutaneous bleeding
• bleeding after surgery
• oozing of blood or fluid from the surgical wound
• swelling of the limbs
• limb pain
• kidney function disorders (which may be indicated by the results of tests ordered by the doctor)
• 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 of the skin
• increased activity of some liver enzymes, which may be visible in the results of a blood test.

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 the results of tests ordered by the doctor)
• 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)
• localized 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 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 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 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
• 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, bile pigment).

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 Adverse Reaction 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 medicine.

5. How to store Rivertaxo

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, after EXP. The expiry date refers to the last day of the month.
No special instructions for storing the medicine.
The batch number on the packaging is marked as "Lot".
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. Package contents and other information

What Rivertaxo contains

• The active substance of the medicine 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 what the package contains

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 about 6.1 mm.
Rivertaxo 15 mg is packaged in blisters. One package contains: 14, 28 or 42 coated tablets in a cardboard box.
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 about 6.1 mm.
Rivertaxo 20 mg is packaged in blisters. One package contains 14 or 28 coated tablets in a cardboard box.

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: