Rivertaxo

Package Leaflet: Information for the Patient

Rivertaxo, 10 mg, Film-Coated Tablets

Rivaroxaban

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

• 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 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. Contents of the pack and other information

1. What is Rivertaxo and what is it used for

Rivertaxo contains the active substance rivaroxaban. It 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 to you because you have an increased risk of blood clots after surgery;
• 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 veins of the legs and/or lungs.

Rivertaxo 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 Rivertaxo

When not to take Rivertaxo

• 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 disorder of any organ that 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 you are taking other medicines 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 (see "Rivertaxo and other medicines");
• if you have liver disease that leads to an increased risk of bleeding;
• if you are pregnant or breastfeeding.

If any of these situations apply to you, do not take Rivertaxo and consult your doctor.

Warnings and precautions

Before starting treatment with Rivertaxo, discuss it with your doctor or pharmacist.

During treatment with Rivertaxo, be particularly careful

• if you have an increased risk of bleeding, in situations such as:
• mild or moderate kidney disease, as kidney function may affect the amount of medicine acting in your body;
• taking other medicines 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 medicines");
• 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) due to gastroesophageal reflux disease (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 eye (retinopathy);
• pulmonary disease in which the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs;
• in patients with artificial heart valves;
• if you have a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide on possible changes to your treatment;
• if you have abnormal blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

If any of these situations apply to you, before taking Rivertaxo, you must

consult your doctor. The doctor will decide whether you should take this medicine and whether close monitoring of your condition is necessary at that time.

If you need to undergo surgery:

• you must strictly follow your 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 at the time specified by your doctor;
• you must immediately inform your doctor if, after the anesthesia is completed, you experience numbness or weakness in your legs or difficulties with bowel or urine excretion, as immediate treatment may be necessary.

Children and adolescents

Rivertaxo 10 mg is not recommended for persons under 18 years of age.
There is a lack of sufficient data on the use of the medicine in children and adolescents.

Rivertaxo and other medicines

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

If you are taking:

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

If any of the above applies to you, you must

tell your doctorbefore taking Rivertaxo, as it may increase the effect of the medicine. The doctor will decide whether you should take Rivertaxo and whether close monitoring of your condition is necessary at that time.
If the doctor believes that you have an increased risk of developing stomach or duodenal ulcers, they may use treatment to prevent the development of ulcer disease.

If you are 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 a group of antibiotics.

If any of the above applies to you, before taking Rivertaxo, you must

tell your doctor, as it may weaken the effect of Rivertaxo. The doctor will decide whether you should take Rivertaxo and whether close monitoring of your condition is necessary at that time.

Pregnancy and breastfeeding

Do not take Rivertaxoif you are pregnant or breastfeeding, suspect you may be pregnant, or plan to have a child. Women of childbearing age should use effective contraception while taking Rivertaxo. If you become pregnant during treatment, you should immediately inform your 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 you have previously been diagnosed with intolerance to some sugars, you should contact your 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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How many tablets to take

To prevent blood clots in the veins after hip or knee replacement surgery
The recommended dose is one Rivertaxo 10 mg tablet taken 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
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.
Your doctor has prescribed Rivertaxo 10 mg once a day for you.
Swallow the tablet with water, preferably with water.
Rivertaxo can be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Rivertaxo. The tablet can be crushed and mixed with water or soft food, such as apple puree, and taken immediately.
If necessary, your doctor may administer the crushed Rivertaxo tablet through a gastric tube.

When to take Rivertaxo

Take one tablet every day until your 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.
Your doctor will decide how long you should continue the treatment.
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.
In patients after major hip surgery, treatment usually lasts 5 weeks. In patients after major knee surgery, treatment usually lasts 2 weeks.

Taking more than the recommended dose of Rivertaxo

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

Missing a dose of Rivertaxo

If you forget to take a tablet, take it as soon as you remember. Take the next dose the next day at the usual time and continue with the recommended dosing.
Do not take a double dose to make up for the missed tablet.

Stopping treatment with Rivertaxo

Do not stop taking Rivertaxo without consulting your doctor, as this medicine 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, Rivertaxo can cause side effects, although not everybody gets them.
Like other medicines with similar blood clot-reducing effects, 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.
You must immediately inform your doctorif you 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. Seek immediate medical attention!);
• prolonged or excessive bleeding;
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris. Your doctor may decide on close monitoring of your condition or changes to your 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);
• 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

Common(may affect up to 1 in 10 people):

• decrease in 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, gum bleeding
• bleeding into the eye (including bleeding from the conjunctiva)
• 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 test results ordered by your doctor)
• fever
• stomach pain, indigestion, 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 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 the 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 test results ordered by your doctor)
• 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
• blood accumulation (hematoma) in the groin as a complication of a heart 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
• bleeding in the kidneys, 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 syndrome due to 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 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivertaxo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original package.
The batch number is indicated on the packaging as "Lot".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rivertaxo contains

• The active substance is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
• The 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, yellow iron oxide (E 172).

What Rivertaxo looks like and contents of the pack

Rivertaxo 10 mg is a pink, round, biconvex film-coated tablet with the inscription "10" on one side, smooth on the other side, with a diameter of approximately 9.1 mm.
Rivertaxo 10 mg is packaged in blisters. One pack contains 10 film-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: