Rivertaxo

Poland
Brand name Rivertaxo
Form tablets, film-coated
Active substance / Dosage
rivaroxaban · 20 mg
Prescription type Prescription only
ATC code
B01AF01
Registration number 100418222
Manufacturer Genepharm S.A.

Table of Contents

Package leaflet: Information for the patient

Rivertaxo, 15 mg, film-coated tablets
Rivertaxo, 20 mg, film-coated tablets
Rivaroxabanum
Please read the entire leaflet before taking this medicine, as it contains important information for the patient.

  • Keep this leaflet for future reference.
  • If you have any questions, please consult your doctor or pharmacist.
  • This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
  • If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

  1. What Rivertaxo is and what it is used for
  2. What you should know 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 Rivertaxo is and what it is 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 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 weighing 30 kg or more to:

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

Rivertaxo belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (Factor Xa), 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 active bleeding;
  • if the patient has an organ disease or disorder increasing the risk of serious bleeding (e.g. stomach ulcer, trauma or intracranial haemorrhage, recent surgery involving the brain or eyes);
  • if the patient is taking other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin); an exception is during transition between anticoagulant therapies or when heparin is administered to maintain catheter patency in a vein or artery;
  • if the patient has a liver disease leading to an increased risk of bleeding;
  • if the patient is pregnant or breastfeeding.

If any of these situations apply to the patient, do not take Rivertaxo and consult a doctor.
Warnings and precautions
Before starting Rivertaxo, discuss this with your doctor or pharmacist.
Special caution is required while taking Rivertaxo

  • if the patient has an increased risk of bleeding, such as in the following situations:
    • severe renal impairment in adults, or moderate to severe renal impairment in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body;
    • taking other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin), except during transition between anticoagulant therapies or when heparin is administered to maintain catheter patency in a vein or artery (see section "Rivertaxo with other medicines");
    • coagulation disorders;
    • very high blood pressure that does not decrease despite medication;
    • stomach or intestinal diseases that may cause bleeding, e.g. gastrointestinal inflammation or oesophagitis (inflammation of the oesophagus), for example due to gastro-oesophageal reflux disease (acid reflux), or tumours located in the stomach, intestines, reproductive or urinary systems;
    • vascular disease of the posterior eye (retinopathy);
    • lung disease with bronchiectasis (dilated airways filled with pus) or previous pulmonary haemorrhage;
  • in patients with prosthetic heart valves;
  • if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment adjustment is necessary;
  • if the patient has abnormal blood pressure or is scheduled for surgery or other treatment to remove a pulmonary embolus.

If any of these situations apply to the patient, consult a doctor before taking Rivertaxo. The doctor will decide whether the patient should take this medicine and whether close monitoring is required.
If the patient needs to undergo surgery:

  • strictly follow the doctor's instructions regarding the timing of Rivertaxo administration before or after surgery;
  • if during surgery a lumbar puncture or spinal catheter placement is planned (e.g. for epidural or spinal anaesthesia or pain relief):
    • it is very important to take Rivertaxo exactly at the time recommended by the doctor;
    • immediately inform the doctor if, after the anaesthesia, the patient experiences numbness or weakness in the legs or problems with bowel or bladder control, as immediate treatment may be necessary.

Children and adolescents
Rivertaxo tablets are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of Rivertaxo in children and adolescents for adult indications.
Rivertaxo with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.
If the patient is taking:

  • certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless used only topically on the skin;
  • ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol);
  • certain antibiotics (e.g. clarithromycin, erythromycin);
  • certain antiviral medicines used in HIV infection or AIDS treatment (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 medicines (e.g. naproxen or acetylsalicylic acid);
  • dronedarone (a medicine used to treat heart rhythm disorders);
  • certain antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If any of the above situations apply, inform the doctor before taking Rivertaxo, as the effect of the medicine may be enhanced. The doctor will decide whether the patient should take Rivertaxo and whether close monitoring is required.
If the doctor considers the patient at increased risk of developing gastric or duodenal ulcers, preventive treatment may be prescribed.
If the patient is taking:

  • certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital);
  • St John's wort (Hypericum perforatum) – a herbal remedy used for depression;
  • rifampicin, an antibiotic.

If any of the above situations apply, inform the doctor before taking Rivertaxo, as the effect of the medicine may be reduced. The doctor will decide whether the patient should take Rivertaxo and whether close monitoring is required.
Pregnancy and breastfeeding
Do not use Rivertaxo if the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant. Women of childbearing potential should use effective contraception during treatment with Rivertaxo. If a patient becomes pregnant during treatment, she should immediately inform her doctor, who will decide on further management.
Driving and operating machinery
Rivertaxo may cause dizziness (common side effects) and fainting (uncommon side effects) – see section 4 "Possible side effects". Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
Rivertaxo contains lactose monohydrate and sodium
Lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
3. How to take Rivertaxo
Always take this medicine exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
Swallow the tablet, preferably with water.
The medicine should be taken with food.
If the patient has difficulty swallowing the whole tablet, discuss alternative ways of taking Rivertaxo with the doctor. The tablet may be crushed and mixed with water or soft food such as apple puree and taken immediately. A meal should be consumed directly afterwards.
If necessary, the doctor may administer crushed Rivertaxo tablets via a gastric tube.
How many tablets to take
Adults
To prevent blood clots in the brain (stroke) and other blood vessels
The recommended dose is one 20 mg tablet once daily.
In patients with renal impairment, the doctor may reduce the dose to one 15 mg tablet once daily.
If a procedure to widen blocked coronary arteries is required (percutaneous coronary intervention – PCI with stent implantation), limited data suggest reducing the dose to one 15 mg Rivertaxo tablet once daily (or one 10 mg Rivertaxo tablet once daily in patients with impaired renal function), in addition to antiplatelet therapy such as clopidogrel.
For treatment of venous thrombosis in the legs, pulmonary embolism, and prevention of recurrent blood clots
The recommended dose is one 15 mg tablet twice daily for the first 3 weeks.
After 3 weeks, the recommended dose is one 20 mg tablet once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily.
If the patient has renal impairment and is taking one 20 mg tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg tablet once daily if the risk of bleeding is greater than the risk of further clot formation.
Children and adolescents
The dose depends on body weight and will be calculated by the doctor.

  • The recommended dose for children and adolescents weighing 30 kg to less than 50 kg is one Rivertaxo 15 mg tablet once daily.
  • The recommended dose for children and adolescents weighing 50 kg or more is one Rivertaxo 20 mg tablet once daily.

Each dose of Rivertaxo should be taken with a meal, accompanied by a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. Consider setting an alarm as a reminder.
For parents or caregivers: monitor the child to ensure the full dose has been taken.
The dose of Rivertaxo is weight-dependent; therefore, it is important to attend scheduled doctor's appointments, as dose adjustments may be necessary due to weight changes.
Never adjust the dose independently. The doctor will adjust the dose if needed.
If a dose is vomited or expelled

  • within 30 minutes of taking the medicine, take a new dose.
  • more than 30 minutes after taking the medicine, do not take another dose. Take the next dose at the usual time.

Contact the doctor if vomiting or expulsion of the dose occurs repeatedly.
When to take Rivertaxo
Take the tablet every day until the doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
The doctor will decide how long treatment should continue.
Prevention of blood clots in the brain (stroke) and other blood vessels
If a cardioversion procedure is required to restore normal heart rhythm, Rivertaxo should be taken at the time recommended by the doctor.
Taking more than the recommended dose of Rivertaxo
If the patient takes more tablets than prescribed, contact a doctor immediately.
Taking too high a dose of Rivertaxo increases the risk of bleeding.
Missed dose of Rivertaxo

  • Adults, children and adolescents: If the patient takes one 20 mg or one 15 mg tablet once daily and misses a dose, take it as soon as remembered. Do not take more than one tablet in a single day to make up for the missed dose. Take the next tablet the following day and continue with one tablet once daily.
  • Adults: If the patient takes one 15 mg tablet twice daily and misses a dose, take it as soon as remembered. Do not take more than two 15 mg tablets in a single day. If a dose was missed, the patient may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, continue taking one 15 mg tablet twice daily.

Stopping Rivertaxo
Do not stop taking Rivertaxo without consulting a doctor, as this medicine prevents serious illness.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar anticoagulant effect, Rivertaxo
may cause bleeding, which potentially could be life-threatening. Excessive bleeding may
lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You must contact your doctor immediately if any of the following adverse reactions occur:

Adverse reactions which may be 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 neck stiffness. A serious, sudden medical emergency. Seek immediate medical help!);
  • prolonged or excessive bleeding;
  • unusual weakness, fatigue, pallor, dizziness, headache, appearance of unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.

Adverse reactions which may be signs of severe skin reactions

  • widespread, acute skin rash, formation of blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis);
  • drug reaction causing rash, fever, internal organ inflammation, haematological and systemic disorders (DRESS syndrome). The frequency of these adverse reactions is very rare (occurring in up to 1 in 10,000 people).

Adverse reactions which may be signs of a serious allergic reaction

  • swelling of the face, lips, oral cavity, tongue or throat, urticaria and breathing difficulties, 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 oedema may occur in 1 in 100 people).

General list of possible adverse reactions in adults, children and adolescents:
Common (may occur in 1 in 10 people):

  • decrease in red blood cells, which may cause pale skin and lead to weakness or shortness of breath;
  • bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums;
  • bleeding into the eye (including bleeding from the sclera of the eye);
  • bleeding into tissues or body cavities (haematoma, bruising);
  • coughing up blood (haemoptysis);
  • bleeding from the skin or under the skin;
  • bleeding after surgery;
  • oozing of blood or fluid from a surgical wound;
  • swelling of limbs;
  • limb pain;
  • kidney function disorders (as indicated by test results ordered by a doctor);
  • fever;
  • stomach pain, indigestion, nausea or vomiting, constipation, diarrhoea;
  • low blood pressure (symptoms may include dizziness or fainting upon standing);
  • general weakness and lack of energy (asthenia, fatigue), headache, dizziness;
  • rash, itching of the skin;
  • increased activity of certain liver enzymes, which may be observed in blood test results.

Uncommon (may occur in 1 in 100 people):

  • bleeding into the brain or inside the skull (see signs of bleeding above);
  • bleeding into a joint causing pain and swelling;
  • thrombocytopenia (low number of platelets, blood cells involved in blood clotting);
  • allergic reactions, including allergic skin reactions;
  • liver function disorders (as indicated by test results ordered by a doctor);
  • blood tests may show increased bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count;
  • fainting;
  • malaise;
  • rapid heartbeat;
  • dry mouth;
  • urticaria.

Rare (may occur in 1 in 1,000 people):

  • bleeding into muscles;
  • cholestasis (bile stasis), hepatitis including liver cell damage;
  • yellowing of the skin and eyes (jaundice);
  • localised swelling;
  • accumulation of blood (haematoma) in the groin as a complication of cardiac catheterisation procedure involving insertion of a catheter into an artery in the leg (pseudoaneurysm).

Very rare (may occur in 1 in 10,000 people):

  • accumulation of eosinophils, a type of granular white blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency not known (frequency cannot be estimated from the available data):

  • kidney failure following severe bleeding;
  • bleeding in the kidneys, sometimes with presence of blood in urine, leading to inability of the kidneys to function properly (drug-induced anticoagulant-associated nephropathy);
  • increased pressure within the muscles of the legs and arms occurring after bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Adverse reactions in children and adolescents
In general, adverse reactions observed in children and adolescents treated with rivaroxaban were
similar in type to those observed in adults and were mostly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 in 10 people):

  • headache;
  • fever;
  • nosebleeds, vomiting.

Common (may occur in 1 in 10 people):

  • rapid heartbeat;
  • blood test results may show increased bilirubin levels (a bile pigment);
  • thrombocytopenia (low platelet count, platelets being cells that help in blood clotting);
  • excessive menstrual bleeding.

Uncommon (may occur in 1 in 100 people):

  • blood test results may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Rivertaxo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions for this medicine.
The batch number on the packaging is marked as "Lot".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Rivertaxo contains

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

What Rivertaxo looks like and contents of the pack
Rivertaxo 15 mg is red, round, biconvex, film-coated tablets, with "15" embossed on one side and smooth on the other, approximately 6.1 mm in diameter.
Rivertaxo 15 mg is packed in blisters. One pack contains: 14, 28 or 42 film-coated tablets in a cardboard box.
Rivertaxo 20 mg is brownish-red, round, biconvex, film-coated tablets, with "20" embossed on one side and smooth on the other, approximately 6.1 mm in diameter.
Rivertaxo 20 mg is packed in blisters. One pack contains 14 or 28 film-coated tablets in a cardboard box.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. (42) 22-53-100
Manufacturer
Genepharm SA
18 km Marathonos Avenue
15351 Pallini Attiki
Greece