Rivertaxo

Package leaflet: Information for the patient

Rivertaxo, 10 mg, film-coated tablets
Rivaroxabanum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet

1. What Rivertaxo is and what it is 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 Rivertaxo is and what it is used for

Rivertaxo contains the active substance rivaroxaban. The medicine is used in adults for:

• preventing the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because you are at increased risk of developing blood clots after surgery;
• treating blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as for preventing recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivertaxo belongs to a group of medicines called anticoagulants. It works by
blocking a blood clotting factor (factor Xa), thereby reducing the tendency for blood clots to form.

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 condition affecting any organ that increases the risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding in the brain, recent surgery involving 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 switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery;
• if the patient has a liver disease that leads 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
your doctor.
Warnings and precautions
Before starting Rivertaxo, discuss this with your doctor or pharmacist.
While taking Rivertaxo, take special care if:

• the patient has an increased risk of bleeding, such as in the following situations:
  • moderate or severe kidney disease, as kidney function may affect the amount of medicine active in the patient's body;
  • taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin), except during a switch in anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery (see section "Rivertaxo with other medicines");
  • blood clotting 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 oesophagitis (throat and oesophagus), for example due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach or intestines, or in the genital or urinary system;
  • blood vessel disease in the back of the eye (retinopathy);
  • lung disease where the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs;
• 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 a change in treatment is needed;
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a blood clot from the lungs.

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

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

Children and adolescents
Rivertaxo 10 mg is not recommended for patients under 18 years of age.
There is insufficient data on the use of this medicine in children and adolescents.
Rivertaxo with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those available without a prescription.
If the patient is taking:

• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are 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 used for bacterial infections (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-relieving medicines (e.g. naproxen or acetylsalicylic acid);
• dronedarone (a medicine used to treat heart rhythm disorders);
• certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If any of the above apply to the patient, tell 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 necessary.
If the doctor considers that the patient has an increased risk of developing stomach or duodenal ulcers, preventive treatment for peptic ulcer disease 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, which belongs to the group of antibiotics.

If any of the above apply to the patient, tell 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 necessary.
Pregnancy and breastfeeding
Do not take 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 while taking Rivertaxo. If the patient becomes pregnant during treatment, she should inform the doctor immediately, 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 monohydrate lactose and sodium
Monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
3. How to take Rivertaxo
Always take this medicine exactly as prescribed by your doctor. In case of doubt, consult 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 once daily.
For the treatment of blood clots in the legs, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots
After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily.
The doctor has prescribed Rivertaxo 10 mg once daily.
Swallow the tablet whole, preferably with water.
Rivertaxo may be taken with or without 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.
If necessary, the doctor may administer crushed Rivertaxo tablets via a gastric tube.
When to take Rivertaxo
Take one 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.
To prevent blood clots in the legs after hip or knee replacement surgery
The first tablet should be taken between 6 and 10 hours after surgery.
In patients undergoing major hip surgery, treatment usually lasts 5 weeks. In patients undergoing major knee surgery, treatment usually lasts 2 weeks.
Taking more than the recommended dose of Rivertaxo
If the patient has taken more tablets than recommended, contact the doctor immediately.
Taking too high a dose of Rivertaxo increases the risk of bleeding.
Missing a dose of Rivertaxo
If the patient forgets to take a tablet, take it as soon as remembered. Take the next dose the following day at the usual time and continue as prescribed.
Do not take a double dose to make up for a missed tablet.
Stopping Rivertaxo
Do not stop taking Rivertaxo without consulting your doctor, as this medicine prevents a serious condition.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Like other medicines with a similar mechanism of action that reduce blood clot formation, 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 should contact your doctor immediately if any of the following adverse effects occur:

Adverse effects 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. This is a serious medical emergency. Seek immediate medical help!);
• Prolonged or excessive bleeding;
• Unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide that close monitoring or a change in treatment is necessary.

Adverse effects which may be signs of severe skin reactions

• Widespread acute skin rash, blistering, or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological abnormalities, and systemic involvement. The frequency of these adverse effects is very rare (occurring in up to 1 in 10,000 people).

Adverse effects which may be signs of a serious allergic reaction

• Swelling of the face, lips, mouth, tongue, or throat, urticaria (hives), 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 edema may occur in 1 in 100 people).

General list of possible adverse effects
Common (may occur in 1 out of 10 people):

• Decrease in red blood cells, which may cause paleness of the 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 conjunctiva);
• Bleeding into tissues or body cavities (hematoma, bruising);
• Coughing up blood (hemoptysis);
• 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 the doctor);
• Fever;
• Stomach pain, indigestion, nausea or vomiting, constipation, diarrhea;
• 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 out of 100 people):

• Bleeding into the brain or inside the skull (see bleeding symptoms above);
• Bleeding into joints causing pain and swelling;
• Thrombocytopenia (low platelet count, platelets being blood cells involved in clotting);
• Allergic reactions, including allergic skin reactions;
• Liver function disorders (as indicated by test results ordered by the doctor);
• Blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count;
• Fainting;
• Malaise;
• Rapid heartbeat;
• Dryness of the mouth;
• Urticaria.

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

• Bleeding into muscles;
• Cholestasis (bile stasis), hepatitis including liver cell damage;
• Yellowing of the skin and eyes (jaundice);
• Localized swelling;
• Accumulation of blood (hematoma) in the groin area as a complication of cardiac catheterization procedure involving insertion of a catheter into an artery in the leg (pseudoaneurysm).

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

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

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

• Kidney failure following severe bleeding;
• Bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (drug-induced anticoagulant-related nephropathy);
• Increased pressure within the muscles of arms or legs following bleeding, which may cause pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the 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 stated on the cardboard packaging and blister pack after EXP. The expiry date refers to the last day of the stated month.
No special requirements for storage.
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 will help protect the environment.

6. Contents of the packaging and other information

What Rivertaxo contains

• The active substance is rivaroxaban. Each coated tablet contains 10 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 10 mg is pink, round, biconvex coated tablets, embossed with the number "10" on one side and smooth on the other, with a diameter of approximately 9.1 mm.
Rivertaxo 10 mg is packed in blisters. One pack contains 10 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