Vixargio

Leaflet accompanying the packaging: information for the user

VIXARGIO, 10 mg, film-coated tablets

Rivaroxaban

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

IMPORTANT: The VIXARGIO packaging contains a Patient Warning Card, which contains important safety information. You should always carry this card with you.

Table of contents of the leaflet

• 1. What is VIXARGIO and what is it used for
• 2. Important information before taking VIXARGIO
• 3. How to take VIXARGIO
• 4. Possible side effects
• 5. How to store VIXARGIO
• 6. Contents of the packaging and other information

1. What is VIXARGIO and what is it used for

VIXARGIO contains the active substance rivaroxaban and 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 because the risk of blood clots is increased after surgery.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the veins of the legs and/or lungs.

VIXARGIO 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 VIXARGIO

When not to take VIXARGIO

• -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 that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery);
• if the patient is taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter;
• -if the patient has liver disease that increases the risk of bleeding;
• if the patient is pregnant or breastfeeding.

Do not take VIXARGIO, and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting VIXARGIO, discuss it with your doctor or pharmacist.

When to be particularly careful when taking VIXARGIO

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in the patient's body;
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter (see "VIXARGIO and other medicines");
• bleeding disorders;
• very high blood pressure that does not decrease despite treatment;
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach and intestines or esophagitis (e.g., due to gastroesophageal reflux disease), or tumors in the stomach, intestines, genital, or urinary tract;
• vascular disease in the back of the eye (retinopathy);
• pulmonary disease with dilated bronchi and pus (bronchiectasis) or previous bleeding from the lungs;
• in patients with artificial heart valves;
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether to change the treatment;
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking VIXARGIO. The doctor will decide whether to prescribe this medicine and whether the patient should be closely monitored.

If the patient needs to undergo surgery:

• they must carefully follow the doctor's instructions regarding the intake of VIXARGIO at a specific time before or after surgery;
• if the patient is scheduled for spinal or epidural anesthesia (e.g., for pain relief) or placement of a spinal or epidural catheter:
• they must carefully follow the doctor's instructions regarding the intake of VIXARGIO at a specific time;
• they should immediately inform their doctor if they experience symptoms such as numbness, weakness of the lower limbs, disturbances in bowel or bladder function, or difficulty urinating, as immediate treatment may be necessary.

Children and adolescents

VIXARGIO 10 mg tablets are not recommended for persons under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.

VIXARGIO and other medicines

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

• -If you are taking
• certain medicines for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin;
• ketokonazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol);
• certain medicines for bacterial infections (e.g., clarithromycin, erythromycin);
• certain antiviral medicines for HIV or AIDS treatment (e.g., ritonavir);
• other medicines that prevent 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 for depression [selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)].

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking VIXARGIO, as the effect of VIXARGIO may be enhanced. The doctor will decide whether to prescribe this medicine and whether the patient should be closely monitored.
If the doctor believes that the patient is at increased risk of stomach or intestinal ulcers, they may prescribe preventive treatment.

• -If you are taking
• certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital);
• St. John's Wort (Hypericum perforatum), a herbal medicine used for depression;
• rifampicin, an antibiotic.

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking VIXARGIO, as the effect of VIXARGIO may be reduced when taken with these medicines. The doctor will decide whether to prescribe VIXARGIO and whether the patient should be closely monitored.

Pregnancy and breastfeeding

Do not take VIXARGIO if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking VIXARGIO. If you become pregnant while taking this medicine, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

VIXARGIO 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, ride a bicycle, or operate tools or machines.

VIXARGIO contains lactose and sodium.

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take VIXARGIO

Always take this medicine exactly as your doctor has told you. If you are not sure, 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 10 mg VIXARGIO tablet once a day.
• For 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 VIXARGIO 10 mg once a day for you.

Swallow the tablet whole, preferably with water.
VIXARGIO can be taken with or without food.
If you have difficulty swallowing the whole tablet, you should talk to your doctor about other ways to take VIXARGIO. The tablet can be crushed and mixed with water or soft food, such as apple sauce, just before taking it.
If necessary, your doctor may give you a crushed VIXARGIO tablet through a gastric tube.

When to take VIXARGIO

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:
The first tablet should be taken 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 VIXARGIO than prescribed

If you have taken more VIXARGIO than prescribed, you should immediately contact your doctor. Taking too much VIXARGIO increases the risk of bleeding.

Missing a dose of VIXARGIO

If you forget to take a dose, take the tablet as soon as you remember.
Take the next tablet the next day, and then take the tablets as usual, once a day.
Do not take a double dose to make up for a missed tablet.

Stopping VIXARGIO treatment

Do not stop taking VIXARGIO without first talking to your doctor, as VIXARGIO prevents a serious disease.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, VIXARGIO can cause side effects, although not everybody gets them.
Like other medicines with similar anticoagulant effects, VIXARGIO may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.

Tell your doctor immediately if you experience any of the following side effects:

• 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 stiffness of the neck. This is a serious medical emergency. Seek medical help immediately!);
• prolonged or excessive bleeding;
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide to closely monitor you or change your treatment.
• Signs of severe skin reactions:
• widespread, severe skin rash, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• drug reaction that causes a rash, fever, inflammation of internal organs, hematologic disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (less than 1 in 10,000 people).
• Signs of serious allergic reactions
• swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing; 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 less 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:

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 genital tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums;
• bleeding into the eye (including bleeding from the conjunctiva);
• bleeding into tissues or body cavities (hematoma, bruising);
• presence of blood in sputum (hemoptysis) while coughing;
• bleeding from the skin or subcutaneous bleeding;
• bleeding after surgery;
• oozing of blood or fluid from the wound after surgery;
• swelling of the limbs;
• limb pain;
• kidney function disorders (can be observed in tests performed by your doctor);
• fever;
• stomach pain, nausea (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 certain liver enzymes, which can be seen 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;
• 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;
• liver function disorders (can be observed in tests performed by your doctor).

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;
• collection of blood (hematoma) in the groin as a complication of cardiac catheterization, when a catheter is inserted 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 granulocytic 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 therapy);
• increased pressure in the muscles of the legs and arms after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store VIXARGIO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry Date (EXP) and on each blister or bottle after: EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Crushed tablets
Crushed tablets are stable in water or apple sauce for up to 2 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What VIXARGIO contains

• The active substance of VIXARGIO is rivaroxaban. One film-coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose 2910, sodium lauryl sulfate, magnesium stearate. See section 2 "VIXARGIO contains lactose and sodium". Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), iron oxide red (E 172).

What VIXARGIO looks like and contents of the pack

VIXARGIO 10 mg film-coated tablets are light pink to pink, round, biconvex with beveled edges (diameter 5.4 mm), with the imprint "RX" on one side and "2" on the other side.
The tablets are available in:

• blisters packaged in cardboard boxes containing 10, 30, or 100 film-coated tablets or
• single-dose blisters packaged in cardboard boxes containing 10 × 1, 28 × 1, 30 × 1, 50 × 1, 98 × 1, or 100 × 1 film-coated tablets or
• bottles containing 98 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer/Importer

McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Irlandia
Mylan Germany GmbH
Benzstrasse 1
61352 Bad Homburg
Niemcy
Mylan Hungary Kft
Mylan utca 1
2900 Komárom
Węgry
Medis International a.s.
Prumyslova 961/16
74723 Bolatice
Czechy
To obtain more detailed information on this medicine and its names in the Member States of the European Economic Area, you should contact the local representative of the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00

Date of last revision of the leaflet: