Vixargio

Leaflet accompanying the packaging: information for the user

VIXARGIO, 15 mg, film-coated tablets

VIXARGIO, 20 mg, film-coated tablets

Treatment initiation packaging

Do not use in children
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 as yours.
• 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.

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:

• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and to prevent the recurrence of blood clots in the blood vessels 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 of the body that leads to an increased 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 the formation of blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery catheter;
• -if the patient has liver disease that leads to an increased 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 in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine that works in the patient's body;
• bleeding disorders;
• taking other medicines that prevent the formation of blood clots (e.g., warfarin, dabigatran, apixaban, or heparin) when changing anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery catheter (see "VIXARGIO and other medicines");
• very high blood pressure that does not decrease despite treatment;
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines and stomach or esophageal inflammation (e.g., due to gastroesophageal reflux disease), or tumors located in the stomach, intestines, genital, or urinary system;
• vascular disease of the back of the eye (retinopathy);
• pulmonary disease in which the bronchi are dilated and filled with 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 been diagnosed with 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 use this medicine and whether the patient should be closely monitored.

If the patient needs to have surgery:

• they must follow their doctor's instructions regarding the intake of VIXARGIO at a strictly specified time before or after surgery;
• if catheterization or spinal puncture is planned during surgery (e.g., for epidural or spinal anesthesia or pain relief):
• it is very important to take VIXARGIO before and after the puncture or catheter removal, according to the doctor's instructions;
• due to the need for special caution, the patient should immediately inform their doctor if they experience numbness or weakness of the legs, bowel or bladder disorders after anesthesia.

Children and adolescents

The VIXARGIO treatment initiation packaging is not recommended for persons under 18 years of age, as it is specifically designed for the initiation of treatment in adult patients and is not suitable for use in children and adolescents.

VIXARGIO and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained 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 norepinephrine 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 increased. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.
If the doctor believes that the patient is at risk of developing stomach or intestinal ulcers, they may use preventive treatment.

• -If you are taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital);
• St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression;
• rifampicin, which belongs to a group of antibiotics.

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 use 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 the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take VIXARGIO

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
VIXARGIO should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing whole tablets, 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, immediately before taking it. After such a mixture, you should take a meal immediately.
If necessary, your doctor may administer a crushed VIXARGIO tablet through a gastric tube.

How many tablets to take

The recommended dose is one 15 mg VIXARGIO tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg VIXARGIO tablet once a day.
The VIXARGIO treatment initiation packaging of 15 mg and 20 mg is intended only for the first 4 weeks of treatment.
After taking the tablets from this packaging, treatment will be continued with a 20 mg VIXARGIO tablet once a day after consulting your doctor.
If you have kidney problems, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg VIXARGIO tablet once a day, if the risk of bleeding is greater than the risk of recurrent blood clots.

When to take VIXARGIO

Take the tablet every day until your doctor decides to stop 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 treatment.

Taking more VIXARGIO than prescribed

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

Missing a dose of VIXARGIO

If you are taking one 15 mg tablet twice a day and you miss a dose, take it as soon as possible. Do not take more than two 15 mg tablets in one day. If you forget to take a dose, you 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, continue taking one 15 mg tablet twice a day.

• If you are taking one 20 mg tablet once a day and you miss a dose, take it as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the next day, and then take one tablet once a day.

Stopping VIXARGIO treatment

Do not stop taking VIXARGIO without first consulting your doctor, as VIXARGIO treats and prevents serious diseases.
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 blood clot-reducing effects, VIXARGIO may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). These signs of bleeding may not always be obvious or visible.

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, paleness, 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 or mucous membranes, such as the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• drug reaction that causes a 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).
• 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 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 paleness of the skin and be the cause of weakness or shortness of breath;
• bleeding from the stomach or intestines, bleeding from the urinary or genital 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);
• appearance of blood in sputum (hemoptysis) while coughing;
• bleeding from the skin or subcutaneous bleeding;
• bleeding after surgery;
• oozing of blood or fluid from a 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) or vomiting, constipation, diarrhea;
• low blood pressure (symptoms may include dizziness or fainting when standing up);
• general decrease in strength and energy (weakness, fatigue), headache, dizziness;
• rash, itching of the skin;
• increased activity of some 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 a joint, causing pain and swelling;
• thrombocytopenia (low platelet count, cells involved in blood clotting);
• allergic reactions, including allergic skin reactions;
• liver function disorders (can be observed in tests performed by your 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 muscles;
• cholestasis (bile stagnation), hepatitis, including liver cell damage;
• jaundice (yellowing of the skin and eyes);
• local swelling;
• blood accumulation (hematoma) in the groin as a complication of heart 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 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 drugs);
• 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 any side effects 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VIXARGIO

Keep the 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 15 mg or 20 mg of rivaroxaban.
• 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 (E171), iron oxide red (E172).

What VIXARGIO looks like and contents of the packaging

VIXARGIO 15 mg film-coated tablets are pink to reddish-brown, round, biconvex with beveled edges (diameter 6.4 mm), with the imprint "RX" on one side and "3" on the other side.
VIXARGIO 20 mg film-coated tablets are reddish-brown, round, biconvex with beveled edges (diameter 7.0 mm), with the imprint "RX" on one side and "4" on the other side.
Treatment initiation packaging for the first 4 weeks of treatment: each packaging contains 49 film-coated tablets for the first 4 weeks of treatment and includes:
One packaging containing 42 film-coated tablets of VIXARGIO 15 mg rivaroxaban (three blisters of 14 × 15 mg with sun and moon symbols) and one packaging containing 7 film-coated tablets of VIXARGIO 20 mg rivaroxaban (marked as day 22, day 23, day 24, day 25, day 26, day 27, and day 28).

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
Ireland
Mylan Germany GmbH
Benzstrasse 1
61352 Bad Homburg
Germany
Mylan Hungary Kft
Mylan utca 1
2900 Komárom
Hungary
Medis International a.s.
Prumyslova 961/16
74723 Bolatice
Czech Republic
To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, 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: