Vixargio

Package Leaflet: Information for the User

VIXARGIO, 15 mg, film-coated tablets

VIXARGIO, 20 mg, film-coated tablets

Rivaroxaban

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

Contents of the pack

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

1. What VIXARGIO is and what it is used for

VIXARGIO contains the active substance rivaroxaban and is used in adults to:

• prevent blood clots in the brain (stroke) and other blood vessels in the body, if you have a form of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem;
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent blood clots from forming again in the blood vessels of the legs and/or lungs. VIXARGIO is used in children and adolescents under 18 years of age and weighing 30 kg or more to:
• treat and prevent blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

VIXARGIO belongs to a group of medicines called anticoagulants. Its action is to block a blood clotting factor (factor Xa) and thus reduce the tendency to form blood clots.

2. Before you take VIXARGIO

When not to take VIXARGIO

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 condition of an organ that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery);

if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to VIXARGIO or when heparin is given to maintain catheter patency in a vein or artery;

if you have liver disease that increases the risk of bleeding;

if you are pregnant or breastfeeding.

Do not take VIXARGIO and inform your doctorif you think any of the above applies to you.

Warnings and precautions

Before taking VIXARGIO, discuss this with your doctor or pharmacist.

When to be extra careful while taking VIXARGIO

• if you have 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 in the body;
• bleeding disorders;
• taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when switching to VIXARGIO or when heparin is given to maintain catheter patency in a vein or artery (see "VIXARGIO with other medicines");
• very high blood pressure that does not decrease with medication;
• 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 in the stomach, intestines, genital or urinary system;
• vascular disease in the back of the eye (retinopathy);
• pulmonary disease with dilated bronchi and pus (bronchiectasis) or previous bleeding in the lungs;
• in patients with artificial heart valves;
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment;
• if you have abnormal blood pressure or are scheduled for surgery to remove a blood clot from the lungs.

If you think any of the above conditions apply to you, inform your

doctorbefore taking VIXARGIO. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.

If you need to have surgery:

• you must carefully follow your doctor's instructions regarding the intake of VIXARGIO at a specific time before or after surgery;
• if catheterization or spinal puncture is planned during surgery (e.g. for spinal anesthesia or pain relief):
• you must carefully follow your doctor's instructions regarding the intake of VIXARGIO at a specific time;
• you should immediately inform your doctor if you experience symptoms such as numbness, weakness of the lower limbs, disturbances in bowel or bladder function after anesthesia, as immediate treatment may be necessary.

Children and adolescents

VIXARGIO tablets are not recommended for children with a body weight below 30 kg.

There is limited data on the use of VIXARGIO in children and adolescents for the indications in adults.

VIXARGIO with 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 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 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 you think any of the above conditions apply to you, inform your

doctorbefore taking VIXARGIO, as the effect of VIXARGIO may be increased. Your doctor will decide whether to use this medicine and whether you need to 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 during treatment with VIXARGIO. If you become pregnant during treatment with 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 been told that you have an 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 essentially "sodium-free".

3. How to take VIXARGIO

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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 puree, immediately before taking. After taking this mixture, you should eat a meal immediately.

If necessary, your doctor may also give you a crushed VIXARGIO tablet through a gastric tube.

How much to take

Adults

• In the prevention of blood clots in the brain (stroke) and other blood vessels in the body, the recommended dose is one 20 mg VIXARGIO tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg VIXARGIO tablet once daily. If you need a procedure to open up the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one 15 mg VIXARGIO tablet once daily (or one 10 mg VIXARGIO tablet once daily in case of kidney function impairment) in combination with an antiplatelet agent such as clopidogrel.
• In the treatment of blood clots in the veins of the legs, blood clots in the lungs, and to prevent blood clots from forming again, the recommended dose is one 15 mg VIXARGIO tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg VIXARGIO tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If you have kidney problems and are taking one 20 mg VIXARGIO tablet once daily, your doctor may decide to reduce the dose to one 15 mg VIXARGIO tablet once daily after 3 weeks of treatment, if the risk of bleeding is higher than the risk of further blood clots.

Children and adolescents

The dose of VIXARGIO depends on body weight and will be calculated by your doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one VIXARGIO 15 mgtablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one VIXARGIO 20 mgtablet once daily. Each dose of VIXARGIO should be taken with a meal, with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. It's a good idea to set an alarm to remind you. For parents or caregivers: you should observe the child to make sure they take the whole dose.

The dose of VIXARGIO is dependent on body weight, so it's essential to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes.

Never adjust the dose yourself.If necessary, your doctor will adjust the dose.

Do not split the tablet to get a partial dose. If a smaller dose is needed, you should use a different form of the medicine, such as an oral suspension.

For children and adolescents who are unable to swallow whole tablets, rivaroxaban should be used in the form of an oral suspension.

If the oral suspension is not available, you can crush the VIXARGIO tablet and mix it with water or apple puree immediately before taking. After taking this mixture, you should eat a meal immediately.

If necessary, your doctor may also give you a crushed VIXARGIO tablet through a gastric tube.

If you spit out a dose or vomit

• less than 30 minutes after taking VIXARGIO, you should take a new dose.
• more than 30 minutes after taking VIXARGIO, do nottake a new dose. In this case, take the next dose of VIXARGIO at the usual time.

You should contact your doctor if you spit out a dose or vomit repeatedly after taking VIXARGIO.

When to take VIXARGIO

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

It's best to take the tablet at the same time every day, as it's easier to remember.

Your doctor will decide how long you should continue treatment.

Prevention of blood clots in the brain (stroke) and other blood vessels in the body:

If your heart rhythm needs to be restored to normal using a procedure called cardioversion, you should take VIXARGIO as directed by your doctor.

Missing a dose of VIXARGIO

• Adults, children, and adolescents: If you take one 20 mg or one 15 mg tablet oncedaily 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 a missed dose. Take the next tablet the next day, and then take one tablet once daily.

Adults:

If you take one 15 mg tablet twicedaily 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 miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in one day.

Take the next dose the next day, and then continue taking one 15 mg tablet twice daily.

Taking more VIXARGIO than you should

If you take more VIXARGIO tablets than you should, contact your doctor immediately.

Taking more VIXARGIO than you should increases the risk of bleeding.

Stopping VIXARGIO treatment

Do not stop taking VIXARGIO without first talking to your doctor, as VIXARGIO treats and prevents serious diseases.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Like other medicines that prevent blood clots, VIXARGIO may cause bleeding, which can be life-threatening.

Excessive bleeding may lead to a sudden drop in blood pressure (shock). These bleeding symptoms may not always be obvious or visible.

You should immediately inform your doctor 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 in the neck. This is a serious medical emergency. You should immediately seek medical attention!);
• prolonged or excessive bleeding;
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide to monitor you closely 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, blood disorders, and systemic symptoms (DRESS syndrome). The frequency of these side effects is very rare (less than 1 in 10,000 people).
• Signs of severe 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 these 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 reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums;
• bleeding into the eye (including bleeding into the white of the eye);
• bleeding into tissues or body cavities (hematoma, bruising);
• presence of blood in sputum when coughing;
• bleeding from the skin or bleeding under the skin;
• bleeding after surgery;
• oozing of blood or fluid from a wound after surgery;
• swelling of the limbs;
• limb pain;
• kidney function disorders (which can be observed in tests performed by your doctor);
• fever;
• stomach pain, nausea, feeling sick, 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;
• 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 a joint, causing pain and swelling;
• thrombocytopenia (low platelet count, cells involved in blood clotting);
• allergic reactions, including allergic skin reactions;
• kidney function disorders (which can be observed in tests performed by your doctor);
• blood test results may show increased bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count;
• fainting;
• feeling unwell;
• rapid heartbeat;
• dry mouth;
• hives.

Rare(may affect up to 1 in 1,000 people)

• bleeding into the muscles;
• cholestasis (bile stasis), liver inflammation, 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 blood cell, 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;
• kidney bleeding, 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).

Side effects in children and adolescents

Overall, the side effects seen in children and adolescents treated with VIXARGIO were similar in type to those seen in adults and were mostly mild to moderate.

Side effects seen more frequently in children and adolescents:

Very common(may affect more than 1 in 10 people)

• headache;
• fever;
• nosebleeds, vomiting.

Common(may affect up to 1 in 10 people)

• rapid heartbeat;
• blood test results may show increased bilirubin levels;
• thrombocytopenia (low platelet count);
• excessive menstrual bleeding.

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased direct bilirubin levels.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly to the national reporting system: Department of Drug Safety, 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. You can also report side effects 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 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. and on each blister or bottle after EXP. The expiry date refers to the last day of the month stated.

There are no special storage instructions for this medicine.

Crushed tablets

Crushed tablets are stable in water or apple puree for up to 2 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What VIXARGIO contains

• The active substance is rivaroxaban. One film-coated tablet contains 15 mg or 20 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 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.

The tablets are available in:

• blister packs in cardboard boxes containing 14, 28, 30, 42, 98, or 100 film-coated tablets or
• unit dose blister packs in cardboard boxes containing 14 × 1, 28 × 1, 30 × 1, 42 × 1, 50 × 1, 98 × 1, or 100 × 1 film-coated tablets or
• bottles containing 98 or 100 film-coated tablets.

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.

The tablets are available in:

• blister packs in cardboard boxes containing 14, 28, 30, 98, or 100 film-coated tablets or
• unit dose blister packs in cardboard boxes containing 14 × 1, 28 × 1, 30 × 1, 50 × 1, 90 × 1, 98 × 1, or 100 × 1 film-coated tablets or
• bottles containing 98 or 100 film-coated tablets or
• calendar blister packs containing 14, 28, or 98 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

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 on this medicine and its authorized names in the European Economic Area, you should contact the local representative of the marketing authorization holder:

ViatrisHealthcare Sp. z o.o.

Tel: +48 22 546 64 00

Date of last revision of the leaflet: