Vixargio

Package leaflet: Information for the user

VIXARGIO, 15 mg, film-coated tablets
VIXARGIO, 20 mg, film-coated tablets
Rivaroxabanum
Please 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 personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

IMPORTANT: The VIXARGIO packaging contains a Patient Alert Card with important safety information. Always carry this card with you.
Contents of the leaflet

1. What VIXARGIO is and what it is used for
2. What you need to know 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 in other blood vessels in the body in patients who have an irregular heart rhythm 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), and to prevent the recurrence of blood clots 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 blood clots and prevent the 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 medicines used to treat blood clots.

VIXARGIO 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 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 active bleeding;
if the patient has a disease or condition affecting an organ that increases the risk of
serious bleeding (e.g. stomach ulcer, trauma or bleeding in the brain, recent surgery
on the brain or eyes);
if the patient is taking other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery;
if the patient has a liver disease that increases the risk of bleeding;
if the patient is pregnant or breastfeeding.
Do not use VIXARGIO and inform your doctor if the patient suspects that any of the above conditions apply.

Warnings and precautions
Before starting treatment with VIXARGIO, discuss this with your doctor or pharmacist.

When to exercise special caution when taking VIXARGIO

• if the patient has an increased risk of bleeding, such as in the following conditions:
• severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body;
• coagulation disorders;
• taking other anticoagulant medicines (e.g. warfarin, etexilate dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "VIXARGIO with other medicines");
• very high blood pressure that does not decrease despite treatment;
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (inflammation of the oesophagus and throat), e.g. due to gastro-oesophageal reflux disease (acid reflux 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 in which the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding;
• 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 if surgery or another treatment to remove a pulmonary clot is planned.

If the patient suspects that any of the above conditions apply, they should inform the
doctor before taking VIXARGIO. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.

If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding the timing of taking VIXARGIO before or after surgery;
• if during surgery catheterisation or spinal puncture (e.g. for epidural or intrathecal anaesthesia or pain relief) is planned:
• strictly follow the doctor's instructions regarding the timing of taking VIXARGIO;
• immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as: numbness, weakness in the lower limbs, difficulty in bowel movement or bladder function, as immediate treatment may be required.

Children and adolescents
VIXARGIO tablets are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of VIXARGIO in children and adolescents for the indications approved in adults.

VIXARGIO with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.

• 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 (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 medicines used to treat depression [selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)].

If the patient suspects that any of the above conditions apply, they should inform the doctor before taking VIXARGIO, as the effect of VIXARGIO may be enhanced. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, they may prescribe treatment to prevent ulcer formation.

• If the patient is taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital);
• St John's wort ( Hypericum perforatum ), a herbal medicine used for depression;
• rifampicin, which belongs to the group of antibiotics.

If the patient suspects that any of the above conditions apply, they should inform the doctor before taking VIXARGIO, as the effect of VIXARGIO may be reduced when taken together with the above-mentioned medicines. The doctor will decide whether to use VIXARGIO and whether the patient requires particularly close monitoring.

Pregnancy and breastfeeding
VIXARGIO must not be used if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with VIXARGIO. If the patient becomes pregnant while taking this medicine, they should inform the doctor immediately, who will decide on further management.

Driving and operating machinery
VIXARGIO 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.

VIXARGIO contains lactose and sodium.
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take VIXARGIO

This medicine should always be taken exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
VIXARGIO should be taken with food.
The tablet(s) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, they should discuss alternative ways of taking VIXARGIO with their doctor. The tablet can be crushed and mixed with water or soft food such as apple puree immediately before administration. After taking this mixture, a meal should be consumed promptly.
If necessary, your doctor may administer crushed VIXARGIO tablets through a gastric tube.

How many tablets to take
Adults

• For the prevention of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one VIXARGIO 20 mg tablet once daily. If the patient has kidney problems, the dose may be reduced to one VIXARGIO 15 mg tablet once daily. If the patient requires a procedure to unblock blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence supporting dose reduction to one VIXARGIO 15 mg tablet once daily (or one VIXARGIO 10 mg tablet once daily in case of renal impairment), in combination with an antiplatelet medicine such as clopidogrel.
• For the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots: The recommended dose is one VIXARGIO 15 mg tablet twice daily for the first 3 weeks. For treatment beyond 3 weeks, the recommended dose is one VIXARGIO 20 mg 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 the patient has kidney problems and is taking one VIXARGIO 20 mg tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one VIXARGIO 15 mg tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.

Children and adolescents
The dose of VIXARGIO depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kg is one VIXARGIO 15 mg tablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one VIXARGIO 20 mg tablet once daily.

Each dose of VIXARGIO should be taken with a meal and with 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: observe the child to ensure they have taken the full dose.

Since the dose of VIXARGIO depends on body weight, it is important to attend scheduled appointments with the doctor, as dose adjustments may be necessary due to changes in weight.
Never adjust the dose on your own. If needed, your doctor will adjust the dose.
Do not split the tablet to achieve a partial dose. If a lower dose is required, a different formulation of the medicine should be used, such as granules for oral suspension.
For children and adolescents who cannot swallow whole tablets, rivaroxaban in the form of granules for oral suspension should be used.
If the oral suspension is not available, the VIXARGIO tablet may be crushed and mixed with water or apple puree immediately before administration. After taking this mixture, a meal should be consumed. If necessary, your doctor may also administer the crushed tablet via a gastric tube.

If a dose is vomited or spat out

• Less than 30 minutes after taking VIXARGIO, take a new dose.
• More than 30 minutes after taking VIXARGIO, do not take a new dose. In this case, take the next dose of VIXARGIO at the usual time.

Contact your doctor if you repeatedly vomit or spit out a dose after taking VIXARGIO.

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 each day, as this makes it 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.

Missed dose of VIXARGIO

• Adults, children and adolescents: If the patient takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet 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 following day, then continue taking one tablet once daily.

Adults:
If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient forgot to take a dose, they 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.

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

Stopping treatment with VIXARGIO
Do not stop taking VIXARGIO without first consulting your doctor, as VIXARGIO treats and prevents serious medical conditions.
If you have any further questions about the use of 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, VIXARGIO 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 immediately inform your doctor if any of the following adverse reactions occur:

• Signs of bleeding:
  • bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness, and neck stiffness. A serious, acute medical emergency. Immediate medical help must be called!);
  • prolonged or excessive bleeding;
  • unusual weakness, fatigue, pallor, 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.
• Signs of severe skin reactions:
  • widespread, acute skin rash, blistering, or lesions on mucous membranes, 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 disorders, and systemic involvement. The frequency of these adverse reactions is very rare (up to 1 in 10,000 people).
• Signs of serious allergic reactions:
  • swelling of the face, lips, oral cavity, tongue, or throat, difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of these 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 reactions:
Common (may occur in 1 out of 10 people)

• decrease in red blood cell count, which may cause skin pallor and lead to weakness or shortness of breath;
• gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding;
• bleeding into the eye (including bleeding from the sclera);
• bleeding into tissues or body cavities (hematoma, bruising);
• presence of blood in sputum (hemoptysis) during coughing;
• bleeding from the skin or under the skin;
• postoperative bleeding;
• oozing of blood or fluid from a surgical wound;
• limb swelling;
• limb pain;
• kidney function disorders (may be observed in tests performed by a doctor);
• fever;
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea;
• low blood pressure (symptoms may include dizziness or fainting upon standing);
• general loss of strength and energy (weakness, fatigue), headache, dizziness;
• rash, itching of the skin;
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in 1 out of 100 people)

• bleeding into the brain or inside the skull (see bleeding signs above);
• bleeding into a joint causing pain and swelling;
• thrombocytopenia (low platelet count, blood cells involved in blood clotting);
• allergic reactions, including allergic skin reactions;
• liver function disorders (may be observed in tests performed by a 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 as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

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

• accumulation of eosinophils, a type of white granulocytic 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 inability of the kidneys to function properly (nephropathy associated with anticoagulant medicines);
• increased pressure within the muscles of arms and legs following 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 VIXARGIO were similar in type to those observed in adults and were mainly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 out of 10 people)

• headache;
• fever;
• nosebleeds, vomiting.
  Common (may occur in 1 out of 10 people)
• rapid heartbeat;
• blood tests may show increased bilirubin levels (a bile pigment);
• thrombocytopenia (low platelet count, blood cells that help in blood clotting);
• excessive menstrual bleeding.
  Uncommon (may occur in 1 out of 100 people)
• blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 directly to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store VIXARGIO

Keep this medicine out of 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 stated month.
No special storage conditions apply for this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 2 hours.
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 pack and other information

What VIXARGIO contains

• The active substance is rivaroxaban. One 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 (E 171), iron oxide red (E 172).

What VIXARGIO looks like and contents of the pack
VIXARGIO 15 mg coated tablets are pink to brick-red, round, biconvex with bevelled edges (diameter 6.4 mm), with an embossed mark "RX" on one side and "3" on the other side.
The tablets are contained in:

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

VIXARGIO 20 mg coated tablets are reddish-brown, round, biconvex with bevelled edges (diameter 7.0 mm), with an embossed mark "RX" on one side and "4" on the other side.
The tablets are contained in:

• blisters packed in cardboard boxes containing 14, 28, 30, 98 or 100 coated tablets, or
• unit-dose blisters packed in cardboard boxes containing 14 × 1, 28 × 1, 30 × 1, 50 × 1, 90 × 1, 98 × 1 or 100 × 1 coated tablets, or
• bottles containing 98 or 100 coated tablets, or
• calendar blisters containing 14, 28 or 98 coated tablets.

Not all pack sizes may be marketed.
Marketing Authorisation 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

For further information about this medicinal product and its trade names in the European Economic Area countries, please contact the local representative of the marketing authorisation holder:
ViatrisHealthcare Sp. z o.o.
Tel: +48 22 546 64 00