Vixargio

Package Leaflet: Information for the User

VIXARGIO, 2.5 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. Important information before taking 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

You have been given VIXARGIO because:

• you have been diagnosed with acute coronary syndrome (a condition where the blood flow to the heart is suddenly blocked, including heart attack and unstable angina, severe chest pain) and have elevated levels of cardiac biomarkers. VIXARGIO reduces the risk of having another heart attack or reduces the risk of death from heart or blood vessel disease in adults. VIXARGIO will not be given to you as the only medicine. Your doctor will also prescribe you to take:
• aspirin or
• aspirin and clopidogrel or ticlopidine

or

• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. VIXARGIO reduces the risk of blood clots (atherothrombotic events) in adults. VIXARGIO will not be given to you as the only medicine. Your doctor will also prescribe you to take aspirin.

In some cases, if you are taking VIXARGIO after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin.
VIXARGIO contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

2. Important information before taking 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 the body 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 that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching from one anticoagulant to another or when heparin is given to maintain the patency of a venous or arterial catheter;
• if you have had acute coronary syndrome and have had bleeding or blood clots in the brain (stroke);
• if you have coronary artery disease or peripheral arterial disease and have had bleeding in the brain (stroke) or blockage of small arteries supplying blood to the brain tissues (cerebral venous sinus thrombosis) or if you have had a blood clot in the brain (ischemic stroke) in the last month;
• -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 conditions apply to you.

Warnings and precautions

Before taking VIXARGIO, discuss it with your doctor or pharmacist.
VIXARGIO should not be taken with other medicines that prevent blood clotting, such as prasugrel or ticagrelor.

When to be extra careful while taking VIXARGIO

• if you have an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in your body;
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching from one anticoagulant to another or when heparin is given to maintain the patency of a venous or arterial catheter (see section "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 intestines and stomach or inflammation of the esophagus (esophagitis) e.g. due to gastroesophageal reflux disease (GERD), or tumors in the stomach, intestines, genital or urinary tract;
• disease of the blood vessels in the back of the eye (retinopathy);
• lung disease where the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs;
• if you are over 75 years old;
• if you weigh less than 60 kg;
• coronary artery disease with severe symptomatic heart failure;
• in patients with prosthetic 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 think any of the above conditions apply to you, inform

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

If you need to have surgery:

• you must carefully follow your doctor's instructions about taking VIXARGIO at a specific time before or after surgery;
• if catheterization or spinal puncture is planned (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, as instructed by your doctor;
• due to the need for extra caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia.

Children and adolescents

VIXARGIO 2.5 mg tablets are not recommended for people under 18 years of age. There is not enough 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 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;
• oral ketoconazole (used to treat Cushing's syndrome, a condition where the body produces too much cortisol);
• certain medicines for bacterial infections (e.g. clarithromycin, erythromycin);
• certain antiviral medicines for HIV or AIDS (e.g. ritonavir);
• other medicines that prevent blood clotting [e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol, prasugrel and ticagrelor (see section "Warnings and precautions")];
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or aspirin);
• dronedarone, a medicine for heart rhythm disorders;
• certain medicines for depression [selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline 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 give you this medicine and whether you need to be closely monitored.
If your doctor thinks you are at risk of stomach or intestinal ulcers, they may give you a medicine to prevent ulcers.

• -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 you think any of the above conditions apply to you, inform

your doctorbefore taking VIXARGIO, as the effect of VIXARGIO may be reduced if taken with these medicines. Your doctor will decide whether to give you VIXARGIO 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 while taking VIXARGIO. If you become pregnant while taking this medicine, tell your doctor immediately, who will decide on further treatment.

Driving and using machines

VIXARGIO may cause dizziness (common side effect) and fainting (uncommon side effect), see section 4. "Possible side effects". Patients who experience these side effects should not drive, ride a bicycle or use tools or machines.

VIXARGIO contains lactose and sodium.

If you have been told that you have an intolerance to some sugars, 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.

How much to take

The recommended dose is one 2.5 mg tablet twice a day. VIXARGIO should be taken at the same time every day (e.g. one tablet in the morning and one in the evening). This medicine can be taken with or without food.
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, just before taking it.
If necessary, your doctor may give you a crushed VIXARGIO tablet through a gastric tube.
VIXARGIO will not be given to you as the only medicine.
Your doctor will also prescribe you to take aspirin. If you are taking VIXARGIO after acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine for you to take.
If you are taking VIXARGIO after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin.
Your doctor will tell you what dose of these medicines to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin and a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start taking VIXARGIO

Treatment with VIXARGIO after acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the latest 24 hours after hospital admission and when parenteral (given by injection) anticoagulant treatment would normally be discontinued.
Your doctor will tell you when to start treatment with VIXARGIO if you have been diagnosed with coronary artery disease or peripheral arterial disease.
Your doctor will decide how long you should continue treatment.

If you take more VIXARGIO than you should

If you take more VIXARGIO than you should, contact your doctor immediately. Taking more VIXARGIO than recommended may increase the risk of bleeding.

If you forget to take VIXARGIO

Do not take a double dose to make up for a forgotten dose. If you forget a dose, take the next dose at the scheduled time.

If you stop taking VIXARGIO

VIXARGIO should be taken regularly and for the duration recommended by your doctor.
Do not stop taking VIXARGIO without first talking to your doctor. If you stop taking this medicine, you may increase the risk of having another heart attack, stroke, or death from heart or blood vessel disease.
If you have any further questions on the use of this medicine, 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). Not all of these signs of bleeding will 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 stiff neck. A serious and sudden medical condition. 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, blood disorders and systemic symptoms (DRESS syndrome). The frequency of these side effects is very rare (up to 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 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)

• reduced number of red blood cells, which can 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, gum bleeding;
• 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 problems (which can be seen 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 weakness and lack of energy (weakness, fatigue), headache, dizziness;
• rash, itching;
• 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 problems (which can be seen in tests performed by your doctor);
• blood test results may show increased levels of bilirubin, 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 the muscles;
• cholestasis (bile flow obstruction), liver inflammation, including liver cell damage;
• yellowing of the skin and eyes (jaundice);
• 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.

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;
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulants);
• increased pressure in the muscles of the legs and arms after bleeding, which can cause pain, swelling, changes in sensation, numbness or paralysis (compartment syndrome after bleeding).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 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 that month.
There are no special storage instructions for this 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 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 2.5 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose 2910, sodium lauryl sulfate, magnesium stearate, yellow iron oxide (E172). See section 2 "VIXARGIO contains lactose and sodium". Tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), yellow iron oxide (E172).

What VIXARGIO looks like and contents of the pack

VIXARGIO 2.5 mg film-coated tablets are light yellow to yellow, round, biconvex with beveled edges (diameter 5.4 mm), with "RX" engraved on one side and "1" on the other side.
The tablets are available in:

• blisters packaged in cardboard boxes containing 10, 28, 56, 60, 100 or 196 film-coated tablets or
• single-dose blisters packaged in cardboard boxes containing 28 × 1, 30 × 1, 56 × 1, 60 × 1 or 90 × 1 film-coated tablets or
• bottles containing 98, 100 or 196 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 authorized 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: