Vixargio

Patient Information Leaflet

VIXARGIO, 15 mg, film-coated tablets
VIXARGIO, 20 mg, film-coated tablets
Initiating treatment pack
Do not use in children
Rivaroxaban
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

IMPORTANT: The VIXARGIO packaging contains a Patient Alert Card containing
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 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

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 recurrence of blood clots in the blood vessels of the legs and/or lungs.

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 of an organ that increases the risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes);
• if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a catheter in a vein or artery;
• if the patient has a liver disease that leads to an increased risk of bleeding;
• if the patient is pregnant or breastfeeding.

VIXARGIO must not be used, and the doctor must be informed if the patient
suspects that any of the above circumstances apply.
Warnings and precautions
Before starting to take VIXARGIO, discuss this with your doctor or pharmacist.
When to exercise particular 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;
• blood clotting disorders;
• taking other medicines that prevent blood clots (e.g. warfarin, etexilate dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a catheter in a vein or artery (see section "VIXARGIO with other medicines");
• very high blood pressure that does not decrease despite treatment with medicines;
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach or intestines or in the genital or urinary system;
• blood vessel disease of the posterior part of the eyeball (retinopathy);
• lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs;
• in patients with prosthetic heart valves;
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary;
• if the patient has been diagnosed with abnormal blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If the patient suspects that any of the above conditions apply, the doctor must be informed
before taking VIXARGIO. The doctor will decide whether to use this medicine and whether
the patient should be placed under particularly close observation.
If the patient needs to undergo surgery:

• it is essential to strictly follow the doctor's instructions regarding the timing of taking VIXARGIO before or after surgery;
• if catheterisation or spinal puncture (e.g. for epidural or intrathecal anaesthesia or pain relief) is planned during surgery:
• it is very important to take VIXARGIO before and after the puncture or removal of the catheter, as directed by the doctor;
• due to the need for special caution, the doctor must be informed immediately if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia ends.

Children and adolescents
The VIXARGIO starter pack is not recommended for patients under 18 years of age,
as it is specifically intended for initiating treatment in adult patients and is not suitable for use in children and adolescents.
VIXARGIO with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

• If the patient is taking
• certain medicines used for fungal infections (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 used for bacterial infections (e.g. clarithromycin, erythromycin);
• certain antiviral medicines used for HIV infection or treatment of 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-noradrenaline reuptake inhibitors (SNRIs)].

If the patient suspects that any of the above conditions apply, the doctor must be informed
before taking VIXARGIO, as the effect of VIXARGIO may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be placed under particularly close observation.
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), an herbal remedy used for depression;
• rifampicin, which belongs to the group of antibiotics.

If the patient suspects that any of the above conditions apply, the doctor must be informed
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 should be placed under particularly close observation.
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 must be used during treatment with VIXARGIO. If the patient becomes pregnant while taking this medicine, she must inform the doctor immediately, who will decide on further treatment.
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 intolerance to certain sugars, the patient should consult the 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 as directed by the doctor. If in doubt, consult the 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, discuss alternative ways of taking VIXARGIO with the doctor. The tablet may be crushed and mixed with water or soft food such as apple puree, immediately before administration. After taking this mixture, the patient should immediately eat a meal.

If necessary, the doctor may administer crushed VIXARGIO tablets via a gastric tube.

How many tablets to take

The recommended dose is one 15 mg VIXARGIO tablet twice daily for the first 3 weeks. The recommended dose after 3 weeks of treatment is one 20 mg VIXARGIO tablet once daily.

The starter pack of VIXARGIO 15 mg and 20 mg is intended only for the first 4 weeks of treatment.

After completing the tablets from this pack, treatment will continue with VIXARGIO 20 mg once daily, following consultation with the doctor.

If a patient has kidney problems, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg VIXARGIO tablet once daily, if the risk of bleeding is greater than the risk of developing further blood clots.

When to take VIXARGIO

The tablet should be taken every day until the 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. The doctor will decide how long the patient should continue treatment.

Taking more VIXARGIO than prescribed

If a patient has taken too many VIXARGIO tablets, seek immediate medical advice from a doctor. Taking too high a dose of VIXARGIO increases the risk of bleeding.

Missing a dose of VIXARGIO

If a patient is taking one 15 mg tablet twice daily and has missed a dose, take the tablet as soon as possible. Do not take more than two 15 mg tablets within one day. If a dose was forgotten, the patient 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, resume taking one 15 mg tablet twice daily.

• If a patient is taking one 20 mg tablet once daily and has missed a dose, take the tablet as soon as possible. Do not take more than one tablet in a single day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.

Stopping VIXARGIO treatment

Do not stop taking VIXARGIO without first consulting the doctor, as VIXARGIO treats and prevents serious medical conditions.

If there are any further questions about the use of this medicine, consult the 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 mechanism of action that reduce blood clot formation, 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 assistance 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 of the patient or a change in treatment is necessary.
• Signs of severe skin reactions:
  • widespread, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis);
  • drug reaction with rash, fever, internal organ inflammation, hematological disorders and systemic involvement (DRESS syndrome). The frequency of these adverse reactions is very rare (occurring in up to 1 in 10,000 people).
• Signs of serious allergic reactions
  • swelling of the face, lips, mouth, tongue or throat, difficulty swallowing; urticaria and breathing difficulties; 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 adverse reactions:
Common (may occur in 1 in 10 people)

• reduction in red blood cells, which may cause skin pallor and lead to weakness or shortness of breath;
• gastrointestinal bleeding 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 of the eye);
• bleeding into tissues or body cavities (hematoma, petechiae);
• presence of blood in sputum (hemoptysis) during coughing;
• skin bleeding or subcutaneous bleeding;
• bleeding after surgery;
• 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 arterial blood pressure (symptoms may include dizziness or fainting upon standing);
• general reduction in strength and energy (weakness, fatigue), headache, dizziness;
• rash, skin itching;
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in 1 in 100 people)

• bleeding into the brain or inside the skull (see signs of bleeding above);
• bleeding into a joint causing pain and swelling;
• thrombocytopenia (low platelet count, the 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 in 1,000 people)

• bleeding into muscles;
• cholestasis (bile stasis), hepatitis including liver cell damage;
• yellowing of the skin and eyes (jaundice);
• localized swelling;
• blood collection (hematoma) in the groin area as a complication of cardiac catheterization procedure when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare (may occur in 1 in 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 presence of blood in urine, leading to inability of the kidneys to function properly (drug-induced nephropathy related to anticoagulant medicines);
• increased pressure in the muscles of the arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to 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 are required.
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. These measures help protect the environment.

6. Contents of the pack and other information

What VIXARGIO contains

• The active substance is rivaroxaban. Each coated tablet contains either 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 (E171), iron oxide red (E172).

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.
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.

Starter pack for the first 4 weeks of treatment: each pack containing 49 coated tablets for the first 4 weeks of treatment includes:
One pack containing 42 coated tablets of VIXARGIO 15 mg rivaroxaban (three blisters of 14 × 15 mg marked with the symbol of sun and moon) and one pack containing 7 coated tablets of VIXARGIO 20 mg rivaroxaban (labelled as day 22, day 23, day 24, day 25, day 26, day 27 and day 28).

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 more detailed information about the medicine and its names in the European Economic Area countries, please contact the local representative of the marketing authorisation holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00