Vixargio

Package leaflet: Information for the user

VIXARGIO, 10 mg, coated tablets
Rivaroxaban
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• 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 Warning 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 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:

• prevent blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of developing blood clots is increased after surgery.
• 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 for blood clots to form.

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 leads to an increased 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 the patency of an intravenous or arterial catheter;
• if the patient has a liver disease that leads to an increased risk of bleeding;
• if the patient is pregnant or breastfeeding.

Do not use VIXARGIO and inform your doctor if you suspect that any of the above circumstances apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking VIXARGIO.
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, as kidney function may affect the amount of medicine acting in the patient's body;
• taking other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of an intravenous or arterial catheter (see section "VIXARGIO with other medicines");
• coagulation disorders;
• very high blood pressure that does not decrease despite medication;
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (inflammation of the throat and oesophagus), e.g. due to gastroesophageal reflux disease (acid reflux into the oesophagus), or tumours located in the stomach or intestines, or in the genital or urinary system;
• vascular disease of the posterior segment of the eyeball (retinopathy);
• lung disease with bronchiectasis (dilated bronchi filled with pus) or previous pulmonary haemorrhage;
• in patients with prosthetic heart valves;
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of thrombosis), the patient should inform the doctor, who will decide whether treatment adjustment is necessary;
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a pulmonary embolus.

If you suspect that any of the above conditions apply to you, inform your 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 a lumbar puncture or placement of a spinal catheter is planned (e.g. for epidural or intrathecal anaesthesia or for pain relief):
• 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, disturbances in bowel movement or bladder function, as immediate treatment is required in such cases.

Children and adolescents
VIXARGIO 10 mg tablets are not recommended for patients under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.
VIXARGIO with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

• If the patient is taking
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used topically on the skin only;
• 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 (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)].

If you suspect that any of the above conditions apply to you, inform your 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 gastric or intestinal ulcers, preventive treatment may be prescribed.

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

If you suspect that any of the above conditions apply to you, inform your 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
Do not use VIXARGIO if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use an effective method of contraception during treatment with VIXARGIO. If you become pregnant while taking this medicine, inform your 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 you have previously been diagnosed with intolerance to certain sugars, you should consult your 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 physician. In case of doubt, consult
your doctor or pharmacist.
How many tablets to take

• To prevent the formation of blood clots in veins after hip or knee replacement surgery: The recommended dose is one tablet of VIXARGIO 10 mg taken once daily.
• For the treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and to prevent recurrence of such clots: After at least 6 months of treatment for blood clots, the recommended dose is either one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed VIXARGIO 10 mg once daily for you.

Swallow the tablet whole, preferably with water.
VIXARGIO may be taken with or without food.
If you have difficulty swallowing the whole tablet, discuss alternative methods of administration
of VIXARGIO with your doctor. The tablet may be crushed and mixed with water or soft food,
such as apple puree, immediately before administration.
If necessary, your doctor may administer crushed VIXARGIO tablets via a gastric tube.
When to take VIXARGIO
Take one 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 treatment should continue.
To prevent blood clots in leg veins after hip or knee replacement surgery:
Take the first tablet between 6 and 10 hours after surgery.
In patients undergoing major hip surgery, treatment usually lasts 5 weeks.
In patients undergoing major knee surgery, treatment usually lasts 2 weeks.
Taking more VIXARGIO than prescribed
If you have taken more VIXARGIO than prescribed, contact your doctor immediately.
Taking too high a dose of VIXARGIO increases the risk of bleeding.
Missing a dose of VIXARGIO
If you forget to take a dose, take the tablet as soon as you remember.
Take the next tablet the following day, then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a missed tablet.
Stopping VIXARGIO treatment
Do not stop taking VIXARGIO without first discussing it with your doctor, as VIXARGIO helps prevent serious illness.
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 experiences them.
As with other medicines of similar action that reduce blood clot formation, VIXARGIO
may cause bleeding, which could potentially 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 sought!);
  • 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 lesions of 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 (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 out of 10 people)

• reduction in red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath;
• bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums;
• bleeding into the eye (including bleeding from the white part of the eye);
• bleeding into tissues or body cavities (hematoma, petechiae);
• presence of blood in sputum (hemoptysis) during coughing;
• bleeding from the skin or subcutaneous bleeding;
• bleeding after surgery;
• oozing of blood or fluid from a surgical wound;
• swelling of limbs;
• 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 seen in blood test results.

Uncommon (may occur in 1 out of 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, blood cells involved in blood clotting);
• allergic reactions, including allergic skin reactions;
• blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count;
• fainting;
• malaise;
• rapid heartbeat;
• dry mouth;
• urticaria;
• liver function disorders (may be observed in tests performed by a doctor).

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 unknown (frequency cannot be determined from available data)

• kidney failure following severe bleeding;
• bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (drug-induced 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 after 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
(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 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. These measures will help protect
the environment.

6. Contents of the packaging and other information

What VIXARGIO contains

• The active substance is rivaroxaban. One coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, 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 10 mg coated tablets are light pink to pink, round, biconvex with bevelled edges (diameter 5.4 mm), embossed with "RX" on one side and "2" on the other side.
The tablets are contained in:

• blisters packed in cardboard boxes containing 10, 30 or 100 coated tablets, or
• unit dose blisters packed in cardboard boxes containing 10 × 1, 28 × 1, 30 × 1, 50 × 1, 98 × 1 or 100 × 1 coated tablets, or
• bottles containing 98 or 100 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 more detailed information about the medicine and its trade 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