Xanirva

Leaflet accompanying the packaging: Patient information

Xanirva, 2.5 mg, film-coated tablets

Rivaroxaban

You should read the contents of this leaflet before taking the medicine because it contains important information for you.

• You should keep this leaflet so that you can read it again if you need to.
• You should consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Xanirva and what is it used for

You have been given Xanirva because:

• you have been diagnosed with acute coronary syndrome (a group of diseases including heart attack and unstable angina, a severe type of chest pain) and have elevated levels of cardiac biomarkers. Xanirva reduces the risk of having another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Xanirva 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. Xanirva reduces the risk of blood clots (atherothrombotic events) in adults. Xanirva 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 given Xanirva 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.

Xanirva contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block a blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

2. Important information before taking Xanirva

When not to take Xanirva:

• -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 leads to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into 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 anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter;
• if you have had an acute coronary syndrome and have had bleeding or a blood clot 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 tissues in the deep structures of the brain (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 leads to an increased risk of bleeding;
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Before taking Xanirva, you should consult your doctor or pharmacist. Xanirva should not be taken with other blood clotting inhibitors, such as prasugrel or ticagrelor, except for aspirin, clopidogrel or ticlopidine.

When to be particularly careful when taking Xanirva

• if you have increased risk of bleeding, in such conditions 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 anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter (see section "Other medicines and Xanirva");
• bleeding disorders;
• very high blood pressure that does not decrease despite taking medicines;
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to reflux disease of the esophagus (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system;
• disease of the blood vessels in the back of the eye (retinopathy);
• pulmonary disease in which the bronchi are dilated 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;
• if you have coronary heart disease with symptoms of severe heart failure;
• in patients with artificial heart valves;
• in patients with antiphospholipid syndrome (disorders of the immune system that cause increased risk of blood clots).

Inform your doctor, who will decide whether to change your treatment if necessary.

If you think any of the above applies to you, you should inform

your doctorbefore taking Xanirva. Your doctor will decide whether to use this medicine and whether you should be monitored particularly closely.

If you are going to have surgery:

• it is very important to take Xanirva before and after surgery at the times specified by your doctor;
• if catheterization or lumbar puncture is planned during surgery (e.g. for spinal anesthesia or epidural anesthesia or to relieve pain):
• it is very important to take Xanirva before and after the procedure at the times specified by your doctor;
• you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems, or other symptoms after anesthesia, as immediate treatment may be necessary.

Children and adolescents

Xanirva 2.5 mg tablets are not recommended for people under 18 years of age. There is limited data on the use of this medicine in children and adolescents.

Xanirva and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription.

• -If you are taking:
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin;
• oral ketoconazole (used to treat Cushing's syndrome, in which the body produces too much cortisol);
• certain antibacterial medicines (e.g. clarithromycin, erythromycin);
• certain antiviral medicines used to treat HIV or AIDS (e.g. ritonavir);
• other medicines that reduce blood clotting [e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin and acenocoumarol, prasugrel and ticagrelor (see section "Warnings and precautions")];
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or aspirin);
• dronedarone, a medicine used to treat heart rhythm disorders;
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If you think any of the above applies to you, you should inform

your doctorbefore taking Xanirva, as the effect of Xanirva may be increased. Your doctor will decide whether to use this medicine and whether you should be monitored particularly closely.
If your doctor thinks you are at increased risk of developing stomach or intestinal ulcers, they may use a treatment to prevent ulcers.

• -If you are taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital);
• St. John's Wort ( Hypericum perforatum), a herbal medicine used

in depression;

• rifampicin, which belongs to a group of antibiotics.

If you think any of the above applies to you, you should inform

your doctorbefore taking Xanirva, as the effect of Xanirva may be reduced when taken with these medicines. Your doctor will decide whether to use Xanirva and whether you should be monitored particularly closely.

Pregnancy and breastfeeding

Xanirva should not be taken if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking Xanirva. If you become pregnant while taking this medicine, you should inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Xanirva may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4, "Possible side effects").
Patient who experience these side effects should not drive, ride a bicycle or operate machinery.

Xanirva contains lactose monohydrate (a type of sugar) and sodium

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Xanirva

This medicine should always be taken exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Xanirva 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 the whole tablet, you should talk to your doctor about other ways to take Xanirva. The tablet can be crushed and mixed with water or soft food, such as apple puree, immediately before taking.
If necessary, your doctor may give you a crushed Xanirva tablet through a gastric tube.
Xanirva will not be given to you as the only medicine.
Your doctor will also prescribe you to take aspirin. If you are given Xanirva after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine for you to take.
If you are given Xanirva 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 doses to take (usually 75 to 100 mg of aspirin per day, or a daily dose of 75 to 100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start treatment with Xanirva

Treatment with Xanirva after an acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the latest 24 hours after hospitalization and when parenteral anticoagulant therapy is normally discontinued.
Your doctor will tell you when to start treatment with Xanirva if you have been diagnosed with coronary artery disease or peripheral arterial disease.
Your doctor will decide how long to continue treatment.

Taking a higher dose of Xanirva than recommended

If you have taken a higher dose of Xanirva than recommended, you should contact your doctor immediately. Taking too much Xanirva increases the risk of bleeding.

Missing a dose of Xanirva

Do not take a double dose to make up for a missed dose. If you miss a dose, you should take the next dose at the normal time.

Stopping treatment with Xanirva

Xanirva should be taken regularly and for the duration specified by your doctor.
Do not stop taking Xanirva without consulting your doctor first.
If you stop taking this medicine, you may increase the risk of having another heart attack, stroke, or death due to heart or blood vessel disease.
If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xanirva can cause side effects, although not everybody gets them.
Like other medicines that reduce blood clotting, Xanirva may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). The signs of bleeding may not always be obvious or visible.
You should immediately inform your doctorif 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 of the neck. A serious medical emergency. You should immediately seek medical help!),
• prolonged or heavy bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina. Your doctor may decide to monitor you very closely or change your treatment.

Signs of severe skin reactions:

• widespread, severe skin rash, blistering or lesions on the mucous membranes, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, inflammation of internal organs, hematological and systemic disorders (DRESS syndrome). These side effects are very rare (may occur in less than 1 in 10,000 people).

Signs of a severe allergic reaction:

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequency of 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)

• reduction in red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath
• bleeding from the stomach or intestine, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• bleeding into the eye (including bleeding from the conjunctiva)
• bleeding into tissues or body cavities (hematoma, bruising)
• presence of blood in sputum when coughing (hemoptysis)
• 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 (can be seen in tests performed by your doctor)
• fever
• stomach pain, nausea (nausea), vomiting, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• increase in the 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 (can be seen in tests performed by your doctor)
• blood test results may show increased levels of bilirubin, some liver or pancreatic 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 stagnation), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes)
• local swelling
• accumulation of blood (hematoma) in the groin as a complication of heart 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 granular blood cells, which can cause

inflammation in the lungs (eosinophilic pneumonia).
Frequency not known(cannot be estimated from the available data)

• kidney failure after severe bleeding
• bleeding in the kidneys, 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 occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness or paralysis (compartment syndrome after bleeding)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. 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
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.

5. How to store Xanirva

Medicines should be kept out of the sight and reach of children.
There are no special precautions for storing this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Xanirva contains

• The active substance of Xanirva is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• Xanirva also contains: tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose 2910, sodium lauryl sulfate, magnesium stearate. coating: hypromellose 2910, titanium dioxide (E 171), macrogol, iron oxide yellow (E 172).

What Xanirva looks like and contents of the pack

Xanirva 2.5 mg: yellow, round, biconvex film-coated tablets with a diameter of about 5 mm, with the inscription "2.5" on one side, smooth on the other.
Xanirva is available in packs of 20, 28, 56, 100, 168 or 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s.
U kabelovny 130, Dolní Mĕcholupy
102 37 Prague 10
Czech Republic

Manufacturer/Importer

S.C. Zentiva S.A.
B-dul Theodor Pallady nr. 50, Sector 3
Bucharest 032266, Romania
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park, Paola
PLA3000 Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic, Bulgaria, Estonia, Lithuania, Latvia, Poland, Romania, Slovakia, United Kingdom, Greece: Xanirva

For more information about this medicine, please contact:

Zentiva Polska Sp. z o. o.
Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00
Date of last revision of the leaflet:February 2024