Xanirva

Package leaflet: Information for the user

Xanirva, 2.5 mg, coated tablets
Rivaroxaban
Read the entire leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• Contact your doctor or pharmacist if you have any further questions.
• 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 adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Xanirva is and what it is used for
2. What you need to know 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 Xanirva is and what it is used for

You have been prescribed Xanirva because:

• You have been diagnosed with acute coronary syndrome (a group of heart conditions including heart attack and unstable angina, a severe type of chest pain) and elevated levels of cardiac biomarkers have been confirmed. Xanirva reduces the risk of subsequent heart attack or the risk of death due to heart- or blood vessel-related disease in adults. Xanirva will not be given to you as a single treatment. Your doctor will also prescribe you:
  • acetylsalicylic acid, or
  • acetylsalicylic acid 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 causing symptoms. Xanirva reduces the risk of blood clots (atherosclerotic thrombotic events) in adults. Xanirva will not be given to you as a single treatment. Your doctor will also prescribe you acetylsalicylic acid. In some cases, if you are receiving Xanirva after a procedure to open a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel to be taken in addition to acetylsalicylic acid for a short period.

Xanirva contains the active substance rivaroxaban and 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 Xanirva

When not to take Xanirva:

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6);
  • if the patient has excessive 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 into the brain, recent brain or eye surgery);
  • if the patient is taking other medicines that prevent blood clotting (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 been diagnosed with acute coronary syndrome and has previously experienced bleeding or blood clot in the brain (stroke);
  • if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and has previously had bleeding in the brain (hemorrhagic stroke), or blockage of small arteries supplying blood to deep brain structures (lacunar stroke), or if the patient has had a blood clot in the brain (ischemic, non-lacunar stroke) within the past month;
  • if the patient has liver disease that leads to an increased risk of bleeding;
  • if the patient is pregnant or breastfeeding.

Xanirva must not be used and the doctor should be informed if the patient suspects
that any of the above conditions apply.
Warnings and precautions
Before starting Xanirva, consult a doctor or pharmacist. Xanirva should not be used in combination
with blood clot-preventing medicines other than acetylsalicylic acid, clopidogrel or ticlopidine, such as
prasugrel or ticagrelor.
When to exercise special caution when taking Xanirva

• 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 medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "Other medicines and Xanirva");
  • blood clotting disorders;
  • very high blood pressure that does not decrease despite medication;
  • stomach or intestinal diseases that may cause bleeding, e.g. inflammatory bowel or stomach disease, or esophagitis (inflammation of the throat and esophagus), e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus), or tumors located in the stomach, intestines, genital or urinary system;
  • blood vessel disease in the back of the eye (retinopathy);
  • lung disease in which bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding;
  • if the patient is over 75 years of age;
  • if the patient weighs less than 60 kg;
  • if the patient has ischemic heart disease with symptoms of severe heart failure;

• in patients with heart valve prostheses;

• in patients with antiphospholipid syndrome (immune system disorders that increase the risk of blood clots).
  The doctor should be informed, who will decide whether a change in treatment is necessary.
  If the patient suspects that any of the above applies to them, they should inform the
  doctor before taking Xanirva. The doctor will decide whether to use this medicine and whether the
  patient requires particularly close monitoring.
  If the patient is to undergo surgery:

• it is very important to take Xanirva exactly at the times prescribed by the treating doctor, both before and after surgery;

• if during surgery catheterization or lumbar puncture of the spine is planned (e.g. for epidural or spinal anesthesia or for pain relief):

  • it is very important to take Xanirva exactly at the times prescribed by the treating doctor, both before and after the puncture or catheter removal;
  • the doctor should be informed immediately if, after anesthesia ends, numbness or weakness in the legs, or bowel or bladder dysfunction occurs, as immediate treatment is required in such cases.

Children and adolescents
Xanirva 2.5 mg tablets are not recommended for patients under 18 years of age. There is insufficient
data on the use of the medicine in children and adolescents.
Xanirva and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken,
including those obtained 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 (e.g. clarithromycin, erythromycin);
  • certain antiviral medicines used for 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 and acenocoumarol, prasugrel and ticagrelor (see section "Warnings and precautions")];
  • anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid);
  • dronedarone, a medicine used to treat heart rhythm disorders;
  • certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects that any of the above applies to them, they should inform the
doctor before taking Xanirva, as the effect of Xanirva 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, preventive treatment may be initiated.

• If the patient is taking

  • certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital);
  • St John's wort ( Hypericum perforatum ), an herbal medicine used for depression;

• rifampicin, which belongs to the group of antibiotics.

If the patient suspects that any of the above applies to them, they should inform the
treating doctor before taking Xanirva, as the effect of Xanirva may be reduced when taken
together with the above-mentioned medicines. The doctor will decide whether to use Xanirva and
whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Xanirva 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
Xanirva. 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
Xanirva 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, cycle or operate tools or machinery.
Xanirva contains lactose monohydrate (a type of sugar) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult
their doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is essentially "sodium-free".

3. How to take Xanirva

This medicine should always be taken as prescribed by your doctor. If you have any doubts, you should
contact your doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Xanirva should be taken at approximately the
same time each day (for example, one tablet in the morning and one in the evening).
This medicine can be taken with or without food.
If a patient has difficulty swallowing the whole tablet, they should speak to their doctor about other
ways of taking Xanirva. 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 Xanirva tablets via a gastric tube.
Xanirva will not be given to the patient as the only medication.
Your doctor will advise the patient to take acetylsalicylic acid. If the patient is receiving Xanirva after
an acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine.
If the patient is receiving Xanirva after a procedure to open a narrowed or blocked artery in the lower
limb to restore blood flow, the doctor may also prescribe clopidogrel for a short period in addition to
acetylsalicylic acid.
Your doctor will inform the patient of the doses to take (usually 75 to 100 mg of acetylsalicylic acid per
day, or a daily dose of 75 to 100 mg of acetylsalicylic acid plus a daily dose of 75 mg of clopidogrel or
the standard daily dose of ticlopidine).
When to start treatment with Xanirva
Treatment with Xanirva after acute coronary syndrome should be started as soon as possible after
stabilization of the acute event, no earlier than 24 hours after hospital admission and at the time
when parenteral antithrombotic treatment (by injection) is normally discontinued.
Your doctor will inform the patient when to start treatment with Xanirva if coronary artery disease or
peripheral arterial disease has been diagnosed.
Your doctor will decide how long treatment should continue.
Taking more than the recommended dose of Xanirva
If a patient has taken more than the recommended dose of Xanirva, they should contact their doctor
immediately. Taking too high a dose of 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 a patient misses a dose, they should take
the next dose at the usual time.
Stopping Xanirva
Xanirva should be taken regularly and for the duration prescribed by the doctor.
Do not stop taking Xanirva without first consulting your doctor.
If treatment with this medicine is stopped, the risk of having another heart attack, stroke, or death due
to heart or blood vessel disease may increase.
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 of similar action that reduce blood clot formation, Xanirva may cause bleeding, which potentially can 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:

• intracranial or cerebral haemorrhage (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness and neck stiffness. A serious medical emergency. Immediate medical assistance must be called!)
• prolonged or heavy 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:

• extensive, acute skin rash, blistering or mucosal lesions, 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 abnormalities and systemic involvement. These adverse reactions are very rare (may occur in less than 1 in 10,000 people).

Signs of serious allergic reaction:

• swelling of the face, lips, oral cavity, 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 less than 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)

• decreased number of red blood cells, which may cause pale skin and lead to weakness or shortness of breath
• gastrointestinal or intestinal bleeding, genitourinary bleeding (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding
• ocular bleeding (including bleeding from the conjunctiva)
• bleeding into tissues or body cavities (haematoma, bruising)
• presence of blood in sputum during coughing (haemoptysis)
• skin bleeding or subcutaneous haemorrhage
• postoperative bleeding
• oozing of blood or fluid from 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, diarrhoea
• low blood pressure (symptoms may include dizziness or fainting upon standing)
• general lack of strength and energy (weakness, fatigue), headache, dizziness
• rash, skin itching
• increased activity of certain liver enzymes, which may be seen in blood tests.

Uncommon (may occur in 1 in 100 people)

• intracranial or cerebral haemorrhage (see bleeding signs above),
• joint bleeding 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 bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count
• fainting
• malaise
• rapid heartbeat
• dry mouth
• urticaria

Rare (may occur in 1 in 1,000 people)

• muscle bleeding
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice)
• localised swelling
• blood collection (haematoma) 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 in 10,000 people)

• accumulation of eosinophils, a type of granular white blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency not known (cannot be estimated from available data)

• kidney failure following severe bleeding
• kidney bleeding, sometimes with blood in urine, leading to impaired kidney function (drug-induced nephropathy associated with anticoagulant medicines)
• increased pressure in the muscles of arms and legs following bleeding, which may cause pain, swelling, sensory changes, numbness or paralysis (compartment syndrome following bleeding)

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, consult your doctor or pharmacist. 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, phone: +48 22 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.
Adverse reactions can also be reported to the Marketing Authorisation Holder or its representative in Poland.

5. How to store Xanirva

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the outer carton and on the blister after: EXP. The expiry date refers to the last day of the stated month.
Medicines should 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 Xanirva contains

• The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• Other ingredients are: tablet core: monohydrate lactose, 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 coated tablets with a diameter of approximately 5 mm,
embossed with the marking "2.5" on one side and smooth on the other.
Available pack sizes: 20, 28, 56, 100, 168 or 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130, Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer / Importer
S.C. Zentiva S.A.
B-dul Theodor Pallady no. 50, Sector 3
Bucharest 032266, Romania
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park, Paola
PLA3000 Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic, Bulgaria, Estonia, Lithuania, Latvia, Poland, Romania, Slovakia, United Kingdom, Greece: Xanirva

For more detailed information about this medicine, please contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00