Xanirva

Leaflet attached to the packaging: Patient information

Xanirva, 10 mg, film-coated tablets

Rivaroxaban
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

• 1. What Xanirva is and what it is 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 Xanirva is and what it is used for

Xanirva contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of 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 prevent the recurrence of blood clots in the veins of the legs and/or lungs.

Xanirva belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thus reducing 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 treatment or when heparin is given to maintain the patency of a vein or artery catheter;
• -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 suspect that you have any of the above conditions.

Warnings and precautions

Before starting treatment with Xanirva, consult your doctor or pharmacist.

When to be particularly careful when taking Xanirva

• -if you have an increased risk of bleeding, such as:
• •moderate or severe kidney disease, as kidney function may affect the amount of medicine that works in your body;
• •if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Other medicines and Xanirva");
• •bleeding disorders;
• •very high blood pressure that does not decrease despite treatment;
• •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 (stomach acid flowing back 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);
• •lung disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs;
• -in patients with heart valve prostheses;
• -in patients with antiphospholipid syndrome (immune system disorders that increase the risk of blood clots). You should inform your doctor, who will decide whether to change the treatment if necessary;
• -if you have abnormal blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, you should

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

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 epidural or spinal anesthesia or pain relief):
• 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 difficulty urinating after anesthesia, as immediate treatment may be necessary.

Children and adolescents

Xanirva 10 mg tablets are not recommended for people under 18 years of age. There is a lack of sufficient 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 taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

• - If you are taking:
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin;
• ketokonazole tablets (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 prevent 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 and noradrenaline reuptake inhibitors (SNRIs)).

If you suspect that any of the above applies to you, you should

inform your doctorbefore taking Xanirva, as the effect of Xanirva may be enhanced if it is taken with the above medicines. Your doctor will decide whether to use this medicine and whether you should be closely monitored.

Pregnancy and breastfeeding

Do not take Xanirva 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 immediately inform your doctor, who will decide on further treatment.

Driving and using machines

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

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 prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

How many tablets to take

• To prevent blood clots in the veins after hip or knee replacement surgeryThe recommended dose is one Xanirva 10 mg tablet taken once a day.
• To treat blood clots in the veins of the legs and lungs, and to prevent the recurrence of blood clotsAfter at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Xanirva 10 mg once a day for you.

Swallow the tablet whole, preferably with water.
Xanirva 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 apple puree, just before taking.
If necessary, your doctor may administer the crushed Xanirva tablet through a gastric tube.

When to start treatment with Xanirva

Take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time every day, as it is easier to remember.
Your doctor will decide how long to continue treatment.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:

The first tablet should be taken 6 to 10 hours after surgery.
In patients after major hip replacement surgery, treatment usually lasts 5 weeks.
In patients after major knee replacement surgery, treatment usually lasts 2 weeks.

Taking a higher dose of Xanirva than recommended

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

Missing a dose of Xanirva

If you miss a dose, you should take it as soon as you remember. Take the next tablet the next day, and then take the tablets as usual, once a day.
Do not take a double dose to make up for the missed tablet.

Stopping treatment with Xanirva

Do not stop taking Xanirva without first talking to your doctor, as Xanirva prevents a serious disease.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xanirva can cause side effects, although not everybody gets them.
Like other medicines with a similar effect of reducing blood clot formation, Xanirva can cause bleeding, which can potentially be life-threatening. Excessive bleeding can 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. This is 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 pectoris. Your doctor may decide to closely monitor you or change the treatment.

Signs of severe skin reactions:

• widespread, acute skin rash, blistering or changes to 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 disorders, 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)

• decrease in red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath
• bleeding from the stomach or intestines, 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)
• appearance 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 observed 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 weakness and lack of energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• 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 the joint causing pain and swelling
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• allergic reactions, including allergic skin reactions
• blood test results may show increased bilirubin levels, 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 stasis), hepatitis, including liver cell damage
• jaundice (yellowing of the skin and eyes)
• local swelling
• blood accumulation (hematoma) in the groin as a complication of heart catheterization, when the 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 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 drugs),
• 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, please tell 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.

5. How to store Xanirva

Keep the medicine out of the sight and reach of children.
There are no special precautions for storing the 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. 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. One film-coated tablet contains 10 mg of rivaroxaban.
• -The other ingredients are: 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 red (E 172).

What Xanirva looks like and contents of the pack

Xanirva, 10 mg: pink, round, biconvex film-coated tablets with a diameter of approximately 8.4 mm, with the inscription "10" on one side, smooth on the other.
Pack sizes: 10, 15, 20, 30, 98, and 100 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 further information on this medicine, please contact:

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