Xanirva

Leaflet accompanying the packaging: Patient information

Xanirva, 15 mg, film-coated tablets

Xanirva, 20 mg, film-coated tablets

Rivaroxaban

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

• You should keep this leaflet so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell 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

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

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs. Xanirva is used in children and adolescents under 18 years of age and weighing 30 kg or more to:
• treat and prevent the recurrence of blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Xanirva belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thereby 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 an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent surgical procedure on the brain or eyes);
• if you are taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when changing 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 any of the above circumstances apply to you.

Warnings and precautions

You should consult a doctor or pharmacist before starting to take Xanirva.

When to be particularly careful when taking Xanirva

• if you have an increased risk of bleeding, such as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine that works in the patient's body;
• taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran etexilate, apixaban or heparin) when changing 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 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 eyeballs (retinopathy);
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs;
• in patients with prosthetic heart valves;
• in patients with antiphospholipid syndrome (disorders of the immune system that cause an increased risk of blood clots). You should inform your doctor, who will decide whether to change the treatment if necessary;
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If you suspect that what is written above applies to you, you should inform

your doctorbefore taking Xanirva. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.

If you are going to have surgery:

• it is very important to take Xanirva exactly as directed by your doctor before and after surgery;
• if catheterization or lumbar puncture is planned during surgery (e.g. for spinal or epidural anesthesia or pain relief):
• it is very important to take Xanirva exactly as directed by your doctor before and after the procedure;
• you should immediately inform your doctor if numbness or weakness of the legs occurs after anesthesia, as well as disorders of bowel or bladder function, as immediate treatment may be necessary.

Children and adolescents

Xanirva 15 mg tablets are not recommended for children with a body weight below 30 kg.
Xanirva 20 mg tablets are not recommended for children with a body weight below 50 kg.
There is a lack of sufficient data on the use of rivaroxaban in children and adolescents for indications in adults.

Xanirva and other medicines

You should 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 that are available without a prescription.

• -If you are taking:
• certain medicines used to treat fungal infections (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 medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin);
• certain antiviral medicines used to treat HIV infection or 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 and norepinephrine reuptake inhibitors (SNRIs)).

If you suspect that what is written above applies to you, you should inform

your doctorbefore taking Xanirva ,because the effect of Xanirva may be enhanced if it is given together with the above-mentioned medicines. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.
If the doctor considers that the patient is at increased risk of developing stomach or duodenal ulcers, he 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 to treat depression;
• rifampicin, which belongs to a group of antibiotics.

If you suspect that what is written above applies to you, you should inform

your doctorbefore taking Xanirva ,because the effect of Xanirva may be reduced if it is given together with the above-mentioned medicines. The doctor will decide whether to use Xanirva and whether the patient should be subject to particularly close monitoring.

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 Xanirva, 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 vehicles, ride bicycles, or operate tools or machines.

Xanirva 15 mg and 20 mg contain lactose monohydrate (a type of sugar) and sodium

If you have been diagnosed with intolerance to some sugars, you should consult 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 directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Xanirva should be taken with food. The tablet(s) should be swallowed, preferably with water.
If you have difficulty swallowing the whole tablet, you should discuss other ways of taking Xanirva with your doctor. The tablet can be crushed and mixed with water or apple sauce, just before taking it. After such a mixture, you should eat a meal immediately.
If necessary, your doctor may also give you a crushed Xanirva tablet through a gastric tube.

How many tablets to take

o Adults

• -To prevent the formation of blood clots in the brain (stroke) and other blood vessels in the bodyThe recommended dose is one Xanirva 20 mg tablet once a day. If you have kidney problems, the dose may be reduced to one Xanirva 15 mg tablet once a day. If you need a procedure to open up the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one Xanirva 15 mg tablet once a day (or one Xanirva 10 mg tablet once a day in case of kidney function impairment) in combination with an antiplatelet medicine such as clopidogrel.
• -To treat blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clotsThe recommended dose is one Xanirva 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Xanirva 20 mg tablet once a day. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once a day or one 20 mg tablet once a day. If you have kidney problems and are taking one Xanirva 20 mg tablet once a day, your doctor may decide to reduce the dose after 3 weeks of treatment to one Xanirva 15 mg tablet once a day if the risk of bleeding is greater than the risk of further blood clots.

o Children and adolescents
The dose of Xanirva depends on body weight and will be calculated by your doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one Xanirva 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Xanirva 20 mgtablet once a day. Each dose of Xanirva should be taken with food, with a drink (e.g. water or juice). Tablets should be taken at approximately the same time every day. It's a good idea to set an alarm to remind you. For parents or caregivers: you should observe the child to make sure they take the entire dose. The dose of Xanirva is based on body weight, so it's essential to come to scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes. Never adjust the dose of Xanirva yourself. If necessary, your doctor will adjust the dose.

Do not divide the tablet to get a partial dose. If a smaller dose is needed, you should use another rivaroxaban-containing medicine in the form of granules for oral suspension.
For children and adolescents who are unable to swallow whole tablets, you should use a rivaroxaban-containing medicine in the form of granules for oral suspension.
If the oral suspension is not available, you can crush the Xanirva tablet and mix it with water or apple sauce, just before taking it. After such a mixture, you should eat a meal immediately.
If necessary, your doctor may also give you a crushed Xanirva tablet through a gastric tube.

In case of spitting up or vomiting

• less than 30 minutes after taking Xanirva, you should take a new dose.
• more than 30 minutes after taking Xanirva, do not take a new dose. In this case, take the next dose of Xanirva at the usual time.

You should consult your doctor if you spit up or vomit the dose repeatedly or if you vomit after taking Xanirva.

When to take Xanirva

The tablet(s) should be taken every day until your doctor decides to stop the treatment.
It's best to take the tablet(s) at the same time every day, as it will be easier to remember.
Your doctor will decide how long you should continue the treatment.
To prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body:
If your heart needs to be restored to a normal rhythm through a procedure called cardioversion, you should take Xanirva as directed by your doctor.

Taking a higher dose of Xanirva than recommended

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

Missing a dose of Xanirva

Adults, children, and adolescents:

• If you take one 20 mg or one 15 mg tablet oncea day and you miss a dose, you should take it as soon as possible. Do not take more than one tablet in a 24-hour period to make up for the missed dose. Take the next tablet at the usual time the next day and then take one tablet once a day.

Adults:

• If you take one 15 mg tablet twice a day and you miss a dose, you should take it as soon as possible. Do not take more than two 15 mg tablets in a 24-hour period. If you miss a dose, you can take two 15 mg tablets at the same time to take a total of two tablets (30 mg) in a 24-hour period. The next day, continue taking one 15 mg tablet twice a day.

Stopping Xanirva

You should not stop taking Xanirva without first consulting your doctor, as Xanirva treats and prevents serious diseases.
If you have any further doubts about taking the 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 with a similar effect of reducing blood clot formation, Xanirva can cause bleeding, which can 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 or your child experience any of the following side effects:

Signs of bleeding:

• bleeding into the brain or 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. Your doctor may decide to monitor you closely or change your 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).
• a drug reaction that causes a 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 in adults, children, and adolescents:

Common(may affect up to 1 in 10 people)

• reduced 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 from the 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 function disorders (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
• skin rash, itching
• increased activity of certain liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or 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 function disorders (can be observed in tests performed by your doctor)
• blood test results may show increased bilirubin levels, increased activity of certain 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 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 after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with rivaroxaban were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed more frequently in children and adolescents:
Very common(may affect more than 1 in 10 people)

• headache
• fever
• nosebleeds,
• vomiting.

Common(may affect up to 1 in 10 people)

• rapid heartbeat
• blood test results may show increased bilirubin levels
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• heavy menstrual bleeding.

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased direct bilirubin levels.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should consult 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 gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.

5. How to store Xanirva

The medicine should be stored out of 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 stated.
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. One film-coated tablet contains 15 mg or 20 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, 15 mg: red, round, biconvex film-coated tablets, approximately 9.5 mm in diameter, with the marking "15" on one side, smooth on the other.
Xanirva 15 mg is available in packs of 10, 14, 28, 30, 42, 50, 98, and 100 film-coated tablets.
Xanirva, 20 mg: reddish-brown, round, biconvex film-coated tablets, approximately 10.5 mm in diameter, with the marking "20" on one side, smooth on the other.
Xanirva 20 mg is available in packs of 10, 14, 28, 30, 50, 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 more information about this medicine, please contact:

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