Xanirva

Package Leaflet: Information for the Patient

Xanirva, 15 mg, hard capsules

Xanirva, 20 mg, hard capsules

Rivaroxaban

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 blood clots in the brain (stroke) and other blood vessels in the body, if you have a form 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 in the blood vessels of the lungs (pulmonary embolism) and prevent blood clots from forming again 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 blood clots in the veins or 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 to block the blood clotting factor (factor Xa) and thus 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 an organ that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery);

if you are taking other medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant treatment or when heparin is given to maintain catheter patency in a vein or artery;

Warnings and precautions

Before starting Xanirva, tell your doctor or pharmacist.

When to be extra 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 in the body;
• taking other medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin) when switching anticoagulant treatment or when heparin is given to maintain catheter patency in a vein or artery (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, such as inflammation of the intestines and stomach or esophageal inflammation (e.g., due to gastroesophageal reflux disease);
• eye blood vessel disease (retinopathy);
• lung disease with dilated bronchi and pus (bronchiectasis) or previous lung bleeding;
• in patients with artificial heart valves;
• 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 treatment if necessary;
• if you have abnormal blood pressure or are scheduled for surgery to remove a blood clot from the lungs.

If you suspect that 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 closely monitored.

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 spinal puncture is planned (e.g., for epidural or spinal 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 you experience numbness or weakness in your legs, bowel or bladder problems, as immediate treatment may be necessary.

Children and adolescents

Xanirva 15 mg capsules are not recommended for children weighing less than 30 kg.
Xanirva 20 mg capsules are not recommended for children weighing less than 50 kg.
There is limited data on the use of rivaroxaban in children and adolescents for the indications in adults.

Xanirva and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained 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, where 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 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 any of the above applies to you, you should inform

your doctorbefore taking Xanirva, as the effect of Xanirva may be increased if taken with the above medicines. Your doctor will decide whether to use this medicine and whether you should be closely monitored.
If your doctor considers that you have an increased risk of stomach or duodenal 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 to treat depression;
• rifampicin, an antibiotic.

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 reduced if taken with the above medicines. Your doctor will decide whether to use Xanirva 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 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, ride a bicycle, or operate tools or machines.

Xanirva 15 mg and 20 mg contain 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 capsule, which is essentially "sodium-free".

3. How to take Xanirva

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
Xanirva should be taken with food.
Swallow the capsule(s) whole with water.
If you have difficulty swallowing the whole capsule, talk to your doctor about other ways to take Xanirva. The contents of the capsule can be mixed with water or apple sauce just before taking. After such a mixture, you should eat a meal immediately. If necessary, your doctor may also give the contents of the Xanirva capsule through a gastric tube.

How many capsules to take

o Adults

• -To prevent blood clots in the brain (stroke) and other blood vessels in the bodyThe recommended dose is one Xanirva 20 mg capsule once a day. If you have kidney problems, the dose may be reduced to one Xanirva 15 mg capsule once a day.

If you need a procedure to open up 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 capsule once a day (or one Xanirva 10 mg capsule once a day in case of kidney dysfunction) in combination with an antiplatelet medicine such as clopidogrel.

• -For the treatment of blood clots in the veins of the legs, blood clots in the lungs, and to prevent blood clots from forming againThe recommended dose is one Xanirva 15 mg capsule twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Xanirva 20 mg capsule 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 capsule once a day or one 20 mg capsule once a day. If you have kidney problems and are taking one Xanirva 20 mg capsule once a day, your doctor may decide to reduce the dose to one Xanirva 15 mg capsule once a day if the risk of bleeding is higher 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 weighing 30 kg to less than 50 kgis one Xanirva 15 mgcapsule once a day.
• The recommended dose for children and adolescents weighing 50 kg or moreis one Xanirva 20 mgcapsule once a day.

Each Xanirva dose should be taken with food, with a drink (e.g., water or juice). Capsules should be taken daily at approximately the same time. It is a good idea to set an alarm to remind you.
For parents or caregivers: you should observe the child to ensure they have taken the entire dose.
The dose of Xanirva is based on body weight, so it is important to attend scheduled doctor's appointments, as the dose may need to be adjusted based on weight changes.
Never adjust the dose of Xanirva yourself. If necessary, your doctor will adjust the dose.
Do not sprinkle the contents of the capsule to obtain a partial dose. If a smaller dose is needed, you should use a different medicine containing rivaroxaban in the form of granules for oral suspension.
For children and adolescents who are unable to swallow whole capsules, you should use a medicine containing rivaroxaban in the form of granules for oral suspension.
If the oral suspension is not available, you can sprinkle the contents of the Xanirva capsule and mix it with water or apple sauce just before taking. After such a mixture, you should eat a meal immediately. If necessary, your doctor may also give the sprinkled contents of the Xanirva capsule through a gastric tube.

If you spit out a dose or vomit

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

You should contact your doctor if you spit out a dose or vomit repeatedly after taking Xanirva.

When to take Xanirva

Take the capsule(s) every day until your doctor decides to stop treatment.
It is best to take the capsule(s) at the same time every day, as this will help you remember.
Your doctor will decide how long you should continue treatment.
To prevent blood clots in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored with a procedure called cardioversion, you should take Xanirva as directed by your doctor.

Taking more Xanirva than prescribed

If you have taken more Xanirva than prescribed, you should contact your doctor immediately. 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 capsule oncea day and miss a dose, you should take it as soon as possible. Do not take more than one capsule in a 24-hour period to make up for a missed dose. Take the next capsule at the usual time the next day.

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

Stopping Xanirva treatment

Do not stop taking Xanirva without first talking to your doctor, as Xanirva treats and prevents serious diseases.
If you have any further questions on the use of 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 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 doctor if you or your child 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, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide to closely monitor you or change your treatment.

Signs of severe skin reactions

• widespread, severe skin rash, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• drug reaction that causes a rash, fever, inflammation of internal organs, hematologic 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 reason for weakness or shortness of breath
• bleeding from the stomach or intestines, bleeding from the urinary or reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• bleeding into the eye (including bleeding from the white part of the eye)
• bleeding into tissues or body cavities (hematoma, bruising)
• blood in the sputum when coughing (hemoptysis)
• bleeding from the skin or bleeding under the skin
• bleeding after surgery
• oozing of blood or fluid from the wound after surgery
• swelling of the limbs
• limb pain
• kidney problems (which 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 weakness and lack of energy (weakness, fatigue), headache, dizziness
• 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 inside the skull (see above signs of bleeding)
• bleeding into a joint, causing pain and swelling
• low platelet count (low number of platelets, cells involved in blood clotting)
• allergic reactions, including allergic skin reactions
• liver problems (which can be seen in tests performed by your doctor)
• blood test results may show increased bilirubin levels, increased activity of certain liver or pancreatic enzymes, or increased 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), liver inflammation, 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 a catheter is inserted into an artery in the leg (pseudoaneurysm) Very rare(may affect less than 1 in 10,000 people)
• accumulation of eosinophils, a type of white granular blood cells that cause lung inflammation (eosinophilic pneumonia).

Frequency not known(cannot be estimated from the available data)

• kidney failure after severe bleeding
• kidney bleeding, 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 cause pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding)

Side effects in children and adolescents

Overall, the side effects seen in children and adolescents treated with rivaroxaban were similar in type to those seen in adults and were mostly mild to moderate.
Side effects seen 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 (a bile pigment)
• low platelet count (low number of platelets, 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 (a bile pigment).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should inform your doctor or pharmacist. You can also report side effects 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.
You can also report side effects to the marketing authorization holder or its representative in Poland.

5. How to store Xanirva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month stated.
PVC/PVDC/Aluminum blisters: Store in a temperature not exceeding 30°C.
Store in the original package to protect from moisture.
OPA/Aluminum/PVC/Aluminum blisters: No special storage precautions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Xanirva contains

• The active substance is rivaroxaban. Each capsule contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: capsule contents:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. capsule shell:gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Xanirva looks like and contents of the pack

Xanirva, 15 mg: light brown, opaque capsules filled with white or almost white powder, size "1" (approximately 19 mm in length).
Xanirva, 20 mg: dark brown, opaque capsules filled with white or almost white powder, size "0" (approximately 22 mm in length).
Hard capsules are packaged in PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters and cartons.
Xanirva, 15 mg: available in packs of 14, 28, 30, 42, 98, or 100 hard capsules.
Xanirva, 20 mg: available in packs of 14, 28, 30, 98, or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Importer

Zentiva SA
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 and in the United Kingdom (Northern Ireland) under the following names:

Czech Republic, Estonia, Latvia, Poland, Romania, Slovakia, United Kingdom (Northern Ireland):
Xanirva

For further information, contact your local representative of the marketing authorization holder:

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