Xaboplax

Leaflet accompanying the packaging: patient information

XABOPLAX, 15 mg, film-coated tablets

XABOPLAX, 20 mg, film-coated tablets

Rivaroxaban

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

You should keep this leaflet, so that you can read it again if you need to.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others.
The medicine may harm another person, even if the symptoms of their illness are the same.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What XABOPLAX is and what it is used for

XABOPLAX contains the active substance rivaroxaban. The medicine is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels in the body in patients with a certain type of irregular heartbeat, called non-valvular atrial fibrillation;
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the legs and/or lungs.

XABOPLAX is used in children and adolescents under 18 years of age and weighing 30 kg or more

• to treat blood clots and prevent the recurrence of blood clots in the veins or blood vessels of the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

XABOPLAX belongs to a group of so-called anticoagulant medicines. 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 XABOPLAX

When not to take XABOPLAX

if the patient is allergic to rivaroxaban or to any of the other ingredients of this

medicine (listed in section 6);

if the patient has a large bleeding;

if the patient has a disease or disorder affecting any organ, which increases the risk of large bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent surgical procedure in the brain or eyes);

if the patient is taking medicines that prevent blood clotting (i.e. warfarin, dabigatran, apixaban or heparin); an exception is the period of change of anticoagulant treatment or the administration of heparin to maintain the patency of a vein or artery catheter;

if the patient has liver disease that increases the risk of bleeding;

if the patient is pregnant or breastfeeding.

If any of these situations apply to the patient, do not take XABOPLAX and consult

a doctor.

Warnings and precautions

Before taking XABOPLAX, you should discuss it with your doctor or pharmacist.

While taking XABOPLAX, you should be particularly careful

• if the patient's risk of bleeding is increased, which may occur in situations 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 acting in the patient's body;
• taking other medicines that prevent blood clotting (i.e. warfarin, dabigatran, apixaban or heparin) during the change of anticoagulant treatment or during the use of heparin to maintain the patency of a vein or artery catheter (see "XABOPLAX and other medicines");
• bleeding disorders;
• very high blood pressure, uncontrolled by medication;
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines or stomach or esophageal inflammation (e.g. due to gastroesophageal reflux disease, in which acidic stomach juice flows 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 eyeballs (retinopathy);
• pulmonary disease with bronchiectasis and filling with pus (bronchiectasis) or previous bleeding from the lungs;
• if the patient has a heart valve prosthesis;
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform the doctor, who will decide on possible changes to the treatment;
• if the doctor considers that the patient's blood pressure is unstable or if the doctor plans to perform surgery on the patient or other treatment aimed at removing a blood clot from the lungs.

If any of these situations apply to the patient, before taking XABOPLAX, consult

a doctor. The doctor will decide whether the patient should take this medicine and whether close monitoring of their condition is necessary.

If the patient needs to undergo surgery

• It is very important to take XABOPLAX before and after surgery at a time strictly determined by the doctor.
• If catheterization or spinal puncture is planned during surgery (e.g. for epidural or spinal anesthesia or to relieve pain):
• it is very important to strictly follow the doctor's instructions regarding the intake of XABOPLAX at a specified time before or after lumbar puncture or catheter removal
• the doctor should be informed immediately if, after the anesthesia is finished, the patient experiences numbness or weakness of the legs or disorders of bowel or bladder function, as immediate treatment is necessary in this case.

Children and adolescents

XABOPLAX is not recommended for children with a body weight below 30 kg. There is not enough information on its use in children and adolescents for indications in adults.

XABOPLAX and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as about medicines they plan to take, including those available without a prescription.

If the patient is taking:

• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin
• ketokonazole in tablets (used to treat Cushing's syndrome, when the body produces too much cortisol)
• certain medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin)
• certain antiviral medicines used to treat HIV/AIDS (e.g. ritonavir)
• other medicines that reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin and 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 any of the above cases apply to the patient, they should tell

their doctorbefore taking XABOPLAX, as it is possible to enhance the effect of the medicine. The doctor will decide whether the patient should take XABOPLAX and whether close monitoring of their condition is necessary.

If the patient is 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 any of the above cases apply to the patient, they should tell

their doctorbefore taking XABOPLAX, as it is possible to reduce the effect of the medicine.

Pregnancy and breastfeeding

If a woman is pregnant or breastfeeding, she must not take XABOPLAX. Female patients of childbearing age should use effective contraception while taking XABOPLAX.

Driving and using machines

XABOPLAX may cause dizziness (a common side effect) or fainting (an uncommon side effect), see section 4 "Possible side effects". If the patient experiences such symptoms, they should not drive vehicles, ride a bicycle or operate tools or machines.

XABOPLAX contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is considered "sodium-free".

3. How to take XABOPLAX

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.

XABOPLAX should be taken with food.

The tablet(s) should be swallowed, preferably with water.

If the patient has difficulty swallowing the whole tablet, they should discuss other ways of taking XABOPLAX with their doctor. The tablet can be crushed, mixed with water or apple sauce, and taken immediately. Then, a meal should be eaten. If necessary, the doctor may also administer the crushed XABOPLAX tablet through a gastric tube.

How many tablets to take

• Adults
• In the prevention of blood clot formation in the brain (stroke) and in other blood vessels. The recommended dose is one 20 mg tablet once a day. In patients with kidney function disorders, the doctor may reduce the dose to one 15 mg tablet once a day.

If a procedure to widen blocked coronary arteries (so-called percutaneous coronary intervention with stent implantation) is necessary, limited data indicate a dose reduction to one XABOPLAX 15 mg tablet once a day (or in patients with impaired renal function to 1 XABOPLAX 10 mg tablet once a day), added to an antiplatelet agent, such as clopidogrel.

• In the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and in the prevention of recurrence of blood clots. The recommended dose is one rivaroxaban 15 mg tablet twice a day for the first 3 weeks. After 3 weeks, the recommended dose is one rivaroxaban 20 mg tablet once a day. After completing at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with one 10 mg tablet taken once a day or one 20 mg tablet taken once a day. In patients with kidney function disorders taking one 20 mg tablet once a day, the doctor may reduce the dose after 3 weeks of treatment to one 15 mg tablet once a day (if the risk of bleeding is greater than the risk of blood clot formation).
• Children and adolescentsThe dose of XABOPLAX depends on body weight and will be calculated by the doctor.
• The recommended dose for children and adolescents with a body weight from 30 kg to less than 50 kgis one 15 mg tabletonce a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one 20 mg tabletonce a day. Each dose of XABOPLAX should be taken with food, with a drink (e.g. water or juice). Tablets 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 make sure they have taken the entire dose.

The dose of XABOPLAX is dependent on body weight, so it is essential to attend scheduled doctor's appointments, as it may be necessary to adjust the dose due to changes in body weight.

Never adjust the dose of XABOPLAX yourself. If necessary, the doctor will adjust the dose.

Do not divide the tablet to obtain a partial dose of the tablet. If a smaller dose is necessary, another form of rivaroxaban should be used - an oral suspension. For children and adolescents who are unable to swallow whole tablets, rivaroxaban should be used in the form of an oral suspension. If the oral suspension is not available, the XABOPLAX tablet can be crushed and mixed with water or apple sauce immediately before administration. Then, a meal should be eaten. If necessary, the doctor may also administer the crushed XABOPLAX tablet through a gastric tube.

In case of spitting out the dose or vomiting

• less than 30 minutes after taking XABOPLAX, a new dose should be taken.
• more than 30 minutes after taking XABOPLAX, a new dose should not be taken. In this case, the next dose of XABOPLAX should be taken at the usual time.

In case of repeated spitting out of the dose or vomiting after taking XABOPLAX, the patient should consult their doctor.

When to take XABOPLAX

The tablet(s) should be taken daily until the doctor recommends stopping the medicine. It is best to take the tablet(s) at the same time every day, as it is easier to remember.

The doctor decides on the duration of treatment.

Prevention of blood clot formation in the brain (stroke) and in other blood vessels:

If the patient's heart rhythm needs to be restored to normal through a cardioversion procedure, XABOPLAX should be taken at the time recommended by the doctor.

Missing a dose of XABOPLAX

• Adults, children, and adolescents:
• - If the patient takes one 20 mg tablet or one 15 mg tablet once a day and misses a dose, they should take it as soon as they remember. They should not take more than one tablet on the same day to make up for the missed dose. The next tablet should be taken the next day, and then one tablet should be taken once a day.
• Adults:
• - If the patient takes one 15 mg tablet twice a day and misses a dose, they should take it as soon as they remember. They should not take more than two 15 mg tablets in one day. If the patient forgets to take a dose, they may take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day. The next day, they should continue taking one 15 mg tablet twice a day.

Taking a higher dose of XABOPLAX than recommended

If the patient has taken too many XABOPLAX tablets, they should contact their doctor immediately.

Taking too much XABOPLAX increases the risk of bleeding.

Stopping XABOPLAX treatment

The patient should not stop taking XABOPLAX without consulting their doctor, as this medicine treats serious conditions and prevents their recurrence.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, XABOPLAX can cause side effects, although not everybody gets them.

As with other medicines with a similar anticoagulant effect, XABOPLAX can cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may be invisible.

The patient should immediately inform their doctor if they 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. Medical help should be sought immediately!),
• prolonged or excessive bleeding
• severe weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina pectoris The doctor may decide to subject the patient to close monitoring or change their treatment.

Signs of a severe skin reaction:

• skin reactions, such as widespread, intense rash, blistering, or changes in the mucous membranes, e.g. in the mouth or eyes (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• a drug reaction causing rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). These side effects are very rare (less than 1 in 10,000 patients).

Signs of a severe allergic reaction

• swelling of the face, lips, mouth, tongue, or throat; hives, and difficulty breathing; sudden drop in blood pressure. Severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in less than 1 in 100 patients).

General list of possible side effects in adults, children, and adolescents:

Common(may affect up to 1 in 10 people)

• decrease in red blood cell count, which may cause pallor, weakness, or shortness of breath
• bleeding from the stomach or intestine, bleeding from the urinary or genital system (including the presence of blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding into the eye (including bleeding from the sclera)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood (hemoptysis)
• bleeding from the skin or subcutaneous bleeding
• bleeding after surgery
• oozing of blood or fluid from the surgical wound
• swelling of the limbs
• limb pain
• kidney function disorders (which may be indicated by the results of tests ordered by the doctor)
• fever
• stomach pain, nausea, vomiting, or diarrhea, constipation
• 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 shown in blood tests

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 - a condition that affects the blood's ability to clot)
• allergic reactions, including skin allergic reactions
• liver function disorders (which may be indicated by the results of tests ordered by the doctor)
• increased bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count shown in blood tests
• fainting
• malaise
• dry mouth
• rapid heartbeat
• hives

Rare(may affect up to 1 in 1,000 people)

• bleeding into the muscles
• bile stasis (reduced bile flow), hepatitis, including liver cell damage
• jaundice (yellowing of the skin and eyes)
• local swelling
• blood accumulation (hematoma) in the groin as a complication of cardiac catheterization involving the insertion of a catheter 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 granulocytic blood cells, which can cause inflammation in the lungs (eosinophilic pneumonia).

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

renal failure after severe bleeding

bleeding in the kidneys, sometimes with the presence of blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant drugs),

increased pressure in the muscles of the legs and arms after bleeding, causing 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 XABOPLAX 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 - a condition that affects the blood's ability to clot)

excessive menstrual bleeding

Uncommon(may affect up to 1 in 100 people):

• blood test results may show increased direct bilirubin levels.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse.

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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store XABOPLAX

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, on each blister, and on the bottle after EXP. The expiry date refers to the last day of the month.

There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 XABOPLAX contains

• The active substance of XABOPLAX is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: sodium lauryl sulfate, lactose, poloxamer 188, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica. See section 2 "XABOPLAX contains lactose and sodium". Coating:hypromellose (type 2910), titanium dioxide (E 171), macrogol 3350, iron oxide red (E 172).

What XABOPLAX looks like and contents of the pack

XABOPLAX 15 mg

The tablets are red, round, biconvex, 5.6 mm in diameter, with the marking "15" on one side and smooth on the other side.

XABOPLAX 20 mg

The tablets are brown-red, round, biconvex, 6.6 mm in diameter, with the marking "20" on one side and smooth on the other side.

The tablets are available in:

• blisters placed in cartons containing 14, 28, or 100 film-coated tablets or in perforated single-dose blisters placed in cartons, containing 14 x 1, 28 x 1, or 100 x 1 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

Rontis Hellas S.A.

P.O. Box 3012, Larissa Industrial Area

410 04 Larisa

Greece

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate

BBG3000 Birzebbugia

Malta

To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50C

02-672 Warsaw

tel. +48 22 209 70 00

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

Netherlands

XABOPLAX 15 mg, film-coated tablets

XABOPLAX 20 mg, film-coated tablets

Austria

XABOPLAX

Poland

XABOPLAX

Date of last revision of the leaflet: 01/2024

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