Xaboplax

Package Leaflet: Information for the Patient

XABOPLAX, 10 mg, Film-Coated Tablets

Rivaroxaban

Before Taking the Medication, Read the Contents of the Leaflet, as it Contains Important Information for the Patient.

Keep this leaflet, as you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medication has been prescribed to a specific person. Do not pass it on to others.
The medication may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

• to prevent the formation of blood clots in the veins after hip or knee replacement surgery. The doctor has prescribed this medication to the patient due to an increased risk of blood clot formation after surgery.
• to 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 veins of the legs and/or lungs.

XABOPLAX belongs to a group of so-called anticoagulant medications. Its action involves 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 any of the other ingredients of this medication (listed in section 6);
if the patient has significant bleeding;
if the patient has a disease or disorder affecting any organ, which increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent surgical procedure in the brain or eyes);
if the patient is taking medications that prevent blood clotting (i.e., warfarin, dabigatran, apixaban, or heparin); an exception is the period of changing 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, discuss it with a doctor or pharmacist.

During XABOPLAX treatment, special caution is required

• if the patient's risk of bleeding is increased, which may occur in situations such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medication acting in the patient's body;
• taking other medications 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 medications");
• bleeding disorders;
• very high blood pressure, uncontrolled by medications;
• stomach or intestinal diseases that may cause bleeding, such as 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, intestines, genital, or urinary system;
• vascular disease of the back of the eye (retinopathy);
• pulmonary disease with bronchiectasis and bronchi filled with pus (bronchiectasis) or previous bleeding from the lungs;
• if the patient has a heart valve prosthesis;
• if the patient has a condition 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 the patient's blood pressure to be unstable or plans to perform surgery or other treatment to remove 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 medication 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 specified by the doctor.
• If catheterization or spinal puncture is planned during surgery (e.g., for epidural or spinal anesthesia or pain relief):
• it is very important to take XABOPLAX at the time specified by the doctor,
• the doctor should be informed immediately if, after the anesthesia, the patient experiences numbness or weakness of the legs, or disorders of bowel or urinary function, as immediate treatment may be necessary.

Children and adolescents

XABOPLAX 10 mg is not recommended for patients under 18 years of age.There is not enough information on its use in children and adolescents.

XABOPLAX and other medications

Tell the doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take, including those available without a prescription.

If the patient is taking:

• certain medications 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 medications used to treat bacterial infections (e.g., clarithromycin, erythromycin)
• certain antiviral medications used to treat HIV/AIDS (e.g., ritonavir)
• other medications that reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin and acenocoumarol)
• anti-inflammatory and pain-relieving medications (e.g., naproxen or acetylsalicylic acid)
• dronedarone (a medication used to treat heart rhythm disorders)
• certain medications 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 inform their

doctorbefore taking XABOPLAX, as the effect of the medication may be enhanced. The doctor will decide whether the patient should take XABOPLAX and whether close monitoring of their condition is necessary.
If the doctor considers that the patient is at increased risk of stomach or intestinal ulcers, they may also prescribe medications to prevent the development of ulcers.

If the patient is taking:

• certain medications used to treat epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort ( Hypericum perforatum), a herbal remedy used to treat depression
• rifampicin (an antibiotic).

If any of the above cases apply to the patient, they should inform their

doctorbefore taking XABOPLAX, as the effect of the medication may be reduced. The doctor will decide whether the patient should take XABOPLAX and whether close monitoring of their condition is necessary.

Pregnancy and breastfeeding

Do not take XABOPLAX if pregnant or breastfeeding. Women of childbearing age should use effective contraception while taking XABOPLAX.
If the patient becomes pregnant during treatment, they should immediately inform their doctor, who will decide on further treatment.

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, ride a bicycle, or operate tools or machines.

XABOPLAX contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medication.
This medication contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is considered "sodium-free".

3. How to take XABOPLAX

Always take this medication exactly as prescribed by the doctor. In case of doubts, consult a doctor or pharmacist.

How many tablets to take

• In the prevention of blood clot formation in the veins after hip or knee replacement surgery: the recommended dose is one tablet (10 mg) once a day.
• In the treatment of blood clots in the veins of the legs and in the blood vessels of the lungs, as well as in the prevention of recurrence of blood clots, after completing at least 6 months of treatment for blood clots, the recommended dose is one tablet of 10 mg taken once a day or one tablet of 20 mg taken once a day. The doctor has prescribed XABOPLAX 10 mg tablets to be taken once a day.

Swallow the tablet with a glass of water.
The medication can be taken with or without food.
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.
If necessary, the doctor may administer the crushed XABOPLAX tablet through a gastric tube.

When to take XABOPLAX

Take the tablets every day until the doctor recommends stopping the medication.
It is best to take the tablet 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 veins after hip or knee replacement surgery
The first tablet should be taken 6 to 10 hours after surgery.
Patients after major hip replacement surgery usually take the medication for 5 weeks, and patients after major knee replacement surgery for 2 weeks.

Taking a higher dose of XABOPLAX than recommended

If the patient has taken more tablets than recommended, they should immediately contact their doctor due to the increased risk of bleeding.

Missing a dose of XABOPLAX

If the patient forgets to take a tablet, they should take it as soon as possible after remembering. The next dose should be taken the next day at the usual time, and the prescribed dosing should be continued.
Do not take a double dose of the medication to make up for the missed dose.

Stopping XABOPLAX treatment

Do not stop taking XABOPLAX without consulting a doctor, as this medication prevents the development of serious disorders.
In case of any further doubts about the use of this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, XABOPLAX can cause side effects, although not everybody gets them.
Like other similar medications with a similar anticoagulant effect, XABOPLAX may cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden decrease in blood pressure (shock). In some cases, bleeding may be invisible.

Inform the doctor immediately if the patient experiences 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. Immediate medical help is required!),

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 severe skin reactions

• Signs of severe allergic reactions:

General list of possible side effects:
Common(may occur in less than 1 in 10 patients)

• decrease in red blood cell count, which may cause pallor, 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 from the gums
• bleeding into the eye (including bleeding from the conjunctiva)
• 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 test results ordered by the doctor)
• fever
• stomach pain, indigestion, nausea, or 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 shown in blood tests

Uncommon(may occur in less than 1 in 100 patients)

• 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 the blood clotting process)
• allergic reactions, including skin allergic reactions
• liver function disorders (which may be indicated by test results 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
• rapid heartbeat
• dry mouth
• hives

Rare(may occur in less than 1 in 1,000 patients)

• bleeding into the muscles
• bile flow disorders (decreased bile flow), liver inflammation, including liver cell damage
• jaundice (yellowing of the skin and eyes) liver inflammation, including liver cell damage
• 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 occur in less than 1 in 10,000 patients)

• 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 medications),
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)

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform 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.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to store XABOPLAX

Keep the medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the carton and on each blister or bottle after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medication.
Medications should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medications 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 10 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

The tablets are round, biconvex, 8.6 mm in diameter, light red in color, with the marking "10" on one side and smooth on the other.
The film-coated tablets are available in:

• blister packs in a carton containing 10 film-coated tablets or in perforated unit dose blisters in a carton containing 10 x 1 film-coated tablet. Marketing authorization holder and manufacturerMarketing authorization holder Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana, 1526
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