Xaboplax

Leaflet accompanying the packaging: patient information

XABOPLAX, 15 mg, film-coated tablets

XABOPLAX, 20 mg, film-coated tablets

Rivaroxaban

Initial treatment packaging.

Do not use in children.

You should read the leaflet carefully 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 their symptoms 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 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 packaging and other information

1. What is XABOPLAX and what is it used for

XABOPLAX contains the active substance rivaroxaban. The medicine is used in adults 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 legs and/or lungs.

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 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); exception is the period of change of anticoagulant treatment or 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, the patient should discuss it with their doctor or pharmacist.

While taking XABOPLAX, the patient should be particularly careful

• if the risk of bleeding is increased, which may occur in situations such as:
• severe kidney disease, as kidney function may affect the amount of medicine working 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 section "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 inflammation of the esophagus (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;
• vascular disease of the back of the eye (retinopathy);
• pulmonary disease with bronchiectasis and filling of the bronchi 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 clots), the patient should inform their doctor, who will decide on possible treatment changes;
• if the doctor considers that the patient's blood pressure is unstable or if they plan 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, they should 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 is 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 (e.g. for epidural or spinal anesthesia or pain relief) is planned during surgery:
• it is very important to strictly follow the doctor's instructions regarding the intake of XABOPLAX at a specified time before or after spinal puncture or catheter removal
• the doctor should be informed immediately if, after the end of anesthesia, the patient experiences numbness or weakness of the legs or disturbances of bowel or bladder function, as immediate treatment is then necessary.

Children and adolescents

The initial treatment packaging of XABOPLAX is not recommended for persons under 18 years of age, as it is specifically intended for the initiation of treatment in adult patients and is not suitable for use in children and adolescents.

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 any 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
• ketoconazole 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 noradrenaline reuptake inhibitors [SNRIs])

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

doctorbefore taking XABOPLAX, as the effect of the medicine 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 medicines to prevent the development of ulcers.

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 the effect of the medicine 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

If a woman is pregnant or breastfeeding, she should not take XABOPLAX. Women of childbearing age should use effective contraception while taking XABOPLAX.
If a patient becomes pregnant during treatment, she should immediately inform her 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 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 contact their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that the medicine 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. The patient should then eat a meal. If necessary, the doctor may administer the crushed XABOPLAX tablet through a gastric tube.

How many tablets to take

The recommended dose is one 15 mg XABOPLAX tablet twice a day for the first 3 weeks.
For treatment after 3 weeks, the recommended dose is one 20 mg XABOPLAX tablet once a day.
The initial treatment packaging of XABOPLAX 15 mg and 20 mg is intended only for the first 4 weeks of treatment. After taking the tablets from this packaging, treatment will be continued with XABOPLAX 20 mg once a day after consultation with the doctor.
If the patient has kidney problems, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg XABOPLAX tablet once a day, if the risk of bleeding is greater than the risk of recurrent blood clots.

When to take XABOPLAX

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

Taking a higher dose of XABOPLAX than recommended

If the patient has taken too many XABOPLAX tablets, they should immediately contact their doctor.
Taking too high a dose of XABOPLAX increases the risk of bleeding.

Missing a dose of XABOPLAX

• -If the patient is taking 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.
• -If the patient is taking one 20 mg tablet once a day and misses a dose, they should take it as soon as possible. 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.

Stopping XABOPLAX

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, rivaroxaban can cause side effects, although not everybody gets them.
Like other medicines with similar anticoagulant effects, XABOPLAX may 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:
Bleeding symptoms:

• 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. A serious medical emergency. Immediate medical help should be sought!),
• prolonged or excessive bleeding
• extreme 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).
• drug reactions 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:
Common(may occur in less than 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 blood in the urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• 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, nausea, vomiting, or 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 people)

• bleeding into the brain or inside the skull (see above bleeding symptoms)
• 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 in blood tests
• fainting
• malaise
• dry mouth
• rapid heartbeat
• hives

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

• bleeding into the muscles
• bile flow obstruction (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 heart 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 people)

• accumulation of eosinophils, a type of granular white blood cell, which causes 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 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)

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 Monitoring of Adverse Reactions to Medicinal Products 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 can help 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 and on each blister pack after EXP. The expiry date refers to the last day of the month stated.
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 packaging and other information

What XABOPLAX contains

• The active substance of the medicine 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 what the pack contains

XABOPLAX 15 mg
The tablets are red, round, biconvex with a diameter of 5.6 mm, with the marking '15' on one side and smooth on the other side.
XABOPLAX 20 mg
The tablets are brown-red, round, biconvex with a diameter of 6.6 mm, with the marking '20' on one side and smooth on the other side.
The initial treatment packaging for the first 4 weeks of treatment contains blisters or perforated unit-dose blisters:
Each packaging with 49 film-coated tablets for the first 4 weeks of treatment contains: 42 film-coated tablets of XABOPLAX 15 mg and 7 film-coated tablets of XABOPLAX 20 mg in a "wallet" packaging in a carton or 49 x 1 tablet: 42 x 1 film-coated tablet of XABOPLAX 15 mg and 7 x 1 film-coated tablets of XABOPLAX 20 mg in a "wallet" packaging in a carton.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana, 1526
Slovenia
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012, Larissa Industrial Area
Larisa, 410 04
Greece
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
Birzebbugia, BBG3000
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 Warszawa
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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