Package leaflet: Information for the patient

XABOPLAX, 10 mg, coated tablets
Rivaroxaban
Read the entire leaflet before using this medicine, as it contains important information
for the patient.
Keep this leaflet, so that you can read it again if necessary.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What XABOPLAX is and what it is used for
Important information before taking XABOPLAX
How to take XABOPLAX
Possible side effects
How to store XABOPLAX
Contents of the pack and other information

1. What XABOPLAX is and what it is used for

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

to prevent the formation of blood clots in veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because you are at increased risk of developing blood clots following 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 recurrence of blood clots in the legs and (or) lungs.

XABOPLAX belongs to a group of medicines known as anticoagulants. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

2. Important information before using XABOPLAX

When not to use 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 active bleeding;
if the patient has a disease or condition affecting any organ that increases the risk of
serious bleeding (e.g. stomach ulcer, trauma or bleeding in the brain, recent
surgery involving the brain or eyes);
if the patient is taking anticoagulant medicines (i.e. warfarin, dabigatran, apixaban,
or heparin); the exception is during transition between anticoagulant therapies or when
administering heparin to maintain patency of a venous or arterial 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 using XABOPLAX, discuss this with your doctor or pharmacist.
Special caution is required when using XABOPLAX

if the patient has an increased risk of bleeding, which may occur in the following situations:
moderate or severe kidney disease, as kidney function may affect the amount of active drug in the patient's body;
taking other anticoagulant medicines (i.e. warfarin, dabigatran, apixaban or heparin) during transition between anticoagulant therapies or when using heparin to maintain patency of a venous or arterial catheter (see section "XABOPLAX with other medicines");
coagulation disorders;
very high blood pressure not controlled by medication;
stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestine or stomach or inflammation of the oesophagus (e.g. due to gastro-oesophageal reflux disease, in which acidic gastric juice flows back into the oesophagus) or tumours located in the stomach or intestines or in the genital or urinary system;
vascular disease of the posterior segment of the eye (retinopathy);
lung disease with bronchiectasis and pus-filled bronchi (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 causing increased risk of thrombosis), the patient should inform the doctor, who will decide whether a change in treatment is necessary;
if the doctor considers the patient's blood pressure unstable or if surgery or other treatment to remove a pulmonary embolism is planned.

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 is required.
If the patient needs to undergo surgery

It is very important to take XABOPLAX at the exact times specified by the doctor before and after surgery.
If catheterization or spinal puncture (e.g. for epidural or spinal anaesthesia or for pain relief) is planned during surgery:
it is very important to take XABOPLAX exactly at the time recommended by the doctor,
immediately inform the doctor if, after the anaesthesia ends, the patient experiences numbness or weakness in the legs or disturbances in bowel or bladder function, as immediate treatment is required.

Children and adolescents
XABOPLAX 10 mg tablets are not recommended for patients under 18 years of age. There is insufficient data on its use in children and adolescents.
XABOPLAX with other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.
If the patient is taking:

certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used topically on the skin only
ketoconazole tablets (used in the treatment of Cushing's syndrome when the body produces too much cortisol)
certain antibiotics (e.g. clarithromycin, erythromycin)
certain antiviral medicines used in the treatment of 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 antidepressants (selective serotonin reuptake inhibitors [SSRI] or serotonin-noradrenaline reuptake inhibitors [SNRI])

If any of the above situations apply, inform the doctor before 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 is required.
If the doctor considers that the patient has an increased risk of stomach or intestinal ulceration, they may also prescribe medicines to prevent peptic ulcer disease.
If the patient is taking:

certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital)
St. John's wort (Hypericum perforatum), a herbal medicine used to treat depression
rifampicin (an antibiotic)

If any of the above situations apply, inform the doctor before 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 is required.
Pregnancy and breastfeeding
Do not use XABOPLAX if the woman is pregnant or breastfeeding. Women of childbearing potential should use effective contraception during treatment with XABOPLAX.
If a woman becomes pregnant during treatment, she should immediately inform her doctor, who will decide on further management.
Driving and operating machinery
XABOPLAX may cause dizziness (a common side effect) or fainting (an uncommon side effect), see section 4 "Possible side effects". If such symptoms occur, do not drive, ride a bicycle, or operate tools or machinery.
XABOPLAX contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".
3. How to use XABOPLAX
Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
How many tablets to take

For prevention of blood clots in veins after hip or knee replacement surgery: the recommended dose is one tablet (10 mg) once daily.
For treatment of blood clots in the legs and in the blood vessels of the lungs, and for prevention of recurrence of blood clots: after completing at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed XABOPLAX 10 mg tablets to be taken once daily.

Swallow the tablet with water.
The medicine can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, discuss alternative ways of taking XABOPLAX with the doctor. The tablet may be crushed, mixed with water or apple puree, and taken immediately.
If necessary, the doctor may administer crushed XABOPLAX tablets via a gastric tube.
When to take XABOPLAX
Tablets should be taken daily until the doctor advises stopping the medicine.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
The duration of treatment is determined by the doctor.
Prevention of blood clots in veins after hip or knee replacement surgery
The first tablet should be taken 6 to 10 hours after surgery.
Patients undergoing major hip surgery usually take the medicine for 5 weeks, and patients undergoing major knee surgery for 2 weeks.
Taking more than the recommended dose of XABOPLAX
If the patient takes more tablets than recommended, contact a doctor immediately due to increased risk of bleeding.
Missed dose of XABOPLAX
If the patient forgets to take a tablet, they should take it as soon as they remember. The next dose should be taken the following day at the usual time, and the prescribed dosing schedule should be continued.
Do not take a double dose to make up for a missed dose.
Stopping XABOPLAX
Do not stop taking XABOPLAX without consulting your doctor, as this medicine helps prevent serious complications.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
As with other similar medicines that have a comparable effect in reducing blood clot formation,
XABOPLAX may cause bleeding, which can even be life-threatening. Excessive
bleeding may lead to a sudden drop in blood pressure (shock). In some
cases, bleeding may be invisible.
You should immediately inform your doctor if any of the following adverse reactions occur:

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 neck stiffness. A serious, sudden
medical emergency. Seek immediate medical help!),

prolonged or excessive bleeding
extreme weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide to place you under close monitoring or change your treatment regimen.
- Signs of severe skin reaction
skin reactions such as widespread, intense rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome or toxic epidermal necrolysis).
drug reaction causing rash, fever, internal organ inflammation, hematological disorders and systemic involvement (DRESS syndrome). These adverse reactions are very rare (occurring in fewer than 1 in 10,000 patients).
- Signs of severe allergic reaction:
swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. Severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock, may occur in fewer than 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in fewer than 1 in 100 patients).

General list of possible adverse reactions:
Common (may occur in fewer than 1 in 10 patients)

decrease in red blood cells, which may cause pale skin, weakness or shortness of breath
bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding
bleeding into the eye (including bleeding from the white of the eye)
bleeding into tissues or body cavities (hematoma, bruising)
coughing up blood (haemoptysis)
bleeding from the skin or subcutaneous bleeding
bleeding after surgery
oozing of blood or fluid from the surgical wound
limb swelling
limb pain
kidney function disorder (as indicated by test results ordered by your doctor)
fever
stomach pain, indigestion, nausea or vomiting, constipation, diarrhoea
low blood pressure (symptoms may include dizziness or fainting upon standing)
general weakness and lack of energy (asthenia, fatigue), headache, dizziness
rash, skin itching
increased activity of certain liver enzymes shown in blood tests

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

bleeding into the brain or within the skull (see signs of bleeding above)
bleeding into a joint causing pain and swelling
thrombocytopenia (low number of platelets – blood cells involved in the clotting process)
allergic reactions, including skin allergic reactions
liver function disorders (as indicated by test results ordered by your 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
urticaria

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

bleeding into muscles
cholestasis (reduced bile flow), hepatitis, including liver cell damage
yellowing of the skin and eyes (jaundice), hepatitis including liver cell damage
local swelling
accumulation of blood (hematoma) in the groin as a complication of cardiac catheterization procedure involving insertion of a catheter into an artery in the leg (pseudoaneurysm)

Very rare (may occur in 1 in 10,000 people)

accumulation of eosinophils, a type of granulocyte white blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency not known (cannot be estimated from available data):
renal failure following severe bleeding
bleeding in the kidneys, sometimes with blood in urine, leading to kidney inability to
function properly (anticoagulant-related nephropathy),
increased pressure in the muscles of arms and legs following bleeding, causing pain, swelling,
sensory changes, numbness or paralysis (compartment syndrome following bleeding)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store XABOPLAX

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and on each blister or bottle after "EXP". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What XABOPLAX contains
The active substance 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, colloidal anhydrous silica. See section 2
"XABOPLAX contains lactose and sodium".
Coating: h ypromellose (type 2910), t itanium dioxide (E 171), m acrogol 3350, i ron 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 colour, marked with '10' on one side and smooth on the other.
Film-coated tablets are available in:

blister packs contained in cardboard boxes containing 10 film-coated tablets or in perforated unit dose blisters contained in a cardboard box, containing 10 x 1 film-coated tablet. Marketing Authorisation Holder and Manufacturer Marketing Authorisation 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
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
tel. +48 22 209 70 00