Xaboplax

Package leaflet: Information for the patient

XABOPLAX, 15 mg, coated tablets
XABOPLAX, 20 mg, coated tablets
Rivaroxaban
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
It may harm them even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet:

1. What XABOPLAX is and what it is used for
2. What you need to know 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 known as 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 veins of 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 in the 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 medicines called anticoagulants. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency to form blood clots.

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 major bleeding;
if the patient has a disease or disorder affecting any organ that increases
the risk of major bleeding (e.g. stomach ulcer, trauma or intracranial bleeding, 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 the transition period between anticoagulant therapies or when
heparin is administered to maintain catheter patency in a vein or artery;
if the patient has liver disease that increases the risk of bleeding;
if the woman 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 this with your doctor or pharmacist.
Special caution is required while using XABOPLAX

• if the risk of bleeding is increased in the patient, which may occur in the following situations:
• severe renal impairment in adults and moderate or severe renal impairment in children and adolescents, as kidney function may affect the amount of active drug in the patient's body;
• concomitant use of other anticoagulant medicines (i.e. warfarin, dabigatran, apixaban or heparin) during transition between anticoagulant therapies or when heparin is used to maintain catheter patency in a vein or artery (see section "XABOPLAX with other medicines");
• coagulation disorders;
• very high blood pressure uncontrolled by medication;
• gastrointestinal diseases that may cause bleeding, e.g. inflammatory bowel disease or gastritis, or oesophagitis (e.g. due to gastro-oesophageal reflux disease, in which acidic gastric juice flows back into the oesophagus) or tumours located in the stomach, intestines, genital or urinary tract;
• vascular disease of the posterior segment of the eyeball (retinopathy);
• lung disease with bronchiectasis and pus-filled bronchi (bronchiectasis) or previous pulmonary haemorrhage;
• if the patient has a heart valve prosthesis;
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder causing increased risk of thrombosis), the patient should inform the doctor, who will decide whether treatment adjustment is necessary;
• if the doctor considers the patient's blood pressure unstable or if surgery or other treatment to remove a pulmonary embolus is planned.

If any of these situations apply to the patient, before taking XABOPLAX the patient should
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 prescribed by the doctor, both before and after surgery.
• If catheterisation or spinal puncture (e.g. for epidural or intrathecal anaesthesia or for pain relief) is planned during surgery:
• it is essential to strictly follow the doctor's instructions regarding the timing of XABOPLAX administration before or after lumbar puncture or catheter removal;
• the doctor should be informed immediately if, after the end of anaesthesia, the patient experiences numbness or weakness in the legs or disturbances in bowel or urinary function, as immediate treatment may be necessary.

Children and adolescents
XABOPLAX is not recommended for children weighing less than 30 kg. There is insufficient information on its use in children and adolescents for adult indications.

XABOPLAX with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

If the patient is taking:

• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin;
• oral ketoconazole (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 infection (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 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 to the patient, 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 gastric 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 to the patient, 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
Women who are pregnant or breastfeeding must not use XABOPLAX. Women of childbearing potential should use effective contraception while taking XABOPLAX. If a woman becomes pregnant during treatment, she should inform her doctor immediately, who will decide on further management.

Driving and using machines
XABOPLAX may cause dizziness (a common adverse effect) or fainting (an uncommon adverse effect), see section 4 "Possible side effects". If such symptoms occur, the patient should not drive, cycle or operate tools or machinery.

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

3. How to use XABOPLAX
Always use this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

XABOPLAX should be taken with food.

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

If the patient has difficulty swallowing the whole tablet, discuss alternative methods of taking XABOPLAX with the doctor. The tablet can be crushed, mixed with water or apple puree, and taken immediately. A meal should be consumed directly afterwards. If necessary, the doctor may administer crushed XABOPLAX tablets via a gastric tube.

How many tablets to take

• Adults
• For prevention of blood clots in the brain (stroke) and in other blood vessels: The recommended dose is one 20 mg tablet once daily. In patients with impaired kidney function, the doctor may reduce the dose to one 15 mg tablet once daily.

If a procedure to widen blocked arteries involving the heart (so-called percutaneous coronary intervention with stent placement) is required, limited data suggest reducing the dose to one 15 mg XABOPLAX tablet once daily (or in patients with impaired kidney function to one 10 mg XABOPLAX tablet once daily), in addition to an antiplatelet agent such as clopidogrel.

• For treatment of blood clots in the legs, blood clots in the pulmonary vessels, and prevention of recurrent blood clots: The recommended dose is one 15 mg rivaroxaban tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg rivaroxaban tablet once daily. After completing at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with one 10 mg tablet once daily or one 20 mg tablet once daily. In patients with impaired kidney function who are taking one 20 mg tablet once daily, the doctor may reduce the dose after 3 weeks of treatment to one 15 mg tablet once daily (if the risk of bleeding is greater than the risk of further clots).
• Children and adolescents The 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 of 30 kg to below 50 kg is one 15 mg tablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg tablet once daily. Each dose of XABOPLAX should be taken with a meal and a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. Consider setting an alarm as a reminder. For parents or caregivers: monitor the child to ensure the full dose has been taken.

The dose of XABOPLAX depends on body weight, so it is important to attend scheduled doctor's appointments, as dose adjustments may be necessary due to changes in body weight.
Never adjust the dose of XABOPLAX independently. The doctor will adjust the dose if necessary.
Do not split the tablet to achieve a partial dose. If a lower dose is required, use another formulation of rivaroxaban – granules for oral suspension. For children and adolescents unable to swallow whole tablets, use rivaroxaban granules for oral suspension. If the oral suspension is not available, the XABOPLAX tablet may be crushed and mixed with water or apple puree immediately before administration. A meal should be consumed after this mixture. If necessary, the doctor may also administer the crushed tablet via a gastric tube.

If a dose is vomited or expelled

• within 30 minutes of taking XABOPLAX, take a new dose.
• more than 30 minutes after taking XABOPLAX, do not take a new dose. In this case, take the next dose of XABOPLAX at the usual time.

Contact the doctor if the patient repeatedly vomits or expels the dose after taking XABOPLAX.

When to take XABOPLAX
Take the tablet(s) daily until the doctor advises stopping the medicine. It is best to take the tablet(s) 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 the brain (stroke) and in other blood vessels:
If heart function requires restoration of normal rhythm via cardioversion, XABOPLAX should be taken at the time prescribed by the doctor.

Missed dose of XABOPLAX

• Adults, children and adolescents:
• If the patient takes one 20 mg tablet or one 15 mg tablet once daily and misses a dose, take it as soon as remembered. Do not take more than one tablet in the same day to make up for the missed dose. Take the next tablet the following day, then continue with one tablet once daily.
• Adults:
• If the patient takes one 15 mg tablet twice daily and misses a dose, take it as soon as remembered. Do 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 achieve a total of two tablets (30 mg) taken in one day. The next day, continue taking one 15 mg tablet twice daily.

Taking more than the recommended dose of XABOPLAX
If the patient has taken too many XABOPLAX tablets, contact a doctor immediately.
Taking too high a dose of XABOPLAX increases the risk of bleeding.

Stopping XABOPLAX
Do not stop taking XABOPLAX without consulting your doctor, as this medicine treats serious conditions and prevents their recurrence.
If you have any further doubts 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 will experience them.
As with other medicines with a similar action of reducing blood clot formation, XABOPLAX
can cause bleeding, which may 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 paralysis, vomiting, seizures, decreased level of consciousness and neck stiffness. A serious 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 observation or change your treatment regimen.

Signs of severe skin reactions:

• 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 symptoms (DRESS syndrome). These adverse reactions occur very rarely (in fewer than 1 in 10,000 patients).

Signs of serious allergic reaction

• swelling of the face, lips, mouth, tongue or throat; urticaria and breathing difficulties; sudden drop in blood pressure. Severe allergic reactions occur very rarely (anaphylactic reactions, including anaphylactic shock, may occur in fewer than 1 in 10,000 patients) and uncommonly (angioedema and allergic edema may occur in fewer than 1 in 100 patients).

General list of possible adverse reactions in adults, children and adolescents:
Common (may occur in fewer than 1 in 10 people)

• reduction in red blood cell count, which may cause paleness of the skin, weakness or shortness of breath
• bleeding from the stomach or intestines, bleeding from the genitourinary system (including presence of blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• bleeding into the eye (including bleeding from the sclera)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood (hemoptysis)
• skin bleeding or subcutaneous bleeding
• postoperative bleeding
• oozing of blood or fluid from a surgical wound
• limb swelling
• limb pain
• kidney function disorders (as 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 upon standing)
• general weakness and lack of energy (weakness, 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 people)

• bleeding into the brain or within the skull (see signs of bleeding above)
• bleeding into a joint causing pain and swelling
• thrombocytopenia (low platelet count - cells involved in blood clotting)
• allergic reactions, including skin allergic reactions
• liver function disorders (as 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
• dry mouth
• rapid heartbeat
• urticaria

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

• bleeding into muscles
• cholestasis (reduced bile flow), hepatitis, including liver cell damage
• yellowing of the skin and eyes (jaundice)
• 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 granular white blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency not known (cannot be determined from available data):
kidney failure following severe bleeding
bleeding in the kidneys, sometimes with presence of blood in urine, leading to kidneys being unable to
function properly (drug-induced anticoagulant-related nephropathy),
following bleeding, increased pressure in leg and arm muscles causing pain, swelling,
sensory changes, numbness or paralysis (compartment syndrome after bleeding)
Adverse reactions in children and adolescents
Generally, adverse reactions observed in children and adolescents treated with XABOPLAX
were similar in type to those observed in adults and were mainly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 in 10 people)
headache
fever
nosebleeds
vomiting
Common (may occur in fewer than 1 in 10 people)
rapid heartbeat
blood tests may show increased bilirubin levels (a bile pigment)
thrombocytopenia (low platelet count - cells that help blood to clot)
excessive menstrual bleeding
Uncommon (may occur in fewer than 1 in 100 people):

• blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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 Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store XABOPLAX

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

6. Contents of the pack and other information

What XABOPLAX contains

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• 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: 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
Tablets are red, round, biconvex, with a diameter of 5.6 mm, marked with '15' on one side and smooth on the other.
XABOPLAX 20 mg
Tablets are brown-red, round, biconvex, with a diameter of 6.6 mm, marked with '20' on one side and smooth on the other.
Tablets are available in:

• blisters packed in cardboard boxes containing 14, 28, or 100 coated tablets, or in perforated unit-dose blister packs contained in cardboard boxes, containing 14 x 1, 28 x 1, or 100 x 1 coated tablet.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturers
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
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
This medicinal product is authorised for marketing in the European Economic Area countries under
the following names:
Netherlands XABOPLAX 15 mg, film-coated tablets
XABOPLAX 20 mg, film-coated tablets
Austria XABOPLAX
Poland XABOPLAX