Package leaflet: Information for the patient

Xiltess, 15 mg, film-coated tablets
Xiltess, 20 mg, film-coated tablets
Rivaroxabanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
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

What Xiltess is and what it is used for
What you need to know before taking Xiltess
How to take Xiltess
Possible side effects
How to store Xiltess
Contents of the pack and other information

1. What Xiltess is and what it is used for

Xiltess, film-coated tablets contain the active substance rivaroxaban.
Xiltess, 15 mg and 20 mg, film-coated tablets are used in adults for:

preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body in patients who have a type of irregular heartbeat known as non-valvular atrial fibrillation.
treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and for preventing the recurrence of blood clots in the veins of the legs and/or lungs.

Xiltess, 15 mg and 20 mg, film-coated tablets are used in children and adolescents under 18 years of age
and with body weight of 30 kg or more for:

treatment of blood clots and prevention of 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 anticoagulant medicines used to treat blood clots.

Xiltess 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 Xiltess

When not to use Xiltess

if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
if the patient has excessive bleeding,
if the patient has a disease or condition of an organ leading to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent surgical procedure on the brain or eyes),
if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain patency of a venous or arterial catheter,
if the patient has a liver disease that leads to an increased risk of bleeding,
if the patient is pregnant or breastfeeding. Do not use Xiltess, and inform the doctor if the patient suspects that any of the above circumstances apply.

Warnings and precautions
Before starting treatment with Xiltess, consult a doctor or pharmacist.
Exercise special caution when using Xiltess

if the patient has an increased risk of bleeding, such as in the following conditions:
- severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body,
- use of other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain patency of a venous or arterial catheter (see section "Xiltess with other medicines"),
- blood clotting disorders,
- very high blood pressure that does not decrease despite medication,
- diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach or intestines, or in the genital or urinary system,
- blood vessel disease in the back of the eye (retinopathy),
- lung disease with dilated and pus-filled bronchi (bronchiectasis) or previous lung bleeding.
in patients with prosthetic heart valves,
if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment should be changed,
if the doctor determines that blood pressure is unstable or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

If the patient suspects that any of the above conditions apply, they should inform the
doctor before using Xiltess. The doctor will decide whether to use this medicine and whether
the patient should be placed under particularly close observation.
If the patient needs to undergo surgery:

strictly follow the doctor's instructions regarding taking Xiltess at a specific time before or after surgery,
if during surgery catheterization or spinal puncture (e.g. for epidural or spinal anaesthesia or pain relief) is planned:
- it is very important to take Xiltess before and after the puncture or catheter removal, as directed by the doctor,
- due to the need for special caution, immediately inform the doctor if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia ends.

Children and adolescents
Xiltess coated tablets are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of Xiltess in children and adolescents for the indications approved for adults.
Xiltess with other medicines
Tell the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use.

If the patient is taking:
- certain medicines used for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
- ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol),
- certain antibiotics used for bacterial infections (e.g. clarithromycin, erythromycin),
- certain antiviral medicines used in HIV infection or AIDS treatment (e.g. ritonavir),
- other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin or 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects that any of the above conditions apply, they should
inform the doctor before using Xiltess, as the effect of Xiltess may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be placed under particularly close observation.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, they may prescribe treatment to prevent peptic ulcer disease.

If the patient is taking:
- certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
- St John's wort ( Hypericum perforatum ), a herbal remedy used for depression,
- rifampicin, which belongs to the group of antibiotics.

If the patient suspects that any of the above conditions apply, they should
inform the doctor before using Xiltess, as the effect of Xiltess may be reduced. The doctor will decide whether to use Xiltess and whether the patient should be placed under particularly close observation.
Pregnancy and breastfeeding
Do not use Xiltess if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Xiltess. If the patient becomes pregnant while taking Xiltess, they should immediately inform the doctor, who will decide on further treatment.
Driving and operating machinery
Xiltess may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
Xiltess contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Xiltess

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Xiltess 15 mg and 20 mg film-coated tablets should be taken with food.
The tablet(s) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, discuss alternative ways of taking Xiltess with the
doctor. The tablet may be crushed and mixed with water or apple puree immediately before
administration. A meal should be taken promptly after this mixture.
If necessary, a crushed Xiltess film-coated tablet may be administered through a gastric tube by a
doctor.
How many tablets to take
Adults

For the prevention of blood clots in the brain (stroke) and other blood vessels in the body: the recommended dose is one 20 mg film-coated Xiltess tablet once daily. If the patient has kidney problems, the dose may be reduced to one 15 mg film-coated Xiltess tablet once daily.

If a procedure to open blood vessels in the heart is required (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one 15 mg Xiltess tablet once daily (or one 10 mg Xiltess tablet once daily in case of renal impairment), in combination with an antiplatelet medicine such as clopidogrel.

For the treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots: the recommended dose is one 15 mg film-coated Xiltess tablet twice daily for the first 3 weeks. For treatment beyond 3 weeks, the recommended dose is one 20 mg film-coated Xiltess tablet once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has kidney problems and is taking one 20 mg film-coated Xiltess tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg film-coated Xiltess tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.

Children and adolescents
The dose of Xiltess 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 below 50 kg is one 15 mg film-coated Xiltess tablet once daily.
The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg film-coated Xiltess tablet once daily.

Each dose of Xiltess should be taken with a meal, accompanied by a drink (e.g. water or juice). Tablets should be taken every day at approximately the same time. Consider setting an alarm to remind you.
For parents or caregivers: observe the child to ensure the full dose has been taken.
Since the dose of Xiltess depends on body weight, it is important to attend scheduled medical appointments, as dose adjustments may be necessary as body weight changes.
Never adjust the dose independently. If needed, the doctor will adjust the dose.
Do not split the tablet to achieve a partial dose. If a lower dose is required, the treating doctor may recommend using rivaroxaban granules for oral suspension.
For children and adolescents unable to swallow whole tablets, the Xiltess film-coated tablet may be crushed and mixed with water or apple puree immediately before administration. A meal should be taken after this mixture. If necessary, the doctor may also administer the crushed tablet via a gastric tube.
If a dose is vomited or spit out

within 30 minutes of taking Xiltess, take a new dose.
more than 30 minutes after taking Xiltess, do not take another dose. In this case, take the next dose of Xiltess at the usual time. Contact your doctor if vomiting or spitting out the dose occurs repeatedly after taking Xiltess.

When to take Xiltess
The tablet(s) should be taken every day until the doctor decides to stop treatment.
It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
The doctor will decide how long treatment should continue.
For the prevention of blood clots in the brain (stroke) and other blood vessels in the body:
if a procedure to restore normal heart rhythm (cardioversion) is required, Xiltess film-coated tablets should be taken at the time prescribed by the doctor.
Taking more than the recommended dose of Xiltess
If a patient has taken too many Xiltess film-coated tablets, contact a doctor immediately.
Taking too high a dose of Xiltess increases the risk of bleeding.
If a dose of Xiltess is missed
Adults, children and adolescents:

If the patient takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet as soon as possible. Do not take more than one tablet in a single day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily. Adults:
If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in a single day. If the patient forgot 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 within one day. The next day, resume taking one 15 mg tablet twice daily.

Stopping Xiltess
Do not stop taking Xiltess without first consulting your doctor, as Xiltess treats and prevents serious conditions.
If you have any further questions about the use of 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 of similar action that reduce blood clot formation, Xiltess may cause bleeding, which potentially could be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You should contact your doctor immediately 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,
unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide that close monitoring or a change in treatment is necessary.
Signs of severe skin reactions:
widespread, acute skin rash, blistering, or mucosal lesions, e.g., in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological disorders, and systemic involvement. The frequency of these adverse reactions is very rare (up to 1 in 10,000 people).
Signs of severe allergic reactions:
swelling of the face, lips, oral cavity, tongue, or throat; difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible adverse reactions in adults, children, and adolescents:
Common (may occur in up to 1 in 10 patients):

decrease in red blood cell count, which may cause skin pallor and lead to weakness or shortness of breath,
gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding,
bleeding into the eye (including conjunctival hemorrhage),
bleeding into tissues or body cavities (hematoma, bruising),
presence of blood in sputum (hemoptysis) during coughing,
bleeding from or under the skin,
postoperative bleeding,
oozing of blood or fluid from surgical wound sites,
limb swelling,
limb pain,
kidney function disorders (may be observed in tests performed by a doctor),
fever,
stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
low blood pressure (symptoms may include dizziness or fainting upon standing),
general decrease in strength and energy (weakness, fatigue), headache, dizziness,
rash, skin itching,
increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in up to 1 in 100 patients):

intracranial or cerebral hemorrhage (see bleeding signs above),
bleeding into joints causing pain and swelling,
thrombocytopenia (low platelet count, blood cells involved in clotting),
allergic reactions, including allergic skin reactions,
liver function disorders (may be observed in tests performed by a doctor),
blood tests may show increased bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
fainting,
malaise,
rapid heartbeat,
dry mouth,
urticaria.

Rare (may occur in up to 1 in 1,000 patients):

bleeding into muscles,
cholestasis (bile stasis), hepatitis including liver cell damage,
yellowing of the skin and eyes (jaundice),
localized swelling,
blood collection (hematoma) in the groin as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).
Very rare (may occur in fewer than 1 in 10,000 people):
accumulation of eosinophils, a type of granular white blood cells, causing lung inflammation (eosinophilic pneumonia).

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

kidney failure following severe bleeding,
bleeding in the kidneys, sometimes with blood in urine, leading to inability of the kidneys to function properly (drug-induced anticoagulant-related nephropathy),
increased pressure in the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after bleeding).

Adverse reactions in children and adolescents
Generally, adverse reactions observed in children and adolescents treated with Xiltess were similar in type to those seen in adults and were mostly 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 1 in 10 people):

rapid heartbeat,
blood test results may show increased bilirubin levels (a bile pigment),
thrombocytopenia (low platelet count, cells that help in blood clotting),
excessive menstrual bleeding.

Uncommon (may occur in 1 in 100 people):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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
Phone: +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, additional information on the safety of the medicine can be collected.

5. How to store Xiltess

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP".
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
No special precautions regarding storage temperature are required.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Xiltess contains

The active substance is rivaroxaban. Each coated tablet contains 15 mg or 20 mg of rivaroxaban.
Other ingredients are:
Tablet core: microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silica.
Tablet coating: hypromellose 2910, macrogol 3350, talc, titanium dioxide (E171), iron oxide red (E172).

What Xiltess looks like and contents of the pack
Xiltess 15 mg, coated tablets: round, biconvex, red-brown coated tablets with the marking "E843" on one side and no marking on the other side, with a diameter of approximately 8.1 mm.
Xiltess 20 mg, coated tablets: round, biconvex, brown coated tablets with the marking "E844" on one side and no marking on the other side, with a diameter of approximately 9.1 mm.
Xiltess 15 mg, coated tablets
28, 42, 98 or 100 coated tablets in blisters made of OPA/Aluminum/PVC/Aluminum foil, packed in a folding carton.
Xiltess 20 mg, coated tablets
28, 98 or 100 coated tablets in blisters made of OPA/Aluminum/PVC/Aluminum foil, packed in a folding carton.
Each blister contains 10 or 14 coated tablets, depending on the pack size.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer
Egis Pharmaceuticals PLC
Bökényföldi út 118-120
1165 Budapest
Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands Xiltess 15 mg, 20 mg filmomhulde tabletten
Bulgaria Xiltess 15 mg, 20 mg филмирани таблетки
Xiltess 15 mg, 20 mg film-coated tablets
Czech Republic Xiltess
Hungary Xiltess 15 mg, 20 mg filmtabletta
Lithuania Xiltess 15 mg, 20 mg plėvele dengtos tabletės
Latvia Xiltess 15 mg, 20 mg apvalkotās tabletes
Poland Xiltess
Romania Xiltess 15 mg, 20 mg comprimate filmate
Slovakia Xiltess 15 mg, 20 mg filmom obalené tablety

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00