Xiltess

Package Leaflet: Information for the Patient

Xiltess, 15 mg, film-coated tablets

Xiltess, 20 mg, film-coated tablets

Rivaroxaban

Read the package leaflet carefully before taking the medicine, as 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Xiltess and what is it used for
• 2. Important information before taking Xiltess
• 3. How to take Xiltess
• 4. Possible side effects
• 5. How to store Xiltess
• 6. Contents of the pack and other information

1. What is Xiltess and what is it used for

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

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body, if the patient has a form of irregular heart rhythm called non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and to prevent the recurrence of blood clots in the blood vessels 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 weighing 30 kg or more to:

• treat and prevent blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Xiltess belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thereby reducing the tendency to form blood clots.

2. Important information before taking Xiltess

When not to take Xiltess

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have a disease or condition of the body that leads 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 you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a venous or arterial catheter,
• if you have liver disease that leads to an increased risk of bleeding,
• if you are pregnant or breastfeeding. Do not take Xiltess, and inform your doctorif you suspect that these circumstances apply to you.

Warnings and precautions

Before starting treatment with Xiltess, consult your doctor or pharmacist.

Be careful when taking Xiltess

• if you have an increased risk of bleeding, such as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine that works in the body,
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a venous or arterial catheter (see "Xiltess and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment,
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to reflux disease of the esophagus (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• disease of the blood vessels in the back of the eye (retinopathy),
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs.
• in patients with prosthetic valves,
• if you have a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change the treatment,
• if your doctor finds that your blood pressure is unstable or if other treatment or surgery is planned to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, inform

your doctorbefore taking Xiltess. Your doctor will decide whether to use this medicine and whether you should be closely monitored.

If you need to have surgery:

• follow your doctor's instructions carefully regarding the intake of Xiltess at a strictly specified time before or after surgery,
• 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 Xiltess before and after the puncture or catheter removal, as instructed by your doctor,
• due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia.

Children and adolescents

Xiltess, film-coated tablets are not recommended for children weighing less than 30 kg.There is a lack of sufficient data on the use of Xiltess in children and adolescents for indications in adults.

Xiltess and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• If you are taking:
• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV or AIDS (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 (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you suspect that you have any of the above conditions, inform

your doctorbefore taking Xiltess, as the effect of Xiltess may be enhanced. Your doctor will decide whether to use this medicine and whether you should be closely monitored.
If your doctor believes that you are at increased risk of developing stomach or intestinal ulcers, they may use a treatment to prevent ulcers.
If you are taking:

• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort ( Hypericum perforatum), a herbal medicine used to treat depression,
• rifampicin, which belongs to a group of antibiotics.

If you suspect that you have any of the above conditions, inform

your doctorbefore taking Xiltess, as the effect of Xiltess may be reduced. Your doctor will decide whether to use Xiltess and whether you should be closely monitored.

Pregnancy and breastfeeding

Do not take Xiltess if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking Xiltess. If you become pregnant while taking Xiltess, inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Xiltess may cause dizziness (frequent side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive, ride a bike, or operate tools or machines.

Xiltess contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. the medicine is considered "sodium-free".

3. How to take Xiltess

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Xiltess, 15 mg and 20 mg, film-coated tablets should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing whole tablets, talk to your doctor about other ways to take Xiltess. The tablet can be crushed and mixed with water or apple sauce just before taking. After such a mixture, eat a meal immediately.
If necessary, your doctor may also administer the crushed tablet through a gastric tube.

How many tablets to take

Adults

• In preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body. The recommended dose is one 20 mg Xiltess film-coated tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Xiltess film-coated tablet once daily.

If you need a procedure to open up blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one 15 mg Xiltess tablet once daily (or one 10 mg Xiltess tablet once daily in case of kidney function impairment) in combination with an antiplatelet agent such as clopidogrel.

• In treating blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and preventing the recurrence of blood clots. The recommended dose is one 15 mg Xiltess film-coated tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Xiltess film-coated tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If you have kidney problems and are taking one 20 mg Xiltess film-coated tablet once daily, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Xiltess film-coated 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 your doctor.

• The recommended dose for children and adolescents weighing from 30 kg to less than 50 kgis one 15 mg Xiltess film-coated tablet once daily.
• The recommended dose for children and adolescents weighing 50 kg or moreis one 20 mg Xiltess film-coated tablet once daily.

Each dose of Xiltess should be taken with food, with a drink (e.g. water or juice). Tablets should be taken daily, at approximately the same time. It's a good idea to set an alarm to remind you.
For parents or caregivers: observe the child to ensure they have taken the entire dose.
The dose of Xiltess depends on body weight, so it's essential to follow scheduled doctor's appointments, as the dose may need to be adjusted as the child's weight changes.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose.
Do not divide the tablet to get a partial dose. If a smaller dose is needed, your doctor may prescribe a granule for oral suspension containing rivaroxaban.
For children and adolescents who are unable to swallow whole tablets, the Xiltess film-coated tablet can be crushed and mixed with water or apple sauce just before taking. After such a mixture, eat a meal immediately. If necessary, your doctor may also administer the crushed tablet through a gastric tube.

If you spit out a dose or vomit

• less than 30 minutes after taking Xiltess, take a new dose.
• more than 30 minutes after taking Xiltess, do not takea new dose. In this case, take the next dose of Xiltess at the usual time. Contact your doctor if you spit out a dose or vomit repeatedly after taking Xiltess.

When to take Xiltess

Take the tablet(s) every day until your doctor decides to stop the treatment.
It's best to take the tablet(s) at the same time every day, as it's easier to remember.
Your doctor will decide how long you should continue the treatment.
Preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body:
if your heart rhythm needs to be restored to normal using a procedure called cardioversion, take Xiltess, film-coated tablets as instructed by your doctor.

Taking more Xiltess than prescribed

If you have taken more Xiltess tablets than prescribed, contact your doctor immediately.
Taking too much Xiltess increases the risk of bleeding.

Missing a dose of Xiltess

Adults, children, and adolescents:

• If you take one 20 mg or one 15 mg tablet once daily and miss a dose, take it as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet at the usual time the next day, and then take one tablet once daily. Adults:
• If you take one 15 mg tablet twice daily and miss a dose, take it as soon as possible. Do not take more than two 15 mg tablets in one day. If you miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in one day. The next day, continue taking one 15 mg tablet twice daily.

Stopping Xiltess treatment

Do not stop taking Xiltess without first talking to your doctor, as Xiltess treats and prevents serious diseases.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xiltess can cause side effects, although not everybody gets them.
Like other medicines that reduce blood clotting, Xiltess may cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These signs of bleeding may not always be obvious or visible.
Tell your doctor immediately if you experience 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. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris .Your doctor may decide to monitor you closely or change the treatment.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering, or changes to the mucous membranes, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, inflammation of internal organs, hematologic disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (up to 1 in 10,000 people).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives, and difficulty breathing; 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 side effects in adults, children, and adolescents:

Common(may affect up to 1 in 10 people):

• reduced red blood cell count, which can cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary tract (including blood in the urine and heavy menstrual bleeding), nosebleeds,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum when coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney function disorders (can be observed in tests performed by your doctor),
• fever,
• stomach pain, nausea, feeling sick (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 of the skin,
• increased activity of some liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people):

• bleeding into the brain or inside the skull (see above signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, activity of some pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

Rare(may affect up to 1 in 1,000 people):

• bleeding into the muscles,
• cholestasis (bile stasis), liver inflammation, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• hematoma (collection of blood) in the groin as a complication of cardiac catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm). Very rare(may affect less than 1 in 10,000 people)
• accumulation of eosinophils, a type of white granular blood cells, which can cause inflammation in the lungs (eosinophilic pneumonia)

Frequency not known(frequency 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 drugs),
• increased pressure in the muscles of the legs and arms, occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with Xiltess were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed more frequently in children and adolescents:
Very common(may affect more than 1 in 10 people):

• headache,
• fever,
• nosebleeds,
• vomiting.

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xiltess

Keep this medicine out of the 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 that month.
Store in the original package to protect from moisture.
No special precautions for storage temperature are necessary.
Crushed tablets
Crushed tablets are stable in water or apple sauce for up to 4 hours.
Medicines should 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 film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
• The 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, film-coated tablets: round, biconvex, reddish-brown film-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, film-coated tablets: round, biconvex, brown film-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, film-coated tablets
28, 42, 98, or 100 film-coated tablets in blisters of OPA/Aluminum/PVC/Aluminum foil, packed in a folding carton.
Xiltess, 20 mg, film-coated tablets
28, 98, or 100 film-coated tablets in blisters of OPA/Aluminum/PVC/Aluminum foil, packed in a folding carton.
One blister contains 10 or 14 film-coated tablets, depending on the pack size.
Not all pack sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer

Egis Pharmaceuticals PLC
Bökényföldi út 118-120
1165 Budapest
Hungary

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands
Xiltess 15 mg, 20 mg film-coated tablets
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
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet: 16.09.2023