Xiltess

Leaflet accompanying the packaging: patient information

Xiltess, 2.5 mg, coated tablets

Rivaroxaban

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging and other information

1. What is Xiltess and what is it used for

The patient has been given Xiltess, 2.5 mg, coated tablets, because

• they have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, acute chest pain) and have elevated levels of cardiac biomarkers. Xiltess reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Xiltess will not be given to the patient as the only medicine. The doctor will instruct the patient to also take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.

or

• they have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Xiltess reduces the risk of blood clots (atherothrombotic events) in adults. Xiltess will not be given to the patient as the only medicine. The doctor will instruct the patient to also take aspirin. In some cases, if the patient is taking Xiltess after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for the patient to take for a short time in addition to aspirin.

Xiltess contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

2. Important information before taking Xiltess

When not to take 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 that leads to an increased risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if the patient is 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 vein or artery catheter,
• if the patient has been diagnosed with acute coronary syndrome and has had bleeding or a blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and has had bleeding in the brain (stroke) or blockage of small arteries that supply blood to the brain tissues (cerebral sinus thrombosis), or if the patient has had a blood clot in the brain (ischemic stroke, not sinus thrombosis) in the last month),
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not take Xiltess, and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting Xiltess, discuss it with your doctor or pharmacist. Xiltess should not be taken with other blood clotting inhibitors, such as prasugrel or ticagrelor, except for aspirin, clopidogrel, or ticlopidine.

Be careful when taking Xiltess

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in the patient's body,
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), when changing anticoagulant treatment or when receiving heparin to maintain the patency of a vein or artery catheter (see "Xiltess and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines and stomach or esophageal inflammation (e.g., due to gastroesophageal reflux disease) or tumors in the stomach, intestines, genital, or urinary tract,
• vascular disease in the back of the eye (retinopathy),
• lung disease with dilated bronchi and pus (bronchiectasis) or previous lung bleeding,
• if the patient is over 75 years old,
• if the patient weighs less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• in patients with prosthetic valves,
• 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 patient suspects that they have any of the above conditions, they should

tell their doctorbefore taking Xiltess. The doctor will decide whether to prescribe this medicine and whether the patient should be closely monitored.

If the patient needs to have surgery:

• they should carefully follow the doctor's instructions regarding taking Xiltess at a specific time before or after surgery,
• if spinal or epidural puncture is planned (e.g., for regional anesthesia or pain relief):
• it is very important to take Xiltess before and after the puncture or catheter removal, as instructed by the doctor,
• due to the need for special caution, the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder disorders occur after anesthesia.

Children and adolescents

Xiltess, 2.5 mg, coated tablets are not recommended for people under 18 years old. There is a lack of sufficient data on the use of this medicine in children and adolescents.

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 antifungal medicines (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
• oral ketoconazole (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain antibacterial medicines (e.g., clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV or AIDS (e.g., ritonavir),
• other medicines that reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol, prasugrel, and ticagrelor (see "Warnings and precautions")),
• anti-inflammatory and pain-relieving medicines (e.g., naproxen or aspirin),
• 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 the patient suspects that they have any of the above conditions, they should

tell their doctorbefore taking Xiltess, as the effect of Xiltess may be increased. The doctor will decide whether to prescribe this medicine and whether the patient should be closely monitored. If the doctor considers that the patient is at increased risk of stomach or intestinal ulcers, they may prescribe a medicine 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, an antibiotic.

If the patient suspects that they have any of the above conditions, they should

tell their doctorbefore taking Xiltess, as the effect of Xiltess may be reduced. The doctor will decide whether to prescribe Xiltess and whether the patient 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, use effective contraception while taking Xiltess. If you become pregnant while taking this medicine, tell your doctor immediately, who will decide on further treatment.

Driving and using machines

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

Xiltess contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, which means it 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.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Xiltess should be taken at approximately the same time every day (e.g., one tablet in the morning and one in the evening). Xiltess, 2.5 mg, coated tablets can be taken with or without food. If the patient has difficulty swallowing the whole tablet, they should talk to their doctor about other ways to take Xiltess. The tablet can be crushed and mixed with water or apple sauce just before taking. If necessary, the doctor may give the crushed Xiltess tablet through a gastric tube. Xiltess will not be given to the patient as the only medicine. The doctor will instruct the patient to also take aspirin. If the patient is taking Xiltess after acute coronary syndrome, the doctor may also instruct them to take clopidogrel or ticlopidine. If the patient is taking Xiltess after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may prescribe clopidogrel for the patient to take for a short time in addition to aspirin. The doctor will tell the patient what dose to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start taking Xiltess

Treatment with Xiltess after acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the latest 24 hours after hospital admission, and when parenteral (injected) anticoagulant treatment would normally be discontinued. The doctor will tell the patient when to start treatment with Xiltess if they have been diagnosed with coronary artery disease or peripheral arterial disease. The doctor will decide how long to continue treatment.

Taking more Xiltess than prescribed

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

Missing a dose of Xiltess

Do not take a double dose to make up for a missed dose. If you miss a dose, take the next dose at the scheduled time.

Stopping Xiltess

Xiltess should be taken regularly and for the duration prescribed by your doctor. Do not stop taking Xiltess without first consulting your doctor. If you stop taking this medicine, the risk of another heart attack, stroke, or death due to heart or blood vessel disease may increase. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xiltess can cause side effects, although not everybody gets them. As with 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). Not all signs of bleeding will 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 .The doctor may decide to closely monitor the patient or change the treatment.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering, or changes to the mucous membranes, such as the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction that causes 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:

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

• reduced red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or genital tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• blood in the sputum when coughing (hemoptysis),
• 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 disorders (can be observed in tests performed by the doctor),
• fever,
• stomach pain, nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain 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 disorders (can be observed in tests performed by the doctor),
• blood test results may show increased bilirubin levels, activity of certain 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), 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, when a catheter is inserted into an artery in the leg. Very rare(may affect less than 1 in 10,000 people)
• accumulation of eosinophils, a type of white granular blood cells that 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 therapy),
• 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).

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 Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xiltess

Keep the 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 the month. Store in the original packaging to protect from moisture. There are no special precautions for storing the medicine at a certain temperature. 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Xiltess contains

• The active substance is rivaroxaban. Each coated tablet contains 2.5 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, 2.5 mg, coated tablets are round, biconvex, light pink coated tablets with the marking E841 on one side and no marking on the other, with a diameter of approximately 8.1 mm. 56, 98, or 100 coated tablets in blisters of OPA/Aluminum/PVC/Aluminum foil, packaged in a foldable cardboard box. One blister contains 10 or 14 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 2.5 mg film-coated tablets, Bulgaria: Xiltess 2.5 mg филмирани таблетки, Xiltess 2.5 mg film-coated tablets, Czech Republic: Xiltess, Hungary: Xiltess 2.5 mg filmtabletta, Lithuania: Xiltess 2.5 mg plėvele dengtos tabletės, Latvia: Xiltess 2.5 mg apvalkotās tabletes, Poland: Xiltess, Romania: Xiltess 2.5 mg comprimate filmate, Slovakia: Xiltess 2.5 mg filmom obalené tablety. For more information about this medicine, contact your local representative of the marketing authorization holder: EGIS Polska Sp. z o.o., ul. Komitetu Obrony Robotników 45D, 02-146 Warsaw, Tel.: +48 22 417 92 00

Date of last revision of the leaflet: 16.09.2023