Xiltess

Package leaflet: Information for the patient

Xiltess, 2.5 mg, film-coated tablets
Rivaroxabanum
Please read carefully all of this leaflet 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, please 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Xiltess is and what it is used for
2. What you need to know before you take 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 Xiltess is and what it is used for

You have been prescribed Xiltess 2.5 mg film-coated tablets because:

• You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been confirmed. Xiltess reduces the risk of a subsequent heart attack or the risk of cardiovascular death in adults. Xiltess will not be given to you as a single treatment. Your doctor will also prescribe you to take:
  • acetylsalicylic acid, or
  • acetylsalicylic acid and clopidogrel or ticlopidine.

or

• You have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral artery disease causing symptoms. Xiltess reduces the risk of blood clots (atherothrombotic events) in adults. Xiltess will not be given to you as a single treatment. Your doctor will also prescribe you to take acetylsalicylic acid. In some cases, if you are receiving Xiltess after a procedure to unblock a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel to be taken in addition to acetylsalicylic acid for a short period.

Xiltess contains the active substance rivaroxaban and belongs to a group of medicines called 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 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 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 switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery,
• if the patient has been diagnosed with acute coronary syndrome and previously experienced bleeding or blood clot in the brain (stroke),
• if the patient has coronary artery disease or peripheral arterial disease and previously had a brain haemorrhage (haemorrhagic stroke), or blockage of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient had a non-lacunar ischaemic stroke within the last month,
• 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 your doctor if you suspect any of the above conditions apply.

Warnings and precautions
Before starting Xiltess, discuss it with your doctor or pharmacist.
Xiltess should not be used in combination with blood clotting inhibitors other than acetylsalicylic acid, clopidogrel, or ticlopidine, such as prasugrel or ticagrelor.
Exercise special caution when using Xiltess

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
  • taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or during heparin administration to maintain catheter patency in a vein or artery (see section "Xiltess and other medicines"),
  • blood clotting disorders,
  • very high blood pressure that does not decrease despite medication,
  • stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach, intestines, genital or urinary system,
  • blood vessel disease in the back of the eyeball (retinopathy),
  • lung disease with dilated bronchi filled with 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 heart valve prostheses,
• 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 a change in treatment is needed.

If you suspect any of the above conditions apply, inform your doctor
before taking 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 surgery:

• strictly follow the doctor's instructions regarding taking Xiltess at a specific time before or after surgery,
• if catheterisation or spinal puncture (e.g. for epidural or intrathecal anaesthesia or pain relief) is planned during surgery:
  • 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 2.5 mg film-coated tablets are not recommended for patients under 18 years of age.
There is insufficient data on the use of the medicine in children and adolescents.
Xiltess and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

• If the patient is taking:
  • certain antifungal medicines (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 (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, prasugrel and ticagrelor (see section "Warnings and precautions")),
  • anti-inflammatory and pain 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 you suspect any of the above conditions apply, inform your doctor
before taking 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 ulcer formation.

• If the patient is taking:
  • certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
  • St. John's wort ( Hypericum perforatum ), a herbal medicine used for depression,
  • rifampicin, which belongs to the group of antibiotics. If you suspect any of the above conditions apply, inform your doctor before taking 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 you are 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 pregnancy occurs during treatment with this medicine, inform your doctor immediately, who will decide on further management.
    Driving and operating machinery
    Xiltess may cause dizziness (common side effects) or 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 film-coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Xiltess

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should consult your doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Xiltess should be taken at approximately the same time each day (for example, one tablet in the morning and one in the evening). Xiltess 2.5 mg film-coated tablets can be taken with or without food.
If a patient has difficulty swallowing the whole tablet, talk to the doctor about other ways of taking Xiltess. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, the doctor may administer crushed Xiltess tablets via a gastric tube.
Xiltess will not be given to the patient as the only medication.
Your doctor will prescribe acetylsalicylic acid to be taken alongside Xiltess. If the patient is receiving Xiltess after an acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine.
If the patient is receiving Xiltess following a procedure to open a narrowed or blocked artery in the lower limb to restore blood flow, the doctor may also prescribe clopidogrel to be taken for a short period in addition to acetylsalicylic acid.
The doctor will inform the patient of the dose to be taken (usually 75–100 mg of acetylsalicylic acid per day, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of 75 mg clopidogrel, or the standard daily dose of ticlopidine).
When to start taking Xiltess
Treatment with Xiltess after an acute coronary syndrome should be initiated as soon as possible after stabilization of the acute coronary syndrome, no earlier than 24 hours after hospital admission and at the time when parenteral (by injection) anticoagulant treatment would normally be discontinued.
The doctor will inform the patient when to start treatment with Xiltess if coronary artery disease or peripheral arterial disease has been diagnosed.
The doctor will decide how long treatment should continue.
Taking more Xiltess than recommended
If a patient takes more Xiltess than recommended, contact the doctor immediately. Taking too high a dose of 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 a dose is missed, the patient should take the next dose at the scheduled time.
Stopping Xiltess
Xiltess should be taken regularly and for the duration recommended by the doctor.
Do not stop taking Xiltess without first consulting your doctor. If treatment with this medicine is stopped, there may be an increased risk of another heart attack, stroke, or death due to heart- or blood vessel-related disease.
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 with a similar mechanism of 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 immediately contact a 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,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that close monitoring of the patient 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 causing rash, fever, internal organ inflammation, hematological and systemic disorders (DRESS syndrome). The frequency of occurrence of these adverse reactions 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; 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:
Common (may occur in up to 1 in 10 patients):

• decrease in red blood cells, which may cause paleness of the skin and lead to 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, bleeding from the gums,
• bleeding into the eye (including bleeding from the sclera),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from a surgical wound,
• 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 arterial 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 seen in blood test results.

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

• bleeding into the brain or inside the skull (see signs of bleeding above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low platelet count, the blood cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (may be observed in tests performed by a doctor),
• blood tests may show increased levels of bilirubin, 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),
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of cardiac catheterization procedure, 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 impaired kidney function (anticoagulant-related nephropathy),
• increased pressure within the muscles of the arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine 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 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. These measures 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 film-coated tablets are round, biconvex, light pink film-coated tablets with the imprint "E841" on one side and no marking on the other side, approximately 8.1 mm in diameter.
Packaged in blisters made of OPA/Aluminium/PVC/Aluminium foil, containing 56, 98 or 100 film-coated tablets, packed in a folding cardboard box.
Each blister contains 10 or 14 film-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 member countries of the European Economic Area under the following names:
Netherlands: Xiltess 2.5 mg filmomhulde tabletten
Bulgaria: Xiltess 2,5 mg филмирани таблетки
International: 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 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