Xiltess

Leaflet attached to the packaging: patient information

Xiltess, 10 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 pack and other information

1. What is Xiltess and what is it used for

Xiltess, 10 mg, coated tablets, contain the active substance rivaroxaban and are used in adults to:

• prevent blood clots in the veins after hip or knee replacement surgery. The doctor has prescribed this medicine because there is an increased risk of blood clots after surgery.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and to prevent blood clots from forming again in the blood vessels of the legs and/or lungs.

Xiltess belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thus reducing 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 switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter,
• 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, consult your doctor or pharmacist.

Be careful when taking Xiltess

• if the patient has an increased risk of bleeding, such as:
• mild or moderate kidney disease, as kidney function may affect the amount of medicine in the patient's body,
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy 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 (stomach acid flowing back into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• vascular disease of the back of the eye (retinopathy),
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs.
• in patients with prosthetic heart 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 whether to change the treatment,
• if the doctor finds that the patient's blood pressure is unstable or plans other treatment or surgery to remove a blood clot from the lungs.

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

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

If the patient needs to have surgery:

• they should carefully follow the doctor's instructions regarding the timing of Xiltess intake before or after surgery,
• if catheterization or spinal puncture is planned (e.g., for spinal 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, 10 mg, coated tablets are not recommended for persons under 18 years of age. There is insufficient data on the use of the 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 medicines for 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 for bacterial infections (e.g., clarithromycin, erythromycin),
• certain antiviral medicines for HIV or AIDS treatment (e.g., ritonavir),
• other medicines that 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 for treating heart rhythm disorders,
• certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

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

inform their doctorbefore taking Xiltess, as the effect of Xiltess may be increased. The doctor will decide whether to prescribe Xiltess and whether the patient should be closely monitored.
If the doctor believes that the patient is at increased risk of stomach or intestinal ulcers, they may prescribe treatment to prevent stomach ulcers.

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

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

inform 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, you should use effective contraception while taking Xiltess. If you become pregnant while taking Xiltess, you should 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 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

• To prevent blood clots in the veins after hip or knee replacement surgery, the recommended dose is one 10 mg Xiltess coated tablet taken once a day.
• For the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent blood clots from forming again, after at least 6 months of treatment for blood clots, the recommended dose is one 10 mg Xiltess coated tablet taken once a day or one 20 mg Xiltess coated tablet taken once a day. Your doctor has prescribed Xiltess 10 mg once a day for you.

Swallow the tablet with water.
Xiltess, 10 mg, coated tablets can be taken with or without food.
If you have difficulty swallowing the whole tablet, 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 it.
If necessary, the doctor may administer the crushed coated tablet through a gastric tube.

When to take Xiltess

Take one tablet every day until your doctor decides to stop the treatment.
It is best to take the tablet at the same time every day, as it is easier to remember.
Your doctor will decide how long to continue the treatment.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery: take the first tablet 6 to 10 hours after surgery.
In patients after major hip replacement surgery, treatment usually lasts 5 weeks.
In patients after major knee replacement surgery, treatment usually lasts 2 weeks.

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

If you forget to take a dose, take the tablet as soon as you remember.
Take the next tablet the next day, and then take the tablets as usual, once a day.
Do not take a double dose to make up for the missed tablet.

Stopping Xiltess

Do not stop taking Xiltess without talking to your doctor first, as Xiltess prevents a serious disease.
If you have any further questions about taking Xiltess, 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 may lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.
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 monitor the patient closely or change the treatment.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering, or changes to the mucous membranes, e.g., tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, inflammation of internal organs, hematological 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):

• decrease in 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 system (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),
• presence of blood in sputum (hemoptysis) 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 disorders (can be observed in tests performed by the 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 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 the 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 stagnation), 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 (pseudoaneurysm). 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 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 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.
Reporting side effects will help gather more information on the safety of the 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 package to protect from moisture.
There are no special precautions for storing the medicine at a certain temperature.
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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Xiltess contains

• The active substance of Xiltess is rivaroxaban. Each coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium carmellose, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, anhydrous colloidal 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, 10 mg, coated tablets are round, biconvex, dark pink coated tablets with the code E842 on one side and no code on the other, approximately 8.1 mm in diameter.
10, 28, 30, 98, or 100 coated tablets in blisters of OPA/Aluminum/PVC/Aluminum foil, packed in a folding carton.
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 10 mg film-coated tablets
Bulgaria
Xiltess 10 mg филмирани таблетки
Xiltess 10 mg film-coated tablets
Czech Republic
Xiltess
Hungary
Xiltess 10 mg filmtabletta
Lithuania
Xiltess 10 mg plėvele dengtos tabletės
Latvia
Xiltess 10 mg apvalkotās tabletes
Poland
Xiltess
Romania
Xiltess 10 mg comprimate filmate
Slovakia
Xiltess 10 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