Xiltess

Patient Information Leaflet

Xiltess, 10 mg, film-coated tablets
Rivaroxaban
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents

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

Xiltess 10 mg film-coated tablets contain the active substance rivaroxaban and are used in adults for:

• preventing blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because there is an increased risk of blood clots forming after surgery.
• 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 recurrence of blood clots in the blood vessels of the legs and/or lungs.

Xiltess 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, trauma or bleeding into the brain, recent surgery 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 from one anticoagulant treatment to another or if heparin is administered to maintain the patency of a catheter in a vein or artery,
• 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 that any of the above-mentioned circumstances apply to you.
Warnings and precautions
Before starting treatment with Xiltess, consult your doctor or pharmacist.
Exercise special caution when using Xiltess

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • moderate or 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), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a catheter in a vein or artery (see section "Xiltess with other medicines"),
  • disorders of blood coagulation,
  • very high blood pressure that does not decrease despite treatment with medicines,
  • diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (inflammation of the oesophagus), e.g. due to gastroesophageal reflux disease (acid reflux into the oesophagus), or tumours located in the stomach, intestines, genital or urinary tract,
  • blood vessel disease in the back of the eye (retinopathy),
  • lung disease with dilated airways filled with pus (bronchiectasis) or previous bleeding from the lungs.
• in patients with heart valve prostheses,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary,
• if the doctor finds that blood pressure is unstable or if other treatment or surgery is planned to remove a blood clot from the lungs.

If you suspect that any of the above conditions apply to you, inform your doctor
before taking Xiltess. The doctor will decide whether to use this medicine and whether
the patient requires particularly close monitoring.
If the patient needs to undergo surgery:

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

Children and adolescents
Xiltess, 10 mg 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 with other medicines
Tell your doctor or pharmacist about all medicines you are currently 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 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 to treat bacterial infections (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV infection 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If you suspect that any of the above conditions apply to you, inform your doctor
before taking Xiltess, because the effect of Xiltess may be increased. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, he may prescribe treatment to prevent peptic ulcer disease.

• If you are 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 you suspect that any of the above conditions apply to you, inform your doctor
before taking Xiltess, because the effect of Xiltess may be reduced. The doctor will decide whether to use Xiltess and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Xiltess if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use an effective method of contraception during treatment with Xiltess. If you become pregnant while taking Xiltess, inform your doctor immediately, 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
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, i.e. the medicine is considered "sodium-free".

3. How to take Xiltess

This medicine should always be taken as directed by the doctor. If in doubt, consult your
doctor or pharmacist.
How many tablets to take

• To prevent the formation of blood clots in the veins following hip or knee replacement surgery, the recommended dose is one Xiltess 10 mg coated tablet once daily.
• 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, after at least 6 months of treatment for blood clots, the recommended dose is one Xiltess 10 mg coated tablet once daily or one Xiltess 20 mg coated tablet once daily. The doctor has prescribed Xiltess 10 mg once daily for the patient.

The tablet should be swallowed whole, preferably with water.
Xiltess 10 mg coated tablets may be taken with food or independently of meals.
If the patient has difficulty swallowing the whole tablet, discuss alternative methods of taking Xiltess with the doctor. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, the doctor may administer crushed Xiltess coated tablets via a gastric tube.
When to take Xiltess Take one tablet every day until the doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
The doctor will decide how long treatment should continue.
To prevent blood clots in leg veins after hip or knee replacement surgery: the first tablet should be taken between 6 and 10 hours after surgery.
In patients undergoing major hip surgery, treatment usually lasts 5 weeks.
In patients undergoing major knee surgery, treatment usually lasts 2 weeks.
Taking more Xiltess than recommended If the patient has taken more than the recommended dose of Xiltess, contact the doctor immediately. Taking too high a dose of Xiltess increases the risk of bleeding.
Missing a dose of Xiltess If the patient forgets to take a dose, take the tablet as soon as remembered.
Take the next tablet the following day, then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a missed tablet.
Stopping Xiltess Do not stop taking Xiltess without first discussing it with the doctor, as Xiltess helps prevent a serious condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
As with other medicines with a similar anticoagulant effect, 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 effects 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. This is 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 disorders and systemic symptoms (DRESS syndrome). The frequency of these adverse effects is very rare (occurring in 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 anaphlyactic 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 effects:
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 breathlessness,
• gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• 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 blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may be evident in blood test results.

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

• bleeding into the brain or within 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,
• dryness of the 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,
• accumulation of blood (hematoma) in the groin area 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 white granulocytic 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 the urine, leading to impaired kidney function (drug-induced anticoagulant-related nephropathy),
• increased pressure in the muscles of the arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to 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 specified 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 in use. This will help protect the environment.

6. Contents of the package and other information

What Xiltess contains

• The active substance is rivaroxaban. Each coated tablet contains 10 mg of rivaroxaban.
• Other components are:
  Tablet core: microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, 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 10 mg film-coated tablets are round, biconvex, dark pink coated tablets with the imprint "E842" on one side and no marking on the other side, with a diameter of approximately 8.1 mm.
10, 28, 30, 98 or 100 film-coated tablets in blisters made of OPA/Aluminium/PVC/Aluminium foil, packed in a folding carton.
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 States of the European Economic Area under the following names:
Netherlands: Xiltess 10 mg filmomhulde tabletten
Bulgaria: Xiltess 10 mg филмирани таблетки
International: 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

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