Xerdoxo

Leaflet accompanying the packaging: patient information

Xerdoxo, 10 mg, film-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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Xerdoxo and what is it used for

Xerdoxo contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. The doctor has prescribed this medicine because the risk of blood clots is increased 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 prevent the recurrence of blood clots in the veins of the legs and/or lungs.

Xerdoxo 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 Xerdoxo

When not to take Xerdoxo

• 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 the body 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 administered to maintain the patency of a vein or artery 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 Xerdoxo, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting Xerdoxo, consult your doctor or pharmacist.

When to be particularly careful when taking Xerdoxo

• if the patient has an increased risk of bleeding, such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
• if the patient is taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a vein or artery catheter (see "Xerdoxo and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus), such as reflux disease of the esophagus (backflow of stomach acid into the esophagus) or tumors located in the stomach, intestines, genital, or urinary system,
• vascular disease of 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 artificial 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 the doctor, who will decide whether to change the treatment,
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment 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 Xerdoxo. The doctor will decide whether to prescribe this medicine and whether the patient should be closely monitored.

If the patient needs to undergo surgery

• they should carefully follow the doctor's instructions regarding the intake of Xerdoxo at a specific time before or after surgery,
• if spinal puncture or catheter insertion into the spine is planned during surgery (e.g., for epidural or spinal anesthesia, or to relieve pain):
• they should carefully follow the doctor's instructions regarding the intake of Xerdoxo at a specific time,
• they should immediately inform their doctor if they experience symptoms such as numbness or weakness of the lower limbs, bowel or bladder dysfunction, as immediate treatment may be necessary.

Children and adolescents

Xerdoxo, 10 mg, film-coated tablets are not recommended for persons under 18 years of age. There is a lack of sufficient data on the use of the medicine in children and adolescents.

Xerdoxo and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

• 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 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 treating depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

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

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

• If you are taking
• certain medicines for treating 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 you suspect that you have any of the above conditions, you should

tell your doctorbefore taking Xerdoxo, as the effect of Xerdoxo may be reduced. The doctor will decide whether to prescribe Xerdoxo and whether you should be closely monitored.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take Xerdoxo if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, use effective contraception while taking Xerdoxo. If you become pregnant while taking this medicine, tell your doctor immediately, who will decide on further treatment.

Driving and using machines

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

Xerdoxo contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Xerdoxo

Always take this medicine exactly as your doctor has told you. If you are not sure, consult 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 Xerdoxo 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 the recurrence of blood clots, after at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Xerdoxo 10 mg once a day for you.

Swallow the tablet whole, preferably with water.
Xerdoxo can be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Xerdoxo. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before taking it.
If necessary, your doctor may administer the crushed Xerdoxo tablet through a gastric tube.

When to take Xerdoxo

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:

The first tablet should be taken 6 to 10 hours after surgery.
Treatment usually lasts 5 weeks in patients after major hip surgery.
Treatment usually lasts 2 weeks in patients after major knee surgery.

Taking more Xerdoxo than prescribed

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

Missing a dose of Xerdoxo

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 a missed tablet.

Stopping Xerdoxo treatment

Do not stop taking Xerdoxo without consulting your doctor first, as Xerdoxo prevents a serious disease.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xerdoxo can cause side effects, although not everybody gets them.
Like other medicines with similar blood clot-reducing effects, Xerdoxo can cause bleeding, which can be life-threatening. Excessive bleeding can 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 pectoris. Your doctor may decide to closely monitor you or change your treatment.

Signs of severe skin reaction

• widespread, acute skin rash, blistering, or changes to the mucous membranes, such as the mouth 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 patients).

Signs of severe allergic reaction

• 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 up to 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 intestines, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum (hemoptysis) while 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 dysfunction (may be observed in tests performed by your doctor),
• fever,
• stomach pain, nausea, feeling of nausea (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 may be visible 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 dysfunction (may be observed in tests performed by your 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 cardiac catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white granular blood cells, which cause inflammation in the lungs (eosinophilic pneumonia).

Frequency not known(frequency cannot be estimated from the available data)

• kidney failure after severe bleeding,
• kidney bleeding, 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).

Reporting side effects

If you experience any side effects, including any side effects 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 Xerdoxo

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
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 Xerdoxo contains

• The active substance of Xerdoxo is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are: mannitol, microcrystalline cellulose, macrogol 8000, poloxamer 188, sodium lauryl sulfate, sodium croscarmellose, colloidal silicon dioxide, and sodium stearyl fumarate in the tablet core, and hypromellose 2910, macrogol 4000, titanium dioxide (E 171), and iron oxide, red (E 172) in the tablet coating. See section 2 "Xerdoxo contains sodium".

What Xerdoxo looks like and contents of the pack

Brown-red, round, slightly biconvex film-coated tablets with "10" engraved on one side.
Dimensions: diameter approximately 6.5 mm.
Xerdoxo is available in cartons containing:

• calendar packaging: 14, 28, or 42 film-coated tablets in blisters.

A patient warning card is included with each pack of the medicine.
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer/Importer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
Krka - Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00
Date of last revision of the leaflet:08.02.2024