Xerdoxo

Leaflet accompanying the packaging: patient information

Xerdoxo, 15 mg, film-coated tablets

Xerdoxo, 20 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.
• In case of any doubts, consult a 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. Package contents and other information

1. What is Xerdoxo and what is it used for

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

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs. Xerdoxo is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:
• treat and prevent the recurrence of blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Xerdoxo belongs to a group of medicines called anticoagulants. Its action is based on blocking a blood clotting factor (factor Xa) and thereby 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 the formation of blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery catheter,

Do not take Xerdoxo, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Xerdoxo, consult a doctor or pharmacist.

When to be particularly careful when taking Xerdoxo

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease in adults, and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body,
• taking other medicines that prevent the formation of blood clots (e.g., warfarin, dabigatran etexilate, apixaban, or heparin) when changing anticoagulant treatment 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 taking medicines,
• 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 (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• vascular disease in the back of the eye (retinopathy),
• pulmonary disease in which the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic valves,
• if the patient has a disorder 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 changes in 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 use this medicine and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery

• they must strictly follow the doctor's recommendations regarding the intake of Xerdoxo at a precisely specified time before or after surgery,
• if spinal or epidural anesthesia is planned during surgery (e.g., to perform a spinal or epidural block, or to reduce pain):
• it is very important to take Xerdoxo before and after the procedure, according to the doctor's recommendations,
• the patient should immediately inform their doctor if, after the anesthesia, they experience symptoms such as:

numbness or weakness of the lower limbs, disorders of bowel or bladder function, as immediate treatment may be necessary.

Children and adolescents

Xerdoxo is not recommended for children with a body weight below 30 kg. There is a lack of sufficient data on the use of Xerdoxo in children and adolescents for indications in adults.

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 used to treat 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 used to treat bacterial infections (e.g., clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV 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 (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

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

inform their doctorbefore taking Xerdoxo, as the action of Xerdoxo may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.
If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use a treatment 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, 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 Xerdoxo, as the action of Xerdoxo may be reduced. The doctor will decide whether to use Xerdoxo and whether the patient should be subject to particularly close monitoring.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Do not take Xerdoxo if you are pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use effective contraception while taking Xerdoxo. If the patient becomes pregnant while taking Xerdoxo, they should immediately inform their doctor, 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").
Patients who experience these side effects should not drive vehicles, ride bicycles, 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, ask your doctor or pharmacist.
Xerdoxo should be taken with food.
Swallow the tablet(s) whole, with water if possible.
If you have difficulty swallowing whole tablets, 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. After such a mixture, eat a meal immediately.
If necessary, your doctor may also give you a crushed Xerdoxo tablet through a gastric tube.

How many tablets to take

• Adults
• In the prevention of blood clots in the brain (stroke) and other blood vessels in the body, the recommended dose is one Xerdoxo 20 mg tablet once a day. If the patient has kidney disease, the dose may be reduced to one Xerdoxo 15 mg tablet once a day.

If the patient needs a procedure to open up blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one Xerdoxo 15 mg tablet once a day (or one Xerdoxo 10 mg tablet once a day in case of kidney function disorder) in combination with an antiplatelet medicine, such as clopidogrel.

• In 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, the recommended dose is one Xerdoxo 15 mg tablet twice a day for the first 3 weeks. After 3 weeks, the recommended dose is one Xerdoxo 20 mg tablet once a day. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with one 10 mg tablet once a day or one 20 mg tablet once a day. If the patient has kidney disease and is taking one Xerdoxo 20 mg tablet once a day, the doctor may decide to reduce the dose after 3 weeks of treatment to one Xerdoxo 15 mg tablet once a day, if the risk of bleeding is greater than the risk of further blood clots.
• Children and adolescentsThe dose of Xerdoxo depends on body weight and will be calculated by the doctor.
• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one Xerdoxo 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Xerdoxo 20 mgtablet once a day. Each dose of Xerdoxo should be taken with food, with a drink (e.g., water or juice). The tablets should be taken every day at approximately the same time. It is a good idea to set an alarm to remind you. For parents or caregivers: observe the child to ensure they have taken the entire dose.

The dose of Xerdoxo is dependent on body weight, so it is essential to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes.
Never adjust the dose yourself.If necessary, the doctor will adjust the dose.
Do not divide the tablet to obtain a partial dose of the tablet. If a smaller dose is necessary, use a different form of rivaroxaban, an oral suspension.
For children and adolescents who are unable to swallow whole tablets, use a rivaroxaban oral suspension.
If an oral suspension is not available, you can crush the Xerdoxo tablet and mix it with water or apple sauce immediately before taking. After such a mixture, eat a meal immediately. If necessary, the doctor may also give you a crushed Xerdoxo tablet through a gastric tube.

In case of spitting up a dose or vomiting

• less than 30 minutes after taking Xerdoxo, take a new dose.
• more than 30 minutes after taking Xerdoxo, do nottake a new dose. In this case, take the next dose of Xerdoxo at the usual time.

Contact your doctor if you spit up a dose or vomit after taking Xerdoxo multiple times.

When to take Xerdoxo

Take the tablet(s) every day until the doctor decides to stop the treatment.
It is best to take the tablet(s) at the same time every day, as it will be easier to remember.
The doctor will decide how long the patient should continue the treatment.
Preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body:
If the patient's heart rhythm needs to be restored using a procedure called cardioversion, Xerdoxo should be taken as recommended by the doctor.

Missing a dose of Xerdoxo

• Adults, children, and adolescents If the patient takes one 20 mg or one 15 mg tablet oncea day and misses a dose, they should take it as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the next day, and then take one tablet once a day.
• Adults If the patient takes one 15 mg tablet twicea day and misses a dose, they should take it as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient misses a dose, they can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in one day. The next day, continue taking one 15 mg tablet twice a day.

Taking a higher dose of Xerdoxo than recommended

If the patient takes a higher dose of Xerdoxo than recommended, they should contact their doctor immediately. Taking too much Xerdoxo increases the risk of bleeding.

Stopping Xerdoxo

Do not stop taking Xerdoxo without first consulting your doctor, as Xerdoxo treats and prevents serious diseases.
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 a similar action that reduces blood clot formation, 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, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina.

Signs of a severe skin reaction

• widespread, acute skin rash, blistering, or changes in the mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (less than 1 in 10,000 patients).

Signs of a 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 less than 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in less than 1 in 100 people).

General list of possible side effects in adults, children, and adolescents:

Common(may affect up to 1 in 10 people)

• reduced red blood cell count, which can cause paleness and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum 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 function disorders (can be observed in tests performed by the doctor),
• fever,
• stomach pain, nausea, 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,
• skin rash, itching,
• 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 function disorders (can be observed in tests performed by the doctor),
• blood test results may show increased bilirubin levels, certain liver or pancreatic enzyme activities, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

Rare(may affect up to 1 in 1,000 people)

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• hematoma (collection of blood) 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 that 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 after bleeding, which can cause pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with rivaroxaban were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed more frequently in children and adolescents:

Very common(may affect more than 1 in 10 people)

• headache
• fever
• nasal bleeding
• vomiting

Common(may affect up to 1 in 10 people)

• rapid heartbeat
• blood test results may show increased bilirubin levels
• thrombocytopenia (low platelet count)
• excessive menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased direct bilirubin levels

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, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (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 the "EXP" abbreviation. The expiry date refers to the last day of the month stated.
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. Package contents and other information

What Xerdoxo contains

• The active substance of Xerdoxo is rivaroxaban. 15 mg:

Each film-coated tablet contains 15 mg of rivaroxaban.
20 mg:
Each film-coated tablet contains 20 mg of rivaroxaban.

• Other ingredients are: mannitol, microcrystalline cellulose, macrogol 8000, poloxamer 188, sodium lauryl sulfate, croscarmellose sodium, anhydrous colloidal silica, and sodium stearyl fumarate in the tablet core, and hypromellose 2910, macrogol 4000, titanium dioxide (E 171), iron oxide red (E 172), and iron oxide yellow (E 172) - only in 15 mg film-coated tabletsin the tablet coating. See section 2 "Xerdoxo contains sodium".

What Xerdoxo looks like and contents of the pack

15 mg:
Reddish-brown to brown-red, round, slightly convex film-coated tablets with a score line and the imprint "15" on one side of the tablet.
Dimensions: diameter approximately 6.5 mm.
20 mg:
Pink to dark pink, round, slightly convex film-coated tablets with a score line and the imprint "20" on one side of the tablet.
Dimensions: diameter approximately 7 mm.
15 mg:
Xerdoxo is available in calendar packs containing:

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

A patient warning card is included with each pack of the medicine.
20 mg:
Xerdoxo is available in calendar packs containing:

• 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 on 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