Xerdoxo

Package Leaflet: Information for the Patient

Xerdoxo, 15 mg, Film-Coated Tablets

Xerdoxo, 20 mg, Film-Coated Tablets

Rivaroxaban

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform 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. 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 heart rhythm 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 medications 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 medication (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 medications 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 inform your doctorif you suspect that any of the above conditions apply to you.

Warnings and precautions

Before starting Xerdoxo, consult a doctor or pharmacist.

When to exercise special caution 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 medication acting in the patient's body,
• taking other medications that prevent the formation of blood clots (e.g., warfarin, dabigatran, 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 medications"),
• bleeding 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 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, intestines, genital, or urinary system,
• disease of the blood vessels in 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 prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform their doctor, who will decide on possible changes to 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 any of the above conditions apply to them, they should

inform their doctorbefore taking Xerdoxo. The doctor will decide whether to administer this medication and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery

• it is essential to follow the doctor's instructions 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 spinal or epidural anesthesia or to reduce pain):
• it is crucial to take Xerdoxo before and after the procedure, as instructed by the doctor,
• 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 medications

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

• If you are taking
• certain medications used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketoconazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain medications used to treat bacterial infections (e.g., clarithromycin, erythromycin),
• certain antiviral medications used to treat HIV or AIDS (e.g., ritonavir),
• other medications used to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol),
• anti-inflammatory and pain-relieving medications (e.g., naproxen or acetylsalicylic acid),
• dronedarone, a medication used to treat heart rhythm disorders,
• certain medications used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects that any of the above conditions apply to them, they should

inform their doctorbefore taking Xerdoxo, as the effect of Xerdoxo may be enhanced. The doctor will decide whether to administer this medication 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 medications used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum), a herbal remedy used to treat depression,
• rifampicin, which belongs to a group of antibiotics.

If the patient suspects that any of the above conditions apply to them, they should

inform their doctorbefore taking Xerdoxo, as the effect of Xerdoxo may be reduced. The doctor will decide whether to administer Xerdoxo and whether the patient should be subject to particularly close monitoring.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medication.
Do not take Xerdoxo if the patient is 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 medication contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medication is considered "sodium-free".

3. How to take Xerdoxo

This medication should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
Xerdoxo should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If the patient has difficulty swallowing whole tablets, they should discuss other ways of taking Xerdoxo with their doctor. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before intake. After such a mixture, the patient should eat a meal immediately. If necessary, the doctor may also administer the crushed tablet through a gastric tube.

How many tablets to take

• Adults
• In preventing the formation 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 requires a procedure to clear 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 medication, such as clopidogrel.

• In treating blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and preventing 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 recurrent 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, preferably with a drink (e.g., water or juice). Tablets should be taken daily at approximately the same time. It is a good idea to set an alarm as a reminder. 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. 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 rivaroxaban in the form of an oral suspension.
If the oral suspension is not available, the Xerdoxo tablet can be crushed and mixed with water or apple sauce immediately before intake. After such a mixture, the patient should eat a meal. If necessary, the doctor may also administer the crushed tablet through a gastric tube.

In case of spitting out the 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 the doctor in case of repeated spitting out of the dose or vomiting after taking Xerdoxo.

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 requires restoration of a normal rhythm using a procedure called cardioversion, Xerdoxo should be taken as directed 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) taken 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 treatment

Do not stop taking Xerdoxo without first consulting your doctor, as Xerdoxo treats and prevents serious diseases.
In case of any further doubts about the use of this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Xerdoxo can cause side effects, although not everybody gets them.
Like other medications with a similar effect of reducing blood clot formation, Xerdoxo may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Not all bleeding will be obvious or visible.
Immediately inform your doctor 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. The doctor may decide to monitor the patient closely or change the treatment.

Signs of a severe skin reaction

• widespread, acute skin rash, blistering, or changes in the mucous membranes, such as 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 (up to 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 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 in adults, children, and adolescents:

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 intestines, 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 when coughing (hemoptysis),
• 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 (which can be observed in tests performed by the doctor),
• fever,
• stomach pain, nausea (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 (which 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 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 heart catheterization, when the 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 medications),
• 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).

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
• nosebleeds
• 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 levels of a bilirubin subtype (direct bilirubin).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 medication.

5. How to store Xerdoxo

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging and blister after the "EXP" abbreviation. The expiration date refers to the last day of the specified month.
There are no special precautions for storing the medication.
Medications should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medications 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. 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".
• only in 15 mg film-coated tablets

What Xerdoxo looks like and contents of the pack

15 mg:
Reddish-orange to brown-orange, round, slightly biconvex film-coated tablets with the imprint "15" on one side of the tablet.
Dimensions: diameter approximately 6.5 mm.
20 mg:
Pink to dark pink, round, slightly biconvex film-coated tablets with the imprint "20" on one side of the tablet.
Dimensions: diameter approximately 7 mm.
15 mg:
Xerdoxo is available in packages containing:

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

A patient warning card is included with each package of the medication.
20 mg:
Xerdoxo is available in packages containing:

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

A patient warning card is included with each package of the medication.
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 medication, 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