XERDOXO

Package leaflet: Information for the user

Xerdoxo, 10 mg, film-coated tablets
Rivaroxabanum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

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

• prevent blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing 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 to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Xerdoxo 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 Xerdoxo

When not to use 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 an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in 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 anticoagulant therapy or if heparin is administered to maintain the patency of a venous or arterial catheter,
• 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 Xerdoxo and inform your doctor if the patient suspects that any of the above circumstances apply.
Warnings and precautions
Before starting to take Xerdoxo, consult a doctor or pharmacist.
When to exercise particular caution when using Xerdoxo

• 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,
• 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 venous or arterial catheter (see section "Xerdoxo with other medicines"),
• disorders of blood coagulation,
• very high blood pressure that does not decrease despite taking medication,
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus) or tumours located in the stomach or intestines or in the genital or urinary system,
• blood vessel disease of the back of the eyeball (retinopathy),
• lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with prosthetic heart valves,
• 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 to change the treatment,
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a blood clot from the lungs.

If the patient suspects that any of the above conditions apply, they should inform the doctor
before using Xerdoxo. The doctor will decide whether to use this medicine and whether the
patient needs to be placed under particularly close observation.
If the patient needs to undergo surgery

• it is essential to strictly follow the doctor's instructions regarding the timing of taking Xerdoxo before or after surgery,
• if during surgery a lumbar puncture or placement of a catheter into the spine is planned (e.g. for epidural or intrathecal anaesthesia, or for pain relief):
• it is essential to strictly follow the doctor's instructions regarding the timing of taking Xerdoxo,
• the patient should immediately inform the doctor if, after the anaesthesia ends, symptoms such as numbness or weakness in the lower limbs, or disturbances in bowel or bladder function occur, as immediate treatment will be necessary in such cases.

Children and adolescents
Xerdoxo 10 mg tablets are not recommended for patients under 18 years of age. There is
insufficient data on the use of this medicine in children and adolescents.
Xerdoxo with 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 the patient is taking
• certain antifungal medicines (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 (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used in HIV infection or AIDS treatment (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 the patient suspects that any of the above conditions apply, they should inform the doctor
before using Xerdoxo, as the effect of Xerdoxo may be enhanced. The doctor will decide whether
to use this medicine and whether the patient needs to be placed under particularly close observation.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal
ulcers, they may prescribe treatment to prevent peptic disease.

• If the patient is 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 the patient suspects that any of the above conditions apply, they should inform the doctor
before using Xerdoxo, as the effect of Xerdoxo may be reduced. The doctor will decide whether
to use Xerdoxo and whether the patient needs to be placed under particularly close observation.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child,
she should consult a doctor or pharmacist before using this medicine.
Do not use Xerdoxo if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Xerdoxo. If the patient becomes pregnant while taking this medicine, she should immediately inform the doctor, who will decide on further treatment.
Driving and using machines
Xerdoxo 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.
Xerdoxo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Xerdoxo

This medicine should always be taken exactly as your doctor has told you. If you are unsure, you should consult your doctor or pharmacist.

How many tablets to take

• To prevent blood clots in veins after hip or knee replacement surgery, the recommended dose is one 10 mg Xerdoxo tablet taken 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 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed Xerdoxo 10 mg to be taken once daily.

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

When to take Xerdoxo
Take the tablet every day until your 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.
Your doctor will decide how long treatment should continue.
To prevent blood clots in the leg veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.

If you take more Xerdoxo than you should
If you take more Xerdoxo than prescribed, contact your doctor immediately. Taking too high a dose of Xerdoxo increases the risk of bleeding.

If you forget to take Xerdoxo
If you forget to take a dose, take it as soon as you remember. Take the next tablet the following day, and then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a forgotten tablet.

Stopping Xerdoxo
Do not stop taking Xerdoxo without first talking to your doctor, as Xerdoxo helps prevent a serious condition.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

As with other medicines with a similar anticoagulant effect, Xerdoxo may cause bleeding, which could potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.

Immediately inform your doctor if any of the following adverse reactions occur:

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 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 reaction

• Widespread, acute skin rash, blistering, or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Signs of severe allergic reaction

• 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 anaphylactic shock, may occur in up to 1 in 10,000 individuals) and uncommon (angioedema and allergic edema may occur in up to 1 in 100 individuals).

General list of possible adverse reactions

Common (may occur in up to 1 in 10 people)

• Decrease in red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath,
• Bleeding from the stomach or intestines, bleeding from the genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• Bleeding into the eye (including bleeding from the white of the eye),
• Bleeding into tissues or body cavities (hematoma, bruising),
• Presence of blood in sputum (hemoptysis) during coughing,
• Bleeding from or under the skin,
• Bleeding after surgery,
• Oozing of blood or fluid from a surgical wound,
• Swelling of limbs,
• 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 loss of strength and energy (weakness, fatigue), headache, dizziness,
• Rash, itching of the skin,
• Increased activity of certain liver enzymes, which may be seen in blood test results.

Uncommon (may occur in up to 1 in 100 people)

• Bleeding into the brain or within the skull (see signs of bleeding above),
• Bleeding into joints causing pain and swelling,
• Thrombocytopenia (low platelet count, the blood cells involved in 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 people)

• Bleeding into muscles,
• Cholestasis (bile stasis), hepatitis, including liver cell damage,
• Yellowing of the skin and eyes (jaundice),
• Localized swelling,
• Blood collection (hematoma) in the groin as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare (may occur in up to 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 arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions

If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Xerdoxo

Keep this 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
abbreviation "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Xerdoxo contains

• The active substance is rivaroxaban. Each coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are: mannitol, microcrystalline cellulose, polyethylene glycol 8000, poloxamer 188, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, and sodium stearyl fumarate in the tablet core; and hypromellose 2910, polyethylene glycol 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 coated tablets with the imprint "10" on one side.
Dimensions: approximately 6.5 mm in diameter.
Xerdoxo is available in calendar packs containing:

• blister packs: 14, 28 or 42 coated tablets.

A patient warning card is included with each package of the medicine.
Not all pack sizes may be marketed.
Marketing Authorisation 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
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Krka - Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
telephone: +48 22 573 75 00