Razarxo

Package Leaflet: Information for the Patient

Razarxo, 15 mg, Film-Coated Tablets

Razarxo, 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 to a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• 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 Razarxo and What is it Used For
• 2. Important Information Before Taking Razarxo
• 3. How to Take Razarxo
• 4. Possible Side Effects
• 5. How to Store Razarxo
• 6. Package Contents and Other Information

1. What is Razarxo and What is it Used For

Razarxo contains the active substance rivaroxaban. Razarxo 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 heart valve problems.
• 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. Razarxo 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.

Razarxo belongs to a group of medications called anticoagulants. Its action involves blocking a blood clotting factor (factor Xa) and thereby reducing the tendency to form blood clots.

2. Important Information Before Taking Razarxo

When Not to Take Razarxo

• 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 an organ that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in 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 Razarxo, and inform your doctorif you suspect that you have any of the above conditions.

Warnings and Precautions

Before starting Razarxo, consult a doctor or pharmacist.

When to Exercise Particular Caution When Taking Razarxo

• 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 "Razarxo and Other Medications"),
• bleeding disorders,
• very high blood pressure that does not decrease despite medication,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines and stomach or esophageal inflammation (e.g., due to gastroesophageal reflux disease), or tumors located in the stomach, intestines, genital, or urinary system,
• vascular disease in the back of the eye (retinopathy),
• pulmonary disease, in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic heart valves,
• if the patient has a condition 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 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 Razarxo. 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 Razarxo at a specific time before or after surgery,
• if a spinal puncture or catheter insertion into the spine is planned during the surgical procedure (e.g., for spinal anesthesia or pain relief):
• it is crucial to take Razarxo before and after the puncture or catheter removal, as instructed by the doctor,
• the doctor should be informed immediately if, after the anesthesia, the patient experiences 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

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

Razarxo 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 the Patient is Taking
• certain medications used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
• ketokonazole 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 They Have Any of the Above Conditions, They Should

inform their doctorbefore taking Razarxo, as the effect of Razarxo 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 medication to prevent ulcers.

• If the Patient is 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 They Have Any of the Above Conditions, They Should

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

Pregnancy, Breastfeeding, and Fertility

Do not take Razarxo if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, use effective contraception while taking Razarxo. If you become pregnant while taking Razarxo, inform your doctor immediately, who will decide on further treatment.

Driving and Operating Machinery

Razarxo 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, ride a bicycle, or operate tools or machinery.

Razarxo Contains Sodium

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

3. How to Take Razarxo

Always take this medication exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Razarxo should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing whole tablets, talk to your doctor about other ways to take Razarxo. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before ingestion. After such a mixture, the meal should be consumed 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 20 mg Razarxo tablet once daily. If the patient has kidney disease, the dose may be reduced to one 15 mg Razarxo tablet once daily.

If the patient requires 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 15 mg Razarxo tablet once daily (or one 10 mg Razarxo tablet once daily in case of kidney function impairment) in combination with an antiplatelet medication, such as clopidogrel.

• For the treatment of blood clots in the veins of the legs, blood clots in the lungs, and to prevent the recurrence of blood clots, the recommended dose is one 15 mg Razarxo tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Razarxo tablet once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has kidney disease and is taking one 20 mg Razarxo tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Razarxo tablet once daily, if the risk of bleeding is higher than the risk of recurrent blood clots.
• Children and AdolescentsThe dose of Razarxo 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 15 mg Razarxotablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one 20 mg Razarxotablet once daily.

Each Razarxo dose should be taken with food, 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 to remind you.
For parents or caregivers: observe the child to ensure they have taken the entire dose.
The dose of Razarxo is based on body weight, so it is essential to attend scheduled doctor's appointments, as the dose may need to be adjusted based on weight changes.
Never adjust the dose yourself.If necessary, the doctor will adjust the dose.
Do not split the tablet to obtain a partial dose. If a smaller dose is required, 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 Razarxo tablet can be crushed and mixed with water or apple sauce immediately before ingestion. After such a mixture, the meal should be consumed immediately. If necessary, the doctor may also administer the crushed tablet through a gastric tube.

If a Dose is Spat Out or Vomited

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

Contact your doctor if you spit out or vomit the dose or vomit after taking Razarxo multiple times.

When to Take Razarxo

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 to continue the treatment.
To prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body:
If the heart rhythm needs to be restored using a procedure called cardioversion, take Razarxo as instructed by the doctor.

Missing a Dose of Razarxo

• Adults, children, and adolescents If you take one 20 mg or one 15 mg tablet oncedaily and miss a dose, 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 daily.
• Adults If you take one 15 mg tablet twicedaily and miss a dose, take it as soon as possible. Do not take more than two 15 mg tablets in one day. If you miss a dose, you 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 daily.

Taking More Than the Recommended Dose of Razarxo

If you take more Razarxo than recommended, contact your doctor immediately. Taking too much Razarxo increases the risk of bleeding.

Stopping Razarxo Treatment

Do not stop taking Razarxo without first consulting your doctor, as Razarxo treats and prevents serious diseases.
If you have any further questions about the use of this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Razarxo can cause side effects, although not everybody gets them.
Like other medications with similar blood clot-reducing effects, Razarxo may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.
Inform 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. The doctor may decide to monitor the patient closely or change the treatment.

Signs of Severe Skin Reactions

• widespread, severe skin rash, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, hematologic disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (less than 1 in 10,000 patients).

Signs of Severe Allergic Reactions

• 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 may cause pallor 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, 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),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• 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, certain liver or pancreatic enzyme activity, 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), liver inflammation, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• localized 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 can 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 occurring 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 direct bilirubin levels

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 Adverse Reaction Monitoring 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 Razarxo

Keep this medication out of the sight and reach of children.
Do not use this medication 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 precautions for storing the medication.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Razarxo Contains

• The active substance of Razarxo 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, silicon dioxide, and sodium stearyl fumarate in the tablet core, and hypromellose 2910 - 15 cP, 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 "Razarxo contains sodium".

What Razarxo Looks Like and Contents of the Package

15 mg:
Reddish-orange to brownish-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.
Razarxo is available in packs containing:

• 10, 15, 30, 60, 90, and 100 film-coated tablets, in a non-perforated blister.
• 10 x 1, 30 x 1, 60 x 1, 90 x 1, and 100 x 1 film-coated tablets, in a perforated single-dose blister.
• calendar packs: 14, 28, 42, 56, 98 film-coated tablets, in a non-perforated blister.

A patient alert card is included with each pack of Razarxo.
Not all pack sizes may be marketed.

Marketing Authorization Holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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 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: