Razarxo

Leaflet accompanying the packaging: patient information

Razarxo, 15 mg, film-coated tablets

Razarxo, 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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 not listed in this leaflet, they should tell 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. Contents of the pack 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 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. 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 medicines used to treat blood clots.

Razarxo 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 Razarxo

When not to take Razarxo

• 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 given to maintain the patency of a vein or artery catheter,

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

Warnings and precautions

Before taking Razarxo, consult your doctor or pharmacist.

When to be particularly careful 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 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 given to maintain the patency of a vein or artery catheter (see "Razarxo 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,
• 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 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 the 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 aimed at removing 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 use this medicine and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery

• it is very important to follow the doctor's instructions regarding the intake of Razarxo at a precisely specified 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 or epidural anesthesia, or to reduce pain):
• it is very important 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 is completed, 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 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 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 noradrenaline reuptake inhibitors (SNRIs)).

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

inform your doctorbefore taking Razarxo, as the effect of Razarxo 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 considers 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 you suspect that you have any of the above conditions, you should

inform your doctorbefore taking Razarxo, as the effect of Razarxo may be reduced. The doctor will decide whether to use 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, you should use effective contraception while taking Razarxo. If you become pregnant while taking Razarxo, you should inform your doctor immediately, who will decide on further treatment.

Driving and using machines

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 machines.

Razarxo 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 Razarxo

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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 taking. After such a mixture, the meal should be taken immediately. If necessary, the doctor may also administer the crushed tablet through a gastric tube.

How many tablets to take

• Adults
• In the prevention of blood clot formation in the brain (stroke) and other blood vessels in the body, the recommended dose is one Razarxo 20 mg tablet once a day. If the patient has kidney disease, the dose may be reduced to one Razarxo 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 Razarxo 15 mg tablet once a day (or one Razarxo 10 mg tablet once a day in case of kidney function disorder) in combination with an antiplatelet agent, such as clopidogrel.

• 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, the recommended dose is one Razarxo 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Razarxo 20 mg tablet once a day. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment using 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 Razarxo 20 mg tablet once a day, the doctor may decide to reduce the dose after 3 weeks of treatment to one Razarxo 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 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 Razarxo 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Razarxo 20 mgtablet once a day.

Each Razarxo dose should be taken with food, with a drink (e.g. water or juice).
Tablets should be taken every day at about the same time. It's a good idea to set an alarm to remind you.
For parents or caregivers: observe the child to make sure they have taken the entire dose.
The dose of Razarxo is dependent on body weight, so it's 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 get a partial dose. If a smaller dose is needed, use a different form of rivaroxaban, an oral suspension granule.
For children and adolescents who are unable to swallow whole tablets, use rivaroxaban in the form of an oral suspension granule.
If the oral suspension is not available, the Razarxo tablet can be crushed and mixed with water or apple sauce immediately before taking. After such a mixture, the meal should be taken 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, the next dose of Razarxo should be taken at the usual time.

Contact your doctor if you spit out or vomit a dose of Razarxo multiple times.

When to take Razarxo

Take the tablet(s) every day until the doctor decides to stop the treatment.
It's best to take the tablet(s) at the same time every day, as it's easier to remember.
The doctor will decide how long the patient should continue the treatment.
Prevention of blood clot formation 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, Razarxo should be taken as instructed by the doctor.

Missing a dose of Razarxo

• 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. The next tablet should be taken the next day, and then one tablet should be taken 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, they should continue taking one 15 mg tablet twice a day.

Taking more Razarxo than prescribed

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

Stopping Razarxo treatment

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

4. Possible side effects

Like all medicines, Razarxo can cause side effects, although not everybody gets them.
As with other medicines that have a similar effect of reducing blood clot formation, Razarxo 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.
You must 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. You should immediately seek medical help!),
• 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 severe skin reactions

• widespread, acute skin rash, blistering, or changes to 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, blood 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 can 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 sclera),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance 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 (which can be observed in tests performed by the 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 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 the 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 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, 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,
• bleeding in the kidneys, 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).

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 levels of a bilirubin subtype (direct bilirubin).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Adverse Reaction 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 Razarxo

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 "EXP" abbreviation. The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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, sodium croscarmellose, anhydrous colloidal silica, 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 pack

15 mg:
Reddish-brown to brownish-red, round, slightly biconvex 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 biconvex film-coated tablets with a score line and 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 the medicine.
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
For more 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: