Razarxo

Leaflet accompanying the packaging: patient information

Razarxo, 2.5 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.
• If you have any doubts, consult your 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 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

The patient has been given Razarxo because

• they have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, acute chest pain) and have elevated levels of cardiac biomarkers. Razarxo reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Razarxo will not be given to the patient as the only medicine. The doctor will instruct the patient to also take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.

or

• they have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Razarxo reduces the risk of blood clots (atherothrombotic events) in adults. Razarxo will not be given to the patient as the only medicine. The doctor will instruct the patient to also take aspirin. In some cases, if the patient is taking Razarxo after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for the patient to take for a short time in addition to aspirin.

Razarxo contains the active substance rivaroxaban and belongs to a group of medicines 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 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 blood clotting (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,
• if the patient has been diagnosed with acute coronary syndrome and has had bleeding or a blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and has had bleeding in the brain (stroke) or blockage of small arteries supplying blood to the brain tissues (cerebral sinus thrombosis) or has had a blood clot in the brain (ischemic stroke) in the last month,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not take Razarxo, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Razarxo, consult your doctor or pharmacist.
Razarxo should not be taken with other blood clotting inhibitors, such as prasugrel or ticagrelor, except for aspirin, clopidogrel, or ticlopidine.

When to be particularly careful when taking Razarxo

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in the patient's body,
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, 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 esophagitis (throat and esophagus), e.g., due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus) or tumors located in the stomach, intestines, genital, or urinary system,
• vascular disease of the back of the eye (retinopathy),
• lung disease, in which the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if the patient is over 75 years old,
• if the patient weighs less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• 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 clots, the patient should inform the doctor, who will decide whether to change the treatment).

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 closely monitored.

If the patient needs to undergo surgery

• they must strictly follow the doctor's instructions regarding the intake of Razarxo at a precisely specified time before or after surgery,
• if catheterization or spinal puncture is planned during surgery (e.g., for epidural or spinal anesthesia, or pain relief):
• it is very important to take Razarxo before and after the puncture or catheter removal, according to the doctor's instructions,
• due to the need for special caution, the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder disorders occur after anesthesia.

Children and adolescents

Razarxo, 2.5 mg, film-coated tablets are not recommended for persons under 18 years of age. There is a lack of sufficient data on the use of the medicine in children and adolescents.

Razarxo and other medicines

Tell your doctor or pharmacist about all medicines you are 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 antifungal medicines (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 antibacterial medicines (e.g., clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV or AIDS (e.g., ritonavir),
• other medicines that reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol, prasugrel, and ticagrelor (see "Warnings and precautions")),
• anti-inflammatory and pain-relieving medicines (e.g., naproxen or aspirin),
• 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 Razarxo, as the effect of Razarxo may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.
If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use preventive treatment.

• 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 Razarxo, as the effect of Razarxo may be reduced. The doctor will decide whether to use Razarxo and whether the patient should be closely monitored.

Pregnancy, breastfeeding, and fertility

Razarxo should not be taken 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 Razarxo.
If the patient becomes pregnant while taking this medicine, they should inform their 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

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

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Razarxo should be taken at approximately the same time every day (e.g., one tablet in the morning and one in the evening).
This medicine can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should talk to their 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 it.
If necessary, the doctor may administer the crushed Razarxo tablet through a gastric tube.
Razarxo will not be given to the patient as the only medicine.
The doctor will instruct the patient to also take aspirin.
If the patient is taking Razarxo after acute coronary syndrome, the doctor may also instruct them to take clopidogrel or ticlopidine.
If the patient is taking Razarxo after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may prescribe clopidogrel for the patient to take for a short time in addition to aspirin.
The doctor will tell the patient how much to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start taking Razarxo

Treatment with Razarxo after acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the latest 24 hours after hospital admission, and when parenteral (by injection) anticoagulant treatment would normally be discontinued.
The doctor will tell the patient when to start treatment with Razarxo if they have been diagnosed with coronary artery disease or peripheral arterial disease.
The doctor will decide how long to continue treatment.

Taking more Razarxo than prescribed

If the patient has taken more Razarxo than prescribed, they should contact their doctor immediately. Taking too much Razarxo increases the risk of bleeding.

Missing a dose of Razarxo

Do not take a double dose to make up for a missed dose. If the patient misses a dose, they should take the next dose at the scheduled time.

Stopping Razarxo

Razarxo should be taken regularly and for the time prescribed by the doctor.
Do not stop taking Razarxo without consulting your doctor first. If the patient stops taking this medicine, the risk of another heart attack, stroke, or death due to heart or blood vessel disease may increase.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Razarxo can cause side effects, although not everybody gets them.
Like other medicines with similar blood clotting-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.

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. The doctor may decide to closely monitor the patient or change the treatment.

Signs of severe skin reactions

• widespread, severe skin rash, blistering, or changes to the mucous membranes, such as the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• 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 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 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

Common(may affect up to 1 in 10 people)

• decrease in red blood cell count, which may cause paleness 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 gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum (hemoptysis) while 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 disorders (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 the joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver disorders (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 stagnation), hepatitis, including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg.

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).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Razarxo

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 "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the 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. Contents of the pack and other information

What Razarxo contains

• The active substance of Razarxo is rivaroxaban. Each film-coated tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are: mannitol, microcrystalline cellulose, macrogol 8000, poloxamer 188, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, and sodium stearyl fumarate in the tablet core, and hypromellose 2910 - 15 cP, macrogol 4000, titanium dioxide (E 171), and yellow iron oxide (E 172) in the tablet coating. See section 2 "Razarxo contains sodium".

What Razarxo looks like and contents of the pack

Light brown to brownish-yellow, round, slightly biconvex film-coated tablets with the imprint "2.5" on one side of the tablet. Dimensions: diameter approximately 6.5 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 warning 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
To obtain more detailed 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: