Rivaroxaban Intas

Leaflet accompanying the packaging: information for the user

Rivaroxaban Intas, 2.5 mg, film-coated tablets

Rivaroxaban

You should read the contents of this leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rivaroxaban Intas and what is it used for
• 2. Important information before taking Rivaroxaban Intas
• 3. How to take Rivaroxaban Intas
• 4. Possible side effects
• 5. How to store Rivaroxaban Intas
• 6. Contents of the packaging and other information

1. What is Rivaroxaban Intas and what is it used for

You have been given Rivaroxaban Intas because

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

or

• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Rivaroxaban Intas reduces the risk of blood clots (atherothrombotic events) in adults. Rivaroxaban Intas will not be given to you as the only medicine. Your doctor will also prescribe you to take aspirin.

In some cases, if you are taking Rivaroxaban Intas after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin.
Rivaroxaban Intas contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

2. Important information before taking Rivaroxaban Intas

When not to take Rivaroxaban Intas

• -if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have 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 you are 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 you have had acute coronary syndrome and have had bleeding or a blood clot in the brain (stroke),
• if you have coronary artery disease or peripheral arterial disease and have had bleeding in the brain (stroke) or blockage of small arteries supplying blood to the brain tissues (cerebral sinus thrombosis) or if you have had a blood clot in the brain (ischemic stroke) in the last month,
• if you have liver disease that leads to an increased risk of bleeding,
• if you are pregnant or breastfeeding.
• Do not take Rivaroxaban Intas, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Rivaroxaban Intas, you should discuss it with your doctor or pharmacist. Rivaroxaban Intas should not be taken at the same time as other medicines that inhibit blood clotting, such as prasugrel or ticagrelor, except for aspirin, clopidogrel or ticlopidine.

When to be particularly careful when taking Rivaroxaban Intas

• if you have an increased risk of bleeding, in such conditions as:
• severe kidney disease, as kidney function may affect the amount of medicine acting in your 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 section "Rivaroxaban Intas 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);
• lung disease in which the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs;
• if you are over 75 years old;
• if you weigh less than 60 kg;
• coronary artery disease with severe symptomatic heart failure;
• in patients with artificial heart valves;
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change the treatment.

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

your doctorbefore taking Rivaroxaban Intas. Your doctor will decide whether to use this medicine and whether you should be under close observation.

If you need to have surgery:

• you should follow your doctor's instructions very carefully regarding the intake of Rivaroxaban Intas at a specific time before or after surgery,
• if catheterization or spinal puncture is planned (e.g., for spinal anesthesia or epidural anesthesia or pain relief):
• it is very important to take Rivaroxaban Intas before and after the puncture or removal of the catheter, according to your doctor's instructions
• due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness in your legs or bowel or bladder problems after the anesthesia is completed.

Children and adolescents

Rivaroxaban Intas 2.5 mg tablets are not recommended for people under 18 years of age. There is a lack of sufficient data on the use of the medicine in children and adolescents.

Rivaroxaban Intas and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as the medicines you plan to take, including those that are available without a prescription.

• -If you are taking
• certain antifungal medicines (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally 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 used to reduce blood clotting (e.g., enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol, prasugrel and ticagrelor (see section "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 noradrenaline reuptake inhibitors (SNRIs)).

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

your doctorbefore taking Rivaroxaban Intas, as the effect of Rivaroxaban Intas may be enhanced. Your doctor will decide whether to use this medicine and whether you should be under close observation.
If your doctor thinks that you are at increased risk of developing stomach or intestinal ulcers, he or she 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 in 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 Rivaroxaban Intas, as the effect of Rivaroxaban Intas may be reduced if taken with the above medicines. Your doctor will decide whether to use Rivaroxaban Intas and whether you should be under close observation.

Pregnancy and breastfeeding

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

Driving and using machines

Rivaroxaban Intas may cause dizziness (frequent side effects) or fainting (uncommon side effects) (see section 4, "Possible side effects").
Patient who experience these side effects should not drive, ride a bicycle or operate tools or machines.

Rivaroxaban Intas contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

Rivaroxaban Intas contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Rivaroxaban Intas

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Rivaroxaban Intas 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 you have difficulty swallowing the whole tablet, you should talk to your doctor about other ways of taking Rivaroxaban Intas. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before taking it.
If necessary, your doctor may give you a crushed Rivaroxaban Intas tablet through a gastric tube.
Rivaroxaban Intas will not be given to you as the only medicine.
Your doctor will also prescribe you to take aspirin. If you are taking Rivaroxaban Intas after acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine for you to take.
If you are taking Rivaroxaban Intas after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may prescribe clopidogrel for you to take for a short time in addition to aspirin.
Your doctor will tell you what dose of these medicines 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 Rivaroxaban Intas

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

Taking a higher dose of Rivaroxaban Intas than recommended

If you have taken a higher dose of Rivaroxaban Intas than recommended, you should contact your doctor immediately. Taking too much Rivaroxaban Intas increases the risk of bleeding.

Missing a dose of Rivaroxaban Intas

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

Stopping treatment with Rivaroxaban Intas

Rivaroxaban Intas should be taken regularly and for the time prescribed by your doctor.
You should not stop taking Rivaroxaban Intas without first discussing it with your doctor.
If you stop taking this medicine, the risk of having another heart attack, stroke or death due to heart or blood vessel disease may increase.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other medicines with similar anticoagulant effects, Rivaroxaban Intas may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Not all of these will be obvious or visible signs of bleeding.
You should tell your doctor immediatelyif 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. A serious, sudden medical condition. You should seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide to monitor you very closely or change the treatment.

Signs of severe skin reactions:

• widespread, severe skin rash, blistering or changes in 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, hematological disorders and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (may occur in 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 patients) and uncommon (angioedema and allergic edema may occur in less than 1 in 100 patients).

General list of possible side effects:

Common(may affect up to 1 in 10 people)

• reduction in red blood cell count, which may cause paleness of the skin 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 (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 problems (can be observed in tests performed by your doctor),
• fever,
• stomach pain, 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 some 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 problems (can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, activity of some 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,
• collection of blood (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 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 those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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 Rivaroxaban Intas

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Crushed tablets
Crushed tablets are stable in water or apple sauce for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rivaroxaban Intas contains

• The active substance of the medicine is rivaroxaban. One film-coated tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose 2910, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate. Tablet coating: macrogol 4000, hypromellose 2910, titanium dioxide (E 171), yellow iron oxide (E 172).

What Rivaroxaban Intas looks like and contents of the pack

Rivaroxaban Intas 2.5 mg film-coated tablets are yellow, round, biconvex film-coated tablets with the inscription "IL4" on one side.
The tablets are:

• in blisters packaged in cardboard boxes, containing 10, 14, 28, 30, 56, 60, 98 or 100 film-coated tablets or
• in HDPE bottles with HDPE caps with a child-resistant closure, containing 30 or 90 film-coated tablets, or
• in HDPE bottles with HDPE caps, containing 100 or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Intas Third Party Sales 2005, S.L.
World Trade Center, Moll Barcelona s/n
08039 Barcelona
Spain

Manufacturer/Importer

Laboratori Fundacio Dau
C/c 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Pharmadox Healthcare Limited
KW20A Corradino Industrial Estate
Paola, PLA 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands
Rivaroxaban Intas 2.5 mg, film-coated tablets
France
Rivaroxaban Intas 2.5 mg, coated tablets
Germany
Rivaroxaban Intas 2.5 mg, film-coated tablets
Poland
Rivaroxaban Intas 2.5 mg, film-coated tablets

Date of last revision of the leaflet:

April 2025