RIVAROXABAN INTAS

Package leaflet: Information for the user

Rivaroxaban Intas, 2.5 mg, coated tablets
rivaroxaban
Please read 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents

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

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

You have been prescribed Rivaroxaban Intas because:

• You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been confirmed. Rivaroxaban Intas reduces the risk of further heart attack in adults and reduces the risk of death due to heart- or blood vessel-related disease. Rivaroxaban Intas will not be given to you as a single medicine. Your doctor will also prescribe you:
  • acetylsalicylic acid, or
  • acetylsalicylic acid 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 causing symptoms. Rivaroxaban Intas reduces the risk of blood clots (atherosclerotic thrombotic events) in adults. Rivaroxaban Intas will not be given to you as a single medicine. Your doctor will also prescribe you acetylsalicylic acid.

In certain cases, if you are receiving Rivaroxaban Intas after a procedure to unblock a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may additionally prescribe clopidogrel to be taken for a short period alongside acetylsalicylic acid.

Rivaroxaban Intas contains the active substance rivaroxaban and 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 taking Rivaroxaban Intas

When not to take Rivaroxaban Intas

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has active bleeding,
• if the patient has a disease or condition affecting an organ that increases the risk of serious bleeding (e.g., stomach ulcer, trauma or bleeding in the brain, recent surgery on the brain or eyes),
• if the patient is taking other anticoagulant medicines (e.g., warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery,
• if the patient has been diagnosed with acute coronary syndrome and previously experienced bleeding or blood clot in the brain (stroke),
• if the patient has coronary artery disease or peripheral artery disease and previously had bleeding in the brain (hemorrhagic stroke), or blockage of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient had a non-lacunar ischemic stroke within the last month,
• if the patient has liver disease that increases the risk of bleeding,
• if the patient is pregnant or breastfeeding.
• Do not use Rivaroxaban Intas and inform your doctor if you suspect any of the above conditions apply.

Warnings and precautions
Before starting Rivaroxaban Intas, discuss this with your doctor or pharmacist. Do not take Rivaroxaban Intas together with other anticoagulant medicines besides acetylsalicylic acid, clopidogrel or ticlopidine, such as prasugrel or ticagrelor.
When to exercise special caution when taking Rivaroxaban Intas

• if the patient has an increased risk of bleeding, such as in the following conditions:
• severe kidney disease, as kidney function may affect the amount of medicine acting in the patient’s body;
• use of other anticoagulant medicines (e.g., warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is used to maintain catheter patency in a vein or artery (see section “Rivaroxaban Intas with other medicines”);
• coagulation disorders;
• very high blood pressure that does not decrease despite medication;
• stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the stomach or intestines or esophagus (throat and esophagus), e.g., due to gastroesophageal reflux disease (acid reflux into the esophagus), or tumors located in the stomach, intestines, genital or urinary systems;
• blood vessel disease at the back of the eye (retinopathy);
• lung disease with dilated bronchi filled with pus (bronchiectasis) or previous lung bleeding;
• if the patient is over 75 years of age;
• if the patient weighs less than 60 kg;
• coronary artery disease with severe symptomatic heart failure;
• in patients with heart valve prostheses;
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform their doctor, who will decide whether treatment adjustment is needed. If the patient suspects any of the above conditions apply, they should inform their doctor

before taking Rivaroxaban Intas. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the patient needs surgery:

• strictly follow the doctor’s instructions regarding the timing of taking Rivaroxaban Intas before or after surgery;
• if spinal catheterization or puncture (e.g., for epidural or intrathecal anesthesia or pain relief) is planned during surgery:
• it is very important to take Rivaroxaban Intas before and after the puncture or catheter removal exactly as directed by the doctor;
• due to the need for special caution, immediately inform the doctor if numbness or weakness in the legs, or bowel or bladder dysfunction occurs after the anesthesia wears off.

Children and adolescents
Rivaroxaban Intas 2.5 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.
Rivaroxaban Intas with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription.

• If the patient is taking
• certain antifungal medicines (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless 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, prasugrel and ticagrelor (see section “Warnings and precautions”));
• anti-inflammatory and pain medicines (e.g., naproxen or acetylsalicylic acid);
• dronedarone, a medicine used to treat heart rhythm disorders;
• certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If the patient suspects any of the above conditions apply, they should inform their doctor
before taking Rivaroxaban Intas, as the effect of Rivaroxaban Intas may be enhanced. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers the patient to be at increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for peptic ulcer disease.

• If the patient is taking
• certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital),
• St John’s wort ( Hypericum perforatum ), a herbal remedy used for depression,
• rifampicin, an antibiotic.

If the patient suspects any of the above conditions apply, they should inform their doctor
before taking Rivaroxaban Intas, as the effect of Rivaroxaban Intas may be reduced when taken together with the above-mentioned medicines. The doctor will decide whether to use Rivaroxaban Intas and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Rivaroxaban Intas 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 Rivaroxaban Intas. If the patient becomes pregnant while taking this medicine, she should inform her doctor immediately, who will decide on further treatment.
Driving and using machines
Rivaroxaban Intas may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, “Possible side effects”). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban Intas contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Rivaroxaban Intas contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is considered “sodium-free”.

3. How to take RIVAROXABAN INTAS

This medicine should always be taken as directed by the doctor. In case of any doubts, consult
the doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. RIVAROXABAN INTAS should be taken
approximately at the same time each day (for example, one tablet in the morning and one in the
evening). This medicine may be taken with or without food.
If a patient has difficulty swallowing the whole tablet, discuss alternative ways of taking
RIVAROXABAN INTAS with the doctor. The tablet may be crushed and mixed with water or soft food
such as apple puree immediately before administration.
If necessary, the doctor may administer crushed RIVAROXABAN INTAS tablets via a gastric tube.
RIVAROXABAN INTAS will not be given to the patient as the only medication.
The doctor will prescribe acetylsalicylic acid for the patient. If the patient is receiving
RIVAROXABAN INTAS after an acute coronary syndrome, the doctor may also prescribe clopidogrel or
ticlopidine.
If the patient receives RIVAROXABAN INTAS after a procedure to open a narrowed or blocked artery
in the lower limb to restore blood flow, the doctor may also prescribe clopidogrel to be taken
for a short time in addition to acetylsalicylic acid.
The doctor will inform the patient about the dose of these medications to take (usually 75–100 mg
of acetylsalicylic acid daily, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily
dose of 75 mg clopidogrel, or the standard daily dose of ticlopidine).
When to start taking RIVAROXABAN INTAS
Treatment with RIVAROXABAN INTAS after acute coronary syndrome should be initiated as soon as
possible after stabilization of the acute coronary syndrome, no earlier than 24 hours after
hospital admission and at the time when parenteral (by injection) anticoagulant treatment would
normally be discontinued.
The doctor will inform the patient when to start treatment with RIVAROXABAN INTAS if coronary
artery disease or peripheral arterial disease has been diagnosed.
The doctor will decide how long treatment should continue.
Taking more than the recommended dose of RIVAROXABAN INTAS
If a patient has taken more than the recommended dose of RIVAROXABAN INTAS, contact the doctor
immediately. Taking too high a dose of 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 a dose is missed, the next dose
should be taken at the scheduled time.
Stopping treatment with RIVAROXABAN INTAS
RIVAROXABAN INTAS should be taken regularly and for the duration recommended by the doctor.
Do not stop taking RIVAROXABAN INTAS without first consulting the doctor.
Discontinuing treatment with this medicine may increase the risk of another heart attack, stroke,
or death due to heart- or blood vessel-related disease.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
As with other medicines with a similar anticoagulant effect, Rivaroxaban Intas may cause bleeding, which potentially can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You should contact your doctor immediately 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 or a change in treatment is necessary.

Signs of severe skin reactions:

• widespread, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, internal organ inflammation, hematological and systemic disorders (DRESS syndrome). The frequency of these adverse reactions 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; 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 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 adverse reactions:
Common (may occur in 1 in 10 patients)

• 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, bleeding from gums,
• bleeding into the eye (including conjunctival hemorrhage),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the surgical wound,
• swelling of limbs,
• limb pain,
• kidney function disorders (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, feeling of nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in 1 in 100 patients)

• bleeding into the brain or inside the skull (see signs of bleeding above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low platelet count, platelets being blood cells involved in blood 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, activity of certain pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dryness of the mouth,
• urticaria.

Rare (may occur in 1 in 1,000 patients)

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• local swelling,
• accumulation 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 occur in 1 in 10,000 people)

• accumulation of eosinophils, a type of granulocyte white 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 presence of blood in urine, leading to kidneys being unable to function properly (drug-induced anticoagulant-related nephropathy),
• increased pressure within the muscles of the 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 adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 the medicine.

5. How to store Rivaroxaban Intas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton after:
Expiry date and on each blister or bottle after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Intas contains

• The active substance is rivaroxaban. One 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 anhydrous silica, magnesium stearate.
  Tablet coating: macrogol 4000, hypromellose 2910, titanium dioxide (E 171), iron oxide yellow (E 172).

What Rivaroxaban Intas looks like and contents of the pack
Rivaroxaban Intas 2.5 mg coated tablets are light yellow, round, biconvex coated tablets, with the imprint "IL4" on one side.
The tablets are contained in:

• Blister packs in cardboard cartons containing 10, 14, 28, 30, 56, 60, 98 or 100 coated tablets, or
• HDPE bottles with HDPE screw caps with child-resistant closure containing 30 or 90 coated tablets, or
• HDPE bottles with HDPE screw caps containing 100 or 500 coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised for marketing in the European Economic Area under the following names:
Netherlands Rivaroxaban Intas 2.5 mg, filmomhulde tabletten
France Rivaroxaban Intas 2.5 mg comprimé pelliculé
Germany Rivaroxaban Intas 2.5 mg Filmtabletten
Poland Rivaroxaban Intas 2.5 mg tabletki powlekane

April 2025