Rivaroxaban intas

Package leaflet: Information for the user

Rivaroxaban Intas, 15 mg, coated tablets
rivaroxaban
Please read the entire leaflet before taking the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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

Rivaroxaban Intas contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body in patients with a type of irregular heartbeat known as non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Intas is used in children and adolescents under 18 years of age and with body weight of 30 kg or more to:

• treat blood clots and prevent recurrence of blood clots in the veins or blood vessels of the lungs, after at least 5 days of initial treatment with injectable medicines used for treating blood clots.

Rivaroxaban Intas belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (factor Xa), thereby reducing the tendency to form blood clots.

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 excessive bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes),
• if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or
  if heparin is administered to maintain the patency of a catheter in a vein or artery,
• if the patient has a liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not use Rivaroxaban Intas, and also inform the doctor if the patient
suspects that any of the above circumstances apply.
Warnings and precautions
Before starting to take Rivaroxaban Intas, discuss this with your doctor or
pharmacist.
When to be especially careful when using Rivaroxaban Intas

• if the patient has an increased risk of bleeding, such as in the following conditions:
• severe kidney disease in adults, and moderate or severe kidney disease in children and adolescents, because kidney function may affect the amount of medicine acting in the patient's body,
• blood clotting disorders,
• taking other medicines that prevent blood clots (e.g. warfarin, edoxaban, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a catheter in a vein or artery (see section "Rivaroxaban Intas and other medicines"),
• very high blood pressure that does not decrease despite taking medication,
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus) or tumours located in the stomach or intestines or in the genital or urinary system,
• blood vessel disease in the back of the eye (retinopathy),
• lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment should be changed,
• if the patient has abnormal blood pressure or surgery is planned or other treatment intended to remove a blood clot from the lungs.

If the patient suspects that any of the above conditions apply, inform the
doctor before taking Rivaroxaban Intas. The doctor will decide whether to use this medicine and
whether the patient should be placed under particularly close observation.
If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Intas before or after surgery,
• if catheterisation or spinal puncture (e.g. for epidural or intrathecal anaesthesia or pain relief) is planned during surgery:
• it is very important to take Rivaroxaban Intas before and after the puncture or removal of the catheter, as directed by the doctor,
• due to the need for special caution, immediately inform the doctor if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia ends.

Children and adolescents
Rivaroxaban Intas tablets are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of rivaroxaban in children and adolescents for the indications approved for adults.
Rivaroxaban Intas and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

• If the patient is taking:
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are 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 treatment of 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 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects that any of the above conditions apply, inform the
doctor before taking Rivaroxaban Intas, because the effect of Rivaroxaban Intas
may be enhanced when taken together with the above-mentioned medicines. The doctor will decide
whether to use this medicine and whether the patient should be placed under particularly close observation.
If the doctor considers that the patient has an increased risk of developing gastric or duodenal ulcers,
they may prescribe treatment to prevent peptic ulcer disease.

• If the patient is taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St John's wort ( Hypericum perforatum ), a herbal remedy used for depression,
• rifampicin, which belongs to the group of antibiotics.

If the patient suspects that any of the above conditions apply, inform the
doctor before taking Rivaroxaban Intas, because 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 should be placed under particularly close
observation.
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 Rivaroxaban Intas, inform the doctor immediately, who will decide on further management.
Driving and using machines
Rivaroxaban Intas may cause dizziness (common side effects) or fainting (uncommon side effects) (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, the patient should
consult the doctor before taking this medicine.
Rivaroxaban Intas contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Rivaroxaban Intas

This medicine should always be taken as instructed by the doctor. In case of doubts, consult the
doctor or pharmacist.
Rivaroxaban Intas should be taken with food. Swallow the tablet(s) whole, preferably with water.
If the 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 apple puree immediately before administration. After taking this mixture, the patient should immediately consume a meal.
If necessary, the doctor may administer crushed Rivaroxaban Intas tablets via a gastric tube.

How many tablets to take

• Adults
  o For prevention of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one Rivaroxaban Intas 20 mg tablet once daily. If the patient has kidney disease, the dose may be reduced to one Rivaroxaban Intas 15 mg tablet once daily.
  If the patient requires a procedure to unblock blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one Rivaroxaban Intas 15 mg tablet once daily (or one Rivaroxaban Intas 10 mg tablet once daily if renal function is impaired), in combination with an antiplatelet medicine such as clopidogrel.
  o For treatment of blood clots in the leg veins, blood clots in the lung blood vessels, and prevention of recurrence of blood clots: The recommended dose is one Rivaroxaban Intas 15 mg tablet twice daily for the first 3 weeks.
  After 3 weeks of treatment, the recommended dose is one Rivaroxaban Intas 20 mg tablet once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has kidney problems and is taking one Rivaroxaban Intas 20 mg tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban Intas 15 mg tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.

• Children and adolescents
  The dose of Rivaroxaban Intas depends on body weight and will be calculated by the doctor.

  • Recommended dose for children and adolescents with a body weight of 30 kg to below 50 kg is one Rivaroxaban Intas 15 mg tablet once daily.
  • Recommended dose for children and adolescents with a body weight of 50 kg or more is one Rivaroxaban Intas 20 mg tablet once daily.
    Each dose of Rivaroxaban Intas should be taken with a meal and with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. Consider setting an alarm to remind you. For parents or caregivers: observe the child to ensure the full dose has been taken.

The dose of Rivaroxaban Intas depends on body weight, so it is important to attend scheduled doctor’s appointments, as dose adjustments may be needed due to changes in weight.
Never adjust the dose independently. If necessary, the doctor will adjust the dose.
Do not split the tablet to achieve partial doses. If a lower dose is required, use another available form of Rivaroxaban Intas, namely the granules for oral suspension.
For children and adolescents who cannot swallow whole tablets, another available formulation of Rivaroxaban Intas should be used.
If the oral suspension is not available, the Rivaroxaban Intas tablet may be crushed and mixed with water or apple puree immediately before administration. After taking this mixture, the patient should consume a meal. If necessary, the doctor may also administer the crushed tablet via a gastric tube.

In case of spitting out the dose or vomiting

• Within 30 minutes after taking Rivaroxaban Intas, take a new dose.
• More than 30 minutes after taking Rivaroxaban Intas, do not take a new dose. In this case, take the next dose of Rivaroxaban Intas at the usual time.

Contact the doctor if the patient repeatedly spits out the dose or vomits after taking Rivaroxaban Intas.

When to take Rivaroxaban Intas
Take the tablet(s) every day until the doctor decides to stop treatment. It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
The doctor will decide how long the patient should continue treatment.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If the heart rhythm requires restoration to normal rhythm by a procedure called cardioversion, Rivaroxaban Intas should be taken as directed by the doctor.

Missed dose of Rivaroxaban Intas

• Adults, children and adolescents: If the patient takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet 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 following day, then continue taking one tablet once daily.
• Adults: If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient forgot to take a dose, they may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, continue taking one 15 mg tablet twice daily.

Accidental overdose of Rivaroxaban Intas
If the patient has taken too many Rivaroxaban Intas tablets, contact the doctor immediately. Taking too high a dose of Rivaroxaban Intas increases the risk of bleeding.

Stopping Rivaroxaban Intas treatment
Do not stop taking Rivaroxaban Intas without first consulting the doctor, as Rivaroxaban Intas treats and prevents serious medical conditions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Rivaroxaban Intas may cause adverse reactions, although not everyone experiences them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban Intas may cause bleeding, which potentially could be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
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. A serious, acute medical emergency. Seek immediate medical help!),
  • prolonged or excessive bleeding,
  • unusual weakness, fatigue, pallor, 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, formation of blisters or mucosal lesions, e.g., in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction with eosinophilia and systemic symptoms (DRESS), characterized by rash, fever, internal organ inflammation, hematological abnormalities, and systemic involvement. 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 in adults, children, and adolescents:
Common (may occur in 1 in 10 patients)

• decrease in red blood cells, which may cause skin pallor and lead to weakness or shortness of breath,
• gastrointestinal bleeding (including bleeding from the stomach or intestines), bleeding from the genitourinary system (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding,
• bleeding into the eye (including bleeding from the sclera),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• skin bleeding or subcutaneous bleeding,
• postoperative bleeding,
• oozing of blood or fluid from the surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low arterial 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),
• joint bleeding causing pain and swelling,
• thrombocytopenia (low platelet count, blood cells involved in 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, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• urticaria.

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

• muscle bleeding,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• localized 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 patients)

• eosinophilia, an accumulation of a type of white granulocytic blood cells causing lung inflammation (eosinophilic pneumonia).

Frequency not known (frequency cannot be estimated from available data)

• kidney failure following severe bleeding,
• kidney bleeding, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy),
• increased pressure in the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding).

Adverse reactions in children and adolescents
In general, adverse reactions observed in children and adolescents treated with Rivaroxaban Intas were similar in type to those observed in adults and were mainly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 in 10 patients)

• headache
• fever
• nosebleeds, vomiting

Common (may occur in 1 in 10 patients)

• rapid heartbeat
• blood tests may show increased bilirubin levels (a bile pigment)
• thrombocytopenia (low platelet count, blood cells that help in clotting)
• excessive menstrual bleeding

Uncommon (may occur in 1 in 100 patients)

• blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

Reporting of adverse reactions
If any symptoms of adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 to 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 cardboard box following:
EXPIRY and on each blister or bottle following: EXP. The expiry date refers to the last day
of the stated month.
No special storage conditions are required for this medicine.
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. Such measures will help protect
the environment.

6. Contents of the package and other information

What Rivaroxaban Intas contains

• The active substance is rivaroxaban. One coated tablet contains 15 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.
  Coating: macrogol 4000, hypromellose 2910, titanium dioxide (E 171), iron oxide red (E 172).

What Rivaroxaban Intas looks like and contents of the pack
Rivaroxaban Intas 15 mg coated tablets are red, round, biconvex, coated tablets, embossed with the letters "IL" on one side and the number "2" on the other side.
The tablets are contained:

• in blisters packed in cardboard boxes containing 10, 14, 28, 30, 42, 48, 56, 90, 98 or 100 coated tablets, or
• in HDPE bottles with HDPE screw cap and child-resistant closure, containing 90 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 in the Member States of the European Economic Area under the following names:
Netherlands Rivaroxaban Intas 15 mg, filmomhulde tabletten
France Rivaroxaban Intas 15 mg comprimé pelliculé
Germany Rivaroxaban Intas 15 mg Filmtabletten
Poland Rivaroxaban Intas 15 mg tabletki powlekane
April 2025