Rivaroxaban intas

Package leaflet: Information for the user

Rivaroxaban Intas, 20 mg, film-coated tablets
riveroxaban
Read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Rivaroxaban Intas is and what it is 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 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 in other blood vessels in the body in patients who have an irregular heart rhythm known as non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent the 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 weighing 30 kg or more to:

• treat blood clots and prevent the recurrence of blood clots in the veins or in the blood vessels of the lungs, after at least 5 days of initial treatment with injectable medicines used to treat 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 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 is experiencing 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, injury or bleeding in the brain, recent surgery on the brain or eyes),
• if the patient is taking other medicines to 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 inform your doctor if you suspect any of the above-mentioned conditions apply to you.
Warnings and precautions
Before starting treatment with Rivaroxaban Intas, discuss this with your doctor or pharmacist.
When to exercise special caution with Rivaroxaban Intas

• if the patient has an increased risk of bleeding, such as in the following conditions:
• severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, since kidney function may affect the amount of medicine acting in the patient's body,
• blood clotting disorders,
• taking other medicines to prevent blood clots (e.g. warfarin, etexilate of 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 with other medicines"),
• very high blood pressure that does not decrease despite medication,
• stomach or intestinal diseases 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,
• vascular disease of the posterior part of the eyeball (retinopathy),
• lung disease in which 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 a change in treatment is necessary,
• if the patient has abnormal blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If the patient suspects 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 requires particularly close monitoring.
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 catheterization or spinal puncture (e.g. for epidural or spinal anaesthesia or pain relief) is planned during surgery:
• it is very important to take Rivaroxaban Intas before and after the puncture or catheter removal, 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 wears off.

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 in adults.
Rivaroxaban Intas with other medicines
Inform 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 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 used for bacterial infections (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),
• 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects any of the above conditions apply, inform the doctor before taking Rivaroxaban Intas, as 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 requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach 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 medicine used for depression,
• rifampicin, which belongs to the group of antibiotics.

If the patient suspects any of the above conditions apply, inform the 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 Rivaroxaban Intas, inform the doctor immediately, who will decide on further treatment.
Driving and operating machinery
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, they should contact their doctor before taking this medicine.
Rivaroxaban Intas contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivaroxaban Intas

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Rivaroxaban Intas should be taken with food. Swallow the tablet(s) whole, preferably with water.

If a patient has difficulty swallowing the whole tablet, discuss alternative administration methods 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 eat a meal.

If necessary, a 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 20 mg Rivaroxaban Intas tablet once daily.
  If the patient has kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Intas 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 15 mg Rivaroxaban Intas tablet once daily (or one 10 mg Rivaroxaban Intas tablet once daily if kidney 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 blood vessels of the lungs, and prevention of recurrence of blood clots:
  The recommended dose is one 15 mg Rivaroxaban Intas tablet twice daily for the first 3 weeks.
  After 3 weeks of treatment, the recommended dose is one 20 mg Rivaroxaban Intas 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 20 mg Rivaroxaban Intas tablet once daily, the doctor may decide after 3 weeks of treatment to reduce the dose to one 15 mg Rivaroxaban Intas 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: one 15 mg Rivaroxaban Intas tablet once daily.
  • Recommended dose for children and adolescents with a body weight of 50 kg or more: one 20 mg Rivaroxaban Intas 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 every day at approximately the same time. Consider setting an alarm as a reminder. For parents or caregivers: observe the child to ensure they have taken the full dose.

The dose of Rivaroxaban Intas depends on body weight, so it is important to attend scheduled appointments with the doctor, as dose adjustments may be necessary due to weight changes.

Never adjust the dose independently. If necessary, the doctor will adjust the dose.

Do not split the tablet to achieve a partial dose. If a lower dose is required, use another available form of Rivaroxaban Intas, namely granules for oral suspension.

For children and adolescents who are unable to swallow whole tablets, another available formulation of the medicine 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 immediately eat a meal.

If necessary, the doctor may also administer the crushed tablet via a gastric tube.

In case of vomiting or spitting out the dose

• If vomiting or spitting out occurs less than 30 minutes after taking Rivaroxaban Intas, take a new dose.
• If vomiting or spitting out occurs more than 30 minutes after taking Rivaroxaban Intas, do not take a new dose. In this case, take the next dose at the usual time.

Contact your doctor if there are repeated episodes of vomiting or spitting out the dose after taking Rivaroxaban Intas.

When to take Rivaroxaban Intas
Take the tablet(s) every day until your 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. Your doctor will decide how long treatment should continue.

Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure to restore normal heart rhythm (cardioversion) is required, Rivaroxaban Intas should be taken as directed by your doctor.

Missed dose of Rivaroxaban Intas

• Adults, children and adolescents: If the patient is taking 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 a single 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 is taking 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 a single day. If the patient forgets 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, resume the usual regimen of one 15 mg tablet twice daily.

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

Stopping Rivaroxaban Intas
Do not stop taking Rivaroxaban Intas without first consulting your 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 all medicines, Rivaroxaban Intas may cause adverse reactions, although not everyone experiences them.
As with other medicines with a similar mechanism of action reducing 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.
You must 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 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, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction with 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, oral cavity, 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)

• reduction in red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath,
• gastrointestinal bleeding or bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• bleeding into the eye (including bleeding in the white part of the eye),
• 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,
• 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 blood pressure (symptoms may include dizziness or fainting upon standing),
• general reduction 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 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 (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)

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• localized swelling,
• blood collection (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)

• accumulation of eosinophils, a type of granular 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 blood in the urine, leading to impaired kidney function (drug-induced anticoagulant-related nephropathy),
• increased pressure within the muscles of arms and legs following bleeding, which may lead to 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, cells that help in blood 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 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 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 following:
Expiry date and on each blister or bottle following: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
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 pack and other information

What Rivaroxaban Intas contains

• The active substance is rivaroxaban. One coated tablet contains 20 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 20 mg coated tablets are dark red, round, biconvex coated tablets, embossed with the code "IL3" on one side.
The tablets are contained in:

• Blister packs packed in cardboard boxes containing 10, 14, 28, 30, 42, 56, 90, 98 or 100 coated tablets, or
• HDPE bottles with HDPE screw caps and child-resistant closures 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 in the Member States of the European Economic Area under the following names:
Netherlands Rivaroxaban Intas 20 mg, filmomhulde tabletten
France Rivaroxaban Intas 20 mg comprimé pelliculé
Germany Rivaroxaban Intas 20 mg Filmtabletten
Poland Rivaroxaban Intas 20 mg tabletki powlekane
April 2025