Rivaroxaban Intas

Package Leaflet: Information for the User

Rivaroxaban Intas, 20 mg, Film-Coated Tablets

Rivaroxaban

Before Taking the Medication, Read the Contents of the Leaflet, as it Contains Important Information for the Patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their 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 pack and other information

1. What is Rivaroxaban Intas and what is it 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 patient's body, if the patient has a form of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and 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 and prevent the recurrence of blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medications used to treat blood clots.

Rivaroxaban Intas belongs to a group of medications called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and 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 medication (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 surgical procedure on the brain or eyes),
• if the patient is taking other medications that prevent the formation of blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant treatment or

if heparin is administered to maintain the patency of a vein or artery catheter,

• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not take Rivaroxaban Intas, and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Rivaroxaban Intas, discuss it with your doctor or pharmacist.

When to be particularly careful when taking Rivaroxaban Intas

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medication acting in the patient's body,
• bleeding disorders,
• taking other medications that prevent the formation of blood clots (e.g., warfarin, dabigatran, apixaban, or heparin) when changing anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery catheter (see "Rivaroxaban Intas and other medications"),
• very high blood pressure that does not decrease despite taking medications,
• 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,,
• vascular disease in the back of the eye (retinopathy),
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with artificial 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 their doctor, who will decide on possible changes to the treatment,
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Rivaroxaban Intas. The doctor will decide whether to use this medication and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery:

• -the patient should strictly follow the doctor's recommendations regarding the intake of Rivaroxaban Intas at a 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 Rivaroxaban Intas before and after the puncture or catheter removal, according to the doctor's recommendations,
• -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 the anesthesia is completed.

Children and adolescents

Rivaroxaban Intas tablets are not recommended for children with a body weight below 30 kg.
There is a lack of sufficient data on the use of rivaroxaban in children and adolescents for indications in adults.

Rivaroxaban Intas and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including those that are available without a prescription.

• -If the patient is taking:
• certain medications used to treat fungal infections (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 medications used to treat bacterial infections (e.g., clarithromycin, erythromycin),
• certain antiviral medications used to treat HIV or AIDS (e.g., ritonavir),
• other medications used to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol),
• anti-inflammatory and pain medications (e.g., naproxen or acetylsalicylic acid),
• dronedarone, a medication used to treat heart rhythm disorders,
• certain medications 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 Rivaroxaban Intas ,as the effect of Rivaroxaban Intas may be enhanced if taken with the above medications. The doctor will decide whether to use this medication and whether the patient should be subject to particularly close monitoring.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use treatment to prevent ulcer disease.

• -If the patient is taking
• certain medications used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's wort ( Hypericum perforatum), a herbal remedy 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 Rivaroxaban Intas ,as the effect of Rivaroxaban Intas may be reduced if taken with the above medications. The doctor will decide whether to use Rivaroxaban Intas and whether the patient should be subject to particularly close monitoring.

Pregnancy and breastfeeding

Rivaroxaban Intas 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 Rivaroxaban Intas. If the patient becomes pregnant while taking Rivaroxaban Intas, they should inform their 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").
Patients who experience these side effects should not drive vehicles, ride bicycles, or operate tools or machines.

Rivaroxaban Intas contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medication.

Rivaroxaban Intas contains sodium

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

3. How to take Rivaroxaban Intas

This medication should always be taken according to the doctor's recommendations. In case of doubts, the doctor or pharmacist should be consulted.
Rivaroxaban Intas should be taken with food. The tablet(s) should be swallowed, preferably with water.
If the patient has difficulty swallowing the whole tablet, they should discuss other ways of taking Rivaroxaban Intas with their doctor. The tablet can be crushed and mixed with water or apple sauce, just before taking. After such a mixture, the patient should eat a meal immediately.
If necessary, the doctor may also administer the crushed tablet through a gastric tube.

How many tablets to take

• Adultsto prevent the formation 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 a day. If the patient has kidney disease,the dose may be reduced to one Rivaroxaban Intas 15 mg tablet once a day.

If the patient needs a procedure to open up blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one Rivaroxaban Intas 15 mg tablet once a day (or one Rivaroxaban Intas 10 mg tablet once a day in case of kidney function impairment) in combination with an antiplatelet medication such as clopidogrel.
o
In the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots The recommended dose is one Rivaroxaban Intas 15 mg tablet twice a day for the first 3 weeks.
After 3 weeks, the recommended dose is one Rivaroxaban Intas 20 mg tablet once a day. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment using one 10 mg tablet once a day or one 20 mg tablet once a day. If the patient has kidney problems and is taking one Rivaroxaban Intas 20 mg tablet once a day, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban Intas 15 mg tablet once a day, 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.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one Rivaroxaban Intas 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one Rivaroxaban 20 mgtablet once a day. Each dose of Rivaroxaban Intas should be taken with a meal, with a drink (e.g., water or juice). The tablets should be taken daily at approximately the same time. It is a good idea to set an alarm to remind you. For parents or caregivers: the child should be observed to ensure that they have taken the entire dose.

The dose of Rivaroxaban Intas is dependent on body weight, so it is essential to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes.
Never adjust the dose yourself.If necessary, the doctor will adjust the dose.
Do not divide the tablet to obtain a partial dose. If a smaller dose is necessary, Rivaroxaban Intas oral suspension should be used.
For children and adolescents who are unable to swallow whole tablets, another available form of Rivaroxaban Intas should be used.
If the oral suspension is not available, the Rivaroxaban Intas tablet can be crushed and mixed with water or apple sauce, just before taking. After such a mixture, the patient should eat a meal immediately. If necessary, the doctor may also administer the crushed tablet through a gastric tube.

In case of spitting up or vomiting

• less than 30 minutes after taking Rivaroxaban Intas, a new dose should be taken.
• more than 30 minutes after taking Rivaroxaban Intas, do nottake a new dose. In this case, the next dose of Rivaroxaban Intas should be taken at the usual time.

In case of repeated spitting up or vomiting after taking Rivaroxaban Intas, the doctor should be consulted.

When to take Rivaroxaban Intas

The tablet(s) should be taken every day until the doctor decides to stop the treatment.
It is best to take the tablet(s) at the same time every day, as it is easier to remember.
The doctor will decide how long the patient should continue the treatment.
To prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body:
If the heart rhythm needs to be restored using a procedure called cardioversion, Rivaroxaban Intas should be taken as recommended by the doctor.

Missing a dose of Rivaroxaban Intas

• Adults, children, and adolescents: If the patient takes one 20 mg or one 15 mg tablet once a day and misses a dose, they should take it as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. The next tablet should be taken the next day, and then one tablet should be taken once a day.
• Adults: If the patient takes one 15 mg tablet twice a day and misses a dose, they should take it as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient misses a dose, they can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day. The next day, they should continue taking one 15 mg tablet twice a day.

Taking a higher dose of Rivaroxaban Intas than recommended

If the patient has taken too many Rivaroxaban Intas tablets, they should contact their doctor immediately. Taking too much Rivaroxaban Intas increases the risk of bleeding.

Stopping Rivaroxaban Intas

Rivaroxaban Intas should not be stopped without first consulting the doctor, as Rivaroxaban Intas treats and prevents serious diseases.
In case of any further doubts about the use of this medication, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medications, Rivaroxaban Intas can cause side effects, although not everybody gets them.
Like other medications with a similar effect of reducing blood clot formation, 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.
The doctor should be informed immediatelyif any of the following side effects 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 stiffness of the neck. A serious medical emergency. Medical help should be sought immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. The doctor may decide to monitor the patient closely or change the treatment.

Signs of severe skin reactions:

• widespread, acute skin rash, blistering, or changes to the mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing 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 in adults, children, and adolescents: Common(may affect up to 1 in 10 people)

• reduction in red blood cell count, which may cause pallor 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 when 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 function disorders (can be observed in tests performed by the doctor),
• fever,
• stomach pain, nausea, feeling sick, 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,
• 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 a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (can be observed in tests performed by the doctor),
• blood test results may show increased bilirubin levels, certain liver or pancreatic enzyme activity, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

Rare(may affect up to 1 in 1,000 people)

• bleeding into muscles,
• cholestasis (bile stagnation), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• hematoma (collection of blood) in the groin as a complication of heart 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 that 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 therapy),
• increased pressure in the muscles of the legs and arms after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with Rivaroxaban Intas were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed more frequently in children and adolescents:
Very common(may affect more than 1 in 10 patients)

• headache
• fever
• nosebleeds, vomiting Common(may affect up to 1 in 10 patients)
• rapid heartbeat
• blood test results may show increased bilirubin levels (bile pigment)
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• excessive menstrual bleeding Uncommon(may affect up to 1 in 100 patients)
• blood test results may show increased levels of a bilirubin subtype (direct bilirubin, bile pigment).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, more information can be collected on the safety of the medication.

5. How to store Rivaroxaban Intas

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

6. Contents of the pack and other information

What Rivaroxaban Intas contains

• The active substance of Rivaroxaban Intas is rivaroxaban. One film-coated tablet contains 20 mg of rivaroxaban.
• Other ingredients are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose 2910, sodium lauryl sulfate, colloidal silicon dioxide, 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 film-coated tablets are dark red, round, biconvex film-coated tablets with the inscription "IL3" on one side.
The tablets are available in:

• blister packs in cartons, containing 10, 14, 28, 30, 42, 56, 90, 98, or 100 film-coated tablets, or
• bottles with HDPE with a child-resistant closure, containing 30 or 90 film-coated tablets, or
• bottles with HDPE with a closure, 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 20 mg, filmomhulde tabletten
France
Rivaroxaban Intas 20 mg comprimé pelliculé
Germany
Rivaroxaban Intas 20 mg Filmtabletten
Poland
Rivaroxaban Intas 20 mg tabletki powlekane

Date of last revision of the leaflet:

April 2025