RIVAROXABAN 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Rivaroxaban Intas, 10 mg, coated tablets
   1. Table of contents of the leaflet:
3. What is Rivaroxaban Intas and what is it used for
4. Important information before taking Rivaroxaban Intas
   1. When not to take Rivaroxaban Intas
   2. Warnings and precautions
   3. When to be particularly careful when taking Rivaroxaban Intas
   4. If you suspect that you have any of the above conditions, you should inform
   5. If you need to have surgery:
   6. Children and adolescents
   7. Rivaroxaban Intas and other medicines
   8. If you suspect that you have any of the above conditions, you should inform
   9. If you suspect that you have any of the above conditions, you should inform
   10. Pregnancy and breastfeeding
   11. Driving and using machines
   12. Rivaroxaban Intas contains lactose
   13. Rivaroxaban Intas contains sodium
5. How to take Rivaroxaban Intas
   1. How many tablets to take
   2. When to take Rivaroxaban Intas
   3. Taking a higher dose of Rivaroxaban Intas than recommended
   4. Missing a dose of Rivaroxaban Intas
   5. Stopping the intake of Rivaroxaban Intas
6. Possible side effects
   1. Signs of severe skin reactions:
   2. Signs of severe allergic reactions:
   3. General list of possible side effects:
   4. Reporting side effects
   5. Al. Jerozolimskie 181C
   6. 02-222 Warsaw
7. How to store Rivaroxaban Intas
8. Contents of the pack and other information
   1. What Rivaroxaban Intas contains
   2. What Rivaroxaban Intas looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet:

Leaflet attached to the packaging: information for the user

Rivaroxaban Intas, 10 mg, coated tablets

Rivaroxaban
You should read the contents of this leaflet carefully before taking the medicine because it contains important information for the patient
that is important 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 the symptoms of their illness are the same.
• 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 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 veins, after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of blood clot formation is increased after surgery.
• treat blood clots in the veins in the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Intas belongs to a group of medicines called anticoagulants. Its action is based on
blocking the blood clotting factor (factor Xa) and thus reducing 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 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.

When to be particularly careful when taking Rivaroxaban Intas

• if you have an increased risk of bleeding, in such conditions as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
• 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 (see "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,
• vascular disease of the back of the eyeball (retinopathy),
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic valves,
• if you have a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), you should inform your doctor, who will decide on possible changes in treatment,
• if you have been diagnosed with abnormal blood pressure or a surgical procedure or other treatment is planned to remove a blood clot from the lungs.

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

your doctorbefore taking Rivaroxaban Intas .The 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 strictly specified time before or after surgery,
• If a spinal puncture or catheter insertion into the spine is planned during the surgical procedure (e.g. for epidural or spinal anesthesia or to reduce pain):
• you should follow your doctor's instructions very carefully regarding the intake of Rivaroxaban Intas at a strictly specified time,
• you should immediately inform your doctor if, after the anesthesia is completed, you experience symptoms such as numbness, weakness of the lower limbs, disorders of bowel or bladder function, as in such a case immediate treatment is necessary.

Children and adolescents

Rivaroxaban Intas 10 mg tablets are not recommended for people under 18 years of age. There is
insufficient 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 about the medicines you plan to take, including those that are available without a prescription.

• -If you are taking:
• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole,

posaconazole), unless they are used only topically on the skin,

• ketoconazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain medicines used to treat bacterial infections (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),
• 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 (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

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

your doctorbefore taking Rivaroxaban Intas ,because the effect of Rivaroxaban Intas may be enhanced if you take it together with the above medicines. Your doctor will decide whether to use this medicine and
whether you should be under close observation.
If your doctor believes that you are at increased risk of developing stomach or duodenal ulcers, he may use a treatment to prevent stomach ulcers.

• -If you are taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's wort ( Hypericum perforatum), a herbal medicine used to treat 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 ,because the effect of Rivaroxaban Intas may be reduced if you take it together 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 immediately inform your doctor, 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 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 according to your doctor's instructions. If you are unsure, you should ask your doctor or pharmacist.

How many tablets to take

• To prevent blood clots in the veins after hip or knee replacement surgery, the recommended dose is one 10 mg Rivaroxaban Intas tablet taken once a day.
• For the treatment of blood clots in the veins in the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs. After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed you Rivaroxaban Intas 10 mg once a day.

The tablet should be swallowed whole, preferably with water.
Rivaroxaban Intas 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, just before taking it.
If necessary, your doctor may administer the crushed Rivaroxaban Intas tablet through a gastric tube.

When to take Rivaroxaban Intas

You should take one tablet every day until your doctor decides to stop the treatment.
It is best to take the tablet at the same time every day, as it is easier to remember.
Your doctor will decide how long you should continue the treatment.
To prevent blood clots in the veins in the legs after hip or knee replacement surgery:

The first tablet should be taken 6 to 10 hours after the surgical procedure.
In patients after major hip surgery, treatment usually lasts 5 weeks. In patients after major knee surgery, treatment usually lasts 2 weeks.

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

If you have forgotten to take a dose, you should take the tablet as soon as you remember. The next tablet should be taken the next day, and then the tablets should be taken as usual, once a day.
You should not take a double dose to make up for the missed tablet.

Stopping the intake of Rivaroxaban Intas

You should not stop taking Rivaroxaban Intas without first talking to your doctor, because Rivaroxaban Intas prevents the occurrence of a serious disease.
If you have any further doubts about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Intas can cause side effects, although not everybody gets them.
Like other medicines with a similar effect of reducing blood clot formation, Rivaroxaban Intas may cause bleeding, which can potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.
You should immediately inform your doctorif 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 medical emergency. You should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change the treatment.

Signs of severe skin reactions:

• widespread, acute skin rash, blistering or changes in the mucous membrane, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction causing rash, fever, inflammation of internal organs, hematological 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:

You should immediately inform your doctorif you experience any of the following side effects:

• 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 occur in 1 in 10patients)

• decrease in the number of red blood cells, which may cause paleness of the skin and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, 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 white of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance 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,
• pain in the limbs,
• disorders of kidney function (can be observed in tests performed by the doctor)
• fever,
• stomach pain, nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increase in the activity of some liver enzymes, which can be seen in the results of a blood test.

Uncommon( may occur in 1 in 100patients)

• 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,
• blood test results may show an increase in bilirubin, activity of some pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dryness in the mouth,
• hives,
• disorders of liver function (can be observed in tests performed by the doctor).

Rare( may occur in 1 in 1000patients)

• bleeding into the muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• accumulation of blood (hematoma) in the groin as a complication of heart catheterization, when a 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 cell, which can cause inflammation in the lungs (eosinophilic pneumonia).

Side effects with unknown frequency(frequency cannot be estimated from 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 syndromeafter 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 Monitoring of Adverse Reactions to Medicinal Products
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 gather more information on the safety of the 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: 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 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 pack and other information

What Rivaroxaban Intas contains

• The active substance of the medicine is rivaroxaban. One coated tablet contains 10 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 10 mg coated tablets are light pink to pink, round, biconvex, film-coated tablets with the inscription "IL1" on one side.
The tablets are

• in blisters packed in cardboard boxes, containing 5, 10, 14, 28, 30, 98 or 100 coated tablets or
• in HDPE bottles with HDPE caps with a child-resistant closure, containing 30 or 90 coated tablets
• in HDPE bottles with HDPE caps containing 100 or 500 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 10 mg, film-coated tablets
France
Rivaroxaban Intas 10 mg, coated tablet
Germany
Rivaroxaban Intas 10 mg, film-coated tablets
Poland
Rivaroxaban Intas 10 mg, coated tablets

Date of last revision of the leaflet:

April 2025