Rivaroxaban intas

Package leaflet: Information for the user

Rivaroxaban Intas, 10 mg, film-coated tablets
rywaroksaban
Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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 blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing blood clots is increased after surgery.
• 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 recurrence of blood clots in the blood vessels of the legs and/or lungs.

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 active bleeding,
• if the patient has a disease or condition of an organ that increases the 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 that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a venous or arterial catheter,
• if the patient has a liver disease that increases the risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not take Rivaroxaban Intas and inform your doctor if you think any of the above circumstances apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Intas.
When to exercise special caution when taking Rivaroxaban Intas

• if the patient has an increased risk of bleeding, such as in the following conditions:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
• if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a venous or arterial catheter (see section "Rivaroxaban Intas and other medicines"),
• blood clotting disorders,
• 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 oesophagitis (inflammation of the throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (acid reflux into the oesophagus), or tumours located in the stomach, intestines, genital or urinary system,
• blood vessel disease in the back of the eye (retinopathy),
• lung disease with dilated bronchi filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment adjustment is needed,
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If you think any of the above conditions apply to you, inform your 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 a lumbar puncture or placement of a spinal catheter is planned during surgery (e.g. for epidural or spinal anaesthesia or for pain relief):
• strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Intas,
• inform the doctor immediately if, after the anaesthesia ends, the patient experiences symptoms such as numbness, weakness in the lower limbs, or problems with bowel or bladder function, as immediate treatment will be required.

Children and adolescents
Rivaroxaban Intas 10 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 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan 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 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 antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If you think any of the above conditions apply to you, inform your doctor before taking Rivaroxaban Intas, as the effect of Rivaroxaban Intas may be increased when taken together with the above 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 ulcer, 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 you think any of the above conditions apply to you, inform your doctor before taking Rivaroxaban Intas, as the effect of Rivaroxaban Intas may be reduced when taken together with the above medicines. The doctor will decide whether to use Rivaroxaban Intas and whether the patient requires particularly close monitoring.
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 an effective method of contraception during treatment with Rivaroxaban Intas. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on further treatment.
Driving and operating machinery
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. If in doubt, consult the doctor or pharmacist.

How many tablets to take

• To prevent blood clots in veins after hip or knee replacement surgery: The recommended dose is one tablet of Rivaroxaban Intas 10 mg once daily.
• For the treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and to prevent recurrence of such clots: After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. The doctor has prescribed the patient Rivaroxaban Intas 10 mg once daily.

The tablet should be swallowed whole, preferably with water.
Rivaroxaban Intas may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, consult the doctor about alternative ways of taking Rivaroxaban Intas. 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 through a gastric tube.

When to take Rivaroxaban Intas
One tablet should be taken every day until the doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
The doctor will decide how long treatment should continue.

To prevent blood clots in the legs after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks. For patients undergoing major knee surgery, treatment usually lasts 2 weeks.

Taking more Rivaroxaban Intas than prescribed
If the patient has taken more Rivaroxaban Intas than prescribed, contact the doctor immediately. Taking too much Rivaroxaban Intas increases the risk of bleeding.

Missing a dose of Rivaroxaban Intas
If the patient forgets to take a dose, take the tablet as soon as remembered. The next tablet should be taken the following day, and then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a missed tablet.

Stopping Rivaroxaban Intas
Do not stop taking Rivaroxaban Intas without first talking to the doctor, as this medicine prevents serious illness.
If there are any further doubts about the use of this medicine, consult the 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 can potentially 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 immediately inform your doctor 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 with eosinophilia and systemic symptoms (DRESS syndrome), 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 serious allergic reactions:
You should immediately inform your doctor if the following adverse reactions occur:

• 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)

• decreased number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath,
• gastrointestinal or intestinal bleeding, bleeding from the genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• 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,
• postoperative bleeding,
• oozing of blood or fluid from a 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 loss of 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, blood cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• blood tests may show increased bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• urticaria,
• liver function disorders (may be observed in tests performed by a doctor).

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,
• 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 people)
• accumulation of eosinophils, a type of granular white blood cells, causing lung inflammation (eosinophilic pneumonia).

Adverse reactions with unknown frequency (frequency cannot be determined from available data)

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

Reporting of adverse reactions
If you experience any adverse reactions, including those not listed in this leaflet, you should 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 Warszawa
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 carton after: Expiry 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 for this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 10 mg of rivaroxaban.
• The other ingredients are:
  Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose 2910, sodium lauryl sulphate, 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 pink to light pink, round, biconvex, film-coated tablets, with "IL1" embossed on one side.
The tablets are contained:

• in blisters packed in cardboard boxes containing 5, 10, 14, 28, 30, 98 or 100 coated tablets, or
• in HDPE bottles with HDPE screw-cap with child-resistant closure containing 30 or 90 coated tablets,
• in HDPE bottles with HDPE screw-cap 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 European Economic Area countries under the following names:
Netherlands Rivaroxaban Intas 10 mg, filmomhulde tabletten
France Rivaroxaban Intas 10 mg comprimé pelliculé
Germany Rivaroxaban Intas 10 mg Filmtabletten
Poland Rivaroxaban Intas 10 mg tabletki powlekane
April 2025