Rivaroxaban Polpharma

Leaflet attached to the packaging: patient information

Rivaroxaban Polpharma 10 mg film-coated tablets

Rivaroxabanum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rivaroxaban Polpharma and what is it used for
• 2. Important information before taking Rivaroxaban Polpharma
• 3. How to take Rivaroxaban Polpharma
• 4. Possible side effects
• 5. How to store Rivaroxaban Polpharma
• 6. Contents of the packaging and other information

1. What is Rivaroxaban Polpharma and what is it used for

2. Important information before taking Rivaroxaban Polpharma

When not to take Rivaroxaban Polpharma:

• 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 increases the 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 switching anticoagulant therapy or when heparin is given to maintain catheter patency in a vein or artery,
• if you have liver disease that increases the risk of bleeding,

• if you are pregnant or breastfeeding. Do not take Rivaroxaban Polpharma, and inform your doctorif you suspect that you have become pregnant or are planning to become pregnant.

Warnings and precautions

Before taking Rivaroxaban Polpharma, discuss it with your doctor or pharmacist.

Be particularly careful when taking Rivaroxaban Polpharma:

• if you have an increased risk of bleeding, such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) when switching anticoagulant therapy or when heparin is given to maintain catheter patency in a vein or artery (see "Rivaroxaban Polpharma and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach and intestines or esophageal inflammation (e.g., due to gastroesophageal reflux disease) or tumors in the stomach, intestines, genital, or urinary tract,
• blood vessel disease in the back of the eye (retinopathy),
• pulmonary disease with dilated bronchi filled with pus (bronchiectasis) or previous lung bleeding,
• if you have artificial heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment,
• if you have abnormal blood pressure or are scheduled for surgery to remove a blood clot from the lungs.

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

doctorbefore taking Rivaroxaban Polpharma. Your doctor will decide whether to prescribe this medicine and whether you should be under close observation.

If you need to have surgery:

• follow your doctor's instructions carefully regarding the intake of Rivaroxaban Polpharma at a specific time before or after surgery,
• if spinal or epidural anesthesia is planned (e.g., for pain relief):
• it is very important to take Rivaroxaban Polpharma according to your doctor's instructions
• due to the need for caution, immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder dysfunction after anesthesia.

Children and adolescents

Rivaroxaban Polpharma 10 mg is not recommended for persons under 18 years of age. There is insufficient data on the use of the medicine in children and adolescents.

Rivaroxaban Polpharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.

• If you are taking: certain antifungal medicines (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin, ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol), certain antibacterial medicines (e.g., clarithromycin, erythromycin), certain antiviral medicines used to treat HIV or AIDS (e.g., ritonavir), other medicines that 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, inform your

doctorbefore taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be increased. Your doctor will decide whether to prescribe this medicine and whether you should be under close observation.
If your doctor considers that you have an increased risk of stomach or intestinal ulcers, they may prescribe preventive treatment.

• 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, inform your

doctorbefore taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be reduced. Your doctor will decide whether to prescribe Rivaroxaban Polpharma and whether you should be under close observation.

Pregnancy and breastfeeding

Do not take Rivaroxaban Polpharma if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, use an effective method of contraception while taking Rivaroxaban Polpharma. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Rivaroxaban Polpharma 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, ride a bicycle, or operate tools or machines.

Rivaroxaban Polpharma contains lactose and sodium

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Rivaroxaban Polpharma

Always take this medicine exactly as your doctor has told you. If you are not sure, 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 Rivaroxaban Polpharma 10 mg tablet once a day.

• To treat blood clots in the veins of the legs, blood clots in the lungs, and to prevent the recurrence of blood clots: 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 Rivaroxaban Polpharma 10 mg once a day for you.

Swallow the tablet, preferably with water.
Rivaroxaban Polpharma can be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Rivaroxaban Polpharma. The tablet can be crushed and mixed with water or apple sauce, just before taking it. If necessary, your doctor may administer the crushed Rivaroxaban Polpharma tablet through a gastric tube.

When to take Rivaroxaban Polpharma

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 will be easier to remember.
Your doctor will decide how long you should continue the treatment.
To prevent blood clots in the veins after hip or knee replacement surgery:

Take the first tablet 6 to 10 hours after surgery.
Treatment usually lasts 5 weeks for patients after major hip surgery.
Treatment usually lasts 2 weeks for patients after major knee surgery.

Taking more than the recommended dose of Rivaroxaban Polpharma

If you have taken more than the recommended dose of Rivaroxaban Polpharma, contact your doctor immediately. Taking too much Rivaroxaban Polpharma increases the risk of bleeding.

Missing a dose of Rivaroxaban Polpharma

If you forget to take a dose, take the tablet as soon as you remember. Take the next tablet the next day, and then take the tablets as usual, once a day.
Do not take a double dose to make up for the missed dose.

Stopping Rivaroxaban Polpharma treatment

Do not stop taking Rivaroxaban Polpharma without consulting your doctor first, as Rivaroxaban Polpharma prevents a serious disease.
If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Rivaroxaban Polpharma can cause side effects, although not everybody gets them.
Like other medicines with similar blood clot-reducing effects, Rivaroxaban Polpharma may cause bleeding, which can 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.
Tell your doctor immediatelyif 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. This is a serious medical emergency. Call for medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.
• Signs of severe skin reactions:
• widespread, acute skin rash, blistering, or changes to the mucous membranes, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a 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 (up to 1 in 10,000 people).
• Signs of serious allergic reactions
• swelling of the face, lips, mouth, tongue, or throat; 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 up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible side effects:

Common(may affect up to 1 in 10 people)

• decrease 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 reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• 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,
• limb pain,
• kidney dysfunction (which can be observed in tests performed by your doctor),
• fever,
• stomach pain, nausea, feeling of 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,
• 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 dysfunction (which can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, activity of certain pancreatic or liver enzymes, 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 stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• hematoma (blood accumulation) in the groin as a complication of cardiac catheterization, when a 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 granulocytic blood cells, which can cause inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure after severe bleeding,
• kidney bleeding, 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, occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring 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, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Polpharma

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rivaroxaban Polpharma contains

• The active substance of the medicine is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are: tablet core: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate. See section 2 "Rivaroxaban Polpharma contains lactose and sodium". tablet coating (Opadry II Pink 33G34170) : hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 3350, triacetin, yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172) .

What Rivaroxaban Polpharma looks like and contents of the pack

Rivaroxaban Polpharma 10 mg is a pink, round, biconvex film-coated tablet with the number "10" embossed on one side.
The tablets are in transparent blisters packed in cardboard boxes containing 5, 10, 28, 30, or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański

Manufacturer

FARMAPROJECTS, S.A.U.
Parc Cientific de Barcelona
C/ Baldiri Reixac, 4/12 i 15
08028 Barcelona
Spain
Date of last revision of the leaflet:April 2025