Rivaroxaban Polpharma

Leaflet attached to the packaging: patient information

Rivaroxaban Polpharma 2.5 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 those 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 pack and other information

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

You have been given Rivaroxaban Polpharma because

• you have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, severe chest pain) and have elevated levels of cardiac biomarkers. Rivaroxaban Polpharma reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Rivaroxaban Polpharma will not be given to you as the only medicine. Your doctor will also prescribe you to take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.
• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral artery disease, which causes symptoms. Rivaroxaban Polpharma reduces the risk of blood clots (atherothrombotic events) in adults. Rivaroxaban Polpharma will not be given to you as the only medicine. Your doctor will also prescribe you to take aspirin. In some cases, if you are taking Rivaroxaban Polpharma after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin.

Rivaroxaban Polpharma contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

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 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 been diagnosed with acute coronary syndrome and have had bleeding or blood clots in the brain (stroke),
• if you have been diagnosed with coronary artery disease or peripheral artery disease and have had bleeding in the brain (stroke) or blockage of small arteries that supply blood to the brain tissues (cerebral sinus thrombosis), or if you have had a blood clot in the brain (ischemic stroke) in the last month),
• if you have liver disease that leads to an increased risk of bleeding,
• if you are pregnant or breastfeeding. Do not take Rivaroxaban Polpharma, and also inform your doctorif you suspect that these circumstances have occurred.

Warnings and precautions

Before starting treatment with Rivaroxaban Polpharma, discuss it with your doctor or pharmacist. Rivaroxaban Polpharma should not be taken with other medicines that prevent blood clotting, such as prasugrel or ticagrelor, except for aspirin, clopidogrel, or ticlopidine.

Be careful when taking Rivaroxaban Polpharma:

• if you have an increased risk of bleeding, in such conditions as:
• 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 changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Rivaroxaban Polpharma and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that can cause bleeding, e.g. inflammation of the intestines and stomach or esophagitis (throat and esophagus) e.g. due to gastroesophageal reflux disease (stomach acid flowing back into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• vascular disease of the back of the eye (retinopathy),
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if you are over 75 years old,
• if you weigh less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• in patients with prosthetic 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 the treatment.

If you suspect that you have the above conditions, inform

your doctorbefore taking Rivaroxaban Polpharma. Your doctor will decide whether to use this medicine and whether you should be closely monitored.

If you need to have surgery:

• follow your doctor's instructions carefully regarding taking Rivaroxaban Polpharma at a specific 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 Polpharma before and after the puncture or catheter removal, according to your doctor's instructions;
• due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia.

Children and adolescents

Rivaroxaban Polpharma 2.5 mg tablets are not recommended for people under 18 years old. There is a lack of sufficient 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 now or recently, and about medicines you plan to take, including those that are available without a prescription.

• If you are taking: certain medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin, ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol), certain medicines for bacterial infections (e.g. clarithromycin, erythromycin), certain antiviral medicines used to treat HIV or AIDS (e.g. ritonavir), other medicines that prevent blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol, prasugrel and ticagrelor (see "Warnings and precautions")), anti-inflammatory and pain-relieving medicines (e.g. naproxen or aspirin), 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 the above conditions, inform

your doctorbefore taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be increased. Your doctor will decide whether to use this medicine and whether you should be closely monitored.
If your doctor thinks that you are at risk of developing stomach or intestinal ulcers, they may use a treatment to prevent ulcers.

• If you are taking: certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's wort (Hypericum perforatum), a herbal medicine used to treat depression, rifampicin, which is an antibiotic.

If you suspect that you have the above conditions, inform

your doctorbefore taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be reduced. Your doctor will decide whether to use Rivaroxaban Polpharma and whether you should be closely monitored.

Pregnancy and breastfeeding

Do not take Rivaroxaban Polpharma if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking Rivaroxaban Polpharma. 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 Polpharma may cause dizziness (frequent side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects").
Patient who experience these side effects should not drive, ride a bike 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

The recommended dose is one 2.5 mg tablet twice a day. Rivaroxaban Polpharma should be taken at approximately the same time every day (e.g. one tablet in the morning and one in the evening). This medicine 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 Polpharma. The tablet can be crushed and mixed with water or apple sauce, just before taking it. If necessary, your doctor may give you the crushed Rivaroxaban Polpharma tablet through a nasogastric tube.
Rivaroxaban Polpharma will not be given to you as the only medicine.
Your doctor will also prescribe you to take aspirin. If you are taking Rivaroxaban Polpharma after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine for you to take.
If you are taking Rivaroxaban Polpharma after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin.
Your doctor will tell you what dose of these medicines to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start taking Rivaroxaban Polpharma

Treatment with Rivaroxaban Polpharma after an acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the latest 24 hours after hospitalization and when parenteral (by injection) anticoagulant treatment would normally be discontinued.
Your doctor will tell you when to start treatment with Rivaroxaban Polpharma if you have been diagnosed with coronary artery disease or peripheral artery disease.
Your doctor will decide how long to continue treatment.

Taking a higher dose of Rivaroxaban Polpharma than recommended

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

Missing a dose of Rivaroxaban Polpharma

Do not take a double dose to make up for a missed dose. If you miss a dose, you should take the next dose at the scheduled time.

Stopping treatment with Rivaroxaban Polpharma

Rivaroxaban Polpharma should be taken regularly and for the time prescribed by your doctor.
Do not stop taking Rivaroxaban Polpharma without first consulting your doctor. If you stop taking this medicine, you may increase the risk of another heart attack, stroke, or death due to heart or blood vessel disease.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Polpharma can cause side effects, although not everybody gets them.
Like other medicines with a similar effect of reducing blood clot formation, Rivaroxaban Polpharma may cause bleeding, which can potentially be life-threatening.
Bleeding can lead to a sudden drop in blood pressure (shock). These are not always 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 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, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina. Your doctor may decide to closely monitor you or change the treatment.
• Signs of severe skin reactions:
• widespread, severe skin rash, blistering or changes to the mucous membranes, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction that causes a rash, fever, inflammation of internal organs, hematological and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (up to 1 in 10,000 people).
• Signs of severe 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)

• reduction in red blood cell count, which can cause pallor 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 sclera),
• 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 problems (can be observed in tests performed by your doctor),
• fever,
• stomach pain, nausea (nausea) 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,
• rash, itching of the skin,
• increased activity of some liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or 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 problems (can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, activity of some 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 the muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg.

Very rare(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white granular 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,
• 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 syndrome after bleeding).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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 pack and other information

What Rivaroxaban Polpharma contains

• The active substance of the medicine is rivaroxaban. Each film-coated tablet contains 2.5 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 Yellow 03F12967): hypromellose, titanium dioxide (E 171), talc, macrogol 8000, yellow iron oxide (E 172).

What Rivaroxaban Polpharma looks like and contents of the pack

Rivaroxaban Polpharma 2.5 mg is a light yellow, round, biconvex film-coated tablet, with the number "2.5" embossed on one side.
The tablets are in transparent blisters, packaged in cardboard boxes, containing 20, 28, 30, 56, or 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
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:October 2024