RIVAROXABAN POLPHARMA

Package leaflet: Information for the patient

Rivaroxaban Polpharma 2.5 mg film-coated tablets
Rivaroxabanum
Please read this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. This medicine may harm another person, even if their symptoms of illness are the same as yours.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

You have been prescribed Rivaroxaban Polpharma because:

• You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been confirmed. Rivaroxaban Polpharma reduces the risk of a subsequent heart attack and reduces the risk of death due to heart- or blood vessel-related disease in adults. Rivaroxaban Polpharma will not be given to you as the only treatment. Your doctor will also prescribe you to take:
  • acetylsalicylic acid, or
  • acetylsalicylic acid and clopidogrel or ticlopidine.
• You have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease causing symptoms. Rivaroxaban Polpharma reduces the risk of blood clots (atherosclerotic thrombotic events) in adults. Rivaroxaban Polpharma will not be given to you as the only treatment. Your doctor will also prescribe you to take acetylsalicylic acid. In certain cases, if you are receiving Rivaroxaban Polpharma after a procedure to unblock a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel to be taken in addition to acetylsalicylic acid for a short period of time.

Rivaroxaban Polpharma contains the active substance rivaroxaban and 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 using Rivaroxaban Polpharma

When not to use Rivaroxaban Polpharma:

• 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 excessive bleeding,
• if the patient has a disease or organ condition leading to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into 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 an intravenous or intra-arterial catheter,
• if the patient has been diagnosed with acute coronary syndrome and has previously experienced bleeding or a blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and has previously experienced bleeding in the brain (hemorrhagic stroke) or occlusion of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient has had a blood clot in the brain (ischemic, non-lacunar stroke) within the past month,
• if the patient has a liver disease that increases the risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not use Rivaroxaban Polpharma, and you must inform your doctor if you suspect any of the above circumstances apply.

Warnings and precautions
Before starting treatment with Rivaroxaban Polpharma, discuss it with your doctor or
pharmacist. Rivaroxaban Polpharma should not be used in combination with anticoagulant medicines other than acetylsalicylic acid, clopidogrel or ticlopidine, such as
prasugrel or ticagrelor.
Exercise special caution when using Rivaroxaban Polpharma:

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
  • use of other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of an intravenous or intra-arterial catheter (see section "Rivaroxaban Polpharma with other medicines"),
  • coagulation disorders,
  • very high blood pressure that does not decrease despite medication,
  • stomach or intestinal diseases that may cause bleeding, e.g. inflammatory bowel disease or gastritis, or esophagitis (inflammation of the esophagus), e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus), or tumors located in the stomach, intestines, genital or urinary tract,
  • blood vessel disease in the back of the eye (retinopathy),
  • lung disease with dilated bronchi filled with pus (bronchiectasis) or previous lung bleeding,
  • if the patient is over 75 years of age,
  • if the patient weighs less than 60 kg,
  • coronary artery disease with severe symptomatic heart failure,
• in patients with prosthetic heart valves,
• if the patient has a condition called antiphospholipid syndrome (an autoimmune disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment adjustment is necessary.

If you suspect any of the above conditions apply, inform your doctor
before taking Rivaroxaban Polpharma. 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 Rivaroxaban Polpharma administration before or after surgery,
• if catheterization or spinal puncture (e.g. for epidural or spinal anesthesia or pain relief) is planned during surgery:
  • it is very important to take Rivaroxaban Polpharma before and after the puncture or catheter removal, as directed by the doctor;
  • due to the need for special caution, immediately inform the doctor if numbness or weakness in the legs, or bowel or bladder dysfunction occurs after the anesthesia ends.

Children and adolescents
Rivaroxaban Polpharma 2.5 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 Polpharma 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 used only topically on the skin, oral ketoconazole (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, prasugrel and ticagrelor (see section "Warnings and precautions")), anti-inflammatory and pain medicines (e.g. naproxen or acetylsalicylic acid), dronedarone, a medicine used to treat heart rhythm disorders, or certain antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If you suspect any of the above conditions apply, inform your doctor
before taking Rivaroxaban Polpharma, because the effect of Rivaroxaban Polpharma may be enhanced. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor believes the patient has an increased risk of developing stomach or intestinal ulcers, preventive treatment may be prescribed.

• If the patient is taking certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital), St. John's wort ( Hypericum perforatum ), a herbal medicine used for depression, or rifampicin, an antibiotic.

If you suspect any of the above conditions apply, inform your doctor
before taking Rivaroxaban Polpharma, because the effect of Rivaroxaban Polpharma may be reduced. The doctor will decide whether to use Rivaroxaban Polpharma and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Rivaroxaban Polpharma if you are pregnant or breastfeeding. If there is a risk that the patient could become pregnant, an effective method of contraception should be used during treatment with Rivaroxaban Polpharma. If pregnancy occurs during treatment with this medicine, inform your doctor immediately, who will decide on further management.
Driving and operating machinery
Rivaroxaban Polpharma may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects").
Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban Polpharma contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is essentially "sodium-free".

3. How to take Rivaroxaban Polpharma

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Rivaroxaban Polpharma should be taken at
approximately the same time each day (for example, one tablet in the morning and one in the evening).
This medicine may be taken with or without food.
If a patient has difficulty swallowing the whole tablet, they should discuss alternative ways of taking
Rivaroxaban Polpharma with their doctor. The tablet may be crushed and mixed with water or apple
puree immediately before administration. If necessary, a doctor may administer crushed Rivaroxaban
Polpharma tablets via a gastric tube.
Rivaroxaban Polpharma will not be given to the patient as the only medication.
Your doctor will prescribe acetylsalicylic acid for you to take. If you are receiving Rivaroxaban
Polpharma after an acute coronary syndrome, your doctor may also prescribe clopidogrel or
ticlopidine.
If you are receiving Rivaroxaban Polpharma following a procedure to open a narrowed or blocked
artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel to be taken
for a short period in addition to acetylsalicylic acid.
Your doctor will inform you of the dose of these medications to take (usually 75–100 mg of
acetylsalicylic acid daily, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of 75 mg
clopidogrel, or the standard daily dose of ticlopidine).
When to start taking Rivaroxaban Polpharma
Treatment with Rivaroxaban Polpharma after acute coronary syndrome should be initiated as soon
as possible after stabilization of the acute event, no earlier than 24 hours after hospital admission
and at the time when parenteral (injected) anticoagulant therapy would normally be discontinued.
Your doctor will inform you when to start treatment with Rivaroxaban Polpharma if you have been
diagnosed with coronary artery disease or peripheral arterial disease.
Your doctor will decide how long treatment should continue.
Taking more Rivaroxaban Polpharma than prescribed
If you have taken more Rivaroxaban Polpharma than prescribed, contact your doctor immediately.
Taking too high a dose of Rivaroxaban Polpharma increases the risk of bleeding.
If you miss a dose of Rivaroxaban Polpharma
Do not take a double dose to make up for a missed dose. If you miss a dose, take the next dose at
the scheduled time.
Stopping Rivaroxaban Polpharma
Rivaroxaban Polpharma must be taken regularly and for the duration prescribed by your doctor.
Do not stop taking Rivaroxaban Polpharma without first consulting your doctor. If you stop taking
this medicine, your risk of having another heart attack, stroke, or death due to heart or blood vessel
disease may increase.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Like other medicines with a similar effect of reducing blood clot formation, Rivaroxaban Polpharma may cause bleeding, which potentially could 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 contact your doctor immediately 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 of the patient or a change in treatment is necessary.
• Signs of severe skin reactions:
  • widespread, acute skin rash, blistering or mucosal lesions, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • drug reaction causing rash, fever, internal organ inflammation, hematological disorders and systemic symptoms (DRESS syndrome). The frequency of these adverse reactions is very rare (occurring in up to 1 in 10,000 people).
• Signs of serious allergic reactions
  • swelling of the face, lips, mouth, tongue or throat; 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 up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible adverse reactions:
Common (may occur in up to 1 in 10 people)

• decrease in 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 urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from gums,
• bleeding into the eye (including bleeding from the white part of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• 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, feeling of nausea or vomiting, constipation, diarrhea,
• low arterial blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in 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 up to 1 in 100 people)

• bleeding into the brain or inside the skull (see signs of bleeding above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low number of platelets, blood cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (may be observed in tests performed by a doctor),
• blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• urticaria.

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

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• localized swelling,
• accumulation of blood (hematoma) in the groin area as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

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

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

Frequency unknown (frequency cannot be determined from available data)

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with presence of blood in urine, leading to inability of the kidneys to function properly (drug-induced nephropathy associated with anticoagulant medicines),
• increased pressure in the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding).

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
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 Polpharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
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. These measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Polpharma contains

• The active substance is rivaroxaban. Each 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, polyethylene glycol 8000, iron oxide yellow (E 172).

What Rivaroxaban Polpharma looks like and contents of the pack
Rivaroxaban Polpharma 2.5 mg are light yellow, round, biconvex coated tablets with the number "2.5" embossed on one side.
The tablets are contained in transparent blisters packed in cardboard boxes containing 20, 28, 30, 56 or 196 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 and 15
08028 Barcelona
Spain