RIVAROXABAN POLPHARMA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Polpharma 2.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Rivaroxaban Polpharma and what is it used for
2. What you need to know before you take Rivaroxaban Polpharma
3. How to take Rivaroxaban Polpharma
4. Possible side effects
5. Storing Rivaroxaban Polpharma
6. Contents of the pack and other information

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

You have been prescribed this medicine because

1. you have been diagnosed with acute coronary syndrome (a group of disorders that include heart attack and unstable angina, a type of severe chest pain) and your blood tests have shown high results in certain heart tests.

This medicine reduces the risk of having another heart attack in adults, or reduces the risk of death due to heart disease or blood vessel disease. You will be prescribed this medicine along with another medicine. Your doctor will also tell you to take:

• aspirin, or
• aspirin plus clopidogrel or ticlopidine.

or

• you have been diagnosed with a high risk of blood clot formation due to coronary artery disease or peripheral arterial disease that causes symptoms. This medicine reduces the risk of blood clot formation (atherothrombotic events) in adults. You will be prescribed this medicine along with another medicine. Your doctor will also tell you to take aspirin.
• In some cases, if you are given this medicine after an intervention to open a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take in addition to aspirin for a short period of time.

This medicine contains the active substance rivaroxaban, which belongs to a group of medicines called antithrombotic medicines. It works by blocking a clotting factor (factor Xa) and thus reducing the tendency of blood to form clots

2. How to take Rivaroxaban Polpharma

Do not take Rivaroxaban Polpharma

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6).
• if you bleed excessively
• if you have a disease or condition in an organ of the body that increases the risk of severe bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is given by vein or artery to keep them open
• if you have had a coronary syndrome and previously had bleeding or a blood clot in the brain (stroke)
• if you have coronary artery disease or peripheral arterial disease and previously had bleeding in the brain (stroke), or if you had a blockage of the small arteries that supply blood to the deep tissues of the brain (lacunar stroke), or if you had a blood clot in the brain (ischemic stroke, not lacunar) in the last month
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding

Do not take Rivaroxaban Polpharma and tell your doctorif any of these cases apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking this medicine.

This medicine must not be used in combination with other medicines that reduce blood clotting, such as prasugrel or ticagrelor, which are not aspirin and clopidogrel/ticlopidine.

Be careful with Rivaroxaban Polpharma

• if you are at a higher risk of bleeding, as may be the case in the following situations:
• • severe kidney disease, as your kidney function may affect the amount of medicine that works in your body
  • if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), in the case of changing anticoagulant treatment or when heparin is given by vein or artery to keep them open (see the section “Other medicines and Rivaroxaban Polpharma”)
  • bleeding disorders
  • very high blood pressure, not controlled by medical treatment
  • stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines or stomach, or inflammation of the esophagus (throat), e.g. due to gastroesophageal reflux disease (a disease in which stomach acid rises towards the esophagus) or tumors located in the stomach, intestines, genital tract or urinary tract
  • a problem with the blood vessels in the back of the eyes (retinopathy)
  • a lung disease in which your bronchi are enlarged and filled with pus (bronchiectasis), or previous lung bleeding
  • you are over 75 years old
  • you weigh less than 60 kg
  • you have coronary artery disease with severe symptomatic heart failure

• if you have a prosthetic heart valve
• if you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes a higher risk of blood clots), tell your doctor who will decide if it is necessary to change the treatment.

If any of these cases apply to you, tell your doctorbefore taking this medicine. Your doctor will decide if you should be treated with this medicine and if you should be under closer observation.

If you need to have surgery:

• it is very important to take this medicine before and after the operation, exactly at the time your doctor has indicated.
• If your operation involves the use of a catheter or injection in your spinal column (e.g. for epidural or spinal anesthesia, or pain relief):

• it is very important to take this medicine before and after the injection or removal of the catheter, exactly at the time your doctor has indicated
• tell your doctor immediately if you feel numbness or weakness in your legs, or problems with your intestines or bladder after the anesthesia is finished, as urgent attention will be needed.

Children and adolescents

Rivaroxaban Polpharma 2.5 mg film-coated tablets are not recommended for persons under 18 years of age.There is not enough information on its use in children and adolescents.

Using Rivaroxaban Polpharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take

• If you are taking:
• • certain medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
  • ketoconazole tablets (used to treat Cushing's syndrome, when the body produces too much cortisol)
  • certain medicines for bacterial infections (e.g. clarithromycin, erythromycin)
  • certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
  • other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin and acenocoumarol, prasugrel and ticagrelor (see the section “Warnings and precautions”))
  • anti-inflammatory and pain-relieving medicines (e.g. naproxen or aspirin)
  • dronedarone, a medicine to treat abnormal heart rhythms
  • certain medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of these cases apply to you, tell your doctorbefore taking this medicine, as the effect of this medicine may increase. Your doctor will decide if you should be treated with this medicine and if you should be under closer observation.

If your doctor thinks you are at a higher risk of developing stomach or intestinal ulcers, they may also use a preventative treatment for ulcers.

• If you are taking:
• • certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St. John's Wort (Hypericum perforatum), a herbal product used for depression
  • rifampicin, an antibiotic

If any of these cases apply to you, tell your doctorbefore taking this medicine, as the effect of this medicine may be reduced. Your doctor will decide if you should be treated with Rivaroxaban Polpharma and if you should be under closer observation.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding. If you could become pregnant, use a reliable contraceptive method while taking this medicine. If you become pregnant while taking this medicine, tell your doctor immediately, and they will decide how you should be treated.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, ‘Possible side effects’). Do not drive or cycle, or use any tools or machines if you are affected by these symptoms.

This medicine contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially, “sodium-free”.

3. How to take Rivaroxaban Polpharma

Follow exactly the administration instructions of this medicine given by your doctor.

In case of doubt, consult your doctor or pharmacist again.

How much to take

The recommended dose is one 2.5 mg tablet twice a day. Take this medicine 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 a whole tablet, talk to your doctor about other ways to take this medicine. The tablet can be crushed and mixed with water or apple sauce immediately before taking it.

If necessary, your doctor may also give you a crushed tablet of this medicine through a gastric tube.

This medicine will not be given to you alone. Your doctor will also tell you to take aspirin. If you take this medicine after a coronary syndrome, your doctor may tell you to take clopidogrel or ticlopidine as well.

If you are given this medicine after an intervention to open a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take in addition to aspirin for a short period of time.

Your doctor will tell you how much to take (usually between 75 and 100 mg of aspirin per day or a daily dose of 75 to 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 this medicine after a coronary syndrome should be started as soon as possible after the coronary syndrome has been stabilized, not before 24 hours have passed since hospital admission and at the time when parenteral anticoagulant therapy (by injection) would normally be discontinued.

Your doctor will tell you when to start treatment with this medicine if you have been diagnosed with coronary artery disease or peripheral arterial disease.

Your doctor will decide how long you should be treated.

If you take more Rivaroxaban Polpharma than you should

Contact your doctor immediately if you have taken too many tablets of this medicine. Taking too much of this medicine increases the risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken

If you forget to take Rivaroxaban Polpharma

Do not take a double dose to make up for forgotten doses. If you forget a dose, take the next dose at the usual time.

If you stop taking Rivaroxaban Polpharma

Take this medicine regularly and for as long as your doctor prescribes it.

Do not stop taking this medicine without talking to your doctor first. If you stop taking this medicine, you may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel disease.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Like other similar medicines for reducing blood clot formation, this medicine can cause bleeding that can be fatal. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be obvious.

Tell your doctor immediately if you experience any of the following adverse effects:

• Signs of bleeding

• bleeding in the brain or within the skull (symptoms may include headache, unilateral weakness, vomiting, seizures, decreased level of consciousness, and stiffness in the neck.

A serious medical emergency. Seek medical attention immediately)

• prolonged or excessive bleeding
• exceptional weakness, fatigue, pallor, dizziness, headache, unexplained swelling, dyspnea, chest pain or angina.

Your doctor may decide to keep you under stricter observation or change the treatment.

• Signs of severe skin reaction

• intense skin rash that spreads, blisters, or mucosal lesions, for example, in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• A drug reaction that causes skin rash, fever, inflammation of internal organs, blood abnormalities, and systemic disease (DRESS syndrome).

This adverse effect is very rare (affects up to 1 in 10,000 people).

• Signs of severe allergic reaction

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; urticaria and respiratory difficulties; sudden drop in blood pressure.

These adverse effects are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

General list of possible adverse effects:

Common(may affect up to 1 in 10 people):

• reduction in the number of red blood cells that can cause pale skin and weakness or dyspnea
• bleeding in the stomach or intestine, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nasal bleeding, bleeding in the gums
• bleeding in the eye (including bleeding in the white part of the eyes)
• bleeding in tissue or a body cavity (hematoma, bruise)
• bloody cough
• bleeding from the skin or under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling in the limbs
• pain in the limbs
• alteration of kidney function (may be observed in tests performed by your doctor)
• fever
• stomach pain, indigestion, feeling sick or being sick, constipation, diarrhea
• low blood pressure (symptoms may be dizziness or fainting when standing up)
• decrease in general strength and energy (weakness, fatigue), headache, dizziness
• rash, skin irritation
• blood tests may show an increase in some liver enzymes

Uncommon(may affect up to 1 in 100 people):

• bleeding in the brain or within the skull (see above, signs of bleeding)
• bleeding in a joint that causes pain and swelling
• thrombocytopenia (low number of platelets that help blood clot)
• allergic reactions, including skin allergic reactions
• alteration of liver function (may be observed in tests performed by your doctor)
• blood tests may show an increase in bilirubin levels, some pancreatic or liver enzymes, or platelet count
• fainting
• malaise
• faster heartbeats
• dry mouth
• urticaria

Rare(may affect up to 1 in 1,000 people):

• bleeding into a muscle
• cholestasis (decreased bile flow), hepatitis including hepatocellular injury (inflamed liver, including liver damage), yellowing of the skin and eyes (jaundice)
• localized swelling
• blood accumulation (hematoma) in the groin, as a complication of the cardiac procedure in which a catheter is inserted into the leg artery (pseudoaneurysm)

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

• accumulation of eosinophils, a type of granulocytic white blood cell that causes inflammation in the lung (eosinophilic pneumonia)

Unknown(frequency cannot be estimated from available data):

• renal failure after severe bleeding
• bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to malfunction (anticoagulant-related nephropathy)
• increased pressure within the muscles of the legs or arms after bleeding that causes pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after bleeding)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine

5. Storage of Rivaroxaban Polpharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the blister pack after "CAD/EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment

6. Package contents and additional information

Composition ofRivaroxaban Polpharma

• The active ingredient is rivaroxaban. Each 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 "This medicine contains lactose and sodium".

Tablet film coating (Opadry Yellow 03F12967): hypromellose, titanium dioxide (E171), talc, macrogol 8000, iron oxide, yellow (E172).

Appearance and package contents of the product

Rivaroxaban Polpharma 2.5 mg film-coated tablets are light yellow, round, biconvex, and have "2.5" engraved on one side.

They are available in blister packs, in cartons containing 20, 28, 30, 56, or 196 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder andmanufacturer

Marketing authorization holder

Zaklady Farmaceutyczne POLPHARMA S.A.

ul. Pelplinska 19, 83-200 Starogard Gdanski, Poland

Manufacturer

FARMAPROJECTS S.A.U.

Parc Cientific de Barcelona

C/ Baldiri Reixac, 4/12 i 15

08028 Barcelona, Spain

Date of last revision ofthis leaflet:November 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).