RIVAROXABAN SUN 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Sun 2.5 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Rivaroxaban Sun and what is it used for
2. What you need to know before taking Rivaroxaban Sun
3. How to take Rivaroxaban Sun
4. Possible side effects
5. Storage of Rivaroxaban Sun
6. Package contents and additional information

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

You have been prescribed rivaroxaban because

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

Rivaroxaban reduces the risk of having another myocardial infarction in adults, or reduces the risk of death due to heart or blood vessel disease.

You will be prescribed rivaroxaban along with another medication. Your doctor will also instruct 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.

Rivaroxaban reduces the risk of blood clot formation (atherothrombotic events) in adults.

You will be prescribed rivaroxaban along with another medication. Your doctor will also instruct you to take aspirin.

In some cases, if you are given rivaroxaban after an intervention to open a narrowed or closed 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.

Rivaroxaban Sun contains the active ingredient rivaroxaban, which belongs to a group of medications called antithrombotic agents. It works by blocking a clotting factor (factor Xa) and thus reducing the tendency of blood to form clots.

2. What you need to know before taking Rivaroxaban Sun

Do not take Rivaroxaban Sun

• if you are allergic to rivaroxaban or any of the other ingredients of this medication (listed in section 6)
• if you are bleeding excessively
• if you have a disease or problem in an organ of your body that increases the risk of severe bleeding (e.g., stomach ulcer, brain injury or bleeding, or recent brain or eye surgery)
• if you are taking medications to prevent blood clot formation (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter, so that it does not become clogged
• if you have been diagnosed with acute coronary syndrome and have previously had a bleeding or blood clot in the brain (stroke)
• if you have coronary artery disease or peripheral arterial disease and have previously had a bleeding in the brain (stroke) or an obstruction of the small arteries that supply blood to the deep tissues of the brain (lacunar stroke) or if you have had a blood clot in the brain (non-lacunar ischemic stroke) in the past month
• if you have a liver disease that may increase the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Rivaroxaban and inform your doctorif any of these circumstances apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rivaroxaban.

Rivaroxaban should not be used in combination with other medications that reduce blood clotting, other than aspirin or clopidogrel/ticlopidine, such as prasugrel or ticagrelor.

Be careful with Rivaroxaban

• if you have an increased risk of bleeding, as may occur in the following situations:

• severe kidney failure, as kidney function may affect the amount of medication that works in your body
• if you are taking other medications to prevent blood clot formation (e.g., warfarin, dabigatran, apixaban, or heparin), when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter, so that it does not become clogged (see section "Other medications and Rivaroxaban Sun")
• bleeding disorder
• uncontrolled high blood pressure
• diseases of the stomach or intestine that may cause bleeding, such as inflammation of the stomach or intestine, esophageal inflammation (e.g., due to gastroesophageal reflux disease), or tumors in the stomach, intestines, genital tract, or urinary tract
• a problem in the blood vessels of the back of your eyes (retinopathy)
• a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or if you have had a previous bleeding in the lungs
• you are over 75 years old
• your weight is 60 kg or less
• if you have coronary artery disease with severe symptomatic heart failure

• if you have a heart valve prosthesis
• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), inform your doctor to decide if it may be necessary to modify the treatment.

Inform your doctor if you have any of these situationsbefore taking rivaroxaban. Your doctor will decide if you should be treated with this medication and if you should be kept under closer observation.

If you need surgery:

• It is very important to take rivaroxaban before and after the operation, exactly at the times indicated by your doctor.
• If your operation requires the placement of a catheter or injection in the spinal column (e.g., for epidural or spinal anesthesia, or pain relief):

• It is very important to take rivaroxaban before and after the injection or catheter removal, exactly at the times indicated by your doctor.
• Inform your doctor immediately if you experience numbness or weakness in your legs or problems in your intestine or bladder at the end of anesthesia, as urgent attention is necessary.

Children and adolescents

Rivaroxaban Sun 2.5 mg film-coated tablets are not recommended for children and adolescents under 18 years of age.There is not enough information about their use in children and adolescents.

Other medications and Rivaroxaban

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

• If you are taking:

• any medication for a fungal infection (e.g., ketoconazole, itraconazole, voriconazole, posaconazole), unless it is only applied to the skin
• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)
• any medication for bacterial infections (e.g., clarithromycin, erythromycin)
• any antiviral medication for HIV/AIDS (e.g., ritonavir)
• other medications 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 medications and pain relievers (e.g., naproxen or aspirin)
• dronedarone, a medication for the treatment of irregular heartbeat
• certain medications for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of these circumstances apply to you,inform your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may be increased. Your doctor will decide if you should be treated with this medication and if you should be kept under closer observation.

If your doctor considers that you have a higher risk of developing a stomach or intestinal ulcer, they may recommend that you also use a preventive treatment.

• If you are taking:

• any medication for the treatment of epilepsy(phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum), a herbal remedy for the treatment of depression
• rifampicin,an antibiotic

If any of these circumstances apply to you,inform your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may be reduced. Your doctor will decide if you should be treated with rivaroxaban and if you should be kept under closer observation.

Pregnancy and breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is any possibility that you may become pregnant, use a reliable contraceptive while taking rivaroxaban. If you become pregnant while taking rivaroxaban, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, "Possible side effects"). You should not drive, ride a bicycle, or use tools or machines if you are affected by these symptoms.

Rivaroxaban Sun contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking rivaroxaban.

This medication contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially "sodium-free".

3. How to take Rivaroxaban Sun

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

What dose to take

The recommended dose is one 2.5 mg tablet twice a day. Take rivaroxaban at the same time every day (e.g., one tablet in the morning and one in the evening). This medication can be taken with or without food.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways to take rivaroxaban. The tablet can be crushed and mixed with water or apple sauce, immediately before taking it.

If necessary, your doctor may also administer the crushed rivaroxaban tablet through a gastric tube.

You will be prescribed rivaroxaban along with another medication. Your doctor will instruct you to take aspirin (also known as acetylsalicylic acid). If you receive rivaroxaban after an acute coronary syndrome, your doctor may also instruct you to take clopidogrel or ticlopidine.

If you are given rivaroxaban after an intervention to open a narrowed or closed 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 instruct you on the dose to take (usually between 75 and 100 mg of aspirin per day, or a 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 treatment with Rivaroxaban Sun

Treatment with rivaroxaban should be started as soon as possible, once the acute coronary syndrome has been stabilized, i.e., from 24 hours after hospital admission and at the time when parenteral anticoagulant treatment (by injection) would be discontinued.

Your doctor will instruct you on when to start treatment with rivaroxaban if you have been diagnosed with coronary artery disease or peripheral arterial disease.

The doctor will decide how long you should continue taking the treatment.

If you take more Rivaroxaban Sun than you should

If you have taken more rivaroxaban than you should, inform your doctor immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

Taking too much rivaroxaban increases the risk of bleeding.

If you forget to take Rivaroxaban Sun

Do not take more than one tablet in a single day to make up for a forgotten dose. If you forget to take a dose, take the next tablet at the usual time.

If you interrupt treatment with Rivaroxaban Sun

Take rivaroxaban regularly for the time indicated by your doctor.

Do not interrupt treatment with rivaroxaban without first consulting your doctor. If you stop taking this medication, you may increase your risk of having another myocardial infarction, a stroke, or dying from a heart or blood vessel disease.

If you have any other questions about the use of this medication, 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 (antithrombotics), rivaroxaban may cause bleeding that can put the patient's life at risk. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be evident.

Inform your doctor immediately if you experience any of the following symptoms

• Bleeding signs:
• • bleeding in the brain or inside the skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Go to the doctor immediately!)
  • prolonged or excessive bleeding
  • exceptional weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina

Your doctor will decide whether to keep you under closer observation or change your treatment.

• Signs of severe skin reactions
• • intense skin rashes that spread, blisters, or lesions on the mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
  • drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities, and systemic disease (DRESS syndrome).

The frequency of these adverse 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; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure.

Severe allergic reactions 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:

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

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• bleeding in the stomach or intestine, urogenital hemorrhage (including blood in the urine and heavy menstrual bleeding), nasal bleeding, gum bleeding
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into a tissue or cavity of the body (hematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling of the limbs
• pain in the limbs
• alteration of kidney function (may be seen in tests performed by the doctor)
• fever
• stomach pain, indigestion, dizziness or feeling of dizziness, constipation, diarrhea
• low blood pressure (symptoms may be dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• blood tests may show an increase in some liver enzymes

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

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells that help blood clotting)
• allergic reaction, including skin allergic reaction
• alteration of liver function (may be seen in tests performed by the doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or platelet count
• fainting
• feeling of discomfort
• increased heart rate
• dry mouth
• hives

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

• bleeding into a muscle
• cholestasis (decrease in bile flow), hepatitis, including traumatic hepatocellular injury (inflammation or liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• blood accumulation (hematoma) in the groin as a complication after cardiac surgery 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 cells that cause inflammation in the lung (eosinophilic pneumonia).

Frequency not known(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 in the muscles of the legs or arms after bleeding, causing 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 prospectus. You can also report it 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 Sun

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and on each blister after "CAD" or "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 puree for up to 4 hours.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. 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 of Rivaroxaban Sun

• The active ingredient is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are:

Tablet core: microcrystalline cellulose (E460), hypromellose 2910 (E464), lactose monohydrate, low-substituted hydroxypropylcellulose (E463), sodium croscarmellose (E486), sodium lauryl sulfate (E487), magnesium stearate (E572).

Tablet film coating: hypromellose 2910 (E464), lactose monohydrate, macrogol 4000 (E1521), titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172).

See section 2 "Rivaroxaban Sun contains lactose and sodium".

Appearance of the product and package contents

Rivaroxaban Sun 2.5 mg film-coated tablets are pale yellow, round, 6 mm in diameter, and have "?" engraved on one side and "2.5" on the other.

Rivaroxaban Sun 2.5 mg film-coated tablets are packaged in transparent PVC/PVDC/Al blisters, in aluminum foil, in boxes of 10, 20, 21, 28, 30, 56, 60, 98, 100, 196, and 200 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

or

Terapia S.A.

Strada Fabricii Nr. 124,

Cluj-Napoca, Jud. Cluj,

400632, Romania

You can request more information about this medicine by contacting the local representative of the marketing authorization holder: