RIVAROXABAN MACLEODS PHARMA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

Rivaroxaban Macleods 2.5 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to use 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 side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Rivaroxaban Macleods and what is it used for
2. What you need to know before taking Rivaroxaban Macleods
3. How to take Rivaroxaban Macleods
4. Possible side effects

5 Storage of Rivaroxaban Macleods

1. Package contents and additional information

1. What is Rivaroxaban Macleods 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 artery 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 administered rivaroxaban after an intervention to open a narrowed or closed artery in the 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 Macleods 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 Macleods

Do not take Rivaroxaban Macleods

• if you are allergic to rivaroxaban or any of the other ingredients of this medication (listed in section 6)
• if you bleed excessively
• if you have a disease or problem in an organ of the body that increases the risk of severe bleeding (e.g., stomach ulcer, injury or bleeding in the brain, 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, to prevent it from becoming clogged
• if you have acute coronary syndrome and have previously had a bleeding or blood clot in the brain (stroke)
• if you have coronary artery disease or peripheral artery 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 last month
• if you have a liver disease that may increase the risk of bleeding
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rivaroxaban Macleods.

Rivaroxaban Macleods 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 Macleods

• 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 acts 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, to prevent it from becoming clogged (see section "Other medications and Rivaroxaban Macleods")
• bleeding disorder
• very high blood pressure, not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, such as stomach or intestinal inflammation, esophageal inflammation (e.g., due to gastroesophageal reflux disease), or tumors located 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
• if you weigh less than 60 kg
• 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.

Tell your doctor if you have any of these situationsbefore taking Rivaroxaban Macleods. 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 Macleods before and after the injection or catheter removal, exactly at the times indicated by your doctor.
• Tell 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 needed.

Children and adolescents

Rivaroxaban Macleods 2.5 mg tablets are not recommended for children and adolescents under 18 years of age. There is not enough information available on their use in children and adolescents.

Other medications and Rivaroxaban Macleods

Tell 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., fluconazole, itraconazole, voriconazole, posaconazole), except if only applied to the skin
• tablets with ketoconazole (used to treat Cushing's syndrome, in which the body produces an excess of 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, tell 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 medicinal plant for the treatment of depression
• rifampicin, an antibiotic

If any of these circumstances apply to you, tell your doctorbefore taking Rivaroxaban Macleods, as the effect of Rivaroxaban Macleods 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 Macleods 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 Macleods may cause dizziness (frequent side effect) or fainting (uncommon side effect) (see section 4, "Possible side effects"). Do not drive, ride a bicycle, or use tools or machines if you are affected by these symptoms.

Rivaroxaban Macleods contains lactose and sodium

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

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

3. How to take Rivaroxaban Macleods

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

What dose to take

The recommended dose is one 2.5 mg tablet twice a day. Take Rivaroxaban Macleods 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 Macleods tablet through a gastric tube.

You will be prescribed rivaroxaban along with another medication.

Your doctor will also instruct you to take aspirin.

If you receive Rivaroxaban Macleods after an acute coronary syndrome, your doctor may also instruct you to take clopidogrel or ticlopidine.

If you are administered rivaroxaban after an intervention to open a narrowed or closed artery in the 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 indicate 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 Macleods

Treatment with Rivaroxaban Macleods after an acute coronary syndrome 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 finished.

Your doctor will indicate when to start treatment with Rivaroxaban Macleods if you have been diagnosed with coronary artery disease or peripheral artery disease.

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

If you take more Rivaroxaban Macleods than you should

Call your doctor immediately if you have taken too many Rivaroxaban Macleods tablets. Taking too much Rivaroxaban Macleods increases the risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Rivaroxaban Macleods

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 Macleods

Take rivaroxaban regularly for the time indicated by your doctor.

Do not interrupt treatment with rivaroxaban without talking to your doctor first. 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 to reduce blood clot formation, Rivaroxaban Macleods can cause bleeding that can endanger the patient's life. 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:

• Signs of bleeding

• 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 stiffness of the neck. 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.

The frequencies of 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
• stomach or intestinal bleeding, 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)
• bloody cough
• 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 sensitivity, 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 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 Macleods

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". The expiration date is the last day of the month indicated.

Store below 30°C.

Crushed tablets

Crushed tablets are stable in water or apple sauce for up to 4 hours.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Rivaroxaban Macleods

• The active ingredient is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other components are:

Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, anhydrous colloidal silica, hypromellose, sodium lauryl sulfate, magnesium stearate.

Tablet film coating: hypromellose, macrogol, macrogol, titanium dioxide (E 171), red iron oxide (E 172).

Appearance of the product and package contents

Rivaroxaban Macleods 10 mg film-coated tablets are pink, round, biconvex, engraved with "J 8" on one side and smooth on the other.

They are packaged in blisters in packs of 10, 28, 30, and 98 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Macleods Pharma España, S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Manufacturer

Synoptis Industrial Sp. z o.o.

Rabowicka 15, Swarzedz,

62-020, Poland

Date of the last revision of thisprospectus:

January 2024.

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