RIVAROXABAN ALEMBIC 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Alembic 2.5 mg film-coated tablets EFG

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• Keep this leaflet, as 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.

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1. What is Rivaroxaban Alembic and what is it used for
2. What you need to know before you take Rivaroxaban Alembic
3. How to take Rivaroxaban Alembic
4. Possible side effects
5. Storage of Rivaroxaban Alembic

1. Contents of the pack and other information

1. What is Rivaroxaban Alembic 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 high levels 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 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. Rivaroxaban reduces the risk of blood clot formation (atherothrombotic events) in adults.

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

In some cases, if you are given rivaroxaban after a procedure 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.

Rivaroxaban Alembic contains the active substance rivaroxaban, which belongs to a group of medicines 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 you take Rivaroxaban Alembic

Do not take Rivaroxaban Alembic

• 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 problems 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 medicines to prevent blood clot formation (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to another anticoagulant treatment or while being administered heparin through a venous or arterial catheter, so that it does not become 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 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 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 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 medicines that reduce blood clotting, other than aspirin or clopidogrel/ticlopidine, such as prasugrel or ticagrelor.

Be careful with Rivaroxaban Alembic

• 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 medicine that works in your body
  • if you are taking other medicines 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 medicines and Rivaroxaban Alembic")
  • bleeding disorder
  • very high blood pressure, not controlled by medical treatment
  • stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach or intestine, inflammation of the esophagus (throat), e.g. due to gastroesophageal reflux disease (a disease in which stomach acid rises up into the esophagus), 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 have had a previous bleeding in the lungs
  • 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 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. Your doctor will decide if you should be treated with this medicine 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.
  • Tell your doctor immediately if you experience numbness or weakness in your legs or problems in your intestines or bladder at the end of anesthesia, as urgent attention is needed.

Children and adolescents

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

Other medicines and Rivaroxaban Alembic

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

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

If any of the above 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 medicine 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 medicine 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 the above circumstances apply to you, tell 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

If you are pregnant or breastfeeding, do not take rivaroxaban. If there is any possibility that you may become pregnant, use a reliable contraceptive while taking rivaroxaban. If you become pregnant while taking rivaroxaban, tell 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"). Do not drive, ride a bicycle, or use tools or machines if you are affected by these symptoms.

Rivaroxaban Alembic contains lactose and sodium

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

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

3. How to take Rivaroxaban Alembic

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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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 medicine 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 medicine.

Your doctor will also tell you to take aspirin. If you receive rivaroxaban after an acute coronary syndrome, your doctor may also tell you to take clopidogrel or ticlopidine.

If you are given rivaroxaban after a procedure 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 the dose 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).

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Treatment with rivaroxaban 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 tell you 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.

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

You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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

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Take rivaroxaban regularly for the time indicated by your doctor.

Do not stop taking rivaroxaban without talking to your doctor first. If you stop taking this medicine, 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Like other similar medicines to reduce blood clot formation, rivaroxaban can 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 visible.

Tell 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.

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• severe skin rash that spreads, 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 side effects is very rare (up to 1 in 10,000 people).

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• 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
• bleeding from 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 include 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

Infrequent(may affect up to 1 in 100 people)

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• bleeding in 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 in 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

accumulation of blood (hematoma) in the groin as a complication after heart 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 cell that causes inflammation in the lung (eosinophilic pneumonia).

Frequency Not Known(frequency cannot be estimated from available data)

• kidney failure after severe bleeding
• bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to malfunction (nephropathy related to anticoagulants)
• increase in 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 does not appear in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rivaroxaban Alembic

Keep this medicine out of the 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 at the SIGRE point in 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

RivaroxabanA

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

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, Hypromellose 2910 (2.4 to 3.6 mPa.s), sodium lauryl sulfate, magnesium stearate. See section 2 "Rivaroxaban Alembic contains lactose and sodium".

Film coating: macrogol 6000, hypromellose 2910 (6 mPa.s), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), yellow quinoline aluminum lacquer (E 104)

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Rivaroxaban Alembic 2.5 mg film-coated tablets are round, yellow, film-coated, biconvex, engraved with "09" on one side and "L" on the other side. Approximately 4 mm in diameter.

They are presented

• In PVC/PVDC/aluminum foil blisters in packs of 14, 28, 56, 98, 168, or 196 film-coated tablets, or
• In white opaque HDPE bottles with a pharmaceutical cotton plug and a child-resistant polypropylene (PP) cap containing 30 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder

Alembic Pharmaceuticals Europe Ltd

Palazzo Pietro Stiges, 103, Strait Street,

Valletta VLT 1436

Malta

Manufacturer

Pharmadox Healthcare Ltd

KW20A, Kordin Industrial Park, Paola

PLA 3000,

Malta

Date of Last Revision of this Prospectus:February 2024

Other Sources of Information

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