RIVAROXABAN TAD 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban TAD 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 TAD and what is it used for
2. What you need to know before taking Rivaroxaban TAD
3. How to take Rivaroxaban TAD
4. Possible side effects
5. Storage of Rivaroxaban TAD
6. Contents of the pack and further information

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

You are taking Rivaroxaban TAD 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 not be prescribed this medication alone. 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 not be prescribed this medication alone. 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 blocked 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.

This medication 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 TAD

Do not take Rivaroxaban TAD

• if you are allergic to rivaroxaban or any of the other ingredients of this medication (listed in section 6)
• if you have excessive bleeding
• 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 blocked
• 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 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 TAD and inform your doctorif any of these circumstances apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

This medication should not be used in combination with other medications that reduce blood clotting, such as prasugrel or ticagrelor, except for aspirin and clopidogrel/ticlopidine.

Be careful with Rivaroxaban TAD

• 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, to prevent it from becoming blocked (see section "Other medications and Rivaroxaban TAD")
• bleeding disorder
• very high blood pressure, not controlled by medical treatment
• diseases of the stomach or intestine 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
• 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.

Inform your doctor if you have any of these situationsbefore taking this medication. 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 this medication before and after the operation, exactly at the times indicated by your doctor.
• If your operation requires the placement of a catheter or injection into the spinal column (e.g., for epidural or spinal anesthesia, or pain relief):

• it is very important to take this medication before and after the injection or removal of the catheter, 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 TAD 2.5 mg film-coated tablets EFG are not recommended for children and adolescents under 18 years of age.There is not enough information available on its use in children and adolescents.

Other medications and Rivaroxaban TAD

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., 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 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 the above circumstances apply to you, inform your doctorbefore taking this medication, as the effect of this medication 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 gastric 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 the above circumstances apply to you, inform your doctorbefore taking this medication, as the effect of this medication may be reduced. Your doctor will decide if you should be treated with this medication and if you should be kept under closer observation.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

If you are pregnant or breastfeeding, do not take this medication. If there is any possibility that you may become pregnant, use an effective contraceptive method while taking this medication. If you become pregnant while taking this medication, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

This medication 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 TAD contains sodium

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

3. How to take Rivaroxaban TAD

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 this medication 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 this medication. 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 tablet of this medication through a gastric tube.

This medication will not be prescribed to you alone.

Your doctor will also instruct you to take aspirin. If you receive this medication 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 blocked 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 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 TAD

Treatment with this medication 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 discontinued.

Your doctor will instruct you on when to start treatment with this medication 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 TAD than you should

Contact your doctor immediately if you have taken too many tablets of this medication. Taking too much of this medication can increase 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 TAD

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

If you stop taking Rivaroxaban TAD

Take this medication regularly for the time indicated by your doctor.

Do not stop taking this medication 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, this medicine 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 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 pectoris.

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

Signs of Severe Skin Reactions

• intensive 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 patients)

• 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 patients)

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• bleeding into a joint that causes 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 patients)

• 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 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 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)
• increase in pressure in the muscles of the legs or arms after bleeding, which causes pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting of Adverse Effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus. You can also report them 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 TAD

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

This medicine does not require special storage conditions.

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 way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rivaroxaban TAD

• The active ingredient is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• The other components (excipients) are mannitol, microcrystalline cellulose, macrogol, poloxamer, sodium lauryl sulfate, sodium croscarmellose, anhydrous colloidal silica, sodium stearyl fumarate in the core, and hypromellose, macrogol, titanium dioxide (E171), and yellow iron oxide (E172) in the tablet coating. See section 2 "Rivaroxaban TAD contains sodium".

Appearance of the Product and Package Contents

Film-coated tablets of pale yellowish-brown to yellowish-brown color, round, slightly biconvex, engraved with the mark "2.5" on one face of the tablet.

Dimensions: diameter of approximately 6.5 mm.

Rivaroxaban TAD is available in packs containing:

Non-perforated blister: 100 film-coated tablets.

Perforated unit-dose blister: 100 x 1 film-coated tablets.

Non-perforated calendar blister: 28 and 56 film-coated tablets.

The patient alert card is included in each pack of this medicine.

Only some pack sizes may be marketed.

Marketing Authorization Holder

TAD Pharma GmbH, Heinz-Lohmann Straße 5, 27472 Cuxhaven, Germany

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann Straße 5, 27472 Cuxhaven, Germany

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

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of Last Revision of this Prospectus:February 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/