RIVAROXABAN NEURAXPHARM 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Neuraxpharm 15 mg film-coated tabletsEFG

Rivaroxaban Neuraxpharm 20 mg film-coated tabletsEFG

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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Rivaroxaban Neuraxpharm contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent these blood clots from occurring again in the blood vessels of the legs and/or lungs.

Rivaroxaban is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:

• treat blood clots and prevent the recurrence of these blood clots in the veins or in the blood vessels of the lungs, after initial treatment of at least 5 days with injectable medications used to treat blood clots.

This medication 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 Neuraxpharm

Do not take Rivaroxaban Neuraxpharm

• if you are allergic to rivaroxaban or to 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 surgery in the brain or eyes)
• if you are taking medications to prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching treatment or while being administered heparin through a venous or arterial catheter to prevent it from becoming clogged

anticoagulant or while being administered heparin through a venous or arterial catheter to prevent it from becoming clogged

• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take rivaroxaban and inform your doctorif any of these circumstances apply to your case.

Warnings and precautions

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

Be careful with Rivaroxaban Neuraxpharm

• if you have an increased risk of bleeding, as may occur in the following situations:
• • severe kidney failure in adults and moderate or severe kidney failure in children and adolescents, as kidney function may affect the amount of medication that acts in the body
  • if you are taking other medications to prevent blood clotting (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 Neuraxpharm")
  • bleeding disorder
  • very high blood pressure, not controlled by medical treatment
  • stomach or intestinal diseases that may cause bleeding, such as intestinal or stomach inflammation, or inflammation of the esophagus (throat), e.g., due to gastroesophageal reflux disease (a disease in which stomach acid rises up into the esophagus)
  • 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 previous lung bleeding
• 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 clots), inform your doctor so that they can decide if it may be necessary to modify the treatment.
• if your doctor determines that your blood pressure is unstable or if you are scheduled to receive another treatment or undergo surgery to remove a blood clot from your lungs.

Inform your doctor if you have any of these situationsbefore taking Rivaroxaban Neuraxpharm. 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 surgery, 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 intestines or bladder at the end of anesthesia, as urgent attention is necessary.

Children and adolescents

Rivaroxaban Neuraxpharm is not recommended in children with a body weight below 30 kg. There is not enough information available on its use in children and adolescents for the indications in adults.

Other medications and Rivaroxaban Neuraxpharm

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), 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 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)
• anti-inflammatory medications and pain relievers (e.g., naproxen or acetylsalicylic acid)
• 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 its effect 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 the above circumstances apply to you, inform your doctorbefore taking this medication, as its effect 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 and breastfeeding

Do not take Rivaroxaban Neuraxpharm if you are pregnant or breastfeeding. If there is any possibility that you may become pregnant, use a reliable contraceptive 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

Rivaroxaban Neuraxpharm may cause dizziness (frequent side effect) or fainting (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 Neuraxpharm 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 Neuraxpharm

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

You should take this medication with food. Swallow the tablets, preferably with water.

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

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

What dose to take

Adults

• To prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body

The recommended dose is one tablet of Rivaroxaban Neuraxpharm 20 mg once a day.

If you have kidney problems, the dose may be reduced to one tablet of Rivaroxaban Neuraxpharm 15 mg once a day.

If you need to undergo a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to reduce the dose to one tablet of Rivaroxaban Neuraxpharm 15 mg once a day (or to one tablet of Rivaroxaban Neuraxpharm 10 mg once a day in case of kidney dysfunction) in addition to an antiplatelet medication such as clopidogrel.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent these blood clots from occurring again.

The recommended dose is one tablet of Rivaroxaban Neuraxpharm 15 mg twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one tablet of Rivaroxaban Neuraxpharm 20 mg once a day.

After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one tablet of 10 mg once a day or one tablet of 20 mg once a day.

If you have kidney problems and are taking one tablet of Rivaroxaban Neuraxpharm 20 mg once a day, your doctor may decide to reduce the treatment dose to one tablet of Rivaroxaban Neuraxpharm 15 mg once a day after 3 weeks if the risk of bleeding is higher than the risk of having another blood clot.

Children and adolescents

The dose of rivaroxaban depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight between 30 kg and less than 50 kgis one tablet of rivaroxaban 15 mgonce a day.
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one tablet of rivaroxaban 20 mgonce a day.

Take each dose of rivaroxaban with a drink (e.g., water or juice) during a meal. Take the tablets every day at approximately the same time. Consider setting an alarm to remind you.

For parents or caregivers: observe the child to ensure they take the entire dose.

Since the dose of rivaroxaban is based on body weight, it is important to attend scheduled visits with the doctor, as it may be necessary to adjust the dose as the weight changes.

Never adjust the dose of rivaroxaban on your own. Your doctor will adjust the dose if necessary.

Do not divide the tablet to try to obtain a fraction of the tablet dose. You can crush the rivaroxaban tablet and mix it with water or apple sauce immediately before taking it. Take some food after taking this mixture. If necessary, your doctor may also administer the crushed rivaroxaban tablet through a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking rivaroxaban, take a new dose.
• more than 30 minutes after taking rivaroxaban, do nottake a new dose. In this case, take the next dose of rivaroxaban at the usual time.

Call your doctor if you spit out the dose or vomit repeatedly after taking rivaroxaban.

When to take Rivaroxaban Neuraxpharm

Take the tablets every day, until your doctor tells you to stop.

Try to take the tablets at the same time every day to remember when you should take them. The doctor will decide how long you should continue taking the treatment.

To prevent blood clots in the brain (stroke) or in other blood vessels: If it is necessary to normalize your heartbeat through a procedure called cardioversion, take Rivaroxaban Neuraxpharm at the times indicated by your doctor.

If you take more Rivaroxaban Neuraxpharm than you should

Call your doctor immediately if you have taken too many tablets of this medication. Taking too much rivaroxaban 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 Neuraxpharm

Adults, children, and adolescents:

• If you are taking one tablet of 20 mg or one tablet of 15 mg once a day, and you forget to take a dose, take it as soon as you remember. Do not take more than one tablet in one day to make up for a forgotten dose. Take the next tablet the next day and, after that, continue taking one tablet every day.

Adults:

• If you are taking one tablet of 15 mg twice a day, and you forget to take a dose, take it as soon as you remember. Do not take more than two tablets of 15 mg in one day. If you forget to take a dose, you can take two tablets of 15 mg at the same time, for a total of two tablets (30 mg) in one day. The next day, you should continue taking one tablet of 15 mg twice a day.

If you interrupt treatment with Rivaroxaban Neuraxpharm

Do not interrupt treatment with this medication without consulting your doctor first, as rivaroxaban treats and prevents serious conditions.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Rivaroxaban Neuraxpharm can cause side effects, although not everyone will experience them.

Like other similar medications (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 apparent.

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, unilateral weakness, 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, which may be signs of bleeding.

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

• Signs of severe skin reactions

-

• Drug reaction that causes rash, fever, inflammation of internal organs, hematological 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 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 found in adults, children, and adolescents

Common adverse effects(may affect up to 1 in 10 patients)

• 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, nausea or feeling of nausea, constipation, diarrhea
• low blood pressure (symptoms may include feeling of 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 adverse effects(may affect up to 1 in 100 patients)

• 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 adverse effects(may affect up to 1 in 1,000 patients)

• bleeding in a muscle
• cholestasis (decrease in bile flow), hepatitis, including traumatic hepatocellular injury (inflammation or liver damage)
• yellowish discoloration of the skin and eyes (jaundice)
• localized swelling
• blood accumulation (hematoma) in the groin after a complication in heart surgery where a catheter is inserted into the leg artery (pseudoaneurysm)

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)

Adverse effects in children and adolescents

In general, the adverse effects observed in children and adolescents treated with rivaroxaban were similar to those observed in adults and their severity was mainly mild to moderate.

Adverse effects that were more frequently observed in children and adolescents:

Very common(may affect more than 1 in 10 people)

• headache
• fever
• nasal bleeding
• vomiting

Common(may affect up to 1 in 10 people)

• accelerated heart rate
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (low platelet count, cells that help blood clotting)
• heavy menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of adverse effects

If you experience any 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 national reporting system included in 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 Neuraxpharm

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

Do not use this medicine after the expiration date stated on the packaging and on each blister or bottle after “CAD” or “EXP”.

The expiration date is the last day of the month indicated. It does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Rivaroxaban Neuraxpharm

• The active ingredient is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are:

Core of the tablet: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose (E464), sodium lauryl sulfate, magnesium stearate (E470). See section 2 “Rivaroxaban Neuraxpharm contains lactose and sodium”

Coating of the tablet: Opadry 04F565014 Brown (15 mg dose) and Opadry 04F550002 Red (20 mg dose): hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, talc.

Appearance of the product and package contents

The film-coated tablets of Rivaroxaban Neuraxpharm 15 mg are brown, round, and biconvex with “L3” engraved on one side

They are packaged in blisters of 28 and 100 film-coated tablets.

The film-coated tablets of Rivaroxaban Neuraxpharm 20 mg are dark red, round, and biconvex with “L7” engraved on one side.

They are packaged in blisters of 28 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí - Barcelona,

Spain

Date of last revision of this leaflet: June 2022

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/