RIVAROXABAN NEURAXPHARM 15 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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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.

Contents of the pack

1. What is Rivaroxaban Neuraxpharm and what is it used for
2. What you need to know before you take Rivaroxaban Neuraxpharm
3. How to take Rivaroxaban Neuraxpharm
4. Possible side effects
5. Storage of Rivaroxaban Neuraxpharm
6. Pack contents and further 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 happening 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 and prevent blood clots in the veins or in the blood vessels of the lungs after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

This medicine belongs to a group of medicines called antithrombotic agents. It works by blocking a factor involved in blood clotting (factor Xa) and thus reducing the tendency of blood to form clots.

2. What you need to know before you take Rivaroxaban Neuraxpharm

Do not take Rivaroxaban Neuraxpharm

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you have bleeding problems
• if you have a disease or condition that increases the risk of serious 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 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 blocked

if you have 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 you.

Warnings and precautions

Consult your doctor or pharmacist before taking Rivaroxaban Neuraxpharm.

Be particularly careful with Rivaroxaban Neuraxpharm

• if you have an increased risk of bleeding, as may occur in the following situations:
• • severe kidney problems in adults and moderate or severe kidney problems in children and adolescents, as kidney function may affect the amount of medicine that works in the body
  • if you are taking other medicines 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 blocked (see section "Other medicines and Rivaroxaban Neuraxpharm")
  • bleeding disorders
  • 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 (e.g. due to gastroesophageal reflux disease)
  • 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 replacement
• 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 is 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.

Tell your doctor if you have any of these conditionsbefore taking Rivaroxaban Neuraxpharm. Your doctor will decide if you should be treated with this medicine and if you should be kept under closer observation.

If you need to have surgery

• It is very important to take this medicine before and after surgery, exactly at the times indicated by your doctor.
• If your operation requires the insertion 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 medicine before and after the injection or removal of the catheter, exactly at the times indicated by your doctor.
  • Tell your doctor immediately if you experience numbness or weakness in your legs or problems with your intestines or bladder after anesthesia, as urgent attention is needed.

Children and adolescents

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

Other medicines and Rivaroxaban Neuraxpharm

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)
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
• 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 applies to you, tell your doctorbefore taking this medicine, as its effect 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 take a preventive treatment.

If you are taking

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

If any of the above applies to you, tell your doctorbefore taking this medicine, as its effect may be reduced. Your doctor will decide if you should be treated with this medicine 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 a possibility that you may become pregnant, use a reliable contraceptive while taking this medicine. If you become pregnant while taking this medicine, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban Neuraxpharm may cause dizziness (common 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 some 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 Neuraxpharm

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

You should take this medicine 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 puree, immediately before taking it. Then, take food.

If necessary, your doctor may also administer the crushed tablet of this medicine 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 Rivaroxaban Neuraxpharm 20 mg tablet once a day.

If you have kidney problems, the dose may be reduced to one Rivaroxaban Neuraxpharm 15 mg tablet 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 insertion), there is limited evidence to reduce the dose to one Rivaroxaban Neuraxpharm 15 mg tablet once a day (or to one Rivaroxaban Neuraxpharm 10 mg tablet once a day in case of kidney problems) in addition to an antiplatelet medicine such as clopidogrel.

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

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

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

If you have kidney problems and are taking one Rivaroxaban Neuraxpharm 20 mg tablet once a day, your doctor may decide to reduce the treatment dose to one Rivaroxaban Neuraxpharm 15 mg tablet 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 of 30 kg to less than 50 kgis one rivaroxaban 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one rivaroxaban 20 mgtablet once 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 puree 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 to 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 medicine. 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 medicine and the amount taken.

If you forget to take Rivaroxaban Neuraxpharm

Adults, children and adolescents:

• If you are taking one 20 mg or one 15 mg tablet 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, take one tablet every day.

Adults:

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

If you stop taking Rivaroxaban Neuraxpharm

Do not stop taking this medicine without first consulting your doctor, as rivaroxaban treats and prevents serious conditions.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Neuraxpharm can cause side effects, although not everybody gets them.

Like other similar medicines (antithrombotics), 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 apparent.

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, one-sided 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 serious 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 cardiac 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 sensitivity, 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 in type to those observed in adults and were mainly mild to moderate in severity.

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)

• rapid heartbeat
• 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 “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:

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

Tablet film coating: Opadry 04F565014 Brown (15 mg dose) and Opadry 04F550002 Red (20 mg dose): hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, talc.

Appearance and packaging of the product

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

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

Rivaroxaban Neuraxpharm 20 mg film-coated tablets 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/