Rivaroxaban Pensa 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Rivaroxaban pensa 15 mg film-coated tablets EFG

Rivaroxaban pensa 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Rivaroxaban pensa is and what it is used for
2. What you need to know before taking Rivaroxaban pensa
3. How to take Rivaroxaban pensa
4. Possible adverse effects
5. How to store Rivaroxaban pensa
6. Contents of the pack and other information

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

Rivaroxaban Pensa contains the active substance rivaroxaban and is used in adults for:

• preventing the formation of blood clots in the brain (stroke) or in other blood vessels in the body if you have a type of irregular heartbeat known as non-valvular atrial fibrillation.
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and for preventing these blood clots from recurring in the blood vessels of the legs and/or lungs.

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

• treating blood clots and preventing the recurrence of blood clots in the veins or in the blood vessels of the lungs, following an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Rivaroxaban belongs to a group of medicines called antithrombotic agents. It works by blocking a clotting factor (factor Xa), thereby reducing the tendency of the blood to clot.

2. What you need to know before taking Rivaroxaban pensa

Do not take Rivaroxaban pensa

• if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6)
• if you are bleeding excessively
• if you have a disease or organ condition that increases the risk of severe bleeding (e.g., stomach ulcer, injury or bleeding in the brain, or recent surgery on the brain or eyes)
• if you are taking medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching from one anticoagulant treatment to another or while heparin is being administered through a venous or arterial catheter to prevent blockage
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Rivaroxaban pensa and inform your doctor if any of these situations apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

Take special care with Rivaroxaban pensa

• If you have an increased risk of bleeding, such as in the following situations:

  • severe renal impairment in adults, or moderate to severe renal impairment in children and adolescents, as kidney function may affect the amount of medicine active in your body
  • if you are taking other medicines to prevent blood clots (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 blockage (see section "Use of Rivaroxaban pensa with other medicines")
  • bleeding disorders
  • uncontrolled high blood pressure despite medical treatment
  • stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach or intestines, inflammation of the oesophagus (e.g., due to gastro-oesophageal reflux disease—where stomach acid rises into the oesophagus—or tumours in the stomach, intestines, genital or urinary tract)
  • a blood vessel problem at the back of your eyes (retinopathy)
  • a lung disease with dilated bronchi filled with pus (bronchiectasis) or previous lung bleeding

• if you have a heart valve prosthesis

• if you have a condition known as antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether your treatment needs to be adjusted, especially if your blood pressure is unstable or if you are scheduled for another treatment or a procedure to remove a blood clot from your lungs.

Tell your doctor if any of these situations apply to you before taking this medicine. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

If you need surgery:

• It is very important to take rivaroxaban exactly at the times specified by your doctor, both before and after surgery.

• If your surgery requires placement of a catheter or injection into your spine (e.g., for epidural or spinal anaesthesia, or pain relief):

• It is very important to take rivaroxaban exactly at the times your doctor has instructed, both before and after the injection or catheter removal.

• Inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia, as urgent medical attention is required.

Children and adolescents

Rivaroxaban is not recommended in children weighing less than 30 kg. There is insufficient information on its use in children and adolescents for adult indications.

Rivaroxaban pensa and other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

-If you are taking:

• medicines for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), except when applied only to the skin
• ketoconazole tablets used to treat Cushing's syndrome, in which the body produces too much cortisol
• medicines for bacterial infections (e.g., clarithromycin, erythromycin)
• antiviral medicines for HIV/AIDS (e.g., ritonavir)
• other medicines that reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin or acenocoumarol)
• anti-inflammatory and pain-relief medicines (e.g., naproxen or acetylsalicylic acid)
• dronedarone, a medicine used to treat irregular heartbeat
• certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the above apply to you, inform your doctor before taking Rivaroxaban, as the effect of rivaroxaban may be increased. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring. If your doctor considers you at higher risk of developing a stomach or intestinal ulcer, they may recommend preventive treatment.

-If you are taking:

• medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John’s wort (Hypericum perforatum), a herbal remedy used for depression
• rifampicin, an antibiotic

If any of the above apply to you, inform your doctor before taking rivaroxaban, as the effect of rivaroxaban may be reduced. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

Pregnancy and breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is any possibility you could become pregnant, use a reliable method of contraception while taking rivaroxaban. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on the appropriate treatment.

Driving and using machines

Rivaroxaban 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 operate tools or machinery if you are affected by these symptoms.

Rivaroxaban pensa contains lactose and sodium

If your doctor has informed you of 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 pensa

Follow exactly your doctor's instructions on how to take this medicine. If you are unsure, consult your doctor or pharmacist again.

You should take Rivaroxaban pensa with food.

Swallow the tablets whole, preferably with water.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways of taking rivaroxaban. The tablet may be crushed and mixed with water or apple puree immediately before administration. This mixture must be followed immediately by food.

If necessary, your doctor may also administer the crushed Rivaroxaban pensa tablet via a gastric tube.

What dose to take

• Adults

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

The recommended dose is one 20 mg rivaroxaban tablet once daily.

If you have kidney problems, the dose may be reduced to one 15 mg rivaroxaban tablet once daily.

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 supporting reducing the dose to one 15 mg rivaroxaban tablet once daily (or one 10 mg rivaroxaban tablet once daily if your kidneys do not function properly), 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 recurring

The recommended dose is one 15 mg rivaroxaban tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg rivaroxaban tablet once daily.

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

If you have kidney problems and are taking one 20 mg rivaroxaban tablet once daily, your doctor may decide to reduce your treatment dose to one 15 mg rivaroxaban tablet once daily after 3 weeks, if your risk of bleeding is higher than the risk of developing 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 kg is one 15 mg rivaroxaban tablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg rivaroxaban tablet once daily.

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 help you remember.

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

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

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

Do not split the tablet in an attempt to obtain a fraction of the tablet dose.

For children and adolescents who cannot swallow the tablets whole, the rivaroxaban tablet may be crushed and mixed with water or apple puree immediately before administration. Take some food after taking this mixture.

If necessary, your doctor may also administer the crushed rivaroxaban tablet via a tube inserted into the stomach.

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 not take a new dose. In this case, take the next dose of rivaroxaban at the usual time.

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

When to take Rivaroxaban pensa

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

Try to take the tablets at the same time each day to help you remember when to take them. Your doctor will decide how long you should continue treatment.

To prevent the formation of blood clots in the brain (stroke) or in other blood vessels: If a procedure called cardioversion is needed to normalize your heart rhythm, take rivaroxaban at the times your doctor has instructed.

If you take more Rivaroxaban pensa than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rivaroxaban pensa

Adults, children and adolescents

If you are taking one 20 mg or one 15 mg tablet once daily and you miss a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a missed dose. Take the next tablet the following day and then continue taking one tablet each day.

Adults

If you are taking one 15 mg tablet twice daily and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you missed a dose, you may take two 15 mg tablets at the same time to obtain a total of two tablets (30 mg) in one day. The following day, resume taking one 15 mg tablet twice daily.

If you take more Rivaroxaban pensa than you should

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

If you stop taking Rivaroxaban pensa

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

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

4. Possible adverse effects

Like all medicines, rivaroxaban may cause adverse effects, although not everyone experiences them.

Like other similar medicines used to reduce blood clot formation, rivaroxaban can cause bleeding that may be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Contact your doctor immediately if you experience any of the following symptoms:

• Signs of bleeding

• bleeding in the brain or within the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical attention!)

• prolonged or excessive bleeding

• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina, which may be signs of bleeding.

Your doctor may decide to monitor you more closely or change your treatment.

• Signs of serious skin reactions

• severe skin rashes that spread, blisters, or mucosal lesions, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).

• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness.

The frequency of these adverse effects is very rare (up to 1 in 10,000 people).

• Signs of serious 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 serious 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 reported in adults, children, and adolescents:

Common (may affect up to 1 in 10 patients):

• decrease in red blood cells that may cause paleness, weakness, or difficulty breathing
• bleeding from the stomach or intestines, urogenital hemorrhage (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into tissue or body cavities (hematoma, bruising)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• discharge of blood or fluid from a surgical wound
• swelling of the limbs
• limb pain
• impaired kidney function (may be detected in blood tests performed by your doctor)
• fever
• stomach pain, indigestion, dizziness or feeling dizzy, constipation, diarrhea
• low blood pressure (symptoms may include feeling dizzy or faint upon standing)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, skin itching
• blood tests may show an increase in certain liver enzymes

Uncommon (may affect up to 1 in 100 patients):

• bleeding in the brain or within 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
• impaired liver function (may be detected in blood tests performed by your doctor)
• blood tests may show an increase in bilirubin, certain pancreatic or liver enzymes, or platelet count
• fainting
• feeling unwell
• increased heart rate
• dry mouth
• hives

Rare (may affect up to 1 in 1,000 patients):

• bleeding into a muscle
• cholestasis (reduced bile flow), hepatitis, including hepatocellular injury (liver inflammation or damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• accumulation of blood (hematoma) in the groin following a complication from cardiac surgery involving catheter insertion 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 causing lung inflammation (eosinophilic pneumonia)

Frequency not known (cannot be estimated from available data):

• kidney failure following severe bleeding
• bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (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 following bleeding)
• kidney failure following severe bleeding

Adverse effects in children and adolescents

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

Adverse effects observed more frequently in children and adolescents:

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

• headache
• fever
• nosebleeds
• vomiting

Common (may affect up to 1 in 10 people):

• increased 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 effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Rivaroxaban Pensa Storage

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

Do not use this medicine after the expiry date stated on the packaging and on each blister after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Rivaroxaban pensa

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

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

Film coating of the 15 mg tablet: macrogol, hypromellose, titanium dioxide (E-171), iron oxide red (E-172).

Film coating of the 20 mg tablet: macrogol, partially hydrolysed polyvinyl alcohol, titanium dioxide (E-171), iron oxide red (E-172) and talc.

Appearance of the product and pack contents

Rivaroxaban pensa 15 mg film-coated tablets are round, biconvex, reddish-brown in colour, marked with "E3" on one side and smooth on the other.

Rivaroxaban pensa 20 mg film-coated tablets are round, biconvex, dark red in colour, marked with "E4" on one side and smooth on the other.

Rivaroxaban pensa 15 mg film-coated tablets are packaged in PVC-PVdC/Aluminum blisters, in boxes containing 14, 28, 42, 98 or 100 film-coated tablets.

They are also available in HDPE bottles with child-resistant closures, in boxes containing 42, 98 or 100 film-coated tablets.

Rivaroxaban pensa 20 mg film-coated tablets are packaged in PVC-PVdC/Aluminum blisters, in boxes containing 14, 28, 98 or 100 film-coated tablets.

They are also available in HDPE bottles with child-resistant closures, in boxes containing 98 or 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

TOWA Pharmaceutical Europe S.L.

C/Sant Martí s/n, Polígono Industrial, 08107, Martorelles, Barcelona, Spain.

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, PLA3000, Paola, Malta

This medicinal product is authorized in the European Economic Area member states under the following names:

Sweden: Rivadia

Denmark: Rivadia

Netherlands: Rivadia

Norway: Rivadia

Germany: Rivadia

Spain: Rivaroxaban pensa

Italy: Rivaroxaban Pensa

Date of latest revision of this leaflet: January 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/