RIVAROXABAN PENSA 15 mg FILM-COATED TABLETS

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

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

1. Contents of the pack and further information

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

Rivaroxaban Pensa 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 Pensa 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.

Rivaroxaban belongs to a group of medicines called antithrombotic agents. It works by blocking a factor in the blood clotting process (factor Xa) and thus reduces the tendency of the blood to form clots.

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

Do not take Rivaroxaban Pensa

• 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, recent injury or bleeding in the brain or recent brain or eye surgery)
• 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 when heparin is given through a venous or arterial catheter to keep it from getting blocked
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breast-feeding.

Do not take Rivaroxaban Pensa and inform your doctorif any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Be careful with Rivaroxaban Pensa

• If you have an increased risk of bleeding, such as in the following situations:
• severe kidney problems in adults and moderate or severe kidney problems in children and adolescents, as kidney function can affect the amount of medicine that works 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 when receiving heparin through a venous or arterial catheter to keep it from getting blocked (see section "Using Rivaroxaban Pensa with other medicines")
• bleeding disorders
• very high blood pressure that is not controlled by medical treatment
• stomach or intestinal diseases that can 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 in the stomach, intestines, genital or urinary tract
• a problem in the blood vessels of the back of your eyes (retinopathy)
• a lung disease where the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding in the lungs

• if you have a heart valve replacement
• if you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), inform your doctor to 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.

Tell your doctor if you have any of these conditionsbefore taking this medicine. 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 surgery, exactly at the times your doctor tells you.
• If your operation requires the placement of a catheter or injection into the spine (e.g. for epidural or spinal anesthesia, or pain relief):

• It is very important to take rivaroxaban before and after the injection or removal of the catheter, exactly at the times your doctor has indicated.
• 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 is not recommended in children with a body weight below 30 kg.There is not enough information about its use in children and adolescents for the indications in adults.

Rivaroxaban Pensa and other medicines

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
• tablets with ketoconazole 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 medicines and pain relievers (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 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 herbal medicine for the treatment of depression
• rifampicin, an antibiotic.

If any of the above applies 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 this medicine and if you should be kept under closer observation.

Pregnancy and breast-feeding

Do not take rivaroxaban if you are pregnant or breast-feeding. If there is a possibility that you may become pregnant, use a reliable contraceptive while taking rivaroxaban. 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 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 Pensa 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 Pensa

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

You must take Rivaroxaban Pensa 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. The tablet can be crushed and mixed with water or apple sauce, immediately before taking it. This mixture should be followed immediately by food.

If necessary, your doctor may also administer the crushed Rivaroxaban Pensa tablet 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 20 mg rivaroxaban tablet once a day.

If you have kidney problems, the dose may be reduced to one 15 mg rivaroxaban 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 15 mg rivaroxaban tablet once a day (or one 10 mg rivaroxaban tablet once a day if your kidneys do not work properly) in addition to an antiplatelet medicine like 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 happening again

The recommended dose is one 15 mg rivaroxaban tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg rivaroxaban 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 20 mg rivaroxaban tablet once a day, your doctor may decide to reduce the treatment dose to one 15 mg rivaroxaban 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 your 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 kg or moreis 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 about 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 your 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 split the tablet to try to get a fraction of the tablet dose.

For children and adolescents who cannot swallow the tablets whole, 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 up 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 up the dose or vomit repeatedly after taking rivaroxaban.

When to take Rivaroxaban Pensa

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. Your doctor will decide how long you should keep 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 at the times your doctor has indicated.

If you take more Rivaroxaban Pensa than you should

Call 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, 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 Pensa

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 then continue taking one tablet each 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 take more Rivaroxaban Pensa than you should

Call 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 taking rivaroxaban without first talking to 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 Adverse Effects

Like all medicines, rivaroxaban can cause adverse effects, although not all people suffer from 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 evident.

Tell your doctor immediatelyif 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 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, which can be signs of bleeding.

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

• Signs of severe skin reactions

• intense 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 found in adults, children, and adolescents:

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

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• stomach or intestinal bleeding, 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)
• bloody cough
• 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, 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 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 after a complication in heart surgery where 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(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 (anticoagulant-related nephropathy)

• 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)
• kidney failure after severe 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 Frequent(may affect more than 1 in 10 people)

• headache
• fever
• nasal bleeding
• vomiting

Frequent(may affect up to 1 in 10 people)

• accelerated heartbeats
• 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 Adverse Effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through 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 pensa

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. 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

Composition of Rivaroxaban pensa

• 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, sodium lauryl sulfate, magnesium stearate, and hypromellose.

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

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

Appearance of the Product and Package Contents

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

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

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

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

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

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

Not all 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 medicine is authorized in the Member States of the European Economic Area with the following names:

Sweden: Rivadia

Denmark: Rivadia

Netherlands: Rivadia

Norway: Rivadia

Germany: Rivadia

Spain: Rivaroxabán pensa

Italy: Rivaroxaban Pensa

Date of the Last Revision of this Leaflet:January 2024

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/