RIVAROXABAN AUROVITAS 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Aurovitas 15 mg film-coated tablets EFG

Rivaroxaban Aurovitas 20 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package 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, pharmacist or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

Rivaroxaban Aurovitas 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 heart rhythm 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.

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 reducing the tendency of the blood to form clots.

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

Do not take Rivaroxaban Aurovitas

• 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 a recent operation in 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 when heparin is given through a catheter in a vein or artery 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 and inform your doctorif any of these conditions apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Rivaroxaban.

Be particularly careful with Rivaroxaban

• 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 your body.
  • if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), when switching from one anticoagulant treatment to another or when receiving heparin through a catheter in a vein or artery to keep it from getting blocked (see section “Other medicines and Rivaroxaban Aurovitas”).
  • bleeding disorders.
  • very high blood pressure, not controlled by medical treatment.
  • stomach or intestinal diseases 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 in the stomach, intestines, genital or urinary tract.
  • a problem in the blood vessels of the back of the eyes (retinopathy).
  • a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or a previous lung hemorrhage.
• 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 so that he can decide whether 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 a surgical procedure to remove a blood clot from your lungs.

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

If you need to have surgery

• It is very important to take rivaroxaban 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 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 indicated by your doctor.
  • Inform your doctor immediately if you experience numbness or weakness in the legs or problems in the intestines or bladder after anesthesia, as urgent attention is necessary.

Children and adolescents

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

Other medicines and Rivaroxaban Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken or might take 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 noradrenaline reuptake inhibitors (SNRIs)).

If any of these conditions 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 should be kept under closer observation.

If your doctor considers that you have a higher risk of developing stomach or intestinal ulcers, he will recommend that you also use a treatment to prevent ulcers.

• 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 these conditions apply to you, inform your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may be reduced. Your doctor will decide whether you should be treated with rivaroxaban and whether you should be kept under closer observation.

Pregnancy, breast-feeding and fertility

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, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). Do not drive, ride a bicycle or use tools or machines if you are affected by these symptoms.

Rivaroxaban Aurovitas contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Rivaroxaban Aurovitas

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

Take rivaroxaban with food.

Swallow the tablet, 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 puree, immediately before taking it. Then take food. If necessary, your doctor can also administer the crushed rivaroxaban 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:

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 to one 10 mg rivaroxaban tablet once a day in case your kidneys do not work 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 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 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 a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg rivaroxaban tablet 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. If a smaller dose is required, use the alternative presentation of rivaroxaban granules for oral suspension.

In children and adolescents who cannot swallow whole tablets, use rivaroxaban granules for oral suspension.

If the oral suspension is not available, 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 can 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 not take 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 Aurovitas

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 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 at the times indicated by your doctor.

If you take more Rivaroxaban Aurovitas 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 ingested.

If you forget to take Rivaroxaban Aurovitas

• Adults, children and adolescents:

If you are taking one 20 mg or one 15 mg tablet oncea 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 every day.

• Adults:

If you are taking one 15 mg tablet twicea 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 Aurovitas

Do not stop taking rivaroxaban without talking to your doctor first, 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, this medicine can cause adverse effects, although not all people suffer from them.

Like other similar medicines to reduce blood clot formation, rivaroxaban can cause bleeding, which 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 immediatelyif you suffer from any of the following adverse effects:

• Signs of bleeding:
  • 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 stiffness in 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.

Your doctor will decide to keep you under closer observation or modify 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 people):

• Decrease in red blood cells, which 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, bleeding gums.
• 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.
• Discharge 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 include 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 people):

• 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(may affect up to 1 in 1,000 people):

• Bleeding in a muscle.
• Cholestasis (decreased bile flow), hepatitis, including traumatic hepatocellular injury (inflammation or liver damage).
• Yellowing of the skin and eyes (jaundice).
• Localized swelling.
• Accumulation of blood (hematoma) in the groin as a complication after cardiac 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(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).
• Increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (hemorrhagic compartment syndrome).

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):

• 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 adverse effects

If you experience any type of 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 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 Aurovitas

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

Do not use this medicine after the expiration date that appears on the label, blister, carton, or bottle after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple puree for up to 4 hours.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Rivaroxaban Aurovitas

• 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 (Grades 101 and 102), lactose monohydrate, sodium croscarmellose, hypromellose type 2910 (3cPs), sodium lauryl sulfate, magnesium stearate.

Coating of the tablet:polyvinyl alcohol, Macrogol 3350, talc, titanium dioxide (E171), red iron oxide (E172).

Appearance of the product and package contents

Rivaroxaban Aurovitas 15 mg:

Red, round, biconvex film-coated tablets with "M" on one side and "15" on the other.

Rivaroxaban Aurovitas 20 mg:

Dark red to reddish-brown, oval, biconvex film-coated tablets with "M" on one side and "20" on the other.

Rivaroxaban Aurovitas film-coated tablets are available in blister packs and HDPE bottles.

Package sizes:

Blister:5, 10, 14, 15, 28, 30, 42, 56, 60, 90, 98, 100, 168, 196, and 200 film-coated tablets.

HDPE bottles:30, 100, 250, and 500 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Date of the last revision of this leaflet:December 2023

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/).