RIVAROXABAN ARISTO 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Aristo 15 mg film-coated tablets EFG

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, ask 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Rivaroxaban Aristo contains the active substance rivaroxaban.

Rivaroxaban Aristo 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 Aristo 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.

Rivaroxaban 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 Aristo

Do not take Rivaroxaban

• 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 from one anticoagulant treatment to another or while receiving heparin through a venous or arterial catheter to prevent it from becoming blocked
• if you have a liver disease that may increase 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 starting to take Rivaroxaban.

Be 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 medication that works in your 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 blocked (see section "Other medications and Rivaroxaban")
• bleeding disorders
• very high blood pressure, not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, such as stomach or intestinal inflammation, esophageal inflammation (e.g., due to gastroesophageal reflux disease), or tumors in the stomach, intestines, genital tract, or urinary tract.
• 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 have had a previous bleeding in the lungs

• if you have a heart valve prosthesis
• if you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clotting), 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.

Inform your doctor if you have any of these conditionsbefore taking Rivaroxabán. 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 Rivaroxabán before and after the operation, exactly at the times indicated by your doctor.
• If your operation requires the placement of a catheter or injection in the spinal column (e.g., for epidural or spinal anesthesia, or pain relief):

• It is very important to take Rivaroxabán 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 intestine or bladder after anesthesia, as urgent attention is necessary.

Children and adolescents

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

Other medications and Rivaroxaban

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those obtained 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 or 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 these circumstances apply to you,inform your doctorbefore taking Rivaroxabán, as the effect of Rivaroxabán 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 these circumstances apply to you,inform your doctorbefore taking Rivaroxabán, as the effect of Rivaroxabán may be reduced. Your doctor will decide if you should be treated with Rivaroxabán and if you should be kept under closer observation.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

If you are pregnant or breastfeeding, do not take Rivaroxabán. If there is any possibility that you may become pregnant, use a reliable contraceptive while taking Rivaroxabán. If you become pregnant while taking Rivaroxabán, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxabán 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.

Rivaroxabán contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking Rivaroxabán.

Rivaroxabán contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to take Rivaroxabán

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

You must take Rivaroxabán Aristo with food.

Swallow the tablets, preferably with water.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways to take Rivaroxabán Aristo. 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 Rivaroxabán Aristo tablet through a gastric tube.

What dose to take

Adults

• To prevent the formation of blood clots in the brain (stroke) and 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 to one 10 mg rivaroxaban tablet once a day if your kidneys do not function properly) 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 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 Rivaroxabán Aristo 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 Rivaroxabán Aristo 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one Rivaroxabán Aristo 20 mgtablet once a day.

Take each dose of Rivaroxabán Aristo 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 dose.

Since the dose of Rivaroxabán Aristo is based on body weight, it is essential 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 Rivaroxabán Aristo on your own.Your doctor will adjust the dose if necessary.

Do not split the tablet to try to obtain a fraction of the tablet dose. If a smaller dose is required, please use the alternative presentation of rivaroxaban granules for oral suspension. In children and adolescents who cannot swallow the tablets whole, please use rivaroxaban granules for oral suspension.

If the oral suspension is not available, you can crush the Rivaroxabán Aristo 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 Rivaroxabán Aristo tablet through a gastric tube.

If you spit out the dose

• Less than 30 minutes after taking Rivaroxabán Aristo, take a new dose.
• More than 30 minutes after taking Rivaroxabán Aristo, do nottake a new dose. In this case, take the next dose of Rivaroxabán Aristo at the usual time.

When to start treatment with Rivaroxabán

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.

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 forget to take Rivaroxabán

Adults, children, and adolescents

• If you are taking one 20 mg or one 15 mg tablet once a day and forget to take 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 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 forget to take a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single 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 a day. The next day, you should continue taking one 15 mg tablet twice a day.

If you take more Rivaroxabán Aristo than you should

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

If you stop treatment with Rivaroxabán

Do not stop treatment with Rivaroxabán without talking to 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 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 (antithrombotics), Rivaroxaban may cause bleeding that can endanger the patient's life. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be evident.

Tell your doctor immediately if you or your child experience any of the following adverse effects:

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! Seek medical attention immediately!
• Prolonged or excessive bleeding
• Exceptional weakness, fatigue, pallor, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina, as they may be signs of bleeding.

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

Signs of severe skin reactions

• Severe 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, 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:

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

• 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)
• Coughing up blood
• Bleeding from the skin or under the skin
• Bleeding after surgery
• Purulent discharge of blood or fluid from a surgical wound
• Swelling of the limbs
• Pain in the limbs
• Fever
• Decrease in red blood cells that can cause pallor and weakness or difficulty breathing
• 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
• Alteration of kidney function (may be seen in tests performed by the doctor)
• 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
• Fainting
• Feeling of discomfort
• Dry mouth
• Increased heart rate
• Allergic reaction, including skin allergic reaction
• Hives
• 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

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)
• 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(frequency cannot be estimated from available data):

• Increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after bleeding)
• Bleeding in the kidney; sometimes with blood in the urine, which causes the kidneys to fail to function properly (anticoagulant-related nephropathy)
• Renal failure after severe bleeding.

Adverse effects in children and adolescents

In general, the adverse effects observed in children and adolescents treated with Rivaroxaban Aristo 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 of 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 Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rivaroxaban Aristo

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.

This medicine does not require special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple puree for up to 2 hours

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

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

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose 2910, sodium lauryl sulfate, magnesium stearate. See section 2 "Rivaroxaban Aristo contains lactose and sodium".

Tablet film coating: hypromellose 2910, titanium dioxide (E 171), macrogol 3350, red iron oxide (E 172).

Appearance of the product and package contents

Rivaroxaban Aristo 15 mg film-coated tablets are red, round, biconvex (5.6 mm in diameter) and have "15" engraved on one side, and are smooth on the other.

They are available in transparent PVC/PVDC aluminum blisters in cardboard boxes.

Boxes of 7, 10, 14, 28, 30, 42, 45, 56, 98, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

S.C. Labormed-Pharma S.A.

Bd. Theodor Pallady nr. 44B, sector 3

Bucharest cod 032266

Romania

Or

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovakia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medicine is authorized in the EEA Member States and in the United Kingdom (Northern Ireland) with the following names:

Austria Rivaroxaban Aristo 15 mg Filmtabletten

Italy Rivaroxaban Aristo

Norway Rivaroxaban Aristo 15 mg filmdrasjerte tabletter

Spain Rivaroxaban Aristo 15 mg film-coated tablets EFG

Sweden Rivaroxaban Aristo 15 mg filmdragerade tabletter

Portugal Rivaroxaban Aristo

Denmark Rivaroxaban Aristo

Germany Rivaroxaban Aristo 15 mg Filmtabletten

United Kingdom Rivaroxaban

(Northern Ireland)

Date of last revision of this leaflet:January 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/